[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
[[Page 70917]]
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).
[[Page 70918]]
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;
[[Page 70919]]
(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