[Federal Register Volume 69, Number 74 (Friday, April 16, 2004)]
[Proposed Rules]
[Pages 20778-20803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8647]



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Part V





Department of Health and Human Services





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42 CFR Parts 50 and 93



Public Health Service Policies on Research Misconduct; Proposed Rule

  Federal Register / Vol. 69, No. 74 / Friday, April 16, 2004 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 50 and 93

RIN 0940-AA04


Public Health Service Policies on Research Misconduct

AGENCY: Department of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department proposes substantial revisions to the existing 
regulation at 42 CFR part 50, subpart A, ``Responsibilities of Awardee 
and Applicant Institutions for Dealing With and Reporting Possible 
Misconduct in Science,'' 54 FR 32446 (Aug. 8, 1989) (final rule). We 
propose to delete this regulation, which implemented section 493 of the 
PHS Act, and add a new part 93, subparts A, B, C, D, and E. The purpose 
of this proposed rule is to implement legislative and policy changes 
that have occurred since the regulation was issued, including the 
common Federal policies and procedures on research misconduct issued by 
the Office of Science and Technology Policy. We have developed the 
proposed changes based on over 12 years of experience with the existing 
final rule. The proposed rule would help to ensure public confidence in 
the integrity of scientific data and the Public Health Service (PHS) 
supported research process.

DATES: Submit comments on or before June 15, 2004.

ADDRESSES: You may submit comments, identified by RIN 0940-
AA04, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
     E-mail: [email protected], attaching 
either a WordPerfect file--version 9.1 or higher, a Microsoft Word 97 
or 2000 file, or an ASCII file (avoiding special characters and any 
form of encryption).
     Mail: Chris B. Pascal, J.D., Director, Office of 
Research Integrity, 1011 Wooten Parkway, Suite 750, Rockville MD 20852. 
Address all comments concerning this proposal to: Chris B. Pascal, 
J.D., Director, Office of Research Integrity, 1101 Wootton Parkway, 
Suite 750, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brenda Harrington, 301-443-3400 (this 
is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    The National Institutes of Health Revitalization Act of 1993 (NIH 
Act), Pub. L. 103-43, which amended the PHS Act, contains important 
provisions that affect this proposed rule. Section 161 of the NIH Act 
established the Office of Research Integrity (ORI) as an independent 
entity reporting to the Secretary of the U.S. Department of Health and 
Human Services (HHS). Section 162 of the NIH Act required the 
establishment of a Commission on Research Integrity to review a broad 
range of administrative and policy issues relating to research 
integrity, including the definition of research misconduct, and to 
provide a report to the Secretary and the Congress with recommendations 
for PHS policies on research integrity. The Commission began its work 
in 1994 and sent its final report to Congress and the HHS Secretary on 
November 3, 1995. Section 163 of the NIH Act also requires the 
Secretary to promulgate a regulation on the protection of 
whistleblowers involved in cases of possible research misconduct. See 
section 493 of the PHS Act, 42 U.S.C. 289b. We proposed separate 
regulations to implement the whistleblower provisions and published a 
Notice of Proposed Rulemaking, ``Public Health Service Standards for 
the Protection of Research Misconduct Whistleblowers,'' 56 FR 70830 
(Nov. 28, 2000); 65 FR 70830 (Dec. 29, 2000). We have postponed 
finalizing that regulation to ensure that its provisions are consistent 
with the proposed research misconduct rule.
    In implementing the statutory provisions, the Secretary carefully 
reviewed: (1) The report issued by the Commission on Research 
Integrity; (2) the recommendations of an internal HHS review group 
established to evaluate HHS procedures for handling allegations of 
research misconduct; (3) the governmentwide policies on research 
misconduct developed by the Office of Science and Technology Policy 
(OSTP); and (4) other statutory and regulatory authorities such as 42 
U.S.C. 216 and 241 and 42 CFR part 52 which confer broad authority upon 
the Secretary to regulate the use of PHS funds and to operate and 
manage PHS programs, including the authority to investigate and oversee 
investigations of allegations concerning the integrity of researchers 
who apply for or receive PHS funds and to take appropriate 
administrative actions to protect Federal funds and the public health, 
safety, and welfare. We developed this proposed rule to codify several 
important changes described below.
    Section 493 of the PHS Act directs the Secretary to promulgate 
regulations requiring each entity that applies for or receives funds 
under the PHS Act for the conduct of biomedical or behavioral research 
to submit assurances that the entity: (1) Has established an 
administrative process that conforms with the regulation to review 
reports of research misconduct in PHS biomedical or behavioral 
research; (2) will report to the Secretary any investigation of alleged 
research misconduct; and (3) will comply with the regulations. The 
statute also requires the Secretary to establish by regulation the 
process by which the ORI reviews allegations and institutional reports 
of research misconduct and takes appropriate actions in response to 
findings of misconduct.
    In response to the original section 493 of the PHS Act, and to 
carry out its overall responsibilities in this area, the PHS 
established two offices in 1989 for dealing with research misconduct 
and published a Final Rule that contains requirements for extramural 
institutions applying for or receiving PHS research funds. The two 
offices were the Office of Scientific Integrity (OSI), located at the 
National Institutes of Health (NIH), and the Office of Scientific 
Integrity Review (OSIR), located in the Office of the Assistant 
Secretary for Health. OSI had the primary responsibility for overseeing 
investigations of research misconduct carried out by institutions and 
for conducting investigations when necessary. OSIR provided a second 
level of review for investigations and developed research integrity 
policies for the PHS.
    On August 8, 1989, HHS published its final regulation at 42 CFR 
part 50, subpart A. 54 FR 32446. The rule assigns to applicant and 
awardee institutions the primary responsibility for investigating 
possible research misconduct. The regulation requires these 
institutions to file an initial assurance that they have established 
policies and procedures for investigations. Institutions also must 
report annually on the numbers and types of allegations and inquiries 
dealt with during the calendar year. The regulation codified the 
existing PHS definition of research misconduct and established general 
principles for the conduct of institutional inquiries and 
investigations.
    Based on our experience with the 1989 regulation and concerns 
raised by Congress and the public about the effectiveness of the 
existing office structure, we announced the reorganization of our 
research misconduct operations in the Federal Register on June 8, 1992. 
57 FR 24262. The reorganization abolished OSI and OSIR and transferred 
their functions to the newly established ORI within the

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Office of the Assistant Secretary for Health. On November 6, 1992, we 
announced the new PHS procedures for administrative hearing procedures 
before a Research Integrity Adjudications Panel of the HHS Departmental 
Appeals Board. 57 FR 53125 (1992), revised 59 FR 29809 (June 9, 1994). 
Subsequently, a 1995 reorganization of the Office of the Assistant 
Secretary for Health placed ORI within the Office of Public Health and 
Science in the Office of the Secretary. 60 FR 56605 (Nov. 9, 1995).
    In 1996, the Secretary created the HHS Review Group on Research 
Misconduct and Research Integrity, consisting of senior HHS officials 
representing the PHS and the Office of the Secretary, to review ORI's 
policies and procedures. In July of 1999, the HHS Review Group made 14 
recommendations to improve the quality, effectiveness, and efficiency 
of the system for responding to allegations of research misconduct and 
promoting research integrity. The Secretary approved these 
recommendations in October of 1999, and we have implemented them 
through policy changes. Some of the more significant changes are 
included in this NPRM.
    In March of 1999, NIH issued a report entitled ``NIH Initiative to 
Reduce Regulatory Burden--Identification of Issues and Potential 
Solutions.'' We have carefully reviewed the ``Research Integrity'' 
section of the report. We have already implemented a number of the 
recommendations, such as assigning institutions primary responsibility 
for investigating misconduct, promoting increased education programs in 
research integrity, separating adjudication and appeals from the 
inquiry and investigation stages, and providing some flexibility to 
institutions in the assessment, inquiry, and investigation processes. 
Where appropriate, we propose to codify them in this proposed 
regulation.
    In October of 1999, OSTP proposed a governmentwide definition of 
research misconduct for adoption and implementation by Federal agencies 
that conduct and support research. 64 FR 55722 (Oct. 14, 1999). After 
receiving comments, OSTP published a final notice consisting of a 
definition of research misconduct and policies and procedures for 
handling misconduct allegations. 65 FR 76260 (Dec. 6, 2000). The OSTP 
called upon all Federal agencies to adopt a common Federal framework 
for responding to research misconduct. Although our current practices 
are already substantially similar to the new OSTP policy, this proposed 
rule would bring the PHS procedures into conformity in the few 
divergent areas. Therefore, we propose to adopt and incorporate the 
OSTP governmentwide definition and pertinent policy, procedures, and 
guidelines in the proposed regulation.
    On May 12, 2000, the Secretary approved organizational changes that 
moved the responsibility for making proposed findings of research 
misconduct and administrative actions from ORI to the Assistant 
Secretary for Health. The reorganization also moved direct inquiries 
and investigations previously conducted by ORI to components of the PHS 
for intramural research and to the Office of the Inspector General for 
extramural research. ORI continues, among other things, to direct PHS 
research integrity activities on behalf of the Secretary, to coordinate 
the development of research integrity policies regarding whistleblowers 
and respondents, and to perform oversight review of research misconduct 
inquiries and investigations. 65 FR 30600 (May 12, 2000). ORI also has 
the responsibility of proposing findings of research misconduct to the 
Assistant Secretary for Health and, if the Respondent challenges those 
findings, supporting them before the HHS Departmental Appeals Board. 
These changes are included in the proposed regulation.
    As discussed above, the NIH Revitalization Act of 1993 amended 
section 493 of the PHS Act to establish ORI by statute, and, among 
other things, to change the term ``scientific misconduct'' to 
``research misconduct.'' The proposed rule would implement these 
statutory amendments and a number of policy changes that we believe are 
necessary and appropriate, with the exception of the statutory 
provision regarding whistleblowers which we are promulgating in a 
separate regulation at 42 CFR part 94. The proposed rule incorporates 
many of the features of the existing Final Rule concerning 
responsibilities of awardee and applicant institutions, and it sets out 
our procedures for responding to research misconduct.
    We invite public comments on all aspects of this proposed 
regulation and, in particular, on the following topics:

II. Proposed Changes

A. Applicability

    1. Inclusion of PHS Intramural Programs: Based on the OSTP policy 
and a recommendation from the internal HHS review groups, we propose to 
codify a major difference between the existing Final Rule and current 
practice. Under section 93.102 of the proposed rule, PHS intramural 
programs would be treated similarly to extramural research 
institutions. Because the procedures for conducting inquiries and 
investigations are largely the same for both extramural and intramural 
institutions, we have consolidated the procedures in the proposed 
regulation.
    Therefore, in addition to investigating allegations of misconduct 
within their programs, the intramural programs would also submit 
assurances to ORI that they have established administrative processes 
to address allegations of misconduct in connection with research 
conducted by the intramural institution. ORI would continue to provide 
oversight of these intramural investigations just as it does for 
extramural programs. Additional instructions for PHS officials on 
intramural investigations may be issued via internal policies, as 
needed.
    2. Inclusion of Contracts: The existing Final Rule does not include 
contracts involving PHS funds, but is limited to research grants, 
training grants, and cooperative agreements. The proposed rule expands 
the scope of coverage to include procurement contracts as required by 
the PHS Act and consistent with the OSTP policy and current PHS 
practice.

B. Definition of Research Misconduct

    1. The Definition: The regulatory definition of ``scientific 
misconduct'' in the existing Final Rule has been the subject of 
considerable discussion over the years since its introduction, and we 
have considered the comments and concerns expressed by Congress, the 
research community, and other interested organizations. Now, as noted 
above, OSTP has adopted a final new governmentwide Federal definition 
and guidelines on research misconduct.
    As an initial matter, the existing Final Rule refers to 
``Misconduct or Misconduct in Science,'' 42 CFR 50.102, whereas, the 
proposed regulation refers to ``Research Misconduct.'' This change 
would be consistent with the statutory amendments and the OSTP 
governmentwide definition.
    In addition, the existing Final Rule defines ``scientific 
misconduct'' as ``fabrication, falsification, plagiarism, or other 
practices * * * for proposing, conducting, or reporting research.'' 
(Emphasis added.) In contrast, OSTP and section 93.103 of the proposed 
regulation define ``research misconduct'' in relation to ``proposing, 
performing, or reviewing research, or in reporting research results.'' 
(Emphasis added.) The proposed regulation would use the term 
``performing'' instead of ``conducting'' research and would

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change the scope of the covered activity to include misconduct 
occurring in connection with the ``reviewing'' of research. The 
inclusion of ``reviewing'' in section 93.102 is consistent with the 
addition of ``reviewing'' in the proposed definition. This is also 
consistent with the intent of the HHS Review Group and the OSTP policy 
to include the process of submitting an application for research 
support (proposing), and the peer review of an application or a journal 
article (reviewing). We propose to retain the definition of research 
misconduct as ``fabrication, falsification or plagiarism'' (commonly 
called FFP), but would augment it to include OSTP's description for 
each of these terms. The ``other practices'' clause of the existing 
final rule would be dropped.
    We propose to interpret the phrase ``data or results'' in section 
93.226 broadly to encompass all forms of scientific information about 
the research at issue without regard to the type of recording or 
storage media involved. The phrase would include, but not be limited 
to, raw numbers, field notes, interviews, notebooks and folders, 
laboratory observations, computers and other scientific equipment, CD-
ROMs, hard drives, floppy disks, Zip disks, back-up tapes, machine 
counter tapes, research interpretations and analyses, tables, slides, 
photographs, charts, gels, individual facts, statistics, tissue 
samples, reagents, and statements by individuals. The phrase 
``statements by individuals'' refers to documented oral representations 
of research results made by scientists and, therefore, would also be 
considered to be ``data.''
    2. Burden of Proof: We propose to revise slightly the burden for 
establishing research misconduct in three ways: First, in keeping with 
the OSTP policy, the proposed regulation would require that the FFP be 
a ``significant departure'' from accepted practices as opposed to ORI's 
current standard of ``serious deviation.'' As discussed in the OSTP 
policy statement, the phrase ``significant departure'' intends to make 
clear that behavior alleged to invoke research misconduct should be 
assessed in the context of practices generally accepted by the relevant 
research community. As the current definition requires a serious 
deviation from practices generally accepted in the particular 
scientific community, we do not anticipate that this change in 
phraseology would alter the burden of proving or disproving research 
misconduct in any significant way. However, we specifically ask for 
comments on this issue.
    Second, the proposed regulation is consistent with the OSTP 
position on who has the burden of proving honest error or a difference 
of opinion. Proposed sections 93.106(a) and 93.516(c) provide that the 
respondent bears the burden of proving any affirmative defenses raised, 
including honest error and differences of opinion and any mitigating 
factors that the respondent wants the institution or HHS to consider in 
imposing administrative actions. Section 93.106(a) provides that once 
the institution or HHS makes a prima facie showing of research 
misconduct the burden of going forward to prove that the conduct was 
the result of an honest error or difference of opinion shifts to the 
respondent. Under section 93.106(a), the absence of, or a respondent's 
failure to provide, research records adequately documenting the 
questioned research establishes a rebuttable presumption of research 
misconduct, specifically falsification. Credible evidence corroborating 
the research or providing a reasonable explanation for the absence of, 
or respondent's failure to provide, these research records may be used 
by the respondent to rebut the presumption of research misconduct. 
Third, consistent with the OSTP policy, the level of intent would be 
expanded beyond an intentional and knowing standard to include 
recklessness.
    3. Plagiarism and the Definition of Research Misconduct: Section 
93.102 of the proposed regulation would be applicable to PHS supported 
research ``including any research proposed, performed, reviewed, or 
reported * * * regardless of whether the user or reviewer receives PHS 
support * * *.'' (Emphasis added.) Thus, the proposed regulation would 
expressly cover research misconduct involving plagiarism of PHS 
supported research. Neither the respondent nor the respondent's 
research needs to be PHS supported for jurisdiction to attach. The 
misconduct regulation would cover plagiarism where the respondent has 
copied or appropriated ideas or data from another's PHS supported 
research, for example, where the respondent is a reviewer in the PHS 
grants review process or where the respondent is a reviewer for a 
scientific journal.
    The collective experience of the PHS and extramural institutions in 
dealing with alleged research misconduct has revealed the use of 
varying interpretations or definitions of the term ``plagiarism.'' For 
purposes of the existing final rule and proposed regulation, we 
consider plagiarism to include both the copying of words of another and 
the appropriation of ideas, findings, or methods of another without 
giving full and proper credit for those words, ideas, or methods. Under 
the proposed regulation we would continue to limit our interpretation 
of the term plagiarism to exclude those acts that involve limited use 
of identical or nearly identical phrases (1) to describe a commonly 
used method, (2) to describe previous research in a scientific article, 
grant application, or contract proposal, and (3) where the use does not 
materially inflate the contribution of the author as perceived by the 
reader or reviewer in a manner which would be a significant departure 
from accepted standards.
    In keeping with the PHS and OSTP policies, we would also continue 
to exclude disputes involving authorship or credit among collaborators 
unless they involve plagiarism. Past allegations have often involved 
disputes among former or current collaborators who participated jointly 
in the development or conduct of a research project, but who 
subsequently made independent use of the jointly developed concepts, 
methods, descriptive language, or other products of the joint effort. 
The ownership of the intellectual property in many of these situations 
is seldom clear, and the collaborative history among the scientists may 
support a presumption of implied consent for each of the collaborators 
to use their joint efforts. Although these disputes involve very 
important principles, we believe that these matters are best handled by 
the researchers and their institutions. See ``ORI Provides Working 
Definition of Plagiarism,'' ORI Newsletter, Vol. 3, No. 1 (Dec. 1994), 
available at http://ori.dhhs.gov/html/publications/newsletters.asp. 
Therefore, we propose to continue to consider them outside the PHS 
regulatory definition of plagiarism. As these issues are of long-term 
continuing interest, we invite comments on the PHS interpretation.

C. Institutional and Federal Responsibilities

    1. Clarifying the Institutional and Federal Roles: In general, the 
sections of the proposed regulation addressing the respective 
responsibilities of institutions and HHS contain more detail than the 
corresponding provisions of the existing final rule. Over the years, 
institutions have often requested guidance in these matters, but the 
existing final rule contained little in the way of explanation. In most 
instances, the increased detail would require minor, if any, changes to 
the current process used by the institutions and PHS for handling 
research misconduct allegations. Rather, the proposed regulation would 
memorialize current

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practices, as developed through experience and contact with 
institutions, and recommendations already contained in ORI's guidance 
documents and model policies.
    Codifying these practices and policies should be helpful to 
institutions and, in some instances, may provide them with legal 
protection. First, setting out the steps to be taken in a research 
misconduct proceeding would level the playing field by providing the 
accused researcher with much needed notice of the required process to 
be used and protections offered in addressing the allegations. Also as 
noted, many institutions have requested a more specific road map to 
follow in responding to allegations of research misconduct. Finally, 
formalizing the specific process for institutional responses to 
research misconduct allegations provides a mechanism by which all 
players in the process, e.g., respondents, institutions, and 
complainants, may be held accountable.
    2. Institutions' Primary Responsibility: Research institutions' 
responsibilities for handling allegations of research misconduct would 
remain substantially the same under the proposed regulation, in keeping 
with ORI's pre-existing conformity with the OSTP policy. Institutions 
would continue to have primary responsibility for conducting inquiries 
and investigations. In this regard, institutions have conducted over 
95% of the PHS misconduct investigations since 1995 and all of them 
since 2000. Furthermore, as recommended by the HHS Review Group, we 
also propose at section 93.306 to increase institutional flexibility by 
specifically providing that institutions which are too small, or 
otherwise unable to respond adequately to allegations of research 
misconduct, would be able to use the services of a consortium or other 
entity to handle a research misconduct proceeding.
    3. Providing a Clear Road Map: In conducting inquiries and 
investigations of research misconduct, institutions assume an important 
responsibility, made all the more important by the fact that the 
Federal government relies largely on the institution's work in taking 
action against an accused researcher. If an institution does not 
conduct a thorough and fair investigation, the case may be forever 
compromised, either failing to prove misconduct where it actually 
exists or not properly considering evidence that would exonerate the 
accused researcher. Therefore, we propose to modify the existing final 
rule in certain areas where it would assist in clarifying institutional 
responsibilities and PHS expectations. For example, the proposed rule 
has several new definitions to aid in interpreting the regulation. 
Perhaps most importantly, the proposed rule would clarify the steps 
institutions should take to ensure a fair and thorough investigation, 
such as securing the evidence and giving the respondent a reasonable 
opportunity to comment on the investigational report. In addition, we 
propose more explicit guidance regarding what information and evidence 
institutions should provide to enable ORI to perform its oversight 
function.
    4. Institutional Standards: Section 93.319 of the proposed 
regulation would formalize the current policy that institutions may, 
and many do, have different definitions and standards for research 
misconduct than those in the Federal regulation. For example, an 
institution may treat certain authorship disputes as plagiarism under 
its own internal standards for research misconduct while the PHS would 
not. Although an institution must apply the PHS regulatory definition, 
standards, and requirements in evaluating an allegation of research 
misconduct reported to ORI, it may also apply its internal definition 
or standards in determining whether research misconduct or other 
misconduct occurred at the institutional level. Thus, an institution 
may find misconduct under its internal standards and impose 
administrative actions based on that finding, regardless of whether it 
or PHS makes a finding of research misconduct under the PHS standards.

D. Retention of the Inquiry Stage

    The existing final rule defines a two-stage process that takes 
place when an institution receives allegations of research misconduct: 
(1) An inquiry, or preliminary fact-finding, to determine if the 
allegation involves PHS supported research and has sufficient substance 
to warrant an investigation; and (2) an investigation, which is a 
thorough review and analysis of all relevant facts to reach a 
conclusion as to whether research misconduct has occurred, who was 
responsible, and how serious any misconduct was.
    Institutions treat the inquiry phase in a widely varying manner, 
and the distinction between an inquiry and an investigation has caused 
much confusion. Some inquiries conducted by institutions are largely 
indistinguishable from investigations. As the OSTP policy adopts a two-
stage process, we have retained the current two-stage process but 
propose to sharpen the distinction between inquiries and investigations 
by clarifying that the inquiry is only an initial review of the 
allegations to see if they warrant an investigation.

E. Safeguards

    1. Confidentiality: Section 93.108 of the proposed regulation would 
retain the goal of affording confidentiality, to the extent possible, 
for respondents and complainants in research misconduct proceedings, 
except for PHS administrative hearings, which must be open to the 
public in accordance with section 93.517(g). Section 93.108 uses the 
qualifying phrase, ``to the extent possible,'' because research 
misconduct cases are often subject to unpredictable factors beyond 
institutional or agency control, and it is not always possible to 
ensure complete confidentiality for respondents and complainants in 
these proceedings. Except as otherwise required by law, records or 
evidence which could identify research subjects must be maintained 
confidentially. Parties must limit disclosure of this data to those who 
have a need to know to carry out a misconduct proceeding. Note that the 
regulation, Standards for Privacy of Individually Identifiable Health 
Information, 45 CFR parts 160 and 164, permits entities covered by that 
regulation to disclose individually identifiable health information to 
ORI for the oversight functions authorized by the Public Health Service 
Act and the implementing regulation.
    2. Access to Data: Following the OSTP policy, the proposed 
regulation would provide an additional safeguard for respondents. 
Specifically, and in conformance with ORI's current practice, section 
93.305(b) of the proposed regulation would require institutions, where 
appropriate, to give the respondent copies of or reasonable, supervised 
access to, the research records.

F. Proposed Findings of Research Misconduct

    1. Separation of Fact-finding and Decision Making: We propose to 
adopt the current separation of the fact-finding and decision-making 
processes in research misconduct cases within HHS. The proposed 
regulation would codify the PHS practice since 1999, in which the 
decision to find research misconduct is made by the Assistant Secretary 
for Health (ASH) or the official designated by the ASH. OSTP policy 
also supports this separation. ORI would continue to be responsible for 
overseeing institutional inquiries and investigations and making 
recommendations for proposed research misconduct findings, settlements, 
and administrative actions to the ASH in cases where ORI believes 
misconduct

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has occurred. Also, as under current practice, if ORI were to propose 
debarment as an administrative action, that decision would be made by 
the HHS Debarring Official, the Deputy Assistant Secretary for Grants 
and Acquisition Management.
    2. HHS Administrative Actions: As recommended by OSTP, we propose 
in section 93.408 to include consideration of aggravating and 
mitigating factors in determining which HHS administrative actions are 
appropriate to protect the PHS and the research process. Historically, 
PHS has incorporated an aggravating and mitigating factor analysis in 
its assessment, but the proposed regulation would memorialize this 
policy and provide guidance to all parties.

G. HHS Inquiries and Investigations

    HHS would continue to have ultimate oversight authority for PHS 
supported research. As part of this organizational scheme, PHS has 
assigned to ORI the responsibility of conducting oversight reviews of 
these investigations, recommending to the ASH findings and appropriate 
administrative actions necessary to protect the interests of the PHS, 
and supporting these findings before the HHS Departmental Appeals Board 
(DAB). However, infrequent circumstances may arise where it becomes 
necessary for HHS itself to investigate the allegations of research 
misconduct at an extramural or intramural institution. Section 
93.400(a)(4) would codify the HHS Review Group's recommendation that 
the investigatory function for these cases be handled at the 
Departmental level. The HHS Office of Inspector General (OIG) will 
conduct such investigations.

H. Role of Complainants, Witnesses, and Others

    1. Good Faith: The PHS Act requires the Secretary to establish 
regulations for preventing and responding to institutional retaliation 
against employees who raise good faith allegations that an individual 
has committed research misconduct, or that an institution has failed to 
respond adequately to an allegation of research misconduct. 42 U.S.C. 
289b(e)(1). The existing final rule requires institutions to undertake 
``diligent efforts to protect the positions and reputations of those 
persons who, in good faith, make allegations.'' (Emphasis added.) 42 
CFR 50.103(d)(13). Because the attachment of whistleblower protections 
is contingent upon the making of good faith allegations, section 93.210 
of the proposed regulation would define what it means to make an 
allegation in ``good faith'' and, conversely, when an allegation is not 
brought in good faith. With this provision, PHS seeks to clarify a 
common misunderstanding about the nature of whistleblower protection. 
Namely, even if an allegation is wrong, the person bringing that 
allegation is still entitled to protection against retaliation as long 
as the whistleblower made the allegation in good faith. However, if a 
complainant does not make an allegation in good faith, (e.g. makes an 
allegation with knowledge that the factual basis for the allegation is 
untrue), an institution may take reasonable action to redress any harm 
caused by the allegation. In the academic community, these are commonly 
known as ``bad faith'' allegations, and some institutions currently 
have policies and procedures for responding to them.
    2. Complainants and Witnesses in Research Misconduct Proceedings: 
We recognize the critical role of complainants and other witnesses in 
research misconduct proceedings. The vast majority of cases that result 
in misconduct inquiries or investigations result from a complaint 
brought to the attention of appropriate institutional officials. 
However, the responsibility for addressing allegations should not fall 
on those who raise them. In conformance with the OSTP policy, the HHS 
Review Group, and current agency practice, this proposed rule would 
make clear that an institution has an obligation to pursue allegations 
of misconduct independent of the complainant's role. Once the 
complainant has made a formal allegation that research misconduct has 
occurred, that person does not participate in the research misconduct 
proceeding other than as a witness. A complainant is not the equivalent 
of a ``party'' in a private dispute. Complainants are witnesses in that 
they do not control or direct the process, do not have special access 
to evidence except as determined by ORI or the investigative body, and 
do not act as decision makers.
    The proposed regulation would employ a new term, ``complainant,'' 
defined at section 93.203 as a person who in good faith makes an 
allegation of research misconduct. The role of complainants is limited 
by the proposed provisions governing the conduct of inquiries and 
investigations. Under the proposed regulation, the institution may, but 
would no longer be required, to give the complainant an opportunity to 
comment on the inquiry and investigation reports.

I. Compliance

    1. Assurances for Small Institutions: Since 1990, ORI has permitted 
institutions determined to be too small to conduct research misconduct 
proceedings effectively or without any appearance of a conflict of 
interest to submit a ``Small Organization Statement'' under which they 
agree to work with ORI to develop an alternative mechanism to handle 
research misconduct allegations. Proposed section 93.303 would codify 
this option. Because we want to retain the flexibility these small 
institutions need, we have not explicitly defined the upward limit of 
what is considered a small institution. In the past, this alternative 
for small institutions has been applied to institutions with no more 
than 10 employees.
    2. Using a consortium or other entity to conduct research 
misconduct proceedings. The HHS Review Group suggested that 
institutions that were unable to conduct their own research misconduct 
proceedings use the services of a consortium or other entity qualified 
by practice and experience to conduct research misconduct proceedings. 
Section 93.306 would allow institutions that are too small, have real 
or apparent conflicts of interest, lack the capacity, or otherwise 
prefer not to conduct misconduct proceedings to elect this alternative. 
Our experience to date with this process has been positive, but we ask 
for comments as to whether there should be any limitations on an 
institution's ability to choose this option.
    3. Noncompliance with the Regulation: The proposed regulation would 
provide more information on institutional compliance obligations and 
the potential actions we may take in response to compliance concerns. 
The existing final rule provides that an institution's failure to 
comply with its assurance and the applicable regulations may result in 
an enforcement action against the institution. However, that rule does 
not spell out what type of institutional action constitutes a failure 
to comply. Nor does it explain what type of enforcement action an 
institution may face for noncompliance other than revocation of its 
assurance and the loss of PHS funding.
    Over the past several years, ORI has needed to take a number of 
compliance actions but has had to do so without any clear regulatory 
guidance in place for either the institution or ORI. We propose to 
rectify this problem and take some of the guesswork out of compliance 
enforcement. First, section 93.412 of the proposed regulation would

[[Page 20783]]

establish the circumstances under which ORI could find an institution 
out of compliance. These circumstances would include, among other 
things, a failure to establish and comply with policies and procedures 
required by the regulation or a failure to cooperate with review of 
institutional research misconduct proceedings. As we already view all 
of the factors listed in the proposed regulation as examples of 
potential institutional noncompliance, the regulation would essentially 
codify current policy and practice. To that end, like some of the other 
changes in the proposed regulation, we believe it is helpful to spell 
out existing practice.
    A second way in which the proposed regulation would lend clarity to 
the compliance process would be the addition in section 93.413 of a 
more complete explanation of the potential enforcement actions that HHS 
may impose in response to institutional noncompliance. This 
clarification serves several functions. First, it introduces a 
graduated scheme of actions that ORI could take itself or propose to 
other PHS agencies or HHS, as appropriate, in response to a given 
instance of noncompliance. These actions, most of which are already in 
effect through other PHS regulations, range from issuance of a warning 
letter (which could also require an institution to take corrective 
actions) to revocation of an assurance. A graduated scheme of 
compliance actions responds both to the needs of HHS and the 
institutions. The proposed regulation would answer institutional 
concerns that the current compliance system provides only for the 
revocation of an assurance.

J. Maintenance and Custody of Records.

    Responsibility for maintenance and custody of research records and 
evidence: We propose to codify current policy regarding ongoing 
institutional responsibilities for obtaining and maintaining custody of 
the research records of the accused researcher and other evidence 
relevant to the misconduct allegations. To protect respondents, the 
OSTP policy recommends that institutions provide accused researchers 
with reasonable access to the evidence supporting the allegations. It 
cautions that misconduct policies should ensure that the mere filing of 
an allegation does not bring research to a halt nor provide a basis for 
other disciplinary or adverse action absent other compelling reasons. 
Accordingly, section 93.305(b) of the proposed regulation would provide 
that, where appropriate, institutions must ``give the respondent copies 
of or reasonable, supervised access to the research record.'' However, 
we do not propose to limit an institution's control over its employees 
and the research conducted under its auspices. The proposed regulation 
would not give a respondent any rights to continue research in the face 
of reasonable institutional objections.

K. Hearing Process

    We propose to add the HHS hearing process for reviewing PHS 
findings of research misconduct, as the existing final rule did not 
include provisions for a hearing. Since 1992, when we began to offer 
hearings, we have not had clear-cut procedures for research misconduct 
adjudications. Complainants, parties, witnesses, and others have 
commented that the current informal hearing procedures, published at 59 
FR 29809 (1994), lack the consistency and clarity provided by binding 
rules of procedure for other types of cases. Accordingly, we believe 
that adding a hearing regulation applicable only to research misconduct 
cases is advisable to codify a fair, efficient, and timely process for 
accused researchers.
    We have modeled the proposed hearing regulation in subpart E 
primarily on the current regulations, at 42 CFR part 1005, governing 
the hearing process for the exclusion of health care providers used by 
the OIG, while modifying them to reflect current practice, knowledge, 
and experience in research misconduct proceedings. The proposed 
regulation also retains several key features from the current informal 
procedures.
    The current ad hoc hearing process involves a trial-like 
evidentiary hearing on the PHS findings of scientific misconduct and 
proposed HHS administrative actions by a three-person panel of the DAB. 
The panel, which may include one or two outside scientists, in addition 
to the DAB Board Member(s), conducts a de novo review in which the 
merits of the case are heard as if for the first time, without any 
reference to or reliance on any previous decision making or review 
process. In other words, both the PHS and the accused scientist have an 
opportunity to present their side of the case to the DAB. The DAB 
conducts this de novo hearing pursuant to the above noted informal 
guidelines and determines whether the respondent committed scientific 
misconduct and whether the proposed administrative actions should be 
imposed. In reaching its decision, the panel does not rely on the 
administrative record developed by the institution or ORI during its 
oversight review but instead relies solely upon testimony and other 
evidence presented by the parties at the hearing.
    Because proposed subpart E is new, we have described it in greater 
detail than the other subparts and request comment, especially on the 
following issues.
    1. Administrative Law Judges (ALJ): We believe that the proposal in 
section 93.502 to change from the current system of using a panel of 
three decision makers to using a single ALJ appointed from the DAB 
Administrative Law Judges would substantially improve and simplify the 
process for all parties. This change would provide a process similar to 
program exclusion cases brought by the OIG, cases which have similar 
impact on the subjects' reputations and livelihood. In fact, for many 
other HHS programs, including those conducted under the OIG regulation, 
a single decision maker conducts the hearings. Section 93. 506, 
Authority of the Administrative Law Judge (ALJ) , closely follows the 
OIG regulations at 42 CFR 1005.4. Under the OIG regulations, the ALJ 
must follow all Federal laws, regulations, and Secretarial delegations 
of authority. Proposed section 93.506(a) adds applicable HHS policies 
to this list, because certain policies and guidelines apply to PHS 
biomedical and behavioral research and research training grants.
    2. Recommended decision: The ALJ's final ruling on the merits of 
the PHS misconduct findings and the HHS administrative actions will now 
constitute a recommended decision to the Assistant Secretary for 
Health. Under current practice, the DAB's decision on the merits of PHS 
findings of misconduct and HHS administrative actions, other than 
debarment, constitutes final agency action as to these matters. In 
2000, the Secretary redelegated the authority to propose findings of 
research misconduct and administrative actions from the Director, ORI, 
to the Assistant Secretary for Health. The Assistant Secretary for 
Health will now take final agency action on PHS research misconduct 
appeals, exercising the office's delegated authority to affirm, 
reverse, or modify the ALJ's recommended decision. In accordance with 
45 CFR part 76, the ALJ's final ruling constitutes proposed findings of 
fact to the HHS Debarring Official. The respondent may continue to have 
access to a final review in Federal court under the standards of the 
Administrative Procedure Act.
    3. Scientist Advisors and Experts: Substituting a single ALJ for 
the current three-person panel would alter, to some extent, the role of 
the scientist in the proceeding. Although the current

[[Page 20784]]

system theoretically permits the panel to have up to two scientist 
members, most panels to date have had either one or no scientist 
member. However, to ensure that the necessary scientific expertise is 
available, section 93.502(b) would authorize the ALJ to engage an 
expert in the relevant area of science to advise the ALJ on scientific 
or technical issues, and require the employment of such an expert, if 
requested by either party. This is consistent with recent developments 
in the Federal judicial system in which judges may select their own 
outside experts to help them understand cases involving complex 
scientific, medical, or technological issues. The proposed regulation 
contemplates that the ALJ would consult informally with the scientific 
expert, similar to the way experts are used by the Office of Special 
Masters, United States Court of Federal Claims in the National Vaccine 
Injury Compensation Program, rather than following the more formal 
procedures in Federal Rules of Evidence 706. Thus, we do not 
contemplate that the ALJ's expert advisor would provide testimony for 
the record, but either party to the hearing (e.g., the accused 
researcher and PHS) could offer its own experts as witnesses. 
Therefore, the proposed new process should simplify the proceedings 
while providing ample and necessary input from the scientific 
community.
    4. Real or Apparent Conflicts of Interest. Consistent with current 
DAB and Federal court practice, section 93.502 (c) would prohibit the 
appointment of any ALJs or outside science advisors with any real or 
apparent conflict of interest that might reasonably impair their 
objectivity in the proceeding. Section 93.502(d) would establish a 
process for the disqualification of an ALJ or appointed scientist or 
expert and, consistent with Federal court practice, would also permit 
the ALJ to rule on a motion to disqualify. If the ALJ rules, either 
party could appeal the decision directly to the Chief ALJ . This 
process would permit the ALJ and Chief ALJ to address potential 
conflicts of interest while maintaining a fair and objective hearing 
process.
    5. Relation to HHS Debarment Regulations: The HHS Debarring 
Official refers disputed material facts related to a proposed debarment 
in PHS research misconduct proceedings to the DAB for determination. 
See 45 CFR 76.314(b)(2). Subpart E of the proposed regulation would be 
consistent with this practice and would not supersede or otherwise 
alter the existing HHS Debarment regulations or procedures for 
contesting proposed debarments.
    6. Amendment to the PHS Charge Letter: Consistent with current DAB 
practice, section 93.514 would permit the PHS to amend its findings of 
research misconduct up to 30 days before the scheduled hearing. We 
anticipate that this would occur only in rare circumstances where we 
learned of additional acts of research misconduct after the DAB process 
had begun (e.g., the acquisition of new information during the 
discovery process). In addition, the Assistant Secretary for Health and 
the HHS Debarring Official (if debarment were proposed) would have to 
approve any amendments. In this instance, the respondent could request 
a postponement of the hearing to prepare a response to the new charge.
    7. De Novo Proceedings: Consistent with current policy, section 
93.517(b) would codify the current practice of providing a de novo 
hearing to consider challenges to any PHS findings of research 
misconduct and proposed PHS administrative actions. We also propose in 
section 93.503(d) to incorporate the current practice that permits a 
respondent to waive an in-person hearing and have the case decided on 
the basis of the administrative record.
    8. Standardization of Requirements: We believe that the proposed 
regulation would level the playing field by letting respondents know up 
front how the hearing process works. For example, the regulation sets 
up requirements for the content of the hearing request (sections 
93.503-504), time frames for conducting preliminary conferences 
(section 93.511), discovery (section 93.512), submission of witness 
lists and exhibits (section 93.513), and the post-hearing process 
(sections 93.520 through 523). Knowledge of these standards by the 
accused researchers would help promote a fair, timely, efficient, and 
less costly process for all parties.
    9. Limited Discovery: Generally, discovery is not required to be 
made available in administrative proceedings. Under the Administrative 
Procedure Act, agencies may decide the extent of available discovery. 
We propose to follow the standard Federal administrative practice of 
limiting discovery to an exchange of documents. Thus, like other HHS 
procedures, the proposed regulation would not permit other forms of 
discovery available in Federal court litigation, such as requests for 
admissions, written interrogatories, and deposition. See section 
93.512(a). Limited discovery results in a faster and more efficient 
process that reduces litigation costs for all parties. Following 
discussion at a prehearing conference, the ALJ could order the parties 
to develop stipulations and admissions of fact. See section 
93.511(b)(2). In past hearings, however, these mechanisms have not 
resulted in narrowing the issues or improving the efficiency of the 
hearing, because the parties had to prepare, but failed to agree on, 
any stipulations or admissions.
    10. Written Direct Testimony and Use of Telephone and Audio-Visual 
Communication: Section 93.518(b) of the proposed regulation would 
permit the ALJ to admit written witness testimony, including prior 
sworn testimony, if the person is available for cross-examination. 
Section 93.518(c)) would permit testimony by telephonic or audio-visual 
communication. Past experience has shown that these features help 
foster an efficient and streamlined hearing process and reduce the risk 
of unfair surprise and increased cost and inconvenience to the parties 
and witnesses.
    11. Evidentiary Standards: We also propose to clarify the standards 
for admitting evidence at the hearing. Section 93.519(c) addresses the 
standard Federal administrative practice of admitting relevant and 
material evidence and excluding unreliable or unfairly prejudicial 
evidence. To avoid ambiguity, the proposed regulation also incorporates 
several provisions of the Federal Rules of Evidence. See sections 
93.519(f)-(i). Similarly, section 93.519(e) would permit the ALJ to 
take judicial notice of established scientific and technical facts, 
which would reduce the need for expert testimony and, thereby, provide 
a cost savings to the parties.
    12. Other Federal Laws or Regulations: With respect to the hearing 
process, the proposed regulation would not supersede or otherwise alter 
existing Federal laws or regulations that may provide additional 
procedures for Federal employees.
    13. Recordkeeping for Inquiries and Research Misconduct 
Proceedings: The OIG has raised concerns that the 3 year period for 
retaining inquiry records in the current regulation, 42 CFR 
50.103(d)(6), is too short to permit HHS or the Department of Justice 
to investigate potential civil or criminal fraud cases. Accordingly, 
the new NPRM proposes extending the period for retaining records on 
inquiries and misconduct proceedings to 7 years. See proposed sections 
93.309(c) and 93.317(a).

L. Other Features of the Proposed Rule

    1. Coordination with Federal Agencies: Federal agencies try to 
coordinate when allegations arise that affect more than one funding 
agency. For example, NIH and the Department

[[Page 20785]]

of Energy might be jointly funding a particular project which is the 
subject of research misconduct allegations. Failure to coordinate may 
result in overlooking important government policies, adversely 
impacting other agencies' missions and interests, and duplicating or 
wasting resources. Therefore, the NPRM proposes to codify current 
practice to recognize that, in these instances, the agencies may 
coordinate responses with other Federal agencies. The PHS has 
coordinated with other interested Federal agencies in a number of cases 
and will continue to do so.
    2. Limitations period: Because of the problems that may occur in 
investigating older allegations and the potential unfairness to accused 
researchers in defending against them, we propose to limit the scope of 
the misconduct regulations to cases in which the alleged misconduct 
occurred within 6 years before the allegation. The proposed rule models 
this limitation period after the one used in the qui tam provision of 
the False Claims Act, 31 U.S.C. 3731(b), and after the procedures used 
by the OIG in its Medicare and Medicaid exclusion cases. Thus, with a 
few exceptions, we would be barred from going forward with cases where 
the alleged misconduct occurred outside this 6 year window.
    3. Person: Section 93.219 of the proposed regulation would define 
``person'' to include individuals as well as institutions and other 
organizations. This approach to the definition of ``person'' is 
consistent with many regulatory schemes including the governmentwide 
nonprocurement debarment regulation which is cross-referenced with the 
proposed misconduct regulation.
    4. Investigation time limits: The OSTP policy recommends that the 
Federal agencies establish reasonable time lines to balance expeditious 
completion of an institutional research misconduct process against 
fairness and thoroughness. Consistent with the existing final rule, 
sections 93.307(g) and 93.311 would maintain the 60-day time limit for 
institutional inquiries and the 120-day time limit for investigations, 
subject to extensions. As experience has shown that institutions often 
need extensions of time, we seek comments on whether these time limits 
are realistic and provide sufficient time to conduct inquiries and 
investigations.
    5. Institutional Appeals: Although not required under the existing 
Final Rule, some institutions provide respondents with an internal 
process by which to appeal the institutional finding of misconduct. Our 
experience has shown that often these appeals may result in substantial 
delays in completing the institutional process and any subsequent 
review. Therefore, in section 93.314, we have proposed a 120-day 
deadline for completion of institutional appeals. This section would 
provide that any appeals must be completed within 120 days of filing 
the appeal, unless extended by ORI for good cause. The 120-day time 
limit would apply only to a respondent's appeal of the merits of an 
institutional finding of research misconduct, if such a process is 
provided by an institution's research misconduct policy. The 120-day 
time frame would not apply to any other procedures that an institution 
may have, such as tenure proceedings, disciplinary proceedings, or 
honor committee proceedings, that do not go to the merits of a research 
misconduct finding. It also would not apply to any civil law suits 
filed by a respondent challenging a finding of research misconduct. We 
ask for comment on whether this proposed time limit is appropriate and 
would ameliorate the problems caused by delays in completing 
proceedings, and, if so, whether the proposed 120 day deadline is 
sufficient.
    6. Settlements: In making findings of research misconduct, ORI has 
relied on settlement agreements with the accused scientist the great 
majority of the time. These settlements can occur at any stage of the 
investigative process, from the allegation to completion of the 
investigation. Consistent with ORI's prior practice, ORI has expressly 
provided in proposed section 93.409 that ORI may settle a research 
misconduct proceeding at any time in the best interests of the Federal 
government and the public health or welfare. ORI has also participated 
in three-way agreements with the research institution, ORI, and the 
accused scientist. We encourage institutions or respondents (or 
counsel) to contact ORI directly when a settlement agreement appears 
feasible. Finally, we caution institutions about entering into 
settlement agreements with the respondent without consulting with ORI 
in advance. In some cases, the institution has purported to enter into 
a binding agreement with the respondent that seeks to restrict the 
scope of an investigation or otherwise limits ORI's or the 
institution's authority under the regulation. Any such attempt would 
have no binding effect on ORI and would not abrogate the institution's 
regulatory obligations. Accordingly, we request that any institution 
considering such action consult with ORI staff and counsel before 
agreeing to any settlement. However, no regulatory language requires 
that institutions do so.

M. Structure and Format

    We propose to adopt a different approach to the structure and 
format from the existing final rule based on the Presidential 
Memorandum on Plain Language issued on June 1, 1998. This memorandum 
directed Federal agencies to ensure that all of their documents are 
clear and easy to read. We organized the proposed rule so that matters 
common to a particular subject appear together. We also grouped related 
sections within subparts and placed them under unnumbered, centered 
headings. This allows readers easy access to information of particular 
importance to them. We have used fewer legal terms and more commonly 
understood words along with shorter sentences and have tried to make 
each section easy to understand by using clear and simple language 
rather than jargon. We would like your comments on how effectively we 
have used plain language, the organization and format of the proposed 
rule, and whether the document is clear and easy to read.

III. Analysis of Impacts

    As discussed in greater detail below, we have examined the 
potential impact of this proposed rule as directed by Executive Orders 
12866 and 13132, the Unfunded Mandates Act of 1995, the Regulatory 
Flexibility Act, and the Paperwork Reduction Act of 1995.
    We have also determined that this proposed rule would not: (1) Have 
an impact on Family Well-Being under section 654 of the Treasury and 
General Government Appropriations Act of 1999; nor (2) have a 
significant adverse effect on the supply, distribution, or use of 
energy sources under Executive Order 13211.

A. Executive Order 12866

    These proposed regulations have been drafted and reviewed in 
accordance with Executive Order 12866 (58 FR 51735), section 1(b), 
Principles of Regulation. The Department has determined that this 
proposed rule is a ``significant regulatory action'' under Executive 
Order 12866, section 3(f), Regulatory Planning and Review because it 
will materially alter the obligations of recipients of PHS biomedical 
and behavioral research and research training grants. However, the 
proposed regulation is not economically significant as defined in 
section 3(f)(1), because it will not have an annual effect on the 
economy of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy,

[[Page 20786]]

productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities. 
Therefore, the information enumerated in section 6(a)(3)(C) of the 
Executive Order is not required. The proposal has been reviewed by the 
Office of Management and Budget (OMB) under the terms of the Executive 
Order. Recipients of PHS biomedical and behavioral research grants will 
have to comply with the reporting and record keeping requirements in 
the proposed regulation. As shown below in the Paperwork Reduction Act 
analysis, those burdens encompass essentially all of the activities of 
the institutions that are required under the proposed regulation. The 
total annual burden is 18,279.5 hours. The U.S Department of Labor, 
Bureau of Labor Statistics, sets the mean hourly wage for Educational 
Administrators, Postsecondary at $31.14. The mean hourly wage for 
lawyers is $43.90. The average hourly cost of benefits for all civilian 
workers would add $6.41 to these amounts. In order to ensure that all 
possible costs are included and to account for potential higher rates 
at some institutions, we estimated the cost per burden hour at $100. 
This results in a total annual cost for all institutions of $1,827,950.

B. The Unfunded Mandates Reform Act of 1995

    Sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (2 
U.S.C. 1532 and 1535) require that agencies prepare several analytic 
statements before proposing a rule that may result in annual 
expenditures of State, local, and tribal governments, or by the private 
sector, of $100 million or more in any one year. As any final rule 
resulting from this proposal would not result in expenditures of this 
magnitude, the Secretary certifies that such statements are not 
necessary.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires 
agencies to prepare a regulatory flexibility analysis describing the 
impact of the proposed rule on small entities, but also permits agency 
heads to certify that a proposed rule will not, if promulgated, have a 
significant economic impact on a substantial number of small entities. 
The primary effect of this rule would be to require covered 
institutions to implement policies and procedures for responding to 
research misconduct cases. The Department certifies that this proposed 
rule would not have a significant impact on a substantial number of 
small entities, as defined by the Regulatory Flexibility Act, based on 
the following facts.
    Approximately 47 percent (1862) of the 4000 institutions that 
currently have research misconduct assurances are small entities. The 
primary impact of the NPRM on covered institutions results from the 
reporting and record keeping provisions which are analyzed in detail 
under the heading, ``The Paperwork Reduction Act.'' Significant annual 
burdens apply only if an institution learns of possible research 
misconduct and begins an inquiry, investigation, or both. In 2001, 86 
inquiries and 46 investigations were conducted among all the 
institutions. No investigations were conducted by a small entity and 
only one conducted an inquiry. Small entities would be able to avoid 
entirely the potential burden of conducting an inquiry or investigation 
by filing a Small Organization Statement under proposed section 93.303. 
The burden of filing this Statement is .5 hour. Thus, the significant 
burden of conducting inquiries and investigations will not fall on a 
substantial number of small entities.
    A small organization that files the Small Organization Statement 
must report allegations of research misconduct to ORI and comply with 
all provisions of the proposed regulation other than those requiring 
the conduct of inquiries and investigations. The total annual average 
burden per response for creating written policies and procedures for 
addressing research misconduct is approximately 16 hours. However, 
approximately 99 percent of currently funded institutions already have 
these policies and procedures in place and spend approximately .5 hour 
updating them. The most significant of the burdens that might fall on 
an entity filing a Small Organization Statement is taking custody of 
research records and evidence when there is an allegation of research 
misconduct. The average burden per response is 35 hours, but based on 
reports of research misconduct over the last three years, less than 5 
small entities would have to incur that burden in any year.
    Based on the forgoing analysis, the Department concludes that the 
regulations proposed in the NPRM will not impose a significant burden 
on a substantial number of small entities. However, we will carefully 
consider comments on the analysis and conclusion.

D. Executive Order 13132: Federalism

    This proposed rule, if published as a final rule, would not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government. Therefore, 
in accordance with section 6 of Executive Order 13132, we have 
determined that this rule does not have sufficient federalism 
implications to warrant the preparation of a federalism summary impact 
statement.

E. The Paperwork Reduction Act

    Sections 300-305, 307-311, 313-318, and 413 of the proposed rule 
contain information collection requirements that are subject to review 
by the OMB under the Paperwork Reduction Act of l995 (44 U.S.C. 3501, 
et seq.). The title, description, and respondent description of the 
information collection requirements are shown below with an estimate of 
the annual reporting burdens. Included in the estimates is the time for 
reviewing instructions, gathering and maintaining the data needed, and 
completing and reviewing the collection of information. With respect to 
the following information collection description, PHS invites comments 
on: (1) Whether the proposed collection of information is necessary for 
the proper performance of PHS functions, including whether the 
information will have practical utility; (2) the accuracy of the PHS 
estimate of the burden of the proposed collection of information 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of collection of 
information on respondents, including the use of automatic collection 
techniques or other forms of information technology.
    Title: Public Health Service Policies on Research Misconduct.
    Description: This proposed rule revises the current regulation, 42 
CFR 50.101, et seq., in three significant ways and will supersede the 
current regulation. First, the proposed rule integrates the White House 
Office of Science and Technology Policy's (OSTP) December 6, 2000, 
governmentwide Federal Policy on Research Misconduct. Second, the 
proposed rule incorporates the recommendations of the HHS Review Group 
on Research Misconduct and Research Integrity that were approved by the 
Secretary of HHS on August 25, 1999. Third, the proposed rule 
integrates a decade's worth of experience and understanding since the 
agency's first regulations were promulgated.

[[Page 20787]]

    Description of Respondents: The ``respondents'' for the collection 
of information described in this regulation are institutions that apply 
for or receive PHS support through grants, contracts, or cooperative 
agreements for any project or program that involves the conduct of 
biomedical or behavioral research, biomedical or behavioral research 
training, or activities related to that research or training (see 
definition of ``Institution'' at section 93.214).

Subpart C--Responsibilities of Institutions

Compliance and Assurances

Section 93.300(a)

    See section 93.304 for burden statement.

Section 93.300(c)

    See section 93.320 for burden statement.

Section 93.300(i)

    See section 93.301(a) for burden statement.

Section 93.301(a)

    Covered institutions must provide ORI with an assurance either by 
submitting the initial certification (500 institutions) or by 
submitting an annual report (3500 institutions).
    Number of Respondents: 4000.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: .5 hour.
    Total Annual Burden: 2000 hours.

Section 93.302(a)(1)

    See section 93.301(a) for burden statement.

Section 93.302(a)(2)

    See section 93.320 for burden statement.

Section 93.302(a)(3)

    Each applicant institution must inform its scientific and 
administrative staff of the institution's policies and procedures and 
emphasize the importance of compliance with these policies and 
procedures.
    Number of Respondents: 4000.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: .5 hour.
    Total Annual Burden: 2000 hours.

Section 93.302(b)

    See section 93.301(a) for burden statement.

Section 93.302(c)

    In addition to the annual report, covered institutions must submit 
aggregated information to ORI on request regarding research misconduct 
proceedings.
    Number of Respondents: 100.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1 hour.
    Total Annual Burden: 100 hours.

Section 93.303

    Covered institutions that, due to their small size, lack the 
resources to develop their own research misconduct policies and 
procedures may elect to file a ``Small Organization Statement'' with 
ORI.
    Number of Respondents: 75.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: .5 hour.
    Total Annual Burden: 37.5 hours.

Section 93.304

    Covered institutions with active assurances must have written 
policies and procedures for addressing research misconduct. 
Approximately 3500 institutions already have these policies and 
procedures in place in any given year and spend minimal time (.5 hour) 
updating them. Approximately 500 institutions each year spend an 
average of two days creating these policies and procedures for the 
first time.
    Number of Respondents: 4000.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 2.5 hours.
    Total Annual Burden: 10,000 hours.

Section 93.305(a), (b), (d), and (e)

    When a covered institution learns of possible research misconduct, 
it must promptly take custody of all research records and evidence and 
then inventory and sequester them. Covered institutions must also take 
custody of additional research records or evidence discovered during 
the course of a research misconduct proceeding. Once the records are in 
custody, the institutions must maintain them until ORI requests them, 
HHS takes final action, or as required under section 93.317.
    Number of Respondents: 53.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 35 hours.
    Total Annual Burden: 1855 hours.

Section 93.305(c)

    Where appropriate, covered institutions must give the respondent 
copies of or reasonable, supervised access to the research record.
    Number of Respondents: 53.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 5 hours.
    Total Annual Burden: 265 hours.

The Institutional Inquiry

Section 93.307(b)

    At the time of or before beginning an inquiry, covered institutions 
must notify the presumed respondent in writing.
    Number of Respondents: 53.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1 hour.
    Total Annual Burden: 53 hours.

Section 93.307(e)

    See section 93.309 for burden statement.

Section 93.307(f)

    Covered institutions must provide the respondent an opportunity to 
review and comment on the inquiry report and attach any comments to the 
report.
    Number of Respondents: 53.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1 hour.
    Total Annual Burden: 53 hours.

Section 93.308(a)

    Covered institutions must notify the respondent whether the inquiry 
found that an investigation is warranted.
    Number of Respondents: 53.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: .5 hour.
    Total Annual Burden: 26.5 hours.

Section 93.309(a)

    When a covered institution issues an inquiry report in which it 
finds that an investigation is warranted, the institution must provide 
ORI with a specified list of information within 30 days of the inquiry 
report's issuance.
    Number of Respondents: 16.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 16 hours.
    Total Annual Burden: 256 hours.

Section 93.309(b)

    Covered institutions must keep sufficiently detailed documentation 
of

[[Page 20788]]

inquiries to permit a later assessment by ORI of reasons why decision 
was made to forego an investigation.
    Number of Respondents: 37.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1 hour.
    Total Annual Burden: 37 hours.

The Institutional Investigation

Section 93.310(b)

    See section 309(a) for burden statement.

Section 93.310(c)

    Covered institutions must notify the respondent of allegations of 
research misconduct before beginning the investigation.
    Number of Respondents: 16.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1.
    Total Annual Burden: 16 hours.

Section 93.310(d)

    See section 93.305(a), (b), (d) and (e) for burden statement.

Section 93.310(g)

    Covered institutions must record or transcribe all witness 
interviews, provide the recording or transcript to the witness for 
correction, and include the recording or transcript in the record of 
the investigation.
    Number of Respondents: 16.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 15 hours.
    Total Annual Burden: 240 hours.

Section 93.311(b)

    If unable to complete the investigation in 120 days, covered 
institutions must submit a written request for an extension from ORI.
    Number of Respondents: 16.
    Number of Responses per Respondent: 1.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: .5 hour.
    Total Annual Burden: 2.5 hours.

Section 93.315

    At the conclusion of the institutional investigation process, 
covered institutions must submit four items to ORI: The investigation 
report (with attachments and appeals), final institutional actions, the 
institutional finding, and any institutional administrative actions.
    Number of Respondents: 16.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 80 hours.
    Total Annual Burden: 1280 hours.

Section 93.316(a)

    Covered institutions that plan to end an inquiry or investigation 
before completion for any reason must contact ORI before closing the 
case and submitting its final report.
    Number of Respondents: 10.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 2 hours.
    Total Annual Burden: 20 hours.

Other Institutional Responsibilities

Section 93.317(a) and (b)

    See section 93.305(a), (b), (d), and (e) for burden statement.

Section 93.318

    Covered institutions must notify ORI immediately in the event of 
any of an enumerated list of exigent circumstances.
    Number of Respondents: 2.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 1 hour.
    Total Annual Burden: 2 hours.

Subpart D--Responsibilities of the U.S. Department of Health and 
Human Services

Institutional Compliance Issues

Section 93.413(c)(6)

    ORI may require noncompliant institutions to adopt institutional 
integrity agreements.
    Number of Respondents: 1.
    Number of Responses per Respondent: 1.
    Annual Average Burden per Response: 20 hours.
    Total Annual Burden: 20 hours.
    The Department will submit a copy of this proposed rule to OMB for 
its review and approval of this information under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). Send comments regarding 
this burden estimate or any other aspect of this collection of 
information, including suggestions for reducing this burden, to the 
agency official designated for this purpose whose name appears in this 
preamble and to fax number (202) 395-6974, Attn: Fumie Yokota. Submit 
written comments by June 15, 2004.

List of Subjects

42 CFR Part 50

    Administrative practice and procedure, Science and technology, 
Reporting and recordkeeping requirements, Research, Government 
contracts, Grant programs.

42 CFR Part 93

    Administrative practice and procedure, Science and technology, 
Reporting and recordkeeping requirements, Research, Government 
contracts, Grant programs.

    Dated: December 29, 2003.
Cristina V. Beato,
Acting Assistant Secretary for Health.

    Approved: December 31, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.

    Editorial Note: This document was received in the Office of the 
Federal Register on April 13, 2004.

    Accordingly, under the authority of 42 U.S.C. 289b, HHS proposes to 
amend 42 CFR parts 50 and 93 to read as follows:

PART 50--POLICIES OF GENERAL APPLICABILITY

    1. The authority citation for 42 CFR part 50 continues to read as 
follows:

    Authority: Sec. 493, Public Health Service Act, as amended, 99 
Stat. 874-875 (42 U.S.C. 289b); Sec. 501(f), Public Health Service 
Act, as amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)).

Subpart A [Removed]

    2. Part 50, Subpart A is removed and reserved.

PART 93 [ADDED]

    3. A new Part 93, with subparts A, B, C, D and E, is added to read 
as follows:

PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.

[[Page 20789]]

Subpart B--Definitions
93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Deciding official.
93.208 Departmental Appeals Board or DAB.
93.209 Evidence.
93.210 Funding component.
93.211 Good faith.
93.212 Hearing.
93.213 Inquiry.
93.214 Institution.
93.215 Institutional member
93.216 Investigation.
93.217 Notice.
93.218 Office of Research Integrity or ORI.
93.219 Person.
93.220 Preponderance of the evidence.
93.221 Prima facie showing.
93.222 Public Health Service or PHS.
93.223 PHS support.
93.224 Research.
93.225 Research misconduct proceeding.
93.226 Research record.
93.227 Respondent.
93.228 Retaliation.
93.229 Secretary or HHS.
Subpart C--Responsibilities of Institutions

Compliance and Assurances

93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research 
records and evidence.
93.306 Using a consortium or other entity for research misconduct 
proceedings.

The Institutional Inquiry

93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an investigation 
.

The Institutional Investigation

93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.

Other Institutional Responsibilities

93.317 Retention and custody of the research misconduct proceeding 
record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.
Subpart D--Responsibilities of the U.S. Department of Health and Human 
Services

General Information

93.400 General statement of ORI authority.
93.401 Communications with other offices and interim actions.

Research Misconduct Issues

93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 HHS findings on research misconduct proceedings.
93.405 Notifying the respondent of findings of research misconduct 
and HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative 
actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research 
misconduct.
93.411 Final HHS action with a settlement or finding of research 
misconduct.

Institutional Compliance Issues

93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.

Disclosure of Information

93.414 Notice.
Subpart E--Opportunity To Contest PHS Findings of Research Misconduct 
and HHS Administrative Actions

General Information

93.500 General policy.
93.501 Opportunity to contest PHS findings of research misconduct 
and HHS administrative actions.

Hearing Process

93.502 Appointment of the Administrative Law Judge and scientific 
expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge .
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and 
exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.

    Authority: 42 U.S.C. 216, 241, and 289b.


Sec.  93.25  Organization of this part.

    This part is subdivided into five subparts. Each subpart contains 
information related to a broad topic or specific audience with special 
responsibilities as shown in the following table.

------------------------------------------------------------------------
                                             You will find provisions
            In subpart . . .                     related to . . .
------------------------------------------------------------------------
                   A                     General information about this
                                          rule.
                   B                     Definitions of terms used in
                                          this part.
                   C                     Responsibilities of
                                          institutions with PHS support.
                   D                     Responsibilities of the U.S.
                                          Department of Health and Human
                                          Services and the Office of
                                          Research Integrity.
                   E                     Information on how to contest
                                          PHS research misconduct
                                          findings and HHS
                                          administrative actions.
------------------------------------------------------------------------

Sec.  93.50  Special terms.

    This part uses terms throughout the text that have special meaning. 
Those terms are defined in subpart B of this part.

Subpart A--General


Sec.  93.100  General policy.

    (a) The U.S. Department of Health and Human Services (HHS) and 
institutions, including individual researchers who apply for or receive 
Public Health Service (PHS) support for biomedical or behavioral 
research, biomedical or behavioral research training, or activities 
related to that research or training share responsibility for the 
integrity of the research process. HHS has ultimate oversight authority 
for PHS supported research, and for taking other actions as appropriate 
or necessary, including the right to assess allegations and perform 
inquiries or investigations at any time. Institutions have primary 
responsibility for reporting and responding to allegations of research 
misconduct.
    (b) Under this regulation and Section 493 of the PHS Act, 42 U.S.C. 
289b, each institution that applies for or receives PHS support for any 
biomedical or behavioral research or research training activity must 
comply with this part in responding to allegations of research 
misconduct occurring at or involving research or research training 
projects or staff of the institution.
    (c) Research misconduct involving PHS support is contrary to the 
interests of the PHS and the Federal government and to the health and 
safety of the

[[Page 20790]]

public, to the integrity of research, and to the conservation of the 
public fisc.
    (d) Institutions that apply for or receive PHS support and persons 
who work on PHS supported biomedical or behavioral research, biomedical 
or behavioral research training or activities related to that research 
or research training have an affirmative duty to protect those funds 
from misuse by ensuring the integrity of any research or research 
training activities related to the PHS support and by responding to 
allegations of research misconduct as provided in this part.


Sec.  93.101  Purpose.

    The purpose of this part is to--
    (a) Establish the responsibilities of HHS, PHS, the Office of 
Research Integrity (ORI), and institutions in responding to research 
misconduct issues;
    (b) Define what constitutes misconduct in PHS supported research;
    (c) Define the general types of administrative actions HHS and the 
PHS may take in response to research misconduct; and
    (d) Require institutions to develop and implement policies and 
procedures for--
    (1) Reporting and responding to allegations of research misconduct 
in connection with PHS supported research;
    (2) Providing ORI with the assurances necessary to permit the 
institutions to participate in PHS supported research.
    (e) Protect the health and safety of the public, promote the 
integrity of PHS supported research and the research process, and 
conserve the public fisc.


Sec.  93.102  Applicability.

    (a) This part applies to allegations of research misconduct and 
research misconduct involving PHS supported biomedical or behavioral 
extramural and intramural research, biomedical or behavioral research 
training programs, or activities related to that research or research 
training. This includes any research proposed, performed, reviewed, or 
reported, or any research record generated from that research, 
regardless of whether the user or reviewer receives PHS support or 
whether an application or proposal for PHS funds resulted in a grant, 
contract, cooperative agreement, or other form of PHS support.
    (b) This part does not supersede or establish an alternative to any 
existing regulations or procedures for handling fiscal improprieties, 
the ethical treatment of human or animal subjects, criminal matters, 
personnel actions against Federal employees, or actions taken under the 
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR 
subparts 9.4 and 309.4.
    (c) This part does not prohibit or otherwise limit how institutions 
handle allegations of misconduct that do not fall within this part's 
definition of research misconduct or that do not involve PHS support.


Sec.  93.103  Research misconduct.

    Research misconduct means fabrication, falsification, or plagiarism 
in proposing, performing, or reviewing research, or in reporting 
research results.
    (a) Fabrication is making up data or results and recording or 
reporting them.
    (b) Falsification is manipulating research materials, equipment, or 
processes, or changing or omitting data or results such that the 
research is not accurately represented in the research record.
    (c) Plagiarism is the appropriation of another person's ideas, 
processes, results, or words without giving appropriate credit.
    (d) Research misconduct does not include honest error or 
differences of opinion.


Sec.  93.104  Requirements for findings of research misconduct.

    A finding of research misconduct made under this part requires 
that--
    (a) There be a significant departure from accepted practices of the 
relevant research community; and
    (b) The misconduct be committed intentionally, knowingly, or 
recklessly; and
    (c) The allegation be proven by a preponderance of the evidence.


Sec.  93.105  Time limitations.

    (a) Six year limitation. This part applies only to research 
misconduct occurring within six years before the date HHS or an 
institution receives an allegation of research misconduct.
    (b) Exceptions to the six year limitation. Paragraph (a) of this 
section does not apply in the following instances:
    (1) Subsequent use exception. The respondent continues or renews 
any incident of alleged research misconduct that occurred before the 
six year limitation through the use or republication of the fabricated, 
falsified, or plagiarized research record.
    (2) Health or safety of the public exception. If ORI, or the 
institution following consultation with ORI, determines that the 
alleged misconduct, if it occurred, would possibly have a substantial 
adverse effect on the health or safety of the public.
    (3) ``Grandfather'' exception. If HHS or an institution had the 
allegation of research misconduct under review or investigation on the 
effective date of this regulation.


Sec.  93.106  Evidentiary standards.

    The following evidentiary standards apply to findings made under 
this part.
    (a) Burden of proof. (1) The institution or HHS has the burden of 
proof for making a finding of research misconduct. The absence of, or 
respondent's failure to provide, research records adequately 
documenting the questioned research establishes a rebuttable 
presumption of research misconduct that may be relied upon by the 
institution or HHS in proving research misconduct. Credible evidence 
corroborating the research or providing a reasonable explanation for 
the absence of, or respondent's failure to provide, the research 
records may be used by the respondent to rebut this presumption.
    (2) Once the institution or HHS makes a prima facie showing of 
research misconduct, the respondent has the burden of proving any 
affirmative defenses raised, including any honest error or differences 
of opinion and of proving any mitigating factors that the respondent 
wants the institution or HHS to consider in imposing administrative 
actions following research misconduct proceedings.
    (b) Standard of proof. An institutional or HHS finding of research 
misconduct must be established by a preponderance of the evidence.


Sec.  93.107  Rule of interpretation.

    Any interpretation of this part must further the policy and purpose 
of the PHS and the Federal government to protect the health and safety 
of the public, to promote the integrity of research, and to conserve 
the public fisc.


Sec.  93.108  Confidentiality.

    (a) Disclosure of the identity of respondents and complainants in 
research misconduct proceedings is limited, to the extent possible, to 
those who need to know, consistent with a thorough, competent, 
objective and fair research misconduct proceeding, and as allowed by 
law. Provided, however, under section 93.517(g), PHS administrative 
hearings must be open to the public.
    (b) Except as may otherwise be prescribed by applicable law, 
confidentiality must be maintained for any records or evidence from 
which research subjects might be identified. Disclosure is limited to 
those who have

[[Page 20791]]

a need to know to carry out a research misconduct proceeding.


Sec.  93.109  Coordination with other agencies.

    (a) When more than one agency of the federal government has 
jurisdiction of the subject misconduct allegation, the agencies may 
coordinate responses to the allegation.
    (b) In cases involving more than one agency, HHS may refer to 
evidence or reports developed by that agency if HHS determines that the 
evidence or reports will assist in resolving HHS issues. In appropriate 
cases, HHS will seek to resolve allegations jointly with the other 
agency or agencies.

Subpart B--Definitions


Sec.  93.200  Administrative action.

    Administrative action means--
    (a) An HHS action in response to a research misconduct proceeding 
taken to protect the health and safety of the public, to promote the 
integrity of PHS supported research or research training, and to 
conserve the public fisc; or
    (b) An HHS action in response either to a breach of a material 
provision of a settlement agreement in a research misconduct proceeding 
or to a breach of any HHS debarment or suspension.


Sec.  93.201  Allegation.

    Allegation means a disclosure of possible research misconduct 
through any means of communication. The disclosure may be by written or 
oral statement or other communication to an institutional or HHS 
official.


Sec.  93.202  Charge letter.

    Charge letter means the written notice, as well as any amendments 
to the notice, that are sent to the respondent stating the PHS deciding 
official's findings of research misconduct and any HHS administrative 
actions. If the charge letter includes a debarment or suspension 
action, it may be issued jointly by the deciding and debarring 
officials.


Sec.  93.203  Complainant.

    Complainant means a person who in good faith makes an allegation of 
research misconduct.


Sec.  93.204  Contract.

    Contract means an acquisition instrument awarded under the HHS 
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any 
small purchases awarded pursuant to FAR Part 13.


Sec.  93.205  Debarment or suspension.

    Debarment or suspension means the Governmentwide exclusion, whether 
temporary or for a set term, of a person from eligibility for Federal 
grants, contracts, and cooperative agreements under the HHS regulations 
at 45 CFR Part 76 (nonprocurement) and 48 CFR Subparts 9.4 and 309.4 
(procurement).


Sec.  93.206  Debarring official.

    Debarring official means an official authorized to impose debarment 
or suspension. The HHS debarring official is either--
    (a) The Secretary; or
    (b) An official designated by the Secretary.


Sec.  93.207  Deciding official.

    Deciding official means an official authorized to make PHS findings 
of research misconduct and to impose HHS administrative actions. The 
deciding official is either--
    (a) The Secretary; or
    (b) An official designated by the Secretary.


Sec.  93.208  Departmental Appeals Board or DAB.

    Departmental Appeals Board or DAB means, depending on the context--
    (a) The organization, within the Office of the Secretary, 
established to conduct hearings and provide impartial review of 
disputed decisions made by HHS operating components; or
    (b) An Administrative Law Judge (ALJ) at the DAB.


Sec.  93.209  Evidence.

    Evidence means any document, tangible item, or testimony offered or 
obtained during a research misconduct proceeding that tends to prove or 
disprove the existence of an alleged fact.


Sec.  93.210  Funding component.

    Funding component means any organizational unit of the PHS 
authorized to award grants, contracts, or cooperative agreements for 
any activity that involves the conduct of biomedical or behavioral 
research or research training, e.g., agencies, bureaus, centers, 
institutes, divisions, or offices and other awarding units within the 
PHS.


Sec.  93.211  Good faith.

    Good faith means having a belief in the truth of one's allegation 
or testimony that a reasonable person in the complainant's or witness's 
position could have based on the information known to the complainant 
or witness at the time. An allegation or cooperation with a research 
misconduct proceeding is not in good faith if made with knowing or 
reckless disregard for information that would negate the allegation or 
testimony.


Sec.  93.212  Hearing.

    Hearing means that part of the research misconduct proceeding from 
the time a respondent files a request for an administrative hearing to 
contest PHS findings of research misconduct and HHS administrative 
actions until the time the hearing officer issues a recommended 
decision.


Sec.  93.213  Inquiry.

    Inquiry means preliminary information-gathering and preliminary 
fact-finding to determine whether an allegation or apparent instance of 
research misconduct has substance and if an investigation is warranted.


Sec.  93.214  Institution.

    Institution means any individual or entity that applies for or 
receives PHS support for any activity or program that involves the 
conduct of biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or training. 
This includes, but is not limited to, colleges and universities, PHS 
intramural biomedical or behavioral research laboratories, research and 
development centers, national user facilities, industrial laboratories 
or other research institutes, small research institutions, and 
independent researchers.


Sec.  93.215  Institutional member.

    Institutional member or members means a person who is employed by, 
is an agent of, or is affiliated by contract or agreement with an 
institution. Institutional members may include, but are not limited to, 
officials, teaching and support staff, researchers, clinical 
technicians, fellows, students, volunteers, agents, and contractors, 
subcontractors, and subawardees, and their employees.


Sec.  93.216  Investigation.

    Investigation means the formal development of a factual record and 
the examination of that record leading to a decision not to make a 
finding of research misconduct or to a recommendation for a finding of 
research misconduct or other appropriate remedies, including 
administrative actions.


Sec.  93.217  Notice.

    Notice means a written communication served in person, sent by mail 
or its equivalent to the last known street address, facsimile number or 
e-mail address of the addressee. Several sections of Subpart E have 
special notice requirements.

[[Page 20792]]

Sec.  93.218  Office of Research Integrity or ORI.

    Office of Research Integrity or ORI means the office to which the 
HHS Secretary has delegated responsibility for addressing research 
integrity and misconduct issues related to PHS activities.


Sec.  93.219  Person.

    Person means any individual, corporation, partnership, institution, 
association, unit of government, or legal entity, however organized.


Sec.  93.220  Preponderance of the evidence.

    Preponderance of the evidence means proof by information that, 
compared with that opposing it, leads to the conclusion that the fact 
at issue is more probably true than not.


Sec.  93.221  Prima facie showing.

    Prima facie showing means evidence that on its face is sufficient 
to establish research misconduct in the absence of respondent's 
presentation of substantial contradictory evidence.


Sec.  93.222  Public Health Service or PHS.

    Public Health Service or PHS means the unit within the Department 
of Health and Human Services that includes the Office of Public Health 
and Science and the following Operating Divisions: Agency for 
Healthcare Research and Quality, Agency for Toxic Substances and 
Disease Registry, Centers for Disease Control and Prevention, Food and 
Drug Administration, Health Resources and Services Administration, 
Indian Health Service, National Institutes of Health, and the Substance 
Abuse and Mental Health Services Administration, and the offices of the 
Regional Health Administrators.


Sec.  93.223  PHS support.

    PHS support means PHS funding, or applications or proposals 
therefor, for biomedical or behavioral research, biomedical or 
behavioral research training, or activities related to that research or 
training, that may be provided through: Funding for PHS intramural 
research; grants, cooperative agreements, or contracts; or subgrants, 
subcontracts, or other payments under grants, cooperative agreements, 
or contracts.


Sec.  93.224  Research.

    Research means a systematic experiment, study, evaluation, 
demonstration or survey designed to develop or contribute to general 
knowledge (basic research) or specific knowledge (applied research) 
relating broadly to public health by establishing, discovering, 
developing, elucidating or confirming information about, or the 
underlying mechanism relating to, biological causes, functions or 
effects, diseases, treatments, or related matters to be studied.


Sec.  93.225  Research misconduct proceeding.

    Research misconduct proceeding means any actions related to alleged 
research misconduct taken under this part, including but not limited 
to, allegation assessments, inquiries, investigations, ORI oversight 
reviews, hearings, and administrative appeals.


Sec.  93.226  Research record.

    Research record means the record of data or results that embody the 
facts resulting from scientific inquiry, including but not limited to, 
research proposals, laboratory records, both physical and electronic, 
progress reports, abstracts, theses, oral presentations, internal 
reports, journal articles, and any documents and materials provided to 
HHS or an institutional official by a respondent in response to 
questions about the research at issue.


Sec.  93.227  Respondent.

    Respondent means the person against whom an allegation of research 
misconduct is directed or who is the subject of a research misconduct 
proceeding.


Sec.  93.228  Retaliation.

    Retaliation for the purpose of this part means an adverse action 
taken against a complainant, witness, or committee member by an 
institution or one of its members in response to--
    (a) A good faith allegation of research misconduct; or
    (b) Good faith cooperation with a research misconduct proceeding.


Sec.  93.229  Secretary or HHS.

    Secretary or HHS means the Secretary of HHS or any other officer or 
employee of the HHS to whom the Secretary delegates authority.

Subpart C--Responsibilities of Institutions

Compliance and Assurances


Sec.  93.300  General responsibilities for compliance.

    Institutions under this part must--
    (a) Have written policies and procedures for conducting and 
reporting inquiries and investigations of alleged research misconduct 
in compliance with this part;
    (b) Respond to each allegation of research misconduct at the 
institution involving PHS supported research in compliance with this 
part;
    (c) Foster a research environment that promotes the responsible 
conduct of research and research training, discourages research 
misconduct, and deals promptly with allegations or evidence of possible 
research misconduct;
    (d) Take all reasonable and practical steps to protect the 
positions and reputations of good faith complainants, witnesses and 
committee members and protect them from retaliation by respondents and 
other institutional members;
    (e) Provide confidentiality to the extent required by Sec.  93.108 
to all respondents, complainants, and research subjects identifiable 
from research records or evidence;
    (f) Take all reasonable and practical steps to ensure the 
cooperation of respondents and other institutional members with 
research misconduct proceedings, including, but not limited to, their 
providing information, research records, and evidence;
    (g) Cooperate with HHS during any research misconduct proceeding or 
compliance review;
    (h) Assist in administering and enforcing any HHS administrative 
actions imposed on its institutional members; and
    (i) Have an active assurance of compliance.


Sec.  93.301  Institutional assurances.

    (a) General policy. An institution with PHS supported biomedical or 
behavioral research, biomedical or behavioral research training or 
activities related to that research or training must provide PHS with 
an assurance of compliance with this part, satisfactory to the 
Secretary. PHS funding components may authorize funds for biomedical 
and behavioral research, research training, and related activities only 
to institutions that have approved assurances and required renewals on 
file with ORI.
    (b) Institutional Assurance. The responsible institutional official 
must assure on behalf of the institution that the institution--
    (1) Has written policies and procedures in compliance with this 
part for inquiring into and investigating allegations of research 
misconduct; and
    (2) Complies with its own policies and procedures and the 
requirements of this part.


Sec.  93.302  Institutional compliance with assurances.

    (a) Compliance with assurance. ORI considers an institution in 
compliance with its assurance if the institution--

[[Page 20793]]

    (1) Establishes policies and procedures according to this part, 
keeps them in compliance with this part, and upon request, provides 
them to ORI and to other authorized HHS personnel;
    (2) Takes all reasonable and practical specific steps to foster 
research integrity consistent with Sec.  93.300, including--
    (i) Informs the institution's research members participating in or 
otherwise involved with PHS supported biomedical or behavioral 
research, research training or related activities, including those 
applying for support from any PHS funding component, about its policies 
and procedures for responding to allegations of research misconduct, 
and the institution's commitment to compliance with the policies and 
procedures; and
    (ii) Complies with its policies and procedures and each specific 
provision of this part.
    (b) Annual report. An institution must file an annual report with 
ORI which contains information specified by ORI on the institution's 
compliance with this part.
    (c) Additional information. Along with its assurance or annual 
report, an institution must send ORI other aggregated information on 
research misconduct proceedings and compliance with the requirements of 
this part that ORI may request.


Sec.  93.303  Assurances for small institutions.

    (a) If an institution is too small to handle research misconduct 
proceedings, it may file a ``Small Organization Statement'' with ORI in 
place of the formal institutional policies and procedures required by 
Sec.  93.301.
    (b) By submitting a Small Organization Statement, the institution 
agrees to report all allegations of research misconduct to ORI. ORI or 
another appropriate HHS office will work with the institution to 
develop and implement a process for handling allegations of research 
misconduct consistent with this part.
    (c) The Small Organization Statement does not relieve the 
institution from complying with any other provision of this part.


Sec.  93.304  Institutional policies and procedures.

    Institutions seeking an approved assurance must have written 
policies and procedures for addressing research misconduct that include 
the following--
    (a) Consistent with Sec.  93.108, protection of the confidentiality 
of respondents, complainants, and research subjects identifiable from 
research records or evidence;
    (b) A thorough, competent, objective, and fair response to 
allegations of research misconduct consistent with and within the time 
limits of this part;
    (c) Notice to the respondent, consistent with and within the time 
limits of this part;
    (d) Written notice to ORI of any decision to open an investigation 
either within 30 days of the decision or before the date the 
investigation begins, whichever happens first;
    (e) Opportunity for the respondent to provide written comments on 
the institution's inquiry report;
    (f) Opportunity for the respondent to provide written comments on 
the draft report of the investigation, and provisions for the 
institutional investigation committee to consider and address the 
comments before issuing the final report;
    (g) Protocols for handling the research record and evidence, 
including the requirements of Sec.  93.305;
    (h) Appropriate interim institutional actions to protect public 
health, Federal funds and equipment, and the integrity of the PHS 
supported research process;
    (i) Notice to ORI under `` 93.318 and notice of any facts that may 
be relevant to protect public health, Federal funds and equipment, and 
the integrity of the PHS supported research process;
    (j) Institutional actions in response to final findings of research 
misconduct;
    (k) All reasonable and practical efforts, if requested and as 
appropriate, to protect or restore the reputation of persons alleged to 
have engaged in research misconduct but against whom no finding of 
research misconduct is made;
    (l) All reasonable and practical efforts to protect or restore the 
position and reputation of any complainant, witness, or committee 
member and to counter potential or actual retaliation against these 
complainants, witnesses, and committee members; and
    (m) Full and continuing cooperation with ORI during its oversight 
review under Subpart D of this part or any subsequent administrative 
hearings or appeals under Subpart E of this part. This includes 
providing all research records and evidence under the institution's 
control, custody, or possession and access to all persons within its 
authority necessary to develop a complete record of relevant and 
material evidence.


Sec.  93.305  Responsibility for maintenance and custody of research 
records and evidence.

    An institution, as the responsible legal entity for the PHS 
supported research, has a continuing obligation under this part to 
ensure that it maintains adequate records for a research misconduct 
proceeding. The institution must--
    (a) Either before or when the institution notifies the respondent 
of the allegation, inquiry or investigation, promptly take all 
reasonable and practical efforts to obtain custody of all the research 
records and evidence needed to conduct the research misconduct 
proceeding, inventory the records and evidence, and sequester them in a 
secure manner;
    (b) Where appropriate, give the respondent copies of or reasonable, 
supervised access to the research records;
    (c) Undertake all reasonable and practical efforts to take custody 
of additional research records or evidence that are discovered during 
the course of a research misconduct proceeding; and
    (d) Maintain the research records and evidence until ORI requests 
them, HHS takes final action, or as required by Sec.  93.317, as 
applicable.


Sec.  93.306  Using a consortium or other entity for research 
misconduct proceedings.

    (a) If an institution is too small, is otherwise unable to respond 
to allegations of research misconduct because of real or apparent 
conflicts of interest, lacks the capacity, or otherwise prefers not to 
conduct its own research misconduct proceeding, it may use the services 
of a consortium or other entity qualified by practice and experience to 
conduct research misconduct proceedings.
    (b) A consortium may be a group of institutions, professional 
organizations, or mixed groups which will conduct research misconduct 
proceedings for other institutions.
    (c) A consortium or entity acting on behalf of an institution must 
follow the requirements of this part in conducting research misconduct 
proceedings.

The Institutional Inquiry


Sec.  93.307  Institutional inquiry.

    (a) Criteria warranting an inquiry. An inquiry is warranted if the 
allegation--
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Involves PHS supported research; and
    (3) Is sufficiently credible and specific so that potential 
evidence of research misconduct may be identified.
    (b) Notice. At the time of or before beginning an inquiry, an 
institution must make a good faith effort to notify in writing the 
presumed respondent, if any. If the inquiry subsequently identifies 
additional respondents, the institution must notify them.

[[Page 20794]]

    (c) Review of evidence. The purpose of an inquiry is to conduct an 
initial review of the evidence to determine whether to conduct an 
investigation. Therefore, an inquiry does not require a full review of 
all the evidence related to the allegation.
    (d) Criteria warranting an investigation. An inquiry's purpose is 
to decide if an allegation warrants an investigation. An investigation 
is warranted if there is--
    (1) A reasonable basis for concluding that the allegation involves 
PHS supported research and falls within the PHS definition of research 
misconduct; and
    (2) Preliminary information-gathering and preliminary fact-finding 
from the inquiry indicates that the allegation may have substance.
    (e) Inquiry report. The institution must prepare a written report 
that meets the requirements of Sec.  93.309.
    (f) Opportunity to comment. The institution must provide the 
respondent an opportunity to review and comment on the inquiry report 
and attach any comments received to the report.
    (g) Time for completion. The institution must complete the inquiry 
within 60 calendar days of its initiation unless circumstances clearly 
warrant a longer period. If the inquiry takes longer than 60 days to 
complete, the inquiry record must include documentation of the reasons 
for exceeding the 60-day period.


Sec.  93.308  Notice of the results of the inquiry.

    (a) Notice to respondent. The institution must notify the 
respondent whether the inquiry found that an investigation is 
warranted. The notice must include a copy of the inquiry report and 
include or refer to a copy of this part and the institution's policies 
and procedures adopted under its assurance.
    (b) Notice to complainants. The institution may notify the 
complainant who made the allegation whether the inquiry found that an 
investigation is warranted. The institution may provide relevant 
portions of the report to any complainant for comment.


Sec.  93.309  Reporting to ORI on the decision to initiate an 
investigation.

    (a) Within 30 days of finding that an investigation is warranted, 
the institution must provide ORI with the written finding by the 
responsible institutional official and a copy of the inquiry report 
which includes the following information--
    (1) The name and position of the respondent;
    (2) A description of the allegations of research misconduct;
    (3) The PHS support, including, for example, grant numbers, grant 
applications, contracts, and publications listing PHS support;
    (4) The basis for recommending that the alleged actions warrant an 
investigation; and
    (5) Any comments on the report by the respondent, complainant, or a 
witness.
    (b) The institution must provide the following information to ORI 
on request--
    (1) The institutional policies and procedures under which the 
inquiry was conducted;
    (2) The research records and evidence reviewed, transcripts or 
recordings of any interviews, and copies of all relevant documents; and
    (3) The charges for the investigation to consider.
    (c) Documentation of decision not to investigate. Institutions must 
keep sufficiently detailed documentation of inquiries to permit a later 
assessment by ORI of the reasons why the institution decided not to 
conduct an investigation. Consistent with section 93.317, institutions 
must keep these records in a secure manner for at least 7 years after 
the termination of the inquiry, and upon request, provide them to ORI 
or other authorized HHS personnel.
    (d) Notification of special circumstances. In accordance with Sec.  
93.318, institutions must notify ORI and other PHS agencies, as 
relevant, of any special circumstances that may exist.

The Institutional Investigation


Sec.  93.310  Institutional investigation.

    Institutions conducting research misconduct investigations must:
    (a) Time. Begin the investigation within 30 days after determining 
that an investigation is warranted.
    (b) Notice to ORI. Notify the ORI Director of the decision to begin 
an investigation on or before the date the investigation begins and 
provide an inquiry report that meets the requirements of Sec.  93.309.
    (c) Notice to the respondent. Notify the respondent in writing of 
the allegations within a reasonable amount of time after determining 
that an investigation is warranted, but before the investigation 
begins. The institution must give the respondent written notice of any 
new allegations of research misconduct within a reasonable amount of 
time of deciding to pursue allegations not addressed during the inquiry 
or in the initial notice of investigation.
    (d) Custody of the records. Take custody of and sequester any 
relevant research records and evidence needed to conduct the 
investigation not taken into custody at the allegation or inquiry 
stage. Whenever possible, the institution must take custody of the 
records--
    (1) Before or at the time the institution notifies the respondent; 
and
    (2) Whenever additional items become known or relevant to the 
investigation.
    (e) Documentation. Use diligent efforts to ensure that the 
investigation is thorough and sufficiently documented and includes 
examination of all research records and evidence relevant to reaching a 
decision on the merits of the allegations.
    (f) Ensuring a fair investigation. Take reasonable steps to ensure 
an impartial and unbiased investigation to the maximum extent 
practicable, including participation of persons with appropriate 
scientific expertise who do not have unresolved personal, professional, 
or financial conflicts of interest with those involved with the inquiry 
or investigation.
    (g) Interviews. Interview each respondent, complainant, and any 
other available person who may have substantive information regarding 
any relevant aspects of the investigation, including witnesses 
identified by the respondent, and maintain detailed records. Record or 
transcribe each interview, provide the recording or transcript to the 
interviewee for correction, and include the recording or transcript in 
the record of the investigation.
    (h) Pursue leads. Pursue diligently all significant issues and 
leads discovered, including any evidence of additional instances of 
possible research misconduct, and continue the investigation to 
completion.


Sec.  93.311  Investigation time limits.

    (a) Time limit for completing an investigation. An institution must 
complete all aspects of an investigation within 120 days of beginning 
it, including conducting the investigation, preparing the report of 
findings, giving the draft report to the respondent for comment, and 
sending the final report to ORI under Sec.  93.315.
    (b) Extension of time limit. If unable to complete the 
investigation in 120 days, the institution must ask ORI for an 
extension in writing.
    (c) If ORI grants an extension, it may direct the institution to 
file periodic progress reports.

[[Page 20795]]

Sec.  93.312  Opportunity to comment on the investigation report.

    (a) The institution must give the respondent a copy of the draft 
investigation report for review and comment within 30 days of the 
respondent's receipt of the draft report; and
    (b) The institution may provide relevant portions of the report to 
complainants for comment within 30 days of their receipt of the 
relevant portions of the report.


Sec.  93.313  Institutional investigation report.

    The final institutional investigation report must be in writing and 
include:
    (a) Allegations. Describe the nature of the allegations of research 
misconduct.
    (b) PHS support. Describe and document the PHS support, including, 
for example, any grant numbers, grant applications, contracts, and 
publications listing PHS support.
    (c) Institutional charge. Describe the specific allegations of 
research misconduct for consideration in the investigation.
    (d) Policies and procedures. If not already provided to ORI with 
the inquiry report, include the institutional policies and procedures 
under which the investigation was conducted.
    (e) Research records and evidence. Identify and summarize the 
research records and evidence reviewed, and identify any evidence taken 
into custody but not reviewed.
    (f) Statement of findings. For each separate allegation of research 
misconduct identified during the investigation, provide a finding as to 
whether research misconduct did or did not occur, and if so--
    (1) Identify whether the research misconduct was falsification, 
fabrication, or plagiarism, and if it was intentional, knowing, or in 
reckless disregard;
    (2) Summarize the facts and the analysis which support the 
conclusion and consider the merits of any reasonable explanation by the 
respondent;
    (3) Identify the specific PHS support;
    (4) Identify whether any publications need correction or 
retraction;
    (5) Identify the person(s) responsible for the misconduct; and
    (6) List any current support or known applications or proposals for 
support that the respondent has pending with non-PHS Federal agencies.
    (g) Comments. Include and consider any comments made by the 
respondent and complainant on the draft investigation report.
    (h) Maintain and provide records. Maintain and provide to ORI upon 
request all relevant research records, including results of all 
interviews and the transcripts or recordings of such interviews.


Sec.  93.314  Institutional appeals.

    (a) While not required by this part, if the institution's 
procedures provide for appeal by the respondent, the institution must 
complete any appeals within 120 days of filing the appeal.
    (b) If unable to complete any appeals within 120 days, the 
institution must ask ORI for an extension in writing and provide an 
explanation for the request.
    (c) ORI may grant requests for extension for good cause. If ORI 
grants an extension, it may direct the institution to file periodic 
progress reports.


Sec.  93.315  Notice to ORI of institutional findings and actions.

    The institution must give ORI the following:
    (a) Investigation Report. Include a copy of the report, all 
attachments, and any appeals.
    (b) Final institutional action. State whether the institution found 
research misconduct, and if so, who committed the misconduct.
    (c) Findings. State whether the institution accepts the 
investigation's findings.
    (d) Institutional administrative actions. Describe any pending or 
completed administrative actions against the respondent.


Sec.  93.316  Completing the research misconduct process.

    (a) ORI expects institutions to carry inquiries and investigations 
through to completion and to pursue diligently all significant issues. 
If an institution plans to end an inquiry or investigation before 
completion for any reason, including an admission of misconduct by the 
respondent, it must contact ORI before closing the case and submitting 
its final report.
    (b) After review of an institution's decision to end an inquiry or 
investigation before completion, ORI may direct the institution to 
complete its process or refer the matter for further investigation by 
HHS.

Other Institutional Responsibilities


Sec.  93.317  Retention and custody of the research misconduct 
proceeding record.

    (a) Maintenance of record. Institutions must maintain records of 
research misconduct proceedings in a secure manner for 7 years after 
their completion or the completion of any PHS proceeding involving the 
research misconduct allegation under subparts D and E of this part, 
whichever is later.
    (b) Provision for HHS custody. On request, institutions must 
transfer custody of or provide copies to HHS, of any institutional 
record relevant to a research misconduct allegation covered by this 
part, including the research records and evidence, to perform forensic 
or other analyses or as otherwise needed to conduct an HHS inquiry or 
investigation or for ORI to conduct its review or to present evidence 
in any PHS proceeding under subparts D and E of this part.


Sec.  93.318  Notifying ORI of special circumstances.

    At any time during a research misconduct proceeding, as defined in 
section 93.225, an institution must notify ORI immediately if it has 
reason to believe that any of the following conditions exist:
    (a) Health or safety of the public is at risk, including an 
immediate need to protect human or animal subjects.
    (b) HHS resources or interests are threatened.
    (c) Research activities should be suspended.
    (d) There is reasonable indication of possible violations of civil 
or criminal law.
    (e) Federal action is required to protect the interests of those 
involved in the research misconduct proceeding.
    (f) The research institution believes the research misconduct 
proceeding may be made public prematurely so that HHS may take 
appropriate steps to safeguard evidence and protect the rights of those 
involved.
    (g) The research community or public should be informed.


Sec.  93.319  Institutional standards.

    (a) Institutions may have internal standards of conduct different 
from the PHS standards for research misconduct under this part. 
Therefore, an institution may find conduct to be actionable under its 
standards even if the action does not meet this part's definition of 
research misconduct.
    (b) An HHS finding or settlement does not affect institutional 
findings or administrative actions based on an institution's internal 
standards of conduct.

Subpart D--Responsibilities of the U.S. Department of Health and 
Human Services

General Information


Sec.  93.400  General statement of ORI authority.

    (a) ORI review. ORI may respond directly to any allegation of 
research misconduct at any time before, during,

[[Page 20796]]

or after an institution's response to the matter. The ORI response may 
include, but is not limited to--
    (1) Conducting allegation assessments;
    (2) Determining independently if PHS or HHS jurisdiction exists 
under this part in any matter;
    (3) Forwarding allegations of research misconduct to the 
appropriate institution or HHS component for inquiry or investigation;
    (4) Recommending that HHS should perform an inquiry or 
investigation or issue findings and taking all appropriate actions in 
response to the inquiry, investigation, or findings;
    (5) Notifying or requesting assistance and information from PHS 
funding components or other affected Federal and state offices and 
agencies or institutions;
    (6) Reviewing an institution's findings and process; and
    (7) Making recommendations to the HHS deciding or debarring 
officials.
    (b) Requests for information. ORI may request clarification or 
additional information, documentation, research records, or evidence 
from an institution or its members or other persons or sources to carry 
out ORI's review.
    (c) HHS administrative actions.
    (1) In response to a research misconduct proceeding, ORI may 
propose HHS administrative actions against any person to the HHS 
deciding official and implement the actions.
    (2) ORI may propose to the HHS debarring official that a person be 
suspended or debarred from receiving Federal funds and may propose to 
other appropriate PHS components the implementation of HHS 
administrative actions within the components' authorities.
    (d) ORI assistance to institutions. At any time, ORI may provide 
information, technical assistance, and procedural advice to 
institutional officials as needed regarding an institution's 
participation in research misconduct proceedings.
    (e) Review of institutional assurances. ORI may review 
institutional assurances and policies and procedures for compliance 
with this part.
    (f) Institutional compliance. ORI may make findings and impose HHS 
administrative actions related to an institution's compliance with this 
part and with its policies and procedures, including an institution's 
participation in research misconduct proceedings.


Sec.  93.401  Communications with other offices and interim actions.

    (a) ORI may notify and consult with other Federal agencies at any 
time if it has a reason to believe that a research misconduct 
proceeding may involve that agency. If ORI believes that a criminal or 
civil fraud violation may have occurred, it shall promptly refer the 
matter to the Department of Justice, the HHS Inspector General, or 
other appropriate investigative body.
    (b) ORI may notify affected PHS offices and funding components at 
any time to permit them to make appropriate interim responses to 
protect the health and safety of the public, to promote the integrity 
of the PHS supported research and research process, and to conserve the 
public fisc.
    (c) The information provided will not be disclosed as part of the 
peer review and advisory committee review processes, but may be used by 
the Secretary in making decisions about the award or continuation of 
funding.

Research Misconduct Issues


Sec.  93.402  ORI allegation assessments.

    (a) When ORI receives an allegation of research misconduct directly 
or becomes aware of an allegation or apparent instance of research 
misconduct, it may conduct an initial assessment or refer the matter to 
the relevant institution for an assessment, inquiry, or other 
appropriate actions.
    (b) If ORI conducts an assessment, it considers whether the 
allegation of research misconduct appears to fall within the definition 
of research misconduct, appears to involve PHS supported research, and 
whether it is sufficiently specific so that potential evidence may be 
identified and sufficiently substantive to warrant an inquiry. ORI may 
review all readily accessible, relevant information related to the 
allegation.
    (c) If ORI decides that an inquiry is warranted, it forwards the 
matter to the appropriate institution or HHS component.
    (d) If ORI decides that an inquiry is not warranted, it may close 
the case.
    (e) ORI may forward allegations that do not fall within the 
jurisdiction of this part to the appropriate HHS component, Federal or 
State agency, institution, or other appropriate entity.


Sec.  93.403  ORI review of research misconduct proceedings.

    ORI may conduct reviews of research misconduct proceedings. In 
conducting its review, ORI may--
    (a) Determine whether there is PHS jurisdiction under this part;
    (b) Consider any reports, institutional findings, research records, 
and evidence;
    (c) Determine if the institution conducted the proceedings in a 
timely manner with sufficient objectivity, thoroughness, and competence 
to support the conclusions;
    (d) Obtain additional information or materials from the 
institution, the respondent, complainants, or other persons or sources;
    (e) Conduct additional analyses and develop evidence;
    (f) Decide whether research misconduct occurred, and if so who 
committed it;
    (g) Recommend appropriate research misconduct findings and 
administrative actions; and
    (h) Take any other actions necessary to complete HHS' review.


Sec.  93.404  HHS findings on research misconduct proceedings.

    After completing its review, ORI either closes the case without a 
finding of research misconduct or recommends that HHS--
    (a) Make findings of research misconduct and impose HHS 
administrative actions based on the record of the research misconduct 
proceedings and any other information obtained by ORI during its 
review; or
    (b) Accept a proposed settlement.


Sec.  93.405  Notifying the respondent of findings of research 
misconduct and HHS administrative actions.

    (a) When the PHS makes a finding of research misconduct or seeks to 
impose or enforce HHS administrative actions, it notifies the 
respondent in a charge letter. This letter includes the PHS findings of 
research misconduct and the basis for them and any HHS administrative 
actions. The letter also advises the respondent of the opportunity to 
contest the findings and administrative actions under Subpart E of this 
part.
    (b) The PHS sends the charge letter by certified mail or a private 
delivery service to the last known address of the respondent or the 
last known principal place of business of the respondent's attorney.
    (c) In cases involving a debarment or suspension action, the HHS 
debarring official notifies the respondent. At the discretion of the 
debarring official, this notice may be combined with the charge letter 
in paragraph (a) of this section.


Sec.  93.406  Final HHS actions.

    Unless the respondent seeks to contest the charge letter under 
subpart E of this part, the deciding official's decision is HHS' final 
action on the PHS research misconduct issues and the HHS administrative 
actions, except that the debarring official's decision is the final HHS 
action on any debarment or suspension actions.

[[Page 20797]]

Sec.  93.407  HHS administrative actions.

    (a) In response to a research misconduct proceeding, HHS may impose 
HHS administrative actions that include but are not limited to:
    (1) Clarification, correction, or retraction of the research 
record.
    (2) Letters of reprimand.
    (3) Imposition of special certification or assurance requirements 
to ensure compliance with applicable regulations or terms of PHS 
grants, contracts, or cooperative agreements.
    (4) Suspension or termination of a PHS grant, contract, or 
cooperative agreement.
    (5) Restriction on specific activities or expenditures under an 
active PHS grant, contract, or cooperative agreement.
    (6) Special review of all requests for PHS funding.
    (7) Imposition of supervision requirements on a PHS grant, 
contract, or cooperative agreement.
    (8) Certification of attribution or authenticity in all requests 
for support and reports to the PHS.
    (9) No participation in any advisory capacity to the PHS.
    (10) Adverse personnel action if the respondent is a Federal 
employee, in compliance with relevant Federal personnel policies and 
laws.
    (11) Suspension or debarment under 45 CFR Part 76, 48 CFR subparts 
9.4 and 309.4., or both.
    (b) In connection with findings of research misconduct, HHS also 
may seek to recover funds spent on PHS supported biomedical or 
behavioral research, research training or related activities.
    (c) Any authorized HHS component may impose, administer, or enforce 
HHS administrative actions separately or in coordination with other HHS 
components, including, but not limited to, ORI, the Office of Inspector 
General, the PHS funding component, and the debarring official.


Sec.  93.408  Mitigating and aggravating factors in HHS administrative 
actions.

    The purpose of HHS administrative actions is remedial. The 
appropriate administrative action is commensurate with the seriousness 
of the misconduct, and the need to protect the health and safety of the 
public, promote the integrity of the PHS supported research and 
research process, and conserve the public fisc. PHS considers 
aggravating and mitigating factors in determining appropriate HHS 
administrative actions and their terms. PHS may consider other factors 
as appropriate in each case. The existence or nonexistence of any 
factor is not determinative:
    (a) Knowing, intentional, or reckless. Were the respondent's 
actions knowing or intentional or was the conduct reckless?
    (b) Pattern. Was the research misconduct an isolated event or part 
of a continuing or prior pattern of dishonest conduct?
    (c) Impact. Did the misconduct have significant impact on the 
proposed or reported research record, research subjects, other 
researchers, institutions, or the public health or welfare?
    (d) Acceptance of responsibility. Has the respondent accepted 
responsibility for the misconduct by--
    (1) Admitting the conduct;
    (2) Cooperating with the research misconduct proceedings;
    (3) Demonstrating remorse and awareness of the significance and 
seriousness of the research misconduct; and
    (4) Taking steps to correct or prevent the recurrence of the 
research misconduct.
    (e) Failure to accept responsibility. Does the respondent blame 
others rather than accepting responsibility for the actions?
    (f) Retaliation. Did the respondent retaliate against complainants, 
witnesses, committee members, or other persons?
    (g) Present responsibility. Is the respondent presently responsible 
to conduct PHS supported research?
    (h) Other factors. Other factors appropriate to the circumstances 
of a particular case.


Sec.  93.409  Settlement of research misconduct proceedings.

    (a) HHS may settle a research misconduct proceeding at any time it 
concludes that settlement is in the best interests of the Federal 
government and the public health or welfare.
    (b) Settlement agreements are publicly available, regardless of 
whether the PHS made a finding of research misconduct.


Sec.  93.410  Final HHS action with no settlement or finding of 
research misconduct.

    When the final HHS action does not result in a settlement or 
finding of research misconduct, ORI may:
    (a) Provide written notice to the respondent, the relevant 
institution, the complainant, and HHS officials.
    (b) Take any other actions authorized by law.


Sec.  93.411  Final HHS action with settlement or finding of research 
misconduct.

    When a final HHS action results in a settlement or research 
misconduct finding, ORI may:
    (a) Provide final notification of any PHS research misconduct 
findings and HHS administrative actions to the respondent, the relevant 
institution, the complainant, and HHS officials. The debarring official 
may provide a separate notice of final HHS action on any debarment or 
suspension actions.
    (b) Identify publications which require correction or retraction 
and prepare and send a notice to the relevant journal.
    (c) Publish notice of the research misconduct findings.
    (d) Notify the respondent's current employer.
    (e) Take any other actions authorized by law.

Institutional Compliance Issues


Sec.  93.412  Making decisions on institutional noncompliance.

    (a) Institutions must foster a research environment that 
discourages misconduct in all research and that deals forthrightly with 
possible misconduct associated with PHS supported research.
    (b) ORI may decide that an institution is not compliant with this 
part if the institution shows a disregard for, or inability or 
unwillingness to implement and follow the requirements of this part and 
its assurance. In making this decision, ORI may consider, but is not 
limited to, the following factors--
    (1) Failure to establish and comply with policies and procedures 
under this part;
    (2) Failure to respond appropriately when allegations of research 
misconduct arise;
    (3) Failure to report to ORI all investigations and findings of 
research misconduct under this part;
    (4) Failure to cooperate with ORI's review of research misconduct 
proceedings; or
    (5) Other actions or omissions that have a material, adverse effect 
on reporting and responding to allegations of research misconduct.


Sec.  93.413  HHS compliance actions.

    (a) An institution's failure to comply with its assurance and the 
requirements of this part may result in enforcement action against the 
institution.
    (b) ORI may address institutional deficiencies through technical 
assistance if the deficiencies do not substantially affect compliance 
with this part.
    (c) If an institution fails to comply with its assurance and the 
requirements of this part, HHS may take some or all of the following 
compliance actions:
    (1) Issue a letter of reprimand.
    (2) Direct that research misconduct proceedings be handled by HHS.
    (3) Place the institution on special review status.

[[Page 20798]]

    (4) Place information on the institutional noncompliance on the ORI 
web site.
    (5) Require the institution to take corrective actions.
    (6) Require the institution to adopt and implement an institutional 
integrity agreement.
    (7) Recommend that HHS debar or suspend the entity.
    (8) Any other action appropriate to the circumstances.
    (d) If the institution's actions constitute a substantial or 
recurrent failure to comply with this part, ORI may also revoke the 
institution's assurance under Sec. Sec.  93.301 or 93.303.
    (e) ORI may make public any findings of institutional noncompliance 
and HHS compliance actions.

Disclosure of Information


Sec.  93.414  Notice.

    (a) ORI may disclose information to other persons for the purpose 
of providing or obtaining information about research misconduct as 
permitted under the Privacy Act, 5 U.S.C. 552a.
    (b) ORI may publish notice of final agency findings of research 
misconduct, settlements, and HHS administrative actions and release and 
withhold information as permitted by the Privacy Act and the Freedom of 
Information Act, 5 U.S.C. 552.

Subpart E--Opportunity To Contest PHS Findings of Research 
Misconduct and HHS Administrative Actions

General Information


Sec.  93.500  General policy.

    (a) This subpart provides a respondent an opportunity to contest 
PHS findings of research misconduct and HHS administrative actions 
arising under 42 U.S.C. 289b in connection with PHS supported 
biomedical and behavioral research, research training, or activities 
related to that research or research training.
    (b) A respondent has an opportunity to contest PHS research 
misconduct findings and HHS administrative actions made under this part 
by requesting an administrative hearing before an Administrative Law 
Judge (ALJ) affiliated with the HHS DAB, when the PHS has--
    (1) Made a finding of research misconduct against a respondent; or
    (2) Proposed HHS administrative actions other than debarment or 
suspension against a respondent.
    (c) A respondent has an opportunity to contest a debarment or 
suspension action related to this part under the HHS debarment and 
suspension regulations. However, nothing in this subpart modifies, 
alters, or changes any rights provided under the HHS debarment and 
suspension regulations at 45 CFR Part 76, subpart C and 48 CFR Parts 
9.4 and 309.4.
    (d) The ALJ's ruling on the merits of the PHS research misconduct 
findings and the HHS administrative actions constitutes a recommended 
decision to the Assistant Secretary for Health. The Assistant Secretary 
for Health may modify, affirm, or reject the ALJ's ruling in whole or 
in part. The Assistant Secretary for Health's decision is final and 
becomes binding on the date the final decision is issued.
    (e) The decision of the ALJ constitutes a recommendation to the HHS 
debarring official in a debarment or suspension action. The debarring 
official may reject any resultant findings in whole or in part, only 
after specifically determining them to be arbitrary, capricious, or 
clearly erroneous.


Sec.  93.501  Opportunity to contest PHS findings of research 
misconduct and HHS administrative actions.

    (a) Opportunity to contest. A respondent may contest PHS findings 
of research misconduct and any HHS administrative actions, including 
any debarment or suspension action related to this part, by requesting 
a hearing within 30 days of receipt of the charge letter or other 
written notice provided under Sec.  93.405.
    (b) Form of a request for hearing. The respondent's request for a 
hearing must be--
    (1) In writing;
    (2) Signed by the respondent or by the respondent's attorney; and
    (3) Sent by certified mail, or other equivalent (i.e., with a 
verified method of delivery), to the DAB Chair and served on ORI.
    (c) Contents of a request for hearing. The request for a hearing 
must--
    (1) Admit or deny each PHS finding of research misconduct and each 
factual assertion made by PHS in support of the finding;
    (2) Accept or challenge each proposed HHS administrative action;
    (3) Provide detailed, substantive reasons for each denial or 
challenge;
    (4) Identify any legal issues or defenses that the respondent 
intends to raise during the proceeding; and
    (5) Identify any mitigating factors that the respondent intends to 
prove.
    (d) Extension for good cause to supplement the hearing request.
    (1) For good cause shown, the ALJ may grant an additional period of 
no more than 60 days from the respondent's receipt of the charge letter 
or other written notice provided under Sec.  93.405 to permit the 
respondent to supplement the hearing request to comply fully with the 
requirements of subsection (c).
    (2) Good cause means circumstances beyond the control of the 
respondent or respondent's representative and not attributable to 
neglect or administrative inadequacy.

Hearing Process


Sec.  93.502  Appointment of the Administrative Law Judge and 
scientific expert.

    (a) Within 30 days of receiving a request for a hearing, the DAB 
Chair, in consultation with the Chief Administrative Law Judge, must 
designate an Administrative Law Judge to conduct the hearing.
    (b) The ALJ may retain one or more persons with appropriate 
scientific or technical expertise to assist the ALJ in evaluating 
scientific issues related to the PHS findings of research misconduct. 
At the request of either party, the ALJ must retain such an expert.
    (c) No ALJ, or person hired or appointed to assist the ALJ, may 
serve in any proceeding under this subpart if he or she has any real or 
apparent conflict of interest that might reasonably impair his or her 
objectivity in the proceeding.
    (d) Any party to the proceeding may request the ALJ or scientific 
expert to withdraw from the proceeding because of a real or apparent 
conflict of interest under paragraph (c) of this section. The motion to 
disqualify must be timely and state with particularity the grounds for 
disqualification. The ALJ may rule upon the motion or certify it to the 
Chief ALJ for decision. If the hearing officer rules upon the motion, 
either party may appeal the decision to the Chief ALJ.
    (e) An ALJ must withdraw from any proceeding for any reason found 
by the ALJ or Chief ALJ to be disqualifying.


Sec.  93.503  Grounds for granting a hearing request.

    (a) The ALJ must grant a respondent's hearing request if the ALJ 
determines there is a genuine dispute over facts material to the PHS 
findings of research misconduct or HHS administrative actions, 
including any debarment or suspension action, if the debarring official 
has referred the matter to the hearing officer. The respondent's 
general denial or assertion of error for each PHS finding of research 
misconduct, and any basis for the finding, or for any HHS 
administrative actions in the charge letter, is not sufficient to 
establish a genuine dispute.

[[Page 20799]]

    (b) The hearing request must specifically deny each PHS finding of 
research misconduct in the charge letter, each basis for the finding 
and each HHS administrative action in the charge letter, or it is 
considered an admission by the respondent. If the hearing request does 
not specifically dispute the HHS administrative actions, including any 
debarment or suspension actions, they are considered accepted by the 
respondent.
    (c) If the respondent does not request a hearing within the 30-day 
time period, the PHS finding(s) and any HHS administrative action(s), 
including any debarment or suspension actions, become final agency 
actions at the expiration of the 30-day period.
    (d) If the ALJ grants the hearing request, the respondent may waive 
the opportunity for any in-person proceeding, and the ALJ may review 
and decide the case on the basis of the administrative record. The ALJ 
may grant a respondent's request that waiver of the in-person 
proceeding be conditioned upon the opportunity for respondent to file 
additional pleadings and documentation. ORI may also supplement the 
administrative record through pleadings, documents, in-person or 
telephonic testimony, and oral presentations.


Sec.  93.504  Grounds for dismissal of a hearing request.

    (a) The ALJ must dismiss a hearing request if the respondent--
    (1) Does not file the request within 30 days after receiving the 
charge letter;
    (2) Does not raise a genuine dispute over facts or law material to 
the PHS findings of research misconduct and any HHS administrative 
actions, including debarment and suspension actions in the hearing 
request or in any extension to supplement granted by the ALJ under 
Sec.  93.501(d);
    (3) Does not raise any issue which may properly be addressed in a 
hearing;
    (4) Withdraws or abandons the hearing request; or
    (b) The ALJ may dismiss a hearing request if the respondent fails 
to provide ORI with notice in the form and manner required by Sec.  
93.501.


Sec.  93.505  Rights of the parties.

    (a) The parties to the hearing are the respondent and ORI. The 
investigating institution is not a party to the case, unless it is a 
respondent.
    (b) Except as otherwise limited by this subpart, the parties may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any case-related conference held by the ALJ;
    (3) Conduct discovery of documents and other tangible items;
    (4) Agree to stipulations of fact or law that must be made part of 
the record;
    (5) File motions in writing before the hearing officer;
    (6) Present evidence relevant and material to the issues at the 
hearing;
    (7) Present and cross-examine witnesses;
    (8) Present oral arguments;
    (9) Submit written post-hearing briefs, proposed findings of fact 
and conclusions of law, and reply briefs within reasonable time frames 
agreed upon by the parties or established by the hearing officer as 
provided in Sec.  93.522; and
    (10) Submit materials to the ALJ and other parties under seal, or 
in redacted form, when necessary, to protect the confidentiality of any 
information contained in them consistent with this part, the Privacy 
Act, the Freedom of Information Act, or other Federal law or 
regulation.


Sec.  93.506  Authority of the Administrative Law Judge.

    (a) The ALJ assigned to the case must conduct a fair and impartial 
hearing, avoid unnecessary delay, maintain order, and assure that a 
complete and accurate record of the proceeding is properly made. The 
ALJ is bound by all Federal laws and regulations. In conducting the 
proceeding, the ALJ must comply with all Secretarial delegations of 
authority and applicable HHS policies. The ALJ has the authorities set 
forth in this part.
    (b) Subject to review as provided elsewhere in this subpart, the 
ALJ may--
    (1) Set and change the date, time, schedule, and place of the 
hearing upon reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences with the parties to identify or simplify the 
issues, or to consider other matters that may aid in the prompt 
disposition of the proceeding;
    (4) Administer oaths and affirmations;
    (5) Require the attendance of witnesses at a hearing;
    (6) Rule on motions and other procedural matters;
    (7) Require the production of documents and regulate the scope and 
timing of documentary discovery as permitted by this part;
    (8) Require each party before the hearing to provide the other 
party and the hearing officer with copies of any exhibits that the 
party intends to introduce into evidence;
    (9) Issue a ruling, after an in camera inspection if necessary, to 
address the disclosure of any evidence or portion of evidence for which 
confidentiality is requested under this part or other Federal law or 
regulation, or which a party submitted under seal;
    (10) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (11) Examine witnesses and receive evidence presented at the 
hearing;
    (12) Admit, exclude, or limit evidence offered by a party;
    (13) Hear oral arguments on facts or law during or after the 
hearing;
    (14) Upon motion of a party, take judicial notice of facts;
    (15) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact;
    (16) Conduct any conference or oral argument in person, by 
telephone, or by audio-visual communication;
    (17) Take action against any party for failing to follow an order 
or procedure or for disruptive conduct.
    (c) The ALJ does not have the authority to--
    (1) Enter an order in the nature of a directed verdict;
    (2) Compel settlement negotiations; or
    (3) Enjoin any act of the Secretary.


Sec.  93.507  Ex parte communications.

    (a) No party, attorney, or other party representative may 
communicate ex parte with the ALJ on any matter at issue in a case, 
unless both parties have notice and an opportunity to participate in 
the communication. However, a party, attorney, or other party 
representative may communicate with DAB staff about administrative or 
procedural matters.
    (b) If an ex parte communication occurs, the ALJ will disclose it 
to the other party and make it part of the record after the other party 
has an opportunity to comment.
    (c) The provisions of this section do not apply to communications 
between an employee or contractor of the DAB and the ALJ.


Sec.  93.508  Filing, forms, and service.

    (a) Filing.
    (1) Unless the ALJ provides otherwise, all submissions required or 
authorized to be filed in the proceeding must be filed with the ALJ.
    (2) Submissions are considered filed when they are placed in the 
mail, transmitted to a private delivery service for the purpose of 
delivering the item to the ALJ, or submitted in another manner 
authorized by the ALJ.
    (b) Forms.

[[Page 20800]]

    (1) Unless the ALJ provides otherwise, all submissions filed in the 
proceeding must include an original and two copies. The ALJ may 
designate the format for copies of nondocumentary materials such as 
videotapes, computer disks, or physical evidence. This provision does 
not apply to the charge letter or other written notice provided under 
Sec.  93.405.
    (2) Every submission filed in the proceeding must include the title 
of the case, the docket number, and a designation of the nature of the 
submission, such as a ``Motion to Compel the Production of Documents'' 
or ``Respondent's Proposed Exhibits.''
    (3) Every submission filed in the proceeding must be signed by and 
contain the address and telephone number of the party on whose behalf 
the document or paper was filed, or the attorney of record for the 
party.
    (c) Service. A party filing a submission with the ALJ must, at the 
time of filing, serve a copy on the other party. Service may be made 
either to the last known principal place of business of the party's 
attorney if the party is represented by an attorney, or, if not, to the 
party's last known address. Service may be made by--
    (1) Certified mail;
    (2) First-class postage prepaid U.S. Mail;
    (3) A private delivery service;
    (4) Hand-delivery; or
    (5) Facsimile or other electronic means if permitted by the ALJ .
    (d) Proof of service. Each party filing a document or paper with 
the ALJ must also provide proof of service at the time of the filing. 
Any of the following items may constitute proof of service:
    (1) A certified mail receipt returned by the postal service with a 
signature;
    (2) An official record of the postal service or private delivery 
service;
    (3) A certificate of service stating the method, place, date of 
service, and person served that is signed by an individual with 
personal knowledge of these facts; or
    (4) Other proof authorized by the ALJ.


Sec.  93.509  Computation of time.

    (a) In computing any period of time under this part for filing and 
service or for responding to an order issued by the ALJ, the 
computation begins with the day following the act or event, and 
includes the last day of the period unless that day is a Saturday, 
Sunday, or legal holiday observed by the Federal government, in which 
case it includes the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal government must be excluded from the computation.
    (c) Where a document has been filed by placing it in the mail, an 
additional 5 days must be added to the time permitted for any response. 
This paragraph does not apply to a respondent's request for hearing 
under Sec.  93.501.
    (d) Except for the respondent's request for a hearing, the ALJ may 
modify the time for the filing of any document or paper required or 
authorized under the rules in this part to be filed for good cause 
shown. When time permits, notice of a party's request for extension of 
the time and an opportunity to respond must be provided to the other 
party.


Sec.  93.510  Filing motions.

    (a) Parties must file all motions and requests for an order or 
ruling with the ALJ , serve them on the other party, state the nature 
of the relief requested, provide the legal authority relied upon, and 
state the facts alleged.
    (b) All motions must be in writing except for those made during a 
prehearing conference or at the hearing.
    (c) Within 10 days after being served with a motion, or other time 
as set by the ALJ, a party may file a response to the motion. The 
moving party may not file a reply to the responsive pleading unless 
allowed by the ALJ.
    (d) The ALJ may not grant a motion before the time for filing a 
response has expired, except with the parties' consent or after a 
hearing on the motion. However, the ALJ may overrule or deny any motion 
without awaiting a response.
    (e) The ALJ must make a reasonable effort to dispose of all motions 
promptly, and, whenever possible, dispose of all outstanding motions 
before the hearing.


Sec.  93.511  Prehearing conferences.

    (a) The ALJ must schedule an initial prehearing conference with the 
parties within 30 days of the DAB Chair's assignment of the case.
    (b) The ALJ may use the initial prehearing conference to discuss--
    (1) Identification and simplification of the issues, specification 
of disputes of fact and their materiality to the PHS findings of 
research misconduct and any HHS administrative actions, and amendments 
to the pleadings, including any need for a more definite statement;
    (2) Stipulations and admissions of fact including the contents, 
relevancy, and authenticity of documents;
    (3) Respondent's waiver of an administrative hearing, if any, and 
submission of the case on the basis of the administrative record as 
provided in Sec.  93.503(d);
    (4) Identification of legal issues and any need for briefing before 
the hearing;
    (5) Identification of evidence, pleadings, and other materials, if 
any, that the parties should exchange before the hearing;
    (6) Identification of the parties' witnesses, the general nature of 
their testimony, and the limitation on the number of witnesses and the 
scope of their testimony;
    (7) Scheduling dates such as the filing of briefs on legal issues 
identified in the charge letter or the respondent's request for 
hearing, the exchange of witness lists, witness statements, proposed 
exhibits, requests for the production of documents, and objections to 
proposed witnesses and documents;
    (8) Scheduling the time, place, and anticipated length of the 
hearing; and
    (9) Other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.
    (c) The ALJ may schedule additional prehearing conferences as 
appropriate, upon reasonable notice to or request of the parties.
    (d) All prehearing conferences will be audio-taped with copies 
provided to the parties upon request.
    (e) Whenever possible, the ALJ must memorialize in writing any oral 
rulings within 10 days after the prehearing conference.
    (f) By 15 days before the scheduled hearing date, the ALJ must hold 
a final prehearing conference to resolve to the maximum extent possible 
all outstanding issues about evidence, witnesses, stipulations, motions 
and all other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.


Sec.  93.512  Discovery.

    (a) Request to provide documents. A party may only request another 
party to produce documents or other tangible items for inspection and 
copying that are relevant and material to the issues identified in the 
charge letter and in the respondent's request for hearing.
    (b) Meaning of documents. For purposes of this subpart, the term 
documents includes information, reports, answers, records, accounts, 
papers, tangible items, and other data and documentary evidence. This 
subpart does not require the creation of any document. However, 
requested data stored in an electronic data storage system must be 
produced in a form reasonably accessible to the requesting party.
    (c) Nondisclosable items. This section does not authorize the 
disclosure of--

[[Page 20801]]

    (1) Interview reports or statements obtained by any party, or on 
behalf of any party, of persons whom the party will not call as witness 
in its case-in-chief;
    (2) Analyses and summaries prepared in conjunction with the 
inquiry, investigation, ORI oversight review, or litigation of the 
case; or
    (3) Any privileged documents, including but not limited to those 
protected by the attorney-client privilege, attorney-work product 
doctrine, or Federal law or regulation.
    (d) Responses to a discovery request. Within 30 days of receiving a 
request for the production of documents, a party must either fully 
respond to the request, submit a written objection to the discovery 
request, or seek a protective order from the ALJ. If a party objects to 
a request for the production of documents, the party must identify each 
document or item subject to the scope of the request and state the 
basis of the objection for each document, or any part that the party 
does not produce.
    (1) Within 30 days of receiving any objections, the party seeking 
production may file a motion to compel the production of the requested 
documents.
    (2) The ALJ may order a party to produce the requested documents 
for in camera inspection to evaluate the merits of a motion to compel 
or for a protective order.
    (3) The ALJ must compel the production of a requested document and 
deny a motion for a protective order, unless the requested document 
is--
    (i) Not relevant or material to the issues identified in the charge 
letter or the respondent's request for hearing;
    (ii) Unduly costly or burdensome to produce;
    (iii) Likely to unduly delay the proceeding or substantially 
prejudice a party;
    (iv) Privileged, including but not limited to documents protected 
by the attorney-client privilege, attorney-work product doctrine, or 
Federal law or regulation; or
    (v) Collateral to issues to be decided at the hearing.
    (4) If any part of a document is protected from disclosure under 
paragraph (d)(3) of this section, the ALJ must redact the protected 
portion of a document before giving it to the requesting party.
    (5) The party seeking discovery has the burden of showing that the 
ALJ should allow it.
    (e) Refusal to produce items. If a party refuses to provide 
requested documents when ordered by the hearing officer, the ALJ may 
take corrective action, including but not limited to, ordering the non-
compliant party to submit written answers under oath to written 
interrogatories posed by the other party or taking any of the actions 
at Sec.  93.515.


Sec.  93.513  Submission of witness lists, witness statements, and 
exhibits.

    (a) By 60 days before the scheduled hearing date, each party must 
give the ALJ a list of witnesses to be offered during the hearing and a 
statement describing the substance of their proposed testimony, copies 
of any prior written statements or transcribed testimony of proposed 
witnesses, a written report of each expert witness to be called to 
testify that meets the requirements of Federal Rule of Civil Procedure 
26(a)(2)(B), and copies of proposed hearing exhibits, including copies 
of any written statements that a party intends to offer instead of live 
direct testimony. If there are no prior written statements or 
transcribed testimony of a proffered witness, the party must submit a 
detailed factual affidavit of the proposed testimony.
    (b) A party may supplement its submission under paragraph (a) of 
this section until 30 days before the scheduled hearing date if the ALJ 
determines: (1) There are extraordinary circumstances; and (2) there is 
no substantial prejudice to the objecting party.
    (c) The parties must have an opportunity to object to the admission 
of evidence submitted under paragraph (a) of this section under a 
schedule set by the ALJ. However, the parties must file all objections 
before the final prehearing conference.
    (d) If a party tries to introduce evidence after the deadlines in 
paragraph (a) of this section, the ALJ must exclude the offered 
evidence from the party's case-in-chief unless the conditions of 
paragraph (b) of this section are met. If the ALJ admits evidence under 
paragraph (b) of this section, the objecting party may file a motion to 
postpone all or part of the hearing to allow sufficient time to prepare 
and respond to the evidence. The ALJ may not unreasonably deny that 
motion.
    (e) If a party fails to object within the time set by the ALJ and 
before the final prehearing conference, evidence exchanged under 
paragraph (a) of this section is considered authentic, relevant and 
material for the purpose of admissibility at the hearing.


Sec.  93.514  Amendment to the charge letter.

    (a) The PHS may amend the findings of research misconduct up to 30 
days before the scheduled hearing.
    (b) The ALJ may not unreasonably deny a respondent's motion to 
postpone all or part of the hearing to allow sufficient time to prepare 
and respond to the amended findings.


Sec.  93.515  Actions for violating an order or for disruptive conduct.

    (a) The ALJ may take action against any party in the proceeding for 
violating an order or procedure or for other conduct that interferes 
with the prompt, orderly, or fair conduct of the hearing. Any action 
imposed upon a party must reasonably relate to the severity and nature 
of the violation or disruptive conduct.
    (b) The actions may include--
    (1) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (2) Striking pleadings, in whole or in part;
    (3) Staying the proceedings;
    (4) Entering a decision by default;
    (5) Refusing to consider any motion or other action not timely 
filed; or
    (6) Taking a negative inference from the absence of research 
records, documents, or other information.


Sec.  93.516  Standard and burden of proof.

    (a) The standard of proof is the preponderance of the evidence.
    (b) Subject to the rebuttable presumption described in section 
93.106(b)(1), ORI bears the burden of proving the PHS findings of 
research misconduct and the need for any HHS administrative actions, 
including any debarment or suspension actions.
    (c) Once ORI makes a prima facie showing of research misconduct, 
the respondent bears the burden of proving any affirmative defenses 
raised, including honest error or differences of opinion, and of 
proving any mitigating factors that the respondent wants the ALJ to 
consider with respect to the HHS administrative actions.


Sec.  93.517  The hearing.

    (a) The ALJ will conduct an in-person hearing to decide if the 
respondent committed research misconduct and if the HHS administrative 
actions, including any debarment or suspension actions, are 
appropriate.
    (b) The ALJ provides an independent de novo review of the PHS 
findings of research misconduct and HHS administrative actions. The ALJ 
does not review the procedures or findings of the institution's or 
ORI's research misconduct proceedings.
    (c) A hearing under this subpart is not limited to specific 
findings and evidence set forth in the charge letter or

[[Page 20802]]

the respondent's request for hearing. Additional evidence and 
information may be offered by either party during its case-in-chief 
unless the offered evidence is--
    (1) Privileged, including but not limited to those protected by the 
attorney-client privilege, attorney-work product doctrine, or Federal 
law or regulation.
    (2) Otherwise inadmissible under Sec. Sec.  93.515 or 93.519.
    (3) Not offered within the times or terms of Sec. Sec.  93.512 and 
93.513.
    (d) ORI proceeds first in its presentation of evidence at the 
hearing.
    (e) After both parties have presented their cases-in-chief, the 
parties may offer rebuttal evidence even if not exchanged earlier under 
Sec. Sec.  93.512 and 93.513.
    (f) Except as provided in Sec.  93.518(c), the parties may appear 
at the hearing in person or by an attorney of record in the proceeding.
    (g) The hearing must be open to the public, unless the ALJ orders 
otherwise for good cause shown. However, even if the hearing is closed 
to the public, the ALJ may not exclude a party or party representative, 
persons whose presence a party shows to be essential to the 
presentation of its case, or expert witnesses.


Sec.  93.518  Witnesses.

    (a) Except as provided in paragraph (b) of this section, witnesses 
must give testimony at the hearing under oath or affirmation.
    (b) The ALJ may admit written testimony if the witness is available 
for cross-examination, including prior sworn testimony of witnesses 
that has been subject to cross-examination. These written statements 
must be provided to all other parties under Sec.  93.513.
    (c) The parties may conduct direct witness examination and cross-
examination in person by telephone or audio-visual communication as 
permitted by the ALJ. However, a respondent must always appear in-
person to present testimony and for cross-examination.
    (d) The ALJ may exercise reasonable control over the mode and order 
of questioning witnesses and presenting evidence to--
    (1) Make the witness questioning and presentation relevant to 
deciding the truth of the matter; and
    (2) Avoid undue repetition or needless consumption of time.
    (e) The ALJ must permit the parties to conduct cross-examination of 
witnesses.
    (f) Upon request of a party, the hearing officer may exclude a 
witness from the hearing before the witness' own testimony. However, 
the ALJ may not exclude--
    (1) A party or party representative;
    (2) Persons whose presence is shown by a party to be essential to 
the presentation of its case; or
    (3) Expert witnesses.


Sec.  93.519  Admissibility of evidence.

    (a) The ALJ decides the admissibility of evidence offered at the 
hearing.
    (b) Except as provided in this part, the ALJ is not bound by the 
Federal Rules of Evidence (FRE). However, the ALJ may apply the FRE 
where appropriate (e.g., to exclude unreliable evidence).
    (c) The ALJ must admit evidence unless it is clearly irrelevant, 
immaterial, or unduly repetitious. However, the ALJ may exclude 
relevant and material evidence if its probative value is substantially 
outweighed by the danger of unfair prejudice, confusion of the issues, 
or by considerations of undue delay or needless presentation of 
cumulative evidence under FRE 401-403.
    (d) The ALJ must exclude relevant and material evidence if it is 
privileged, including but not limited to evidence protected by the 
attorney-client privilege, the attorney-work product doctrine, or 
Federal law or regulation.
    (e) The ALJ may take judicial notice of matters upon the ALJ's own 
initiative or upon motion by a party as permitted under FRE 201 
(Judicial Notice of Adjudicative Facts).
    (1) The ALJ may take judicial notice of any other matter of 
technical, scientific, or commercial fact of established character.
    (2) The ALJ must give the parties adequate notice of matters 
subject to judicial notice and adequate opportunity to show that the 
ALJ erroneously noticed the matters.
    (f) Evidence of crimes, wrongs, or acts other than those at issue 
in the hearing is admissible only as permitted under FRE 404(b) 
(Character Evidence not Admissible to Prove Conduct; Exceptions, Other 
Crimes).
    (g) Methods of proving character are admissible only as permitted 
under FRE 405 (Methods of Proving Character).
    (h) Evidence related to the character and conduct of witnesses is 
admissible only as permitted under FRE Rule 608 (Evidence of Character 
and Conduct of Witness).
    (i) Evidence about offers of compromise or settlement made in this 
action is inadmissible as provided in FRE 408 (Compromise and Offers to 
Compromise).
    (j) The ALJ must admit relevant and material hearsay evidence, 
unless an objecting party shows that the offered hearsay evidence is 
not reliable.
    (k) The parties may introduce witnesses and evidence on rebuttal.
    (l) All documents and other evidence offered or admitted into the 
record must be open to examination by both parties, unless otherwise 
ordered by the ALJ for good cause shown.
    (m) Whenever the ALJ excludes evidence, the party offering the 
evidence may make an offer of proof, and the ALJ must include the offer 
in the transcript or recording of the hearing in full. The offer of 
proof should consist of a brief oral statement describing the evidence 
excluded. If the offered evidence consists of an exhibit, the ALJ must 
mark it for identification and place it in the hearing record. However, 
the ALJ may rely upon the offered evidence in reaching the decision on 
the case only if the ALJ admits it.


Sec.  93.520  The record.

    (a) HHS will record and transcribe the hearing, and if requested, 
provide a transcript to the parties at HHS' expense.
    (b) The exhibits, transcripts of testimony, any other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for the decision by the ALJ.
    (c) For good cause shown, the ALJ may order appropriate redactions 
made to the record at any time.
    (d) The DAB may return original research records and other similar 
items to the parties or awardee institution upon request after the 
Assistant Secretary for Health's decision becomes final, unless under 
judicial review.


Sec.  93.521  Correction of the transcript.

    (a) At any time, but not later than the time set for the parties to 
file their post-hearing briefs, any party may file a motion proposing 
material corrections to the transcript or recording.
    (b) At any time before the filing of the ALJ's decision and after 
consideration of any corrections proposed by the parties, the ALJ may 
issue an order making any requested corrections in the transcript or 
recording.


Sec.  93.522  Filing post-hearing briefs.

    (a) After the hearing and under a schedule set by the ALJ, the 
parties may file post-hearing briefs, and the ALJ may allow the parties 
to file reply briefs.
    (b) The parties may include proposed findings of fact and 
conclusions of law in their post-hearing briefs.

[[Page 20803]]

Sec.  93.523  The Administrative Law Judge's ruling.

    (a) The ALJ shall issue a final ruling in writing setting forth 
proposed findings of fact and any conclusions of law within 60 days 
after the last submission by the parties in the case. The ALJ shall 
serve a copy of the final ruling upon all parties, the Assistant 
Secretary for Health and the HHS Debarring Official if debarment or 
suspension is under review.
    (b) If unable to meet the 60-day deadline, the ALJ must set a new 
deadline and promptly notify all parties, the Assistant Secretary for 
Health, and the HHS Debarring Official if debarment or suspension is 
under review.
    (c) The final ruling of the ALJ constitutes a recommended decision 
to the Assistant Secretary for Health, as set forth in section 
93.500(d). The final ruling of the ALJ shall constitute proposed 
findings of fact to the HHS Debarring Official in accordance with 
section 93.500(e) and 45 CFR part 76.

[FR Doc. 04-8647 Filed 4-15-04; 8:45 am]
BILLING CODE 4150-31-P