[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Proposed Rules]
[Pages 70915-70921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27607]


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DEPARTMENT OF AGRICULTURE

Office of the Secretary

7 CFR Part 3022

RIN 0524-AA34


United States Department of Agriculture Research Misconduct 
Regulations for Extramural Research

AGENCY: Office of the Secretary, United States Department of 
Agriculture.

ACTION: Proposed rule.

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SUMMARY: The U.S. Department of Agriculture (USDA) proposes to 
establish regulations to implement the

[[Page 70916]]

Federal Policy on Research Misconduct applicable to extramural 
research. The proposed regulation defines research misconduct and 
establishes basic USDA requirements for the conduct of fair and timely 
investigations of alleged or suspected infractions. The proposed 
regulation also includes instructions on USDA administrative actions 
when research misconduct is found.

DATES: Those interested are encouraged to provide comments. Comments 
must be received on or before December 24, 2008.

ADDRESSES: Comments may be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Department of Agriculture--All'' from the 
agency drop-down menu, and select ``Proposed Rules'' from the document 
type menu, then click ``Submit.'' In the document title column, select 
the proposed rule with ``7 CFR 3022, United States Department of 
Agriculture Research Misconduct Regulations for Extramural Research'' 
in the title to submit or view public comments and to view supporting 
and related materials available electronically. Information on using 
Regulations.gov, including instructions for accessing documents, 
submitting comments, and viewing the docket after the close of the 
comment period, is available through the site's ``User Tips'' link.
     E-mail: [email protected] or Fax: (202) 690-1529. 
Include Regulatory Information Number (RIN) 0524-AA34 in the subject 
line of the message.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Peter Laub, OCFO/
CTGPD Room 3451-S, Stop 9010, 1400 Independence Avenue, SW., 
Washington, DC 20250-9010.

Instructions: All submissions received must include the agency name and 
RIN for this rulemaking. All comments received will be posted without 
change to http://www.regulations.gov, including any personal 
information provided.

FOR FURTHER INFORMATION CONTACT: Sara Mazie, USDA Research Integrity 
Officer, 214W Whitten Building, Washington, DC 20250; Telephone: (202) 
720-5923; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 6, 2000, the National Science and Technology Council, 
Office of Science and Technology Policy of the Executive Office of the 
President (OSTP), published in the Federal Register (65 FR 76260) the 
Federal Policy on Research Misconduct (OSTP Policy) as a final, 
government-wide policy addressing research misconduct. The purpose of 
the policy was to establish: (1) Uniformity among the Federal agencies' 
definitions of research misconduct, and (2) consistency in Federal 
agencies' processes for responding to allegations of research 
misconduct. The OSTP Policy covers both intramural research as well as 
extramural research.
    This proposed rule would establish U.S. Department of Agriculture 
(USDA or the Department) regulations to permanently implement the 
provisions of the OSTP Policy applicable to extramural research. An 
interim USDA Research Misconduct Policy was issued as a Secretary's 
Memorandum on Research Misconduct Policies and Procedures in July 2006. 
The Secretary's Memorandum has since expired and been withdrawn. The 
Secretary's Memorandum was consistent with the OSTP Policy, and the 
substance of the proposed regulation is the same as the policies and 
procedures in the former Secretary's Memorandum that relate to 
extramural research. Accordingly, all USDA agencies that conduct or 
support extramural research are expected either to: (1) Establish 
procedures to foster integrity in research activities, respond to 
allegations of research misconduct, and remedy findings of research 
misconduct, consistent with applicable laws, regulations, the OSTP 
Policy, and this proposed regulation; or (2) initiate and sign a 
standing Memorandum of Understanding (MOU) between the agency and 
Research, Education and Economics mission area to have another USDA 
agency act on its behalf in lieu of developing its own research 
misconduct procedures.
    The proposed regulation will be set forth in Title 7 of the Code of 
Federal Regulations, in a new part 3022 (7 CFR part 3022), referred to 
below as the regulation.
    The proposed rule defines a number of terms that are used in new 
part 3022. Definitions of the following terms are set forth in Sec.  
3022.1: Adjudication; Agency Research Integrity Officer (ARIO); 
allegation; applied research; Assistant Inspector General for 
Investigations; basic research; extramural research; fabrication; 
falsification; finding of research misconduct; inquiry; intramural 
research; investigation; OIG; OSTP; plagiarism; preponderance of the 
evidence; research; research institution; research misconduct; research 
record; USDA; and USDA Research Integrity Officer (RIO).

Impact Analysis

Executive Order 12866

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant because it will not 
have an annual effect on the economy of $100 million or more or 
adversely affect a sector of the economy, productivity, competition, 
jobs, the environment, public health or safety, or State, local, or 
tribal governments or communities. This rule will not create any 
serious inconsistencies or otherwise interfere with any actions taken 
or planned by another agency. It will not materially alter the 
budgetary impact of entitlements, grants, user fees or loan programs 
and does not raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or principles set forth in 
Executive Order 12866.

Executive Order 12372

    This program/activity is subject to Executive Order 12372, which 
requires intergovernmental consultation with State and local officials. 
(See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Executive Order 13132

    It has been determined that this proposed rule does not have 
sufficient Federalism implications to warrant the preparation of a 
Federalism Assessment. The provisions contained in this rulemaking will 
not have a substantial direct effect on States or their political 
subdivisions. They also will not impact the distribution of power and 
responsibilities among the various levels of government substantially.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires that an 
analysis be prepared for each rule with a significant economic impact 
on a substantial number of small entities. The analysis should describe 
the rule's impact on small entities and identify any significant 
alternatives to the rule that would minimize the economic impact on 
such entities. Section 605 of the Regulatory Flexibility Act allows

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USDA to certify a rule, in lieu of preparing an analysis, if the 
proposed rulemaking is not expected to have such an impact.
    USDA certifies that this proposed rule would not have a significant 
economic impact on a substantial number of small entities. The final 
rule will have a positive impact on small businesses because of the 
assistance these entities receive from other agencies. It also will 
ease the administrative requirements for USDA to offer financial 
assistance.

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1531-1538) requires agencies to prepare several analyses before 
proposing any rule that may result in annual expenditures of at least 
$100 million or more in any one year by State, local, and Indian tribal 
governments, or the private sector. USDA certifies that this proposed 
rule will not result in expenditures of this magnitude.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Management and Budget, 
Office of Information and Regulatory Affairs, Attention: Desk Officer 
for USDA, [email protected] or fax it to (202) 395-5806. 
Please state that your comments refer to RIN 0524-AA34. Please send a 
copy of your comments to: (1) RIN 0524-AA34, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 
404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. 
A comment to OMB is best assured of having its full effect if OMB 
receives it within 30 days of publication of this proposed rule.
    The primary recordkeeping requirement is creating written policies 
and procedures for addressing research misconduct. The total annual 
average burden per response is approximately 16 hours. However, many 
Federal agencies already implemented the OSTP Policy and so 
approximately 99 percent of currently funded institutions already have 
policies and procedures in place and may spend approximately.5 hour 
updating them. Another recordkeeping requirement occurs when an 
institution learns of possible research misconduct and begins an 
inquiry, investigation, or both. For fiscal years 2004 through 2006 the 
Cooperative State Research, Education, and Extension Service (CSREES) 
(the USDA agency with the majority of extramural awards and therefore, 
used for burden estimate purposes) had an average of 548 different 
institutions funded with only five research misconduct allegations. Of 
the five allegations, one investigation was conducted, three inquiries 
conducted, and one allegation is pending.
    Comments are being solicited from the public (as well as affected 
agencies) concerning the proposed information collection and 
recordkeeping requirements. These comments will help USDA:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agencies' functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated as follows.
    Approximately 543 institutions already have these policies and 
procedures in place in any given year and spend minimal time (.5 hour) 
updating them.
    Number of Respondents--543.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--271.5 hours.
    Approximately 5 institutions each year spend an average of two days 
creating these policies and procedures for the first time.
    Number of Respondents--5.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--16 hours.
    Total Annual Burden--80 hours.
    Approximately five institutions each year spend 19.5 hours 
conducting an institutional inquiry.
    Number of Respondents--5.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--19.5 hours.
    Total Annual Burden--97.5 hours.
    Approximately 1 institution each year must perform an institutional 
investigation.
    Number of Respondents--1.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--99.5 hours.
    Total Annual Burden--99.5 hours.
    Copies of this information collection can be obtained from Sara 
Mazie, USDA Research Integrity Officer, 214W Whitten Building, 
Washington, DC 20250; Telephone: (202) 720-5923; e-mail: 
[email protected].

E-Government Act Compliance

    USDA is committed to compliance with the E-Government Act to 
promote the use of the Internet and other information technologies, to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

List of Subjects in 7 CFR Part 3022

    Intramural research, Research misconduct.

    For the reasons set forth in the preamble, it is proposed to amend 
Title 7 of the Code of Federal Regulations by adding a new part 3022, 
to read as follows:

PART 3022--RESEARCH INSTITUTIONS CONDUCTING USDA-FUNDED EXTRAMURAL 
RESEARCH; RESEARCH MISCONDUCT

Sec.

3022.1 Definitions.
3022.2 Procedures.
3022.3 Inquiry, investigation, and adjudication.
3022.4 USDA panel to determine appropriateness of research 
misconduct policy.
3022.5 Reservation of right to conduct subsequent inquiry, 
investigation, and adjudication.
3022.6 Notification of USDA of allegations of research misconduct.
3022.7 Notification of ARIO during an inquiry or investigation.
3022.8 Communication of research misconduct policies and procedures.
3022.9 Documents required.
3022.10 Reporting to USDA.
3022.11 Research records and evidence.
3022.12 Remedies for non-compliance.
3022.13 Appeals.
3022.14 Relationship to other requirements.

    Authority: Office of Science and Technology Policy (65 FR 76260) 
and USDA OIG, 7 CFR 2610.1(c)(4)(ix).

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Sec.  3022.1  Definitions.

    Adjudication. The stage in response to an allegation of research 
misconduct when the outcome of the investigation is reviewed, and 
appropriate corrective actions, if any, are determined. Corrective 
actions generally will be administrative in nature, such as termination 
of an award, debarment, award restrictions, recovery of funds, or 
correction of the research record. However, if there is an indication 
of violation of civil or criminal statutes, civil or criminal sanctions 
may be pursued.
    Agency Research Integrity Officer (ARIO). The individual appointed 
by a USDA agency that conducts research and who is responsible for:
    (1) Receiving and processing allegations of research misconduct as 
assigned by the USDA RIO;
    (2) Informing OIG and the USDA RIO of allegations of research 
misconduct in the event it is reported to the USDA agency;
    (3) Ensuring that any records, documents and other materials 
relating to a research misconduct allegation are provided to OIG when 
requested;
    (4) Coordinating actions taken to address allegations of research 
misconduct with respect to extramural research with the research 
institution(s) at which time the research misconduct is alleged to have 
occurred, and with the USDA RIO;
    (5) Overseeing proceedings to address allegations of extramurally 
funded research misconduct at intramural research institutions and 
research institutions where extramural research occurs;
    (6) Ensuring that agency action to address allegations of research 
misconduct at USDA agencies performing extramurally funded research is 
performed at an organizational level that allows an independent, 
unbiased, and equitable process;
    (7) Immediately notifying OIG and the USDA RIO if:
    (i) Public health or safety is at risk;
    (ii) USDA's resources, reputation, or other interests need 
protecting;
    (iii) Research activities should be suspended;
    (iv) Federal action may be needed to protect the interest of a 
subject of the investigation or of others potentially affected;
    (v) A premature public disclosure of the inquiry into or 
investigation of the allegation may compromise the process;
    (vi) The scientific community or the public should be informed; or
    (vii) Behavior that is or may be criminal in nature is discovered 
at any point during the inquiry, investigation, or adjudication phases 
of the research misconduct proceedings;
    (8) Documenting the dismissal of the allegation, and ensuring that 
the name of the accused individual and/or institution is cleared if an 
allegation of research misconduct is dismissed at any point during the 
inquiry or investigation phase of the proceedings; and
    (9) Other duties relating to research misconduct proceedings as 
assigned.
    Allegation. A disclosure of possible research misconduct through 
any means of communication. The disclosure may be by written or oral 
statement, or by other means of communication to an institutional or 
USDA official.
    Applied Research. Systematic study to gain knowledge or 
understanding necessary to determine the means by which a recognized 
and specific need may be met.
    Assistant Inspector General for Investigations. The individual in 
OIG who is responsible for OIG's domestic and foreign investigative 
operations through a headquarters office and the six regional offices.
    Basic Research. Systematic study directed toward fuller knowledge 
or understanding of the fundamental aspects of phenomena and of 
observable facts without specific applications towards processes or 
products in mind.
    Extramural research. Research conducted by any research institution 
other than the Federal agency to which the funds supporting the 
research were appropriated. Research institutions conducting extramural 
research may include Federal research facilities.
    Fabrication. Making up data or results and recording or reporting 
them.
    Falsification. 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.
    Finding of research misconduct. The conclusion, proven by a 
preponderance of the evidence, that research misconduct occurred, that 
such research misconduct represented a significant departure from 
accepted practices of the relevant research community, and that such 
research misconduct was committed intentionally, knowingly, or 
recklessly.
    Inquiry. The stage in the response to an allegation of research 
misconduct when an assessment is made to determine whether the 
allegation has substance and whether an investigation is warranted.
    Intramural Research. Research conducted by a Federal Agency, to 
which funds were appropriated for the purpose of conducting research.
    Investigation. The stage in the response to an allegation of 
research misconduct when the factual record is formally developed and 
examined to determine whether to dismiss the case, recommend a finding 
of research misconduct, and/or take other appropriate remedies.
    Office of Inspector General (OIG). The Office of Inspector General 
of the United States Department of Agriculture.
    Office of Science and Technology Policy (OSTP). The Office of 
Science and Technology Policy of the Executive Office of the President.
    Plagiarism. The appropriation of another person's ideas, processes, 
results, or words without giving appropriate credit.
    Preponderance of the evidence. Proof by information that, compared 
with that opposing it, leads to the conclusion that the fact at issue 
is more probably true than not.
    Research. All basic, applied, and demonstration research in all 
fields of science, engineering, and mathematics. This includes, but is 
not limited to, research in economics, education, linguistics, 
medicine, psychology, social sciences, statistics, and research 
involving human subjects or animals regardless of the funding mechanism 
used to support it.
    Research Institution. All organizations using Federal funds for 
research, including, for example, colleges and universities, federally 
funded research and development centers, national user facilities, 
industrial laboratories, or other research institutes.
    Research Misconduct. Fabrication, falsification, or plagiarism in 
proposing, performing, or reviewing research, or in reporting research 
results. Research misconduct does not include honest error or 
differences of opinion.
    Research Record. The record of data or results that embody the 
facts resulting from scientific inquiry, and includes, but is not 
limited to, research proposals, research records (including data, 
notes, journals, laboratory records (both physical and electronic)), 
progress reports, abstracts, theses, oral presentations, internal 
reports, and journal articles.
    United States Department of Agriculture. USDA.
    USDA Research Integrity Officer (USDA RIO). The individual 
designated by the Office of the Under Secretary for Research, 
Education, and Economics (REE) who is responsible for:
    (1) Overseeing USDA agency responses to allegations of research 
misconduct;

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    (2) Ensuring that agency research misconduct procedures are 
consistent with this part;
    (3) Receiving and assigning allegations of research misconduct 
reported by the public;
    (4) Developing Memoranda of Understanding with agencies that elect 
not to develop their own research misconduct procedures;
    (5) Monitoring the progress of all research misconduct cases; and
    (6) Serving as liaison with OIG to receive allegations of research 
misconduct when they are received via the OIG Hotline.


Sec.  3022.2  Procedures.

    Research institutions that conduct extramural research funded by 
USDA must foster an atmosphere conducive to research integrity. They 
must develop or have procedures in place to respond to allegations of 
research misconduct that ensure:
    (a) Appropriate separations of responsibility for inquiry, 
investigation, and adjudication;
    (b) Objectivity;
    (c) Due process;
    (d) Whistleblower protection;
    (e) Confidentiality; and
    (f) Timely resolution.


Sec.  3022.3  Inquiry, investigation, and adjudication.

    A research institution that conducts extramural research funded by 
USDA bears primary responsibility for prevention and detection of 
research misconduct and for the inquiry, investigation, and 
adjudication of research misconduct allegations reported directly to 
it. The research institution must perform an inquiry in response to an 
allegation, and must follow the inquiry with an investigation if the 
inquiry determines the allegation or apparent instance of research 
misconduct has substance. The responsibilities for adjudication must be 
separate from those for inquiry and investigation. In most instances, 
USDA will rely on a research institution conducting extramural research 
to promptly:
    (a) Initiate an inquiry into any suspected or alleged research 
misconduct;
    (b) Conduct a subsequent investigation, if warranted;
    (c) Acquire, prepare, and maintain appropriate records of 
allegations of extramural research misconduct and all related 
inquiries, investigations, and findings; and
    (d) Take action to ensure the following:
    (1) The integrity of research;
    (2) The rights and interests of the subject of the investigation 
and the public are protected;
    (3) The observance of legal requirements or responsibilities 
including cooperation with criminal investigations; and
    (4) Appropriate safeguards for subjects of allegations, as well as 
informants.


Sec.  3022.4  USDA panel to determine appropriateness of research 
misconduct policy.

    Before USDA will rely on a research institution to conduct an 
inquiry, investigation, and adjudication of an allegation in accordance 
with this part, the research institution where the research misconduct 
is alleged must provide the ARIO its policy and procedures related to 
research misconduct at the institution. The research institution has 
the option of providing either a written copy of such policies and 
procedures or a Web site address where such policies and procedures can 
be accessed. The ARIO to whom the policy and procedures were made 
available shall convene a panel comprised of the USDA RIO and ARIOs 
from the Forest Service, the Agricultural Research Service, and the 
Cooperative State Research, Education, and Extension Service. The Panel 
will review the research institution's policy and procedures for 
compliance with the OSTP Policy and render a decision regarding the 
research institution's ability to adequately resolve research 
misconduct allegations. The ARIO will inform the research institution 
of the Panel's determination that its inquiry, investigation, and 
adjudication procedures are sufficient and that the research 
institution may proceed with the inquiry, investigation, and 
adjudication. If the Panel determines that the research institution 
does not have sufficient policy and procedures in place to conduct 
inquiry, investigation, and adjudication proceedings, or that the 
research institution is in any way unfit or unprepared to handle the 
inquiry, investigation, and adjudication in a prompt, unbiased, fair, 
and independent manner, the ARIO will inform the research institution 
in writing of the Panel's decision. An appropriate USDA agency, as 
determined by the Panel, will then conduct the inquiry, investigation, 
and adjudication of research misconduct in accordance with this part. 
If an allegation of research misconduct is made regarding extramural 
research conducted at a Federal research institution (whether USDA or 
not), it is presumed that the Federal research institution has research 
misconduct procedures consistent with the OSTP Policy. USDA reserves 
the right to convene the Panel to assess the sufficiency of a Federal 
agency's research misconduct procedures, should there be any question 
whether the agency's procedures will ensure a fair, unbiased, 
equitable, and independent inquiry, investigation, and adjudication 
process.


Sec.  3022.5  Reservation of right to conduct subsequent inquiry, 
investigation, and adjudication.

    (a) USDA reserves the right to conduct its own inquiry, 
investigation, and adjudication into allegations of research misconduct 
at a research institution conducting extramural research subsequent to 
the proceedings of the research institution related to the same 
allegation. This may be necessary if the USDA RIO or ARIO believes, in 
his or her sound discretion, that despite the Panel's finding that the 
research institution in question had appropriate and OSTP-compliant 
research misconduct procedures in place, the research institution 
conducting the extramural research at issue:
    (1) Did not adhere to its own research misconduct procedures;
    (2) Did not conduct research misconduct proceedings in a fair, 
unbiased, or independent manner; or
    (3) Has not completed research misconduct inquiry, investigation, 
or adjudication in a timely manner.
    (b) Additionally, USDA reserves the right to conduct its own 
inquiry, investigation, and adjudication into allegations of research 
misconduct at a research institution conducting extramural research 
subsequent to the proceedings of the research institution related to 
the same allegation for any other reason that the USDA RIO or ARIO 
considers it appropriate to conduct research misconduct proceedings in 
lieu of the research institution's conducting the extramural research 
at issue.
    (c) In cases where the USDA RIO or ARIO believes it is necessary 
for USDA to conduct its own inquiry, investigation, and adjudication 
subsequent to the proceedings of the research institution related to 
the same allegation, the USDA RIO or ARIO shall reconvene the Panel, 
which will determine whether it is appropriate for the relevant USDA 
agency to conduct the research misconduct proceedings related to the 
allegation(s) of research misconduct. If the Panel determines that it 
is appropriate for a USDA agency to conduct the proceedings, the ARIO 
will immediately notify the research

[[Page 70920]]

institution in question. The research institution must then immediately 
provide the relevant USDA agency with documentation of the research 
misconduct proceedings the research institution has conducted to that 
point, and the USDA agency will conduct research misconduct proceedings 
in accordance with the Agency research misconduct procedures.


Sec.  3022.6  Notification of USDA of allegations of research 
misconduct.

    Research institutions that conduct USDA-funded extramural research 
must promptly notify OIG and the USDA RIO of all allegations of 
research misconduct involving USDA funds. Anyone who suspects that 
researchers or research institutions performing Federally-funded 
research may have engaged in research misconduct is encouraged to make 
a formal allegation of research misconduct to OIG.
    (a) OIG may be notified using any of the following methods:
    Via the OIG Hotline:
    Telephone: (202) 690-1622; (800) 424-9121; (202) 690-1202 (TDD).
    E-mail: [email protected].
    U.S. Mail: United States Department of Agriculture, Office of 
Inspector General, P.O. Box 23399, Washington, DC 20026-3399.
    (b) The USDA RIO may be reached at: USDA Research Integrity 
Officer, 214W Whitten Building, Washington, DC 20250, Telephone: 202-
720-5923, E-mail: [email protected].
    (c) To the extent known, the following details should be included 
in any formal allegation:
    (1) The name of the research project or research projects involved, 
the nature of the alleged misconduct, and the names of the individual 
or individuals alleged to be involved in the misconduct;
    (2) The source or sources of funding for the research project or 
research projects involved in the alleged misconduct;
    (3) Important dates;
    (4) Any documentation that bears upon the allegation; and
    (5) Any other potentially relevant information.
    (d) Safeguards for informants give individuals the confidence that 
they can bring allegations of research misconduct made in good faith to 
the attention of appropriate authorities or serve as informants to an 
inquiry or an investigation without suffering retribution. Safeguards 
include protection against retaliation for informants who make good 
faith allegations, fair and objective procedures for the examination 
and resolution of allegations of research misconduct, and diligence in 
protecting the positions and reputations of those persons who make 
allegations of research misconduct in good faith. The identity of 
informants who wish to remain anonymous will be kept confidential to 
the extent permitted by law or regulation.


Sec.  3022.7  Notification of ARIO during an inquiry or investigation.

    (a) Research institutions that conduct USDA-funded extramural 
research must promptly notify the ARIO should the institution become 
aware during an inquiry or investigation that:
    (1) Public health or safety is at risk;
    (2) The resources, reputation, or other interests of USDA are in 
need of protection;
    (3) Research activities should be suspended;
    (4) Federal action may be needed to protect the interest of a 
subject of the investigation or of others potentially affected;
    (5) A premature public disclosure of the inquiry into or 
investigation of the allegation may compromise the process;
    (6) The scientific community or the public should be informed; or
    (7) There is reasonable indication of possible violations of civil 
or criminal law.
    (b) If research misconduct proceedings reveal behavior that may be 
criminal in nature at any point during the proceedings, the institution 
must promptly notify the ARIO.


Sec.  3022.8  Communication of research misconduct policies and 
procedures.

    Institutions that conduct USDA-funded extramural research are to 
maintain and effectively communicate to their staffs policies and 
procedures relating to research misconduct, including the guidelines in 
this part. The institution is to inform their researchers and staff 
members who conduct USDA-funded extramural research when and under what 
circumstances USDA is to be notified of allegations of research 
misconduct, and when and under what circumstances USDA is to be updated 
on research misconduct proceedings.


Sec.  3022.9  Documents required.

    (a) A research institution that conducts USDA-funded extramural 
research must maintain the following documents related to an allegation 
of research misconduct at the research institution:
    (1) A written statement describing the original allegation;
    (2) A copy of the formal notification presented to the subject of 
the allegation;
    (3) A written report describing the inquiry stage and its outcome 
including copies of all supporting documentation;
    (4) A description of the methods and procedures used to gather and 
evaluate information pertinent to the alleged misconduct during inquiry 
and investigation stages;
    (5) A written report of the investigation, including the 
evidentiary record and supporting documentation;
    (6) A written statement of the findings; and
    (7) If applicable, a statement of recommended corrective actions, 
and any response to such a statement by the subject of original 
allegation, and/or other interested parties, including any corrective 
action plan.
    (b) The research institution must retain the documents specified in 
paragraph (a) of this section for at least three years following the 
final adjudication of the alleged research misconduct.


Sec.  3022.10  Reporting to USDA.

    Following completion of an investigation into allegations of 
research misconduct, the institution conducting extramural research 
must provide to the ARIO a copy of the evidentiary record, the report 
of the investigation, recommendations made to the institution's 
adjudicating official, and the written response of the individual who 
is the subject of the allegation to any recommendations.


Sec.  3022.11  Research records and evidence.

    (a) A research institution that conducts extramural research 
supported by USDA funds, as the responsible legal entity for the USDA-
supported research, has a continuing obligation to create and maintain 
adequate records (including documents and other evidentiary matter) as 
may be required by any subsequent inquiry, investigation, finding, 
adjudication, or other proceeding.
    (b) Whenever an investigation is initiated, the research 
institution must promptly take all reasonable and practical steps to 
obtain custody of all relevant research records and evidence as may be 
necessary to conduct the research misconduct proceedings. This must be 
accomplished before the research institution notifies the researcher/
respondent of the allegation, or immediately thereafter.
    (c) The original research records and evidence taken into custody 
by the research institution shall be inventoried and stored in a secure 
place and

[[Page 70921]]

manner. Research records involving raw data shall include the devices 
or instruments on which they reside. However, if deemed appropriate by 
the research institution or investigator, research data or records that 
reside on or in instruments or devices may be copied and removed from 
those instruments or devices as long as the copies are complete, 
accurate, and have substantially equivalent evidentiary value as the 
data or records when the data or records reside on the instruments or 
devices. Such copies or data or records shall be made by a 
disinterested, qualified technician and not by the subject of the 
original allegation or other interested parties. When the relevant data 
or records have been removed from the devices or instruments, the 
instruments or devices need not be maintained as evidence.


Sec.  3022.12  Remedies for non-compliance.

    USDA agencies' implementation procedures identify the 
administrative actions available to remedy a finding of research 
misconduct. Such actions may include the recovery of funds, correction 
of the research record, debarment of the researcher(s) who engaged in 
the research misconduct, proper attribution, or any other action deemed 
appropriate to remedy the instance(s) of research misconduct. In 
determining the appropriate administrative action, the appropriate 
agency must impose a remedy that is commensurate with the infraction as 
described in the finding of research misconduct.


Sec.  3022.13  Appeals.

    (a) If USDA relied on an institution to conduct an inquiry, 
investigation, and adjudication, the alleged person(s) should first 
follow the institution's appeal policy and procedures.
    (b) USDA agencies' implementation procedures identify the appeal 
process when a finding of research misconduct is elevated to the 
agency.


Sec.  3022.14  Relationship to other requirements.

    Some of the research covered by this part also may be subject to 
regulations of other governmental agencies (e.g., a university that 
receives funding from a USDA agency and also under a grant from another 
Federal agency). Research covered under this part that is also subject 
to requirements of other agencies or funding sources must be conducted 
in compliance with all applicable requirements of this part. USDA 
agencies may include in their implementation procedures a process for 
deferring to or collaborating with other agencies when a research 
institution receives funding or support from multiple sources and 
therefore would be subject to multiple research agencies' research 
misconduct procedures. For example, when a research institution or the 
OIG or a Federal agency other than the relevant USDA agency, has 
previously initiated its own inquiry and investigation, the relevant 
USDA agency may wish to defer its own inquiry or investigation until it 
receives the results of that external inquiry and investigation. If the 
relevant USDA agency does not receive the results of the external 
inquiry within what it believes to be a reasonable time, the relevant 
USDA agency should proceed with its own inquiry and, if warranted, its 
own investigation.

    Dated: November 6, 2008.

    Issued at Washington, DC.

    Approved.
Edward T. Schafer,
Secretary, U.S. Department of Agriculture.
 [FR Doc. E8-27607 Filed 11-21-08; 8:45 am]
BILLING CODE 3410-34-P