[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Proposed Rules]
[Pages 70830-70841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 94

RIN 0905-AE71


Public Health Service Standards for the Protection of Research 
Misconduct Whistleblowers

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department proposes to add a new Subchapter I, Part 94, to 
Title 42 of the Code of Federal Regulations to implement section 493(e) 
of the Public Health Service Act. Under this proposed regulation, 
covered institutions must follow certain requirements for preventing or 
otherwise responding to occurrences of retaliation against 
whistleblowers. The purpose of this part is to protect persons who make 
a good faith allegation that a covered institution or one of its 
members engaged in or failed to respond adequately to an allegation of 
research misconduct and persons who cooperate in good faith with an 
investigation of research misconduct.

DATES: Submit comments on or before January 29, 2001.

ADDRESSES: Address all comments concerning this proposed rule to Chris 
B. Pascal, J.D., Acting Director, Office of Research Integrity, 5515 
Security Lane, Suite 700, Rockville, MD, 20852.
    You may submit comments and data by sending electronic mail (E-
mail) to [email protected].
    Submit comments as either a WordPerfect file, version 5.1 or 
higher, or a Microsoft Word 97 or 2000 file format. Comments can also 
be submitted as an ASCII file avoiding the use of special characters 
and any form of encryption.

FOR FURTHER INFORMATION, CONTACT:
    Legal Information: Gail L. Gibbons, 301-443-3466 (This is not a 
toll-free number).
    Technical Information: Barbara Bullman, 301-443-5300 (This is not a 
toll-free number).

SUPPLEMENTARY INFORMATION: Section 493(e) of the PHS Act requires the 
Secretary to establish regulatory standards for preventing and 
responding to occurrences of retaliation taken against whistleblowers 
by entities which have a research misconduct assurance under Sec. 493 
and by those entities' officials and agents. These entities and their 
officials and agents are prohibited from retaliating against an 
employee with respect to the terms and conditions of employment when 
the employee has in good faith (1) made an allegation that the entity 
or its officials or agents, has engaged in, or failed to respond 
adequately to an allegation of, research misconduct, or (2) cooperated 
with an investigation of such an allegation.
    The Commission on Research Integrity (established by section 162 of 
the NIH Revitalization Act of 1993) recommended that the standards 
stated in its document, ``Responsible Whistleblowing: A Whistleblower's 
Bill of Rights'' (Commission Report, Department, 1995), be adopted by 
regulation. Two of the seven principles in the Whistleblower's Bill of 
Rights relate directly to the prevention of and response to 
whistleblower retaliation. These two are: protection from retaliation 
(``Institutions have a duty not to tolerate or engage in retaliation 
against good faith whistleblowers.''), and fundamentally fair 
procedures (``In cases of alleged retaliation * * * whistleblowers 
should have an opportunity to defend themselves in a proceeding where 
they can present witnesses and confront those they charge with 
retaliation against them. * * *''). The substance of those two 
provisions has been incorporated in this proposed regulation. You may 
obtain the full text of the Commission's proposed Whistleblower's Bill 
of Rights upon request at the Office of Research Integrity address 
above, or on the ORI web page at http://ori.dhhs.gov/whistle.htm.
    The proposed regulation represents a considered effort by the 
Department to implement the statutory directive on whistleblower 
protections in accordance with equitable principles, reason, and sound 
policy. The Department strongly supports good faith whistleblowers who 
place themselves at potential risk in disclosing apparent or actual 
research misconduct involving projects supported by PHS funds. The 
Department also recognizes that institutions bear a substantial burden 
in ensuring the fair resolution of good faith allegations that may 
ultimately prove to be unwarranted. The proposed regulation tries to 
strike a fair balance among those persons and entities with an interest 
in the regulation.
    This proposed regulation does not apply to Federal agencies. 
Federal employees are offered separate whistleblower protections under 
the Federal Whistleblower Protection Act of 1989, 5 U.S.C. 1201, et 
seq.
    When an institution receives a retaliation complaint, the proposed 
regulation allows the whistleblower and the institution up to 30 days 
to negotiate a settlement. The whistleblower and the institution may 
agree to extend this period for up to an additional 60 days. During the 
negotiation period, the parties may agree to use any means of 
settlement that is legal and consistent with this regulation, including 
alternative dispute resolution mechanisms such as mediation. However, 
no settlement under the proposed regulation may prohibit the 
whistleblower from making allegations of research misconduct or 
cooperating with an investigation.
    If the dispute is not resolved by the end of the negotiation 
period, the institution must make an administrative proceeding 
available to the whistleblower to address the retaliation complaint. 
The proceeding offered by the institution must meet all of the 
standards in the proposed regulation. A whistleblower may agree to have 
a retaliation complaint resolved through this proceeding or may elect 
to pursue any other available remedy provided by law.
    Although certain settlement mechanisms such as mediation may be 
used during the negotiation period, they might not qualify as an 
acceptable administrative proceeding after the negotiation period has 
terminated because they do not meet the regulation's requirements. For 
example, mediation does not constitute an acceptable administrative 
proceeding because it does not use an ``objective

[[Page 70831]]

decisionmaker'' who will make a final determination on whether 
retaliation occurred, as required by the regulation.
    The proposed regulation gives institutions wide latitude in the 
types of administrative proceedings they may choose to offer. However, 
the proceeding must meet certain minimum standards such as allowing the 
whistleblower an opportunity to be represented by counsel and having a 
qualified, objective decisionmaker. Although the terms ``qualified'' 
and ``objective'' are not defined in the proposed regulation, the 
decisionmaker should have significant training, experience, or 
expertise in adjudicating disputes. Moreover, the decisionmaker must 
not have any real or apparent conflict of interest in hearing or 
deciding the case.
    One type of administrative proceeding that institutions may make 
available is binding arbitration. Arbitration is specifically 
encouraged in the Conference Report recommendations accompanying the 
NIH Revitalization Act. The Conferees suggested that the regulation 
should, ``where the whistleblower consents, allow for the possible 
adjudication of disputes through an arbitration proceeding conducted 
under the auspices of the American Arbitration Association.'' H.R. 
Conf. Rep. No. 100, 103d Cong., 1st Sess. 19, 107 (1993).
    Another type of administrative proceeding that may be used for 
resolving retaliation disputes is an institutional fact-finding 
procedure similar to an option allowed under the ORI ``Guidelines for 
Institutions and Whistleblowers: Responding to Possible Retaliation 
Against Whistleblowers in Extramural Research'' (November 20, 1995) 
(Whistleblower Guidelines) which will be superseded when this part is 
issued as a final rule. You may obtain a copy of these interim 
Whistleblower Guidelines by contacting ORI at the above address, or on 
the ORI web page at http://ori.dhhs.gov/whistle.htm. Unlike the 
administrative proceedings in the interim Whistleblower Guidelines, an 
institutional fact-finding procedure under the proposed regulation must 
satisfy the minimum standards specifically in this part.
    Other possible administrative proceedings that an institution may 
use for resolving a retaliation complaint under this part include an 
academic or institutional employment hearing, a state statutory 
whistleblower proceeding, or any other administrative proceeding that 
resolves the complaint. A proceeding satisfies the requirements of this 
part only if it meets the minimum standards outlined in the proposed 
regulation. Some states may have whistleblower statutes that provide 
recourse for a whistleblower but that may not include every requirement 
of this part. Therefore, the Department requests comments on whether an 
institution should be permitted to offer a proceeding, whether 
administrative or judicial, under a state whistleblower law if the law 
generally parallels the minimum standards of this part but differs in 
some details.
    Regardless of the type of administrative proceeding used, the 
decisionmaker's final decision must be based on the standards of proof 
set forth in the regulation. The decisionmaker must order an 
institutional remedy if the whistleblower proves by a preponderance of 
the evidence that the act of good faith whistleblowing was a 
contributing factor in the alleged adverse action taken by the 
institution or one of its members against the whistleblower. However, 
even if the whistleblower meets this burden, the decisionmaker may not 
order an institutional remedy if the institution then proves by clear 
and convincing evidence that it would have taken the action at issue 
even in the absence of the whistleblower's allegation or cooperation 
with an investigation. The legislative history of the PHS Act 
Sec. 493(e) shows that the Conferees encouraged adoption of this 
specific standard. Also, the proposed regulatory standard is the same 
as that used in the Federal Whistleblower Protection Act of 1989, 5 
U.S.C. 1201, et seq.
    If the decisionmaker determines that the institution or one of its 
members has retaliated against the whistleblower, the proposed 
regulation allows the decisionmaker to authorize appropriate remedies. 
For example, the decisionmaker could order reinstatement, back pay, 
rehabilitation of reputation, or compensation to the whistleblower for 
expenses, including attorneys' fees, incurred in the administrative 
proceeding.
    The proposed regulation allows both the institution and 
whistleblower to appeal an adverse finding or remedy by the 
decisionmaker only if the administrative proceeding used allows for an 
appeal or an appeal is otherwise provided by state law. The Department 
has chosen this approach consistent with the current misconduct 
regulation, 42 CFR part 50, subpart A, and the Office of Science and 
Technology Policy's (OSTP) proposed government-wide Federal policy for 
research misconduct, 64 FR 55722, 55724, Oct. 14, 1999, which do not 
require offering an opportunity to appeal at the institution to a 
respondent found to have committed misconduct. This is also consistent 
with the general approach of this regulation to allow flexibility and 
to mandate only limited requirements for the institutional 
administrative proceeding. The Department requests comments on whether 
the availability of an appeal should be required.
    Covered institutions would also be required to establish procedures 
for preventing retaliation against good faith whistleblowers. For 
example, under the proposed regulation, an institution's preventive 
activities must include informing all institutional members of the 
institution's whistleblower procedures and the importance of 
compliance. These whistleblower procedures must describe the measures 
that the institution intends to use to prevent retaliation against good 
faith whistleblowers. Although not specified in the proposed 
regulation, these measures may include, for example, cautioning 
respondents or other institutional members against retaliation, 
relocating the whistleblower when appropriate, and providing 
educational materials or group instruction on the topic of 
whistleblower retaliation. We invite suggestions for other steps 
institutions may take to prevent retaliation against good faith 
whistleblowers.
    Section 493(e)(2) of the PHS Act requires the Director of ORI to 
monitor covered institutions' implementation of the proposed regulatory 
standards. Moreover, Sec. 493(e)(3) requires ORI to establish remedies 
for noncompliance with this whistleblower retaliation regulation. 
Therefore, the proposed regulation authorizes ORI to review any covered 
institution's compliance with the regulation and to impose appropriate 
administrative actions for retaliation or other regulatory 
noncompliance. Administrative actions against noncompliant institutions 
may include, but are not limited to, termination or recovery of PHS 
funds.
    Several of the definitions require brief explanations. The proposed 
regulation adopts the term ``research misconduct'' instead of 
``misconduct in science'' as currently used in PHS' scientific 
misconduct regulation at 42 CFR 50.102 (1989). Section 493(a)(3)(A) of 
the PHS Act instructs the Secretary to establish a definition for the 
new term ``research misconduct.'' As discussed earlier, the OSTP has 
published a proposed government-wide Federal policy for research 
misconduct for adoption and implementation by agencies that conduct and 
support research. This policy includes a new proposed definition of 
research misconduct. 64

[[Page 70832]]

FR 55722, Oct.14, 1999. When the OSTP policy is adopted in final form, 
the Department will implement the policy, including the new definition 
of ``research misconduct,'' through rulemaking. In the meantime, the 
term ``research misconduct'' in this proposed regulation will be 
defined in the same manner as ``misconduct in science,'' as used in the 
existing PHS misconduct regulation.
    The proposed regulation uses the term ``whistleblower'' despite 
negative connotations that might be associated with it. The common 
understanding of the term's meaning strongly supports its continued 
usage, in keeping with the authorizing statute, PHS Act Sec. 493(e), 
and consistent with other statutes such as the Whistleblower Protection 
Act of 1989, 5 U.S.C. 1201, et seq. The Department strongly disavows 
any negative inference that might be drawn from the term 
``whistleblower.''
    The proposed regulation does not confine the use of the term 
``whistleblower'' to those who raise an initial allegation of research 
misconduct. Rather, it defines a whistleblower as any institutional 
member, including a non-employee, who makes an allegation that a 
covered institution or one of its members has engaged in, or failed to 
respond adequately to an allegation of, research misconduct, or who 
cooperates with an investigation of the allegation. Although the PHS 
Act Sec. 493(e) specifically protects an ``employee'' with respect to 
the terms and conditions of employment, the Department is proposing 
that the regulation cover all institutional members, i.e., all persons 
who are employed by, affiliated with under a contract or agreement, or 
under the control of, a covered institution, including students, 
fellows, and contractors.
    The Department may extend its jurisdiction to protect non-employee 
whistleblowers based upon its general rulemaking authority as well as 
its authority to establish the terms and conditions of PHS support. 
Potential whistleblowers include more than just employees of the 
covered institution. Students and research fellows at an academic 
institution, for example, may be in a position to allege research 
misconduct or cooperate with a misconduct investigation. The proposed 
regulation's more inclusive definition of whistleblower is consistent 
with the Department's interpretation of the current scientific 
misconduct regulation which is not limited to employees of the 
institution but requires protecting ``those persons who, in good faith, 
make allegations,'' 42 CFR 50.103(d)(13).
    Consistent with the proposed definition of whistleblower, the 
proposed regulation's definition of ``retaliation'' focuses on adverse 
actions that negatively affect the terms or conditions of the 
whistleblower's status at the institution, including employment, 
academic matriculation, and institutional relationship under a grant, 
contract, or cooperative agreement.
    An ``adverse action'' by an institution or one of its members may 
also include the threat of an adverse action if the threat in and of 
itself negatively affects the conditions of the whistleblower's 
institutional status. Whether a threat constitutes an ``adverse 
action'' under the proposed rule must be determined on a case-by-case 
basis. However, the Department believes that only objectively credible 
and imminent threats that substantially and negatively inhibit the 
whistleblower's normal institutional activities would constitute 
adverse actions.
    The proposed regulation requires each covered institution to submit 
an assurance that the institution is in compliance with this 
regulation. This requirement will be incorporated in PHS grant 
application (PHS Form 398) or any other application for PHS contracts 
or cooperative agreements. PHS Form 398 and all other pertinent 
application forms already include a certification of compliance with 
this part which will be changed to an assurance at the next revision.
    The proposed regulation applies only to whistleblower retaliation 
complaints that are made within 180 days of the alleged adverse action, 
or its discovery. This time limitation for filing retaliation 
complaints is consistent with other statutory and regulatory programs 
that establish a date certain after which complaints may not be filed, 
and encourages whistleblowers to come forward with a complaint 
promptly. This improves the opportunity for a rapid resolution of the 
dispute. See, e.g., 29 U.S.C. 1855(b) (Migrant and Seasonal 
Agricultural Worker Protection; Discrimination prohibited); 10 CFR 
50.7(b) (Nuclear Regulatory Commission; Employee Protection). The 180-
day limitation period is also consistent with ORI's interim 
Whistleblower Guidelines, Sec. IV.C.1.
    In addition to cases of whistleblower retaliation that occur after 
this regulation's promulgation, the Department also proposes that the 
regulation cover pending cases of retaliation, if the retaliation 
complaint and the underlying whistleblower activity took place within 
one year before the effective date of the regulation. The Department 
has required covered institutions to protect whistleblowers since at 
least 1989 pursuant to 42 CFR 50.103(d)(13). The proposed regulation 
merely prescribes new procedural, as opposed to substantive, 
requirements for implementing an already established duty. Thus, 
extending the applicability of the proposed regulation to previously 
filed, pending whistleblower complaints does not violate the principle 
of impermissible retroactivity. See Landgraf v. USI Film Products, 511 
U.S. 244 (1994); U.S. v. Riddick, 104 F.3d 1239 (10th Cir. 1997).

Analyses of Impacts

    A. Review under Executive Order 12866, sections 202 and 205 of the 
Unfunded Mandate Reform Act of 1995 (Pub. L. No. 104-4), and the 
Regulatory Flexibility Act (5 U.S.C. 603-605).
    The Department has examined the potential impact of this proposed 
rule as directed by Executive Order 12866, sections 202 and 205 of the 
Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-4), and the 
Regulatory Flexibility Act (5 U.S.C. 603-605).
    Executive Order 12866 directs agencies to assess the costs and 
benefits of available regulatory alternatives, and when regulation is 
necessary, to select regulatory approaches that maximize net benefits. 
This proposed rule is designed to establish regulatory standards for 
institutions that apply for or receive grants, contracts, or 
cooperative agreements under the PHS Act. (The proposal has been 
reviewed by the Office of Management and Budget (OMB) under the terms 
of the Executive Order.)
    The Unfunded Mandates Reform Act of l995, in sections 202 and 205, 
requires 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. As any final rule resulting from this proposal would not 
result in expenditures of this magnitude, such statements are not 
necessary.
    The Regulatory Flexibility Act 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 preventing and responding to whistleblower 
retaliation in research misconduct cases.

[[Page 70833]]

Currently, ORI receives about 125 allegations of research misconduct a 
year from the 3700 entities which file assurances with ORI. Of these, 
only five of the allegations were received from the approximately 1000 
entities which are considered small. Therefore, the Secretary 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.

B. Impact of Proposed Actions on Family Well-Being

    The Department has examined the potential impact of this proposed 
rule as directed by section 654 of the Treasury and General Government 
Appropriations Act of 1999 and determined that this proposed rule would 
not have an impact on Family Well-Being.

C. Estimated Annual Reporting and Record Keeping Burden

    Subchapter I, sections 94.215, 94.310, 94.315, 94.320, 94.340, 
94.345(b), 94.380, and 94.425 of the proposed rule contain information 
collection requirements that are subject to review by the OMB under the 
Paperwork Reduction Act of l995. 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 Standards for the Protection of 
Research Misconduct Whistleblowers.
    Description: This proposed rule implements section 493(e) of the 
PHS Act (added by section 163 of the NIH Revitalization Act of 1993, 
Pub. L. No. 103-43). Section 493(e)(1) requires the Secretary to 
establish standards for preventing and responding to occurrences of 
whistleblower retaliation by entities, their officials or agents, 
against an employee in the terms and conditions of employment in 
response to the employee having made a good faith allegation or 
cooperated with an investigation of such an allegation. In addition, 
sections 493(e) (2) and (3) of the PHS Act require that remedies be 
established for regulatory noncompliance by entities, their officials 
or agents, and that procedures be established for monitoring 
implementation of the standards established by the entities.
    Description of Respondents: The ``respondents'' for the collection 
of information described in this regulation are (1) institutions that 
apply for or receive grants, contracts, or cooperative agreements under 
the PHS Act for any project or program that involves the conduct of 
biomedical or behavioral research, and (2) whistleblowers who seek 
protection from or restitution for retaliation in accordance with the 
regulation.

Section 94.200

    See Section 94.215 for burden statement.

Section 94.205

    See Section 94.215 for burden statement.

Section 94.210

    See Section 94.215 for burden statement.

Section 94.215(a), (b), and (c)

    Number of Respondents--20.
    Number of Responses per Respondent--1.
    To institute an action for whistleblower protection, a 
whistleblower must file a retaliation complaint with the responsible 
official of the covered institution. The retaliation complaint must 
include (1) a statement containing the required elements listed in this 
section, and (2) any supporting dates and facts. We estimate that there 
will be approximately 20 complaints filed by whistleblowers annually. 
This estimate is based on data that we have compiled from the Annual 
Report on Possible Research Misconduct (PHS-6349) form submitted by the 
covered institutions and from the number of actual cases received by 
ORI.
    Annual Average Burden per Response--8 hours
    Total Annual Burden--160 hours

Section 305(a) and (b)

    See Section 94.320 for statement of burden.

Section 94.310

    Number of Respondents--244.
    Number of Responses per Respondent--1
    Each covered institution that uses subawardees or subcontractors to 
carry out its PHS funded research must ensure that the subawardees and 
subcontractors comply with the institution's policies and procedures 
under this part or obtain assurances from them that will enable the 
institution to comply with this part.
    There are 3700 entities that are currently applying for or 
receiving PHS research funds, and each of these entities could 
potentially use a subawardee or subcontractor. We estimate from 
reviewing the available information that 25% of the covered 
institutions use a subawardee or subcontractor. In turn, we estimate 
that only 25% of the subawardees and subcontractors will establish 
their own policies and procedures for addressing whistleblower 
retaliation allegations. The other 75% will use the covered 
institution's compliance procedures.
    Annual Average Burden per Response--8 hours.
    Total Annual Burden--1848 hours.

Section 94.315

    See Section 94.320 for statement of burden.

Section 94.320

    Number of Respondents--3700.
    Number of Responses per Respondent--1.
    Each covered institution that applies for or receives a grant, 
contract, or cooperative agreement under the PHS Act for any project or 
program that involves the conduct of biomedical or behavioral research 
is required to establish written procedures that include (1) specific 
strategies to prevent whistleblower retaliation by the institution or 
one of its members, and (2) appropriate administrative actions for 
verified cases of retaliation.
    There are 3700 entities that currently receive or are eligible to 
receive grants, contracts, or cooperative agreements that would be 
required to meet this single-time requirement to establish and maintain 
current policies and procedures designed to prevent whistleblower 
retaliation and provide a mechanism to respond to a retaliation 
complaint involving PHS funding or applications therefor.
    Annual Average Burden per Response--40 hours.
    Total Annual Burden--148,000 hours.
    We estimate that it will take between 10-80 hours to establish 
these

[[Page 70834]]

procedures with an average of 40 hours per covered institution. This 
burden estimate applies only to the first year when all the covered 
institutions will be required to establish procedures. In subsequent 
years, the burden will only be for new recipients or applicants of PHS 
funding or to update a covered entity's procedures.

Section 94.325(a) and (b)

    See Section 94.320 for statement of burden.

Section 94.340

    Number of Respondents--20.
    Number of Responses per Respondent--1.
    After receipt of a retaliation complaint, a covered institution is 
required by this part to provide the whistleblower with a copy of this 
regulation, 42 CFR Part 94, and the institution's policies and 
procedures for responding to retaliation complaints. The institution 
must also provide the whistleblower with written notification of (1) 
the date the complaint was received by the institution, (2) the date 
the negotiation period will expire, and (3) the institution's 
determination regarding the issue of jurisdiction as discussed in 
Sec. 94.215(b). The institution is also required to process the 
complaint in accordance with this part.
    Annual Average Burden per response--2 hours
    Total Burden--40 hours.

Section 94.345(b)

    Number of Respondents--1.
    Number of Responses per Respondent--1.
    The responsible official of the covered institution is required to 
notify the whistleblower in writing of any decision to provide 
temporary protection before the final resolution of a retaliation 
complaint.
    This estimate is based on the number of retaliation cases that have 
been reported to ORI.
    Annual Average Burden per response--2 hours.
    Total Annual Burden--2 hours.

Section 94.380

    Number of Respondents--20.
    Number of Responses per Respondent--1.
    Covered institutions are required by this part to report to ORI any 
of the following (1) the receipt of any whistleblower retaliation 
complaint, (2) the date received, (3) the date the negotiation period 
under Section 94.365 expires, (4) any temporary protections requested 
or provided to the whistleblower, (5) the administrative proceedings 
used or made available to the whistleblower, and how the institution 
met the standards of Section 94.420, and (6) the final disposition of 
the complaint, including any settlement.
    This reporting estimate is an approximation of the average time 
expected to be necessary for collection of this information by the 
covered institution. The estimate is based on past experiences of 
respondents reporting similar information to ORI.
    Annual Average Burden Per Response--2 hours.
    Total Annual Burden--40 hours.

Section 94.425

    Number of Respondents--20.
    Number of Responses per Respondent--1.
    At the time a covered institution proposes an administrative 
proceeding, it must inform the whistleblower of the requirements, 
rights, procedures, and possible consequences associated with the 
proceeding.
    Annual Average Burden Per Response--1 hour.
    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 the Office of Information and Regulatory Affairs, OMB, 
New Executive Office Bldg., 725 17th Street, N.W., Rm 10235, 
Washington, D.C. 20503, Attn: Allison Eydt. Submit written comments by 
January 29, 2001.

List of Subjects in 42 CFR Part 94

    Administrative practice and procedure, Grant programs-science and 
technology, Reporting and recordkeeping requirements, Research, Science 
and technology, Whistleblowing.

    Dated: July 17, 2000.
David Satcher,
Assistant Secretary for Health and Surgeon General.
    Approved: July 25, 2000.
Donna E. Shalala,
Secretary.
    For reasons set out in the preamble, the Public Health Service 
proposes to add a new subchapter I, part 94, to title 42 of the Code of 
Federal Regulations as follows:

Subchapter I--Policies Relating to Research Misconduct

PART 94--PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF 
RESEARCH MISCONDUCT WHISTLEBLOWERS

Subpart A--General
Sec.
94.100   What is the purpose of this part?
94.105   What is covered in this part?
94.110   Does this part apply to me?
94.115   What provisions of confidentiality apply to this part?
Subpart B--Whistleblower Retaliation Complaints


94.200  When must you file your retaliation complaint?

94.205   Where do you file a retaliation complaint?
94.210   Must your retaliation complaint be in writing?
94.215   What information must you provide in your retaliation 
complaint?
94.220   May you revise your retaliation complaint?
94.225   May you ask the covered institution to take actions to 
protect you?
94.230   May you negotiate or settle your retaliation complaint?
Subpart C--Responsibilities of Covered Institutions

Responsibilities and Procedures

94.300   What institutions are covered by this part?
94.305   What responsibilities does a covered institution have?
94.310   Are subawardees and subcontractors of a covered institution 
included in this part?
94.315   Must a covered institution establish procedures for 
whistleblowers?
94.320   What procedures must a covered institution establish?
94.325   Who must a covered institution inform of these procedures?
94.330   What is an assurance of compliance?
94.335   Who designates the responsible official, and what are the 
responsible official's duties?
94.340   How does a covered institution process whistleblower 
complaints?
94.345   Must a covered institution provide temporary protections to 
whistleblowers?
94.350   What temporary protections may a covered institution offer?
94.355   How long do temporary protections last?

Negotiations and Settlements

94.360   How may a covered institution negotiate and settle a 
retaliation complaint?
94.365   How long may a covered institution conduct negotiations on 
a retaliation complaint?
94.370   What must a covered institution do if it questions 
jurisdiction during negotiations?
94.375   What happens if negotiations do not resolve a retaliation 
complaint?

[[Page 70835]]

Compliance

94.380   What information must a covered institution report to ORI 
regarding retaliation complaints?
94.385   Must a covered institution cooperate with ORI compliance 
reviews?
94.390   What happens if a covered institution retaliates or fails 
to comply with this part?
Subpart D--Administrative Procedures

Election of Remedies

94.400   May a whistleblower elect remedies other than an 
administrative proceeding?
94.405   What actions may a covered institution take if a 
whistleblower elects a remedy other than an administrative 
proceeding?

Administrative Proceedings

94.410   Must a covered institution offer a whistleblower an 
administrative proceeding?
94.415   What types of administrative proceedings may a covered 
institution offer?
94.420   What elements must a covered institution include in its 
administrative proceeding?
94.425   What information must a covered institution provide to a 
whistleblower?
94.430   What happens if a whistleblower fails to timely file 
supporting documentation for the administrative proceeding?
94.435   May a covered institution or whistleblower challenge the 
decisionmaker's qualifications?
94.440   May the decisionmaker be replaced?

Remedies

94.445   What remedies may a decisionmaker impose?

Appeals

94.450   May a covered institution or whistleblower appeal an 
adverse decision or remedy?
Subpart E--Responsibilities of the Office of Research Integrity

General Provisions

94.500   What are ORI's responsibilities?
94.505   What does ORI do when it receives a whistleblower 
retaliation complaint?

Compliance Reviews

94.510   When does ORI do an institutional compliance review?
94.515   What factors does ORI consider in a compliance review?
94.520   What administrative actions may ORI take pursuant to a 
compliance review?
94.525   May a covered institution appeal administrative actions 
imposed by ORI or the Department?
Subpart F--Definitions
94.600   Administrative proceeding
94.605   Adverse action
94.610   Allegation
94.615   Contributing factor
94.620   Covered institution
94.625   Decisionmaker
94.630   Good faith
94.635   Institutional member or member
94.640   Investigation
94.645   Office of Research Integrity or ORI
94.650   Public Health Service or PHS
94.655   PHS funds or PHS funding
94.660   Research misconduct
94.665   Responsible official
94.670   Retaliation
94.675   Secretary
94.680   Whistleblower

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

Subpart A--General


Sec. 94.100  What is the purpose of this part?

    (a) This part describes the standards used by the Office of 
Research Integrity (ORI) and covered institutions for preventing and 
responding to retaliation against whistleblowers who in good faith--
    (1) Allege that a covered institution or institutional member has 
engaged in, or failed to respond adequately to, an allegation of 
research misconduct.
    (2) Cooperate with an investigation of the allegation in paragraph 
(a)(1) of this section.
    (b) These standards apply where the allegation or cooperation 
regarding an investigation concerns research involving Public Health 
Service (PHS) grants, contracts, or cooperative agreements, or 
applications therefor.


Sec. 94.105  What is covered in this part?

    This part explains--
    (a) The rights and responsibilities of whistleblowers who seek 
protection from or remedies for retaliation under this regulation and 
who comply with the requirements of this part.
    (b) Standards for covered institutions and their members for 
preventing or otherwise responding to retaliation against 
whistleblowers.
    (c) Procedures for ORI to determine whether covered institutions 
have established the required standards and that those standards are 
being followed.
    (d) Remedial actions that ORI may administer when a covered 
institution engages in an act of retaliation or otherwise does not 
comply with this regulation.


Sec. 94.110  Does this part apply to me?

    (a) Portions of this part may apply to you if you are a--
    (1) Covered institution;
    (2) Decisionmaker of a covered institution;
    (3) Institutional member of a covered institution;
    (4) ORI;
    (5) Responsible official of a covered institution;
    (6) Subawardee or subcontractor of a covered institution; or
    (7) Whistleblower.
    (b) The following table shows the portions of this part that may 
apply to you:

------------------------------------------------------------------------
                                             then the portions that may
              If you are a--                     apply to you are--
------------------------------------------------------------------------
(1) Covered institution or subawardee or    Subparts A, C, D, E, and F.
 subcontractor of a covered institution.
(2) Decisionmaker.........................  Subparts A, D, and F and
                                             Secs.  94.420 and 94.435-
                                             94.450.
(3) Institutional member..................  Subparts A, C, and F and
                                             Secs.  94.410 and 94.445.
(4) ORI...................................  Subparts A, E, and F.
(5) Responsible official..................  Subparts A, C, and F and
                                             Secs.  94.205, 94.210,
                                             94.225, 94.430, 94.505, and
                                             94.520.
(6) Whistleblower.........................  Subparts A, B, D, and F, and
                                             Secs.  94.360-94.375, and
                                             94.505.
------------------------------------------------------------------------

Sec. 94.115  What provisions of confidentiality apply to this part?

    (a) The provisions in this part for filing whistleblower 
retaliation complaints must not be construed to encourage or allow 
whistleblowers or covered institutions and their members to disclose 
publicly information regarding research misconduct cases other than to 
the person(s) designated in this part, or as otherwise provided by law.
    (b) A covered institution may take appropriate administrative 
actions that are consistent with this part in response to breaches of 
confidentiality.

Subpart B--Whistleblower Retaliation Complaints


Sec. 94.200  When must you file your retaliation complaint?

    (a) You, as a whistleblower, must file your retaliation complaint 
within 180 calendar days of the alleged adverse action or your 
discovery of the alleged adverse action.
    (b) The alleged adverse action must have occurred within one 
calendar year after you made your allegation or cooperated with an 
investigation of the allegation.
    (c) However, if your retaliation complaint was pending on the 
effective date of this part, ORI will consider your complaint to have 
been timely filed if--
    (1) You have filed it within one calendar year before the effective 
date of this part;
    (2) Your allegation or cooperation with an investigation of the 
allegation also occurred within that year; and

[[Page 70836]]

    (3) You refile your pending complaint, using the procedures in this 
subpart for filing complaints, within 120 calendar days of the date on 
which the covered institution provides the Sec. 94.325 written 
information to its members about its whistleblower policies and 
procedures.


Sec. 94.205  Where do you file a retaliation complaint?

    (a) You must file your whistleblower retaliation complaint with the 
responsible official at the covered institution where the alleged 
adverse action occurred.
    (b) If the responsible official does not acknowledge receipt of 
your complaint within 10 business days of receiving it, you may file 
the complaint with ORI. ORI will review the complaint and decide 
whether to refer it to the covered institution.


Sec. 94.210  Must your retaliation complaint be in writing?

    Yes, your whistleblower retaliation complaint must be made in 
writing to the responsible official at the covered institution or to 
ORI.


Sec. 94.215  What information must you provide in your retaliation 
complaint?

    To establish jurisdiction under this part, you must include in your 
whistleblower retaliation complaint a statement containing all the 
following information, including supporting dates and facts:
    (a) That you made an allegation that the covered institution or one 
of its members committed research misconduct or failed to respond 
adequately to an allegation of research misconduct, or that you 
cooperated with an investigation of such an allegation that concerns 
research involving PHS grants, contracts, cooperative agreements, or 
applications therefor.
    (b) That the covered institution or one of its members committed an 
adverse action against you within one year after you made your 
allegation or cooperated with an investigation.
    (c) That the adverse action resulted from your allegation or 
cooperation.
    (d) That you are making the complaint within 180 calendar days of 
the alleged adverse action or your discovery of the adverse action.


Sec. 94.220  May you revise your retaliation complaint?

    Yes, if your whistleblower retaliation complaint does not contain 
all the information required by Sec. 94.215, you may revise it to 
supply that information at any time before the complaint is fully 
resolved, dismissed, or otherwise closed under this part.


Sec. 94.225  May you ask the covered institution to take temporary 
actions to protect you?

    Yes, you may ask the responsible official to take temporary actions 
under Secs. 94.345 through 94.355 to protect you against an existing or 
threatened adverse action by the covered institution or one of its 
members at any time before your whistleblower retaliation complaint is 
fully resolved, dismissed, or otherwise closed under this part.


Sec. 94.230  May you negotiate or settle your retaliation complaint?

    Yes, you may negotiate or settle your whistleblower retaliation 
complaint with the covered institution by using the procedures 
described in Secs. 94.360 through 94.375.

Subpart C--Responsibilities of Covered Institutions

Responsibilities and Procedures


Sec. 94.300  What institutions are covered by this part?

    This part applies to any institution that applies for or receives 
grants, contracts, or cooperative agreements under PHS Act, as amended 
(42 U.S.C. 201, et seq.) for any project or program that involves 
biomedical or behavioral research, research training, or research 
related activities.


Sec. 94.305  What responsibilities does a covered institution have?

    (a) Covered institutions have primary responsibility for preventing 
and otherwise responding to occurrences of whistleblower retaliation.
    (b) A covered institution and its members must--
    (1) Comply with the standards in this part for preventing or 
otherwise responding to retaliation against whistleblowers if the 
underlying research misconduct allegation or act of cooperation with an 
investigation concerns research involving PHS grants, contracts, 
cooperative agreements, or applications therefor;
    (2) Not retaliate against good faith whistleblowers as defined by 
this part; and
    (3) Take all reasonable and necessary steps to prevent or otherwise 
respond to instances of whistleblower retaliation within the 
institution.


Sec. 94.310  Are subawardees and subcontractors of a covered 
institution included in this part?

    (a) Yes, if a covered institution carries out PHS funded research 
through subawardees or subcontractors, the institution must take 
reasonable steps to ensure that subawardees and subcontractors and 
their members comply with this part.
    (b) An institution may either require its subawardees and 
subcontractors to comply with its whistleblower policies and procedures 
or obtain assurances from them sufficient to allow compliance.


Sec. 94.315  Must a covered institution establish procedures for 
whistleblowers?

    Yes, a covered institution must establish whistleblower protection 
procedures and remedies consistent with this part.


Sec. 94.320  What procedures must a covered institution establish?

    A covered institution must establish written procedures for 
whistleblowers that--
    (a) Include specific strategies aimed at preventing whistleblower 
retaliation by the covered institution or its members;
    (b) Provide a mechanism for processing whistleblower complaints;
    (c) Authorize appropriate administrative actions for verified cases 
of retaliation; and
    (d) Ensure to a reasonable extent that its institutional members do 
not retaliate against whistleblowers, including whistleblowers who are 
not institutional members, such as persons who are located at other 
institutions or who are members of the general public.


Sec. 94.325  Who must a covered institution inform of these procedures?

    (a) Each covered institution must provide written information 
informing all of its members about the content of this part and the 
institution's procedures to implement its requirements and must 
emphasize the importance of compliance with those procedures.
    (b) A covered institution must provide its procedures to ORI and 
other authorized representatives of the Secretary upon request.


Sec. 94.330  What is an assurance of compliance?

    (a) Effective on [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION OF 
THE FINAL RULE IN THE FEDERAL REGISTER] each institution, as a 
condition for receiving PHS funding, is required to provide in its 
application for that funding an assurance of compliance with this part 
which is satisfactory to the Secretary.
    (b) The institution must assure that it--
    (1) Has established written whistleblower protection procedures 
consistent with this part;
    (2) Will comply with and enforce these procedures; and

[[Page 70837]]

    (3) Will comply with all other requirements of this part.


Sec. 94.335  Who designates the responsible official, and what are the 
responsible official's duties?

    (a) Each covered institution must--
    (1) Appoint one person as the official responsible for overseeing 
the institution's whistleblower protection procedures;
    (2) Authorize and direct the responsible official to execute or 
coordinate the implementation of the institution's policies and 
procedures in compliance with this part; and
    (3) Authorize the responsible official to oversee each 
whistleblower retaliation case that arises at the institution, to 
oversee the negotiation and settlement process described in 
Secs. 94.360 through 94.375, including implementing and enforcing 
appropriate institutional remedies as part of any agreement with the 
whistleblower, and to serve as a liaison between the covered 
institution and ORI.
    (b) If involvement of the responsible official in a particular case 
creates a real or apparent conflict of interest with the covered 
institution's obligation to protect good faith whistleblowers, or with 
a fair process for adjudicating the retaliation proceeding, the 
institution must appoint a substitute official to oversee the case. If 
the institution is unable to appoint a suitable substitute from within 
the institution, it must designate a person outside the institution who 
has no real or apparent conflict of interest.


Sec. 94.340  How does a covered institution process whistleblower 
complaints?

    (a) A covered institution must process all whistleblower 
retaliation complaints that are made to the responsible official 
pursuant to this part.
    (b) Within 20 calendar days of receiving a whistleblower 
retaliation complaint, the institution must provide the whistleblower 
with copies of this part, the institution's policies and procedures 
implementing this part, including its administrative procedures under 
Sec. 94.415, and a written notification, which includes--
    (1) The dates the institution received the retaliation complaint 
and on which it believes the 30 day negotiation period of 
Sec. 94.365(a) expires; and
    (2) The institution's determination of whether the retaliation 
complaint satisfies the jurisdictional elements required by Sec. 94.215 
and, if the jurisdictional elements are not satisfied, the specific 
basis for that determination.


Sec. 94.345  Must a covered institution provide temporary protections 
to whistleblowers?

    (a) Consistent with Sec. 94.350, a covered institution must provide 
reasonable and necessary temporary protections to whistleblowers before 
the final resolution of a retaliation complaint under this part if, 
based on the evidence, the responsible official reasonably determines 
that protection is warranted.
    (b) The responsible official must notify the whistleblower in 
writing of the decision on whether to provide temporary protections.


Sec. 94.350  What temporary protections may a covered institution 
offer?

    A covered institution must authorize the responsible official to 
provide any reasonable and necessary temporary protection(s), including 
but not limited to--
    (a) Ensuring the confidentiality of an ongoing research misconduct 
investigation or retaliation proceeding;
    (b) Protecting the whistleblower's institutional status; and
    (c) Taking disciplinary actions against institutional members who 
fail to comply with the responsible official's orders.


Sec. 94.355  How long do temporary protections last?

    When a covered institution and a whistleblower have fully resolved 
the retaliation complaint, any temporary protection(s) taken to protect 
the whistleblower may be discontinued or replaced with permanent 
remedies.

Negotiations and Settlements


Sec. 94.360  How may a covered institution negotiate and settle a 
retaliation complaint?

    (a) A covered institution and a whistleblower may negotiate and 
settle a retaliation complaint through any legal means not inconsistent 
with this part at any time after the institution receives the 
complaint.
    (b) If an institution and a whistleblower agree, any alternative 
dispute resolution mechanism, such as mediation, may be used to 
facilitate a resolution during the negotiation period.
    (c) Consistent with Sec. 94.335(a)(3), a covered institution must 
authorize its responsible official to implement any remedies as part of 
any agreement with a whistleblower.
    (d) However, any agreement to settle the complaint must not 
restrict a whistleblower's right or opportunity to make disclosures or 
to otherwise cooperate with institutional officials, ORI, or other 
Federal agencies with respect to the underlying research misconduct 
allegation(s).


Sec. 94.365  How long may a covered institution conduct negotiations on 
a retaliation complaint?

    (a) Except as modified by paragraph (b) of this section, a covered 
institution has 30 calendar days after the responsible official 
receives a written whistleblower retaliation complaint in which to 
negotiate a settlement with a whistleblower.
    (b) If an institution and a whistleblower have not fully resolved 
the retaliation complaint within the 30 day period of paragraph (a) of 
this section, they may mutually agree in writing to extend that period 
for up to an additional 60 calendar days.
    (c) If an institution and a whistleblower fully resolve the 
complaint during the negotiation period, ORI considers the complaint 
closed for purposes of this part. The head of the institution, or 
designee, and the whistleblower must sign an agreement that the 
complaint has been resolved, and the institution must notify ORI of the 
agreement within 30 calendar days of its execution, as required by 
Sec. 94.380(d)(5).


Sec. 94.370  What must a covered institution do if it questions 
jurisdiction during negotiations?

    If a covered institution provided the Sec. 94.340(b)(2) notice to a 
whistleblower that the retaliation complaint does not contain the 
jurisdictional information required by Sec. 94.215, the whistleblower 
has not adequately revised the complaint, and the institution and the 
whistleblower continue to dispute whether the complaint falls within 
the jurisdiction of this part, the institution may, at its discretion, 
either--
    (a) Continue settlement discussions during the 30 to 90 day 
negotiation period allowed under Sec. 94.365 and move to dismiss the 
complaint for lack of jurisdiction during any administrative proceeding 
under subpart D of this part; or
    (b) Immediately end the negotiation period, offer the whistleblower 
an administrative proceeding under subpart D of this part, and in that 
proceeding, make a preliminary motion to dismiss the complaint for lack 
of jurisdiction.


Sec. 94.375  What happens if negotiations do not resolve a retaliation 
complaint?

    (a) If a covered institution and a whistleblower have not fully 
resolved the retaliation complaint by the end of the 30 to 90 day 
negotiation period, or if they mutually agree to end negotiations 
without a settlement, the

[[Page 70838]]

institution must immediately offer the whistleblower an administrative 
proceeding under subpart D of this part.
    (b) The administrative proceeding must begin no later than 90 
calendar days after the negotiations have ended unless the parties 
mutually agree otherwise.

Compliance


Sec. 94.380  What information must a covered institution report to ORI 
regarding retaliation complaints?

    A covered institution must report and submit the following 
information and items to ORI no later than 30 calendar days after each 
of the following events occur:
    (a) Complaint filed. A copy of the whistleblower retaliation 
complaint, the date the institution received it, and the expected 
expiration date of the negotiation period under Sec. 94.365.
    (b) Temporary protection requested. A description of any temporary 
protection either provided to or requested by the whistleblower and the 
responsible official's written decision regarding the request.
    (c) Proceeding held or offered. A description of the administrative 
proceeding used or made available to resolve the complaint under 
subpart D of this part, including an explanation of how the institution 
met the procedural standards of Sec. 94.420.
    (d) Final disposition of complaint. A copy or description of the 
final disposition of the retaliation complaint including, where 
applicable--
    (1) The dismissal of the complaint for jurisdictional inadequacy;
    (2) The whistleblower's failure to timely file any supporting 
documentation required by the proposed administrative proceeding;
    (3) The whistleblower's election of a remedy other than that made 
available by the institution;
    (4) The outcome of the administrative proceeding under subpart D of 
this part, including any remedies imposed; and
    (5) Any mutual settlement agreement of the complaint including a 
statement to that effect signed by the head of the institution or 
designee and the whistleblower. The terms of the settlement agreement 
need not be disclosed, but the agreement must comply with Sec. 94.360.


Sec. 94.385  Must a covered institution cooperate with ORI compliance 
reviews?

    Yes, a covered institution and its members must cooperate with any 
ORI compliance review conducted under Sec. 94.510, including requests 
for information, on-site visits, inspection of relevant records, and 
interview of institutional members.


Sec. 94.390  What happens if a covered institution retaliates or fails 
to comply with this part?

    A covered institution that engages in whistleblower retaliation or 
otherwise fails to comply with any provision of this part may be 
subject to any of the PHS administrative actions provided under 
Sec. 94.520.

Subpart D--Administrative Proceedings

Election of Remedies


Sec. 94.400  May a whistleblower elect remedies other than an 
administrative proceeding?

    (a) Yes, a whistleblower may choose to resolve a retaliation 
complaint either through the administrative proceeding made available 
by the covered institution under this subpart or through any other 
available remedy provided by law, including remedies under any 
applicable Federal or State law or other institutional policy or 
employment agreement.
    (b) If the whistleblower elects a remedy other than settlement or 
the administrative proceeding made available by the covered 
institution, the whistleblower must provide the institution with 
written notice of that election.
    (c) If the whistleblower does not make an election of remedies 
under paragraph (b) of this section before the final disposition of the 
retaliation complaint, whether by settlement, dismissal, or final 
decision, ORI will consider that the institution has fully satisfied 
the requirements of this part.


Sec. 94.405  What actions may a covered institution take if a 
whistleblower elects a remedy other than an administrative proceeding?

    ORI will not require a covered institution to complete any 
administrative proceeding or otherwise pursue a final resolution of the 
complaint if a whistleblower elects a remedy for the retaliation 
complaint other than the administrative proceeding made available under 
this part.

Administrative Proceedings


Sec. 94.410  Must a covered institution offer a whistleblower an 
administrative proceeding?

    Yes, for each case of possible whistleblower retaliation to which 
this part applies and which is not settled, a covered institution must 
make available and comply with an administrative proceeding that meets 
the standards in this part for resolving retaliation complaints.


Sec. 94.415  What types of administrative proceedings may a covered 
institution offer?

    A covered institution may resolve a whistleblower retaliation 
complaint by any of the following types of administrative proceedings, 
if the proceeding satisfies all of the elements of Sec. 94.420:
    (a) An independent and binding arbitration.
    (b) An institutional fact-finding.
    (c) An academic or institutional employment hearing.
    (d) A state statutory whistleblower proceeding.
    (e) Any other administrative proceeding that addresses and resolves 
the retaliation complaint.


Sec. 94.420  What elements must a covered institution include in its 
administrative proceeding?

    A covered institution must have written procedures for 
administrative proceedings to resolve whistleblower retaliation 
complaints. These procedures must include all of the following 
elements:
    (a) A procedure for appointing a qualified and objective 
decisionmaker.
    (b) The opportunity for the whistleblower and the institution to be 
represented by counsel. The institution may, but is not required by 
this part to, provide counsel for the whistleblower.
    (c) An equal opportunity for the institution and the whistleblower 
to present evidence in support of their respective positions or in 
response to contrary evidence, including having an attorney present and 
cross-examining witnesses.
    (d) A presumption that the whistleblower's research misconduct 
allegation or cooperation with an investigation of the allegation was 
made in good faith. If the institution rebuts that presumption in a 
timely manner by submitting prima facie evidence of a lack of good 
faith, the whistleblower then has the burden to prove good faith by a 
preponderance of the evidence.
    (e) A final written decision made according to the following 
standards of proof:
    (1) Subject to paragraph (e)(2) of this section, the decisionmaker 
must order a binding institutional remedy according to Sec. 94.445 if 
the whistleblower proves by a preponderance of the evidence that the 
whistleblower's research misconduct allegation or cooperation with an 
investigation of the allegation was a contributing factor in an adverse

[[Page 70839]]

action taken by the institution or one of its members.
    (2) Even if the whistleblower meets the burden of proof required by 
paragraph (e)(1) of this section, the decisionmaker must not order an 
institutional remedy if the institution proves by clear and convincing 
evidence that the institution or one of its members would have taken 
the action at issue in the absence of the whistleblower's research 
misconduct allegation or cooperation with an investigation of the 
allegation.


Sec. 94.425  What information must a covered institution provide to a 
whistleblower?

    At the time a covered institution proposes an administrative 
proceeding, it must provide the whistleblower with a copy of the 
procedures for the proceeding, and it must fully inform the 
whistleblower of the requirements, rights, procedures, and possible 
consequences associated with that proceeding.


Sec. 94.430  What happens if a whistleblower fails to timely file 
supporting documentation for the administrative proceeding?

    (a) A whistleblower must timely file any supporting documentation 
required by the proposed administrative proceeding, or the 
decisionmaker may dismiss the retaliation complaint for purposes of 
this part. The applicable filing period will be 60 calendar days from 
the day the covered institution proposed the proceeding if the 
institution has not specified a filing date or if the specified date is 
less than 10 calendar days.
    (b) However, the whistleblower's failure to timely file will not be 
grounds for dismissal of the retaliation complaint if either--
    (1) The institution failed to inform the whistleblower of the 
proposed administrative proceeding and its procedures, requirements, 
rights, and possible consequences in a full and timely manner; or
    (2) If the decisionmaker determines there is good cause for the 
whistleblower's failure to timely file.


Sec. 94.435  May a covered institution or whistleblower challenge the 
decisionmaker's qualifications?

    (a) Either the whistleblower or the covered institution may 
challenge the qualifications or objectivity of the administrative 
proceeding's decisionmaker.
    (b) Any challenge must be made within 30 calendar days of the 
notice of the appointment of the decisionmaker.
    (c) If either party challenges the decisionmaker's qualifications 
or objectivity, the challenge must be made part of the record, and may 
be subject to any ORI compliance review under Sec. 94.510.


Sec. 94.440  May the decisionmaker be replaced?

    The covered institution may replace the decisionmaker for good 
cause before final resolution of the retaliation complaint. Good cause 
includes--
    (a) The decisionmaker dies or becomes incapacitated;
    (b) The decisionmaker is determined to have a conflict of interest 
under Sec. 94.435;
    (c) The parties mutually agree to a replacement; or
    (d) The administrative proceedings' procedures otherwise allow 
replacement.

Remedies


Sec. 94.445  What remedies may a decisionmaker impose?

    (a) If the decisionmaker in an administrative proceeding determines 
that the covered institution or one of its members retaliated against 
the whistleblower, the decisionmaker must order one or more remedies 
based on the findings. The decisionmaker has broad discretion in 
determining whether all or any of the following remedies are 
appropriate and warranted:
    (1) Reinstate the terms and conditions of the whistleblower's 
status at the institution that existed before the retaliatory action, 
including but not limited to employment (including tenure eligibility 
and promotion potential), academic matriculation, awarding of degree, 
or relationship established by grant, contract, or cooperative 
agreement.
    (2) Offer a position within the institution that is comparable 
financially, vocationally, and otherwise to the position the 
whistleblower held before the retaliatory action.
    (3) Compensate the whistleblower for any financial or other loss 
incurred between the retaliatory action and the provision of a remedy 
or remedies under this part.
    (4) Restore the whistleblower's reputation, to the greatest extent 
feasible, within the institution and the broader scientific community. 
If the whistleblower agrees, this may include an official retraction of 
negative references or the publication of an exoneration.
    (5) Protect the whistleblower against further potential 
retaliation. This may include monitoring the retaliator for a period of 
time.
    (6) Compensate the whistleblower for part or all expenses, if any, 
incurred pursuant to the administrative proceeding.
    (7) Take any other action allowed under law that reasonably 
restores the whistleblower's status and reputation.
    (b) The institution must implement in a timely manner the remedy(s) 
ordered by the decisionmaker unless the order is revoked or otherwise 
modified by an appeal under Sec. 94.450.

Appeals


Sec. 94.450  May a covered institution or whistleblower appeal an 
adverse decision or remedy?

    Either the covered institution or the whistleblower may appeal an 
adverse finding or remedy by the decisionmaker only if the 
administrative proceeding allows an appeal or an appeal is provided by 
state or other applicable law.

Subpart E--Responsibilities of the Office of Research Integrity

General Provisions


Sec. 94.500  What are ORI's responsibilities?

    (a) ORI is responsible for monitoring covered institutions to 
determine whether they have established administrative procedures and 
are following them in accordance with this part and the institution's 
certification of compliance under Sec. 94.330.
    (b) ORI may take the remedial administrative actions, specified in 
Sec. 94.520, against covered institutions that retaliate against good 
faith whistleblowers or that otherwise do not comply with the standards 
and procedures of this part.


Sec. 94.505  What does ORI do when it receives a whistleblower 
retaliation complaint?

    Consistent with Sec. 94.205, if a whistleblower brings a 
retaliation complaint directly to ORI, ORI reviews the complaint to 
determine if, on its face, it meets the requirements of this part. If 
so, ORI will instruct the whistleblower to send the complaint to the 
covered institution's responsible official or notify the responsible 
official directly.

Compliance Reviews


Sec. 94.510  When does ORI do an institutional compliance review?

    (a) ORI may review a covered institution's compliance with the 
provisions of this part at any time. ORI's decision to begin a 
compliance review may be based on the institution's written 
whistleblower procedures, its certification of compliance, its 
submissions to ORI regarding whistleblower retaliation complaints, or

[[Page 70840]]

any other information ORI considers relevant to the institution's 
compliance with this part.
    (b) ORI's review may include, but is not limited to, requests for 
information, on-site visits, inspection of relevant records, and 
interviews with institutional members.


Sec. 94.515  What factors does ORI consider in a compliance review?

    (a) If a covered institution complies with each provision of this 
part, ORI will consider the institution to be in compliance with the 
institution's certification of compliance and this part.
    (b) ORI may consider a covered institution's failure to comply with 
the provisions of this part to be a material failure to comply with the 
institution's certification of compliance and with the terms and 
conditions of any PHS funding provided under an application in which 
that certification is made.


Sec. 94.520  What administrative actions may ORI take pursuant to a 
compliance review?

    If ORI determines that a covered institution has engaged in 
whistleblower retaliation or has failed to comply with any provision of 
this part, ORI may impose, or recommend to the appropriate authorized 
Department official, imposition of one or more of the following 
administrative actions:
    (a) A corrective action plan including, where applicable, oversight 
of the institution's responsible official and its whistleblower 
protection procedures.
    (b) Probationary status under which the noncompliant institution 
could be subject to cumulative administrative actions if future 
incidents of institutional noncompliance occur including loss of PHS 
funding.
    (c) Special conditions imposed upon any future PHS awards of 
grants, contracts, or cooperative agreements to the institution.
    (d) Recovery of PHS funds misspent in connection with a retaliatory 
action or other institutional noncompliance with this part.
    (e) Termination of PHS current or future funding to the institution 
or any part thereof.
    (f) Public notice of the determination.
    (g) Any other action that ORI finds reasonable and appropriate to 
correct the noncompliance.


Sec. 94.525  May a covered institution appeal administrative actions 
imposed by ORI or the Department?

    A covered institution may appeal any administrative actions imposed 
by ORI or the Department under Sec. 94.520 only if an appeal is 
specifically allowed by an existing Departmental regulation. The 
institution must appeal under the terms of the applicable regulation.

Subpart F--Definitions


Sec. 94.600  Administrative proceeding.

    Administrative proceeding means the procedure that a covered 
institution employs or offers to employ to resolve a whistleblower 
retaliation complaint in compliance with the provisions of this part.


Sec. 94.605  Adverse action.

    Adverse action means any action taken or threatened by a covered 
institution or its member(s) that negatively affects the terms or 
conditions of the whistleblower's status at the institution, including 
but not limited to employment, promotion, academic matriculation, 
awarding of a degree, financial aid, or relationship established by 
grant, contract, or cooperative agreement.


Sec. 94.610  Allegation.

    Allegation means any disclosure, whether by written or oral 
statement, or other communication, to an institutional or Departmental 
official, that a covered institution or one of its members has engaged 
in, or failed to respond adequately to an allegation of, research 
misconduct as defined by this part and that involves the use of PHS 
funds or the application for PHS funds.


Sec. 94.615  Contributing factor.

    Contributing factor means any whistleblower activity protected 
under this part that alone or in combination with other factors results 
in an adverse action against the whistleblower.


Sec. 94.620  Covered institution.

    Covered institution means any entity, whether individual or 
corporate, that applies for or receives grants, contracts, or 
cooperative agreements under the PHS Act, as amended (42 U.S.C. 201, et 
seq.), for any program that involves the conduct of biomedical or 
behavioral research, research training or research related activity. 
Covered institutions do not include Federal agencies.


Sec. 94.625  Decisionmaker.

    Decisionmaker means the person(s) designated by the covered 
institution, according to the rules of the administrative proceeding 
made available under this part, to preside over the proceeding, to make 
preliminary decisions of jurisdictional adequacy, to make a final 
determination of whether retaliation against the whistleblower occurred 
based on the evidence presented, and to order appropriate remedies 
consistent with this part.


Sec. 94.630  Good faith.

    (a) Good faith means having a belief in the truth of one's 
allegation or testimony that a reasonable person in the whistleblower's 
position could have based upon the information known to the 
whistleblower at the time the allegation was made.
    (b) An allegation or cooperation with an investigation is not in 
good faith if made with knowing or reckless disregard of information 
that would negate the allegation or testimony.


Sec. 94.635  Institutional member or member.

    (a) Institutional member or member means a person who is employed 
by, is affiliated with under a contract or agreement, or is under the 
control of a covered institution.
    (b) Institutional members include, but are not limited to, teaching 
and support staff, researchers, clinicians, technicians, fellows, 
students, volunteers, and contractors, subcontractors, and subawardees 
and their employees.


Sec. 94.640  Investigation.

    Investigation, solely for the purpose of this part, means--
    (a) An initial assessment by ORI, the Department, or a covered 
institution.
    (b) An inquiry or investigation by the Department or a covered 
institution.
    (c) Any institutional appeal of an allegation of research 
misconduct involving PHS funds or applications therefor, including 
preparation for and conduct of any research misconduct hearing.
    (d) A review, recommendation, or decision regarding an assessment, 
inquiry, or investigation by ORI or the Department.
    (e) An appeal to the Departmental Appeals Board.
    (f) An investigation of an alleged inadequate response to an 
allegation of research misconduct.


Sec. 94.645  Office of Research Integrity or ORI.

    Office of Research Integrity or ORI means the office to which the 
Secretary has delegated responsibility for addressing research 
misconduct issues related to PHS activities, including the protection 
of whistleblowers.


Sec. 94.650  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,

[[Page 70841]]

Centers for Disease Control and Prevention, Food and Drug 
Administration, Health Resources and Services Administration, Indian 
Health Service, National Institutes of Health, the Substance Abuse and 
Mental Health Services Administration, and the offices of the Regional 
Health Administrator.


Sec. 94.655  PHS funds or PHS funding.

    PHS funds or PHS funding means Public Health Service grants, 
contracts, or cooperative agreements.


Sec. 94.660  Research misconduct.

    Research misconduct means fabrication, falsification, plagiarism, 
or other practices that seriously deviate from those that are commonly 
accepted within the scientific community for proposing, conducting, or 
reporting research. It does not include honest error or honest 
differences in interpretations or judgments of data.


Sec. 94.665  Responsible official.

    Responsible official means the official designated by a covered 
institution to establish and implement the institution's whistleblower 
protection procedures as required by this part.


Sec. 94.670  Retaliation.

    Retaliation for the purpose of this part means an adverse action 
taken against a whistleblower by a covered institution or one of its 
members in response to--
    (a) A good faith allegation that the covered institution or one of 
its members has engaged in, or failed to respond adequately to an 
allegation of, research misconduct; or
    (b) A good faith cooperation with an investigation of an allegation 
in paragraph (a) of this section.


Sec. 94.675  Secretary.

    Secretary means the Secretary of the Department of Health and Human 
Services or any other officer or employee of the Department of Health 
and Human Services to whom the Secretary has delegated authority.


Sec. 94.680  Whistleblower.

    Whistleblower means an institutional member who in good faith--
    (a) Makes an allegation that the covered institution or one of its 
members has engaged in, or failed to respond adequately to an 
allegation of, research misconduct; or
    (b) Cooperates with an investigation of an allegation in paragraph 
(a) of this section.

[FR Doc. 00-29988 Filed 11-27-00; 8:45 am]
BILLING CODE 4160-17-U