[Federal Register: June 28, 2005 (Volume 70, Number 123)]
[Rules and Regulations]
[Page 37010-37016]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn05-2]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF ENERGY
10 CFR Parts 600 and 733
48 CFR Parts 935, 952 and 970
RIN 1901-AA89
Policy on Research Misconduct
AGENCY: Department of Energy.
ACTION: Notice of interim final rulemaking and opportunity for comment.
-----------------------------------------------------------------------
SUMMARY: The Department of Energy (DOE) is publishing an interim final
general statement of policy and interim final financial assistance and
procurement requirements to implement the government-wide Federal
Policy on Research Misconduct. These interim final rules are designed
to protect the integrity of research and development funded by DOE.
DATES: The effective date is July 28, 2005. Written comments must be
received on or before the close of business August 29, 2005.
ADDRESSES: Comments (5 copies) should be addressed to: Christine Chalk,
SC-5, U.S. Department of Energy, Office of Science, Room 3H-051, 1000
Independence Avenue, SW., Washington, DC 20585.
FOR FURTHER INFORMATION CONTACT: Christine Chalk at 202-586-7203
Christine.Chalk@science.doe.gov).
SUPPLEMENTARY INFORMATION:
I. Background.
II. Discussion of the General Statement of Policy and Standard
Requirements.
III. Public Comment Procedures.
IV. Procedural Review Requirements.
A. Review Under Executive Order 12866.
B. Review Under Executive Order 12988.
C. Review Under the Regulatory Flexibility Act.
D. Review Under the Paperwork Reduction Act.
E. Review Under the National Environmental Policy Act.
F. Review Under Executive Order 13132.
G. Review Under The Unfunded Mandates Reform Act of 1995.
H. Review Under the Treasury and General Government
Appropriations Act, 1999.
I. Review Under the Treasury And General Government
Appropriations Act, 2001.
J. Review Under the Small Business Regulatory Enforcement
Fairness Act.
I. Background
In 1996, the White House Office of Science and Technology Policy
(OSTP) began the process of formulating a uniform government-wide
Federal policy on research misconduct. OSTP published a proposed policy
on research misconduct in the Federal Register at 64 FR 55722, October
14, 1999, and published the final policy at 65 FR 76260, December 6,
2000 (Federal Policy). The Federal Policy is available on the Office of
Science Web site at http://www.sc.doe.gov/misconduct/finalpolicy.pdf.
The objective of the Federal Policy is to create a uniform policy
framework for Federal agencies for the handling of allegations of
misconduct in federally funded or supported research. Within this
framework, each Federal agency funding or supporting research is
expected to fashion its own regulations to accommodate the various
types of research transactions in which it is engaged. This rule
implements the Federal Policy for DOE including the National Nuclear
Security Administration. In keeping with these objectives, these DOE
regulations incorporate key aspects of the Federal Policy. In
particular, research misconduct is being defined as including
fabrication, falsification, or plagiarism in proposing, performing, or
reviewing research, or in reporting research results, but not as
including honest error or differences of opinion. In addition, a
finding of research
[[Page 37011]]
misconduct requires a determination, based on a preponderance of the
evidence, that research misconduct has occurred, including a conclusion
that there has been a significant departure from accepted practices of
the relevant research community and that it be knowingly,
intentionally, or recklessly committed.
The core principle of the Federal Policy is that, while research
organizations have the primary responsibility for the inquiry,
investigation, and adjudication of allegations of research misconduct,
Federal agencies have ultimate oversight authority for the research
they fund or support. While there may be some overlap in the actions
that may be pursued by Federal agencies and research organizations, DOE
has designed this rule to assure that if an allegation of research
misconduct is made against a contractor or recipient of financial
assistance, either the contractor or recipient or, if appropriate, DOE,
investigates that allegation. Federal law prescribes procedural
frameworks for adverse contract actions, adverse assistance actions,
suspensions, or debarments that are different from procedural
frameworks for competing for Federal procurement or assistance awards,
and for adverse personnel actions against Federal civil service
employees. Further, the DOE Office of the Inspector General (OIG) may
proceed under its previously existing administrative investigation
process when misconduct is alleged against Federal civil service
employees, contractors or recipients of financial assistance. In
addition, if a contractor or financial assistance recipient cannot
conduct its own research misconduct investigation the rule provides
that DOE will be responsible for conducting the investigation.
In order to best implement the Federal Policy, DOE promulgates a
new 10 CFR part 733 (Allegations of Research Misconduct), which sets
forth a general statement of policy applicable to research conducted
under a DOE contract or financial assistance agreement. Consistent with
the general statement of policy, DOE today amends 10 CFR part 600
(Financial Assistance Rules), 48 CFR part 935 (Research and Development
Contracting), 48 CFR part 952 (Solicitation Provisions and Contract
Clauses), and 48 CFR part 970 (DOE Management and Operating Contracts).
The Secretary of Energy has approved this notice for publication in the
Federal Register. For all contracts, contracting officers must apply
the DOE Acquisition Regulations (DEAR) changes (codified at 48 CFR) to
solicitations issued on or after the effective date of this rule and
may, at their discretion, include these DEAR changes in solicitations
issued before the effective date of this rule, provided award of the
resulting contract(s) occurs on or after the effective date.
For management and operating contracts, contracting officers must
apply these DEAR changes: to contracts extended in accordance with the
Department's extend/compete policies and procedures (48 CFR 917.6, 48
CFR 970.1706, and internal guidance); and to options exercised under
competitively awarded management and operating contracts (48 CFR
970.1706).
For management and operating contracts, contracting officers should
modify existing contracts at the next fee negotiation/annual renewal
after the effective date of this rule.
II. Discussion of the General Statement of Policy and Standard
Requirements
Since research for DOE occurs pursuant to financial assistance
agreements or contracts, the general statement of policy provides that
DOE will implement the Federal Policy through the insertion in
financial assistance agreements and contracts of standard requirements
based on the Federal Policy. DOE expects that these standard
requirements will result in most allegations of research misconduct
being handled in accordance with the Federal Policy by the research
institution where the research misconduct is alleged to have taken
place.
The general statement of policy also sets forth guidance to DOE
offices with regard to the processing of allegations of research
misconduct made directly to DOE. The guidance provides for initial
handling of such allegations by the DOE office programmatically
responsible for an assistance agreement or contract. That office in
turn will consult with the DOE Office of the Inspector General (IG) to
determine whether that office will choose to investigate the
allegation. If the IG declines to investigate, the DOE program office
will refer the allegation to the appropriate contracting officer
responsible for the administration of the assistance agreement or
contract for processing by the assistance recipient or contractor
consistent with requirements of the applicable research misconduct
requirements. If the Department elects to act in lieu of the contractor
or financial assistance recipient, the research misconduct
investigation shall be conducted by the DOE office programmatically
responsible for the assistance agreement or contract with support from
other departmental elements, as appropriate.
DOE is amending the DEAR at 48 CFR part 935 to prescribe the
inclusion of requirements on research misconduct in all DOE contracts
that involve research. DOE also is amending part 952 of the DEAR and 10
CFR part 600, respectively, to add requirements that by accepting the
funds under a contract, including a management and operating contractor
a financial assistance award, the recipient of DOE funds is making
assurances that it has established an administrative process for
reviewing, investigating, and reporting allegations of research
misconduct and that it will comply with its own administrative process
and the requirements of 10 CFR part 733 for review, investigation, and
reporting of research misconduct. DOE also is amending part 970 of the
DEAR to provide that records generated by a management and operating
contractor during the course of responding to allegations of research
misconduct will be considered owned by the contractor.
As suggested in the Federal Policy, DOE expects debarment and
suspension would be available as possible recommended remedies for a
finding of research misconduct. These remedies would exclude a person
or organization from participating in research activities funded by the
Federal Government. DOE's non-procurement suspension and debarment rule
is promulgated at 10 CFR part 606, while the Federal procurement
suspension and debarment rule is promulgated at 48 CFR part 909. Both
regulations require a fact-finding process if there are any facts in
dispute prior to a suspension or debarment determination. The fact-
finding process used to make a determination of research misconduct
under this rule would satisfy the requirements for a fact-finding
hearing as adopted in the DOE's non-procurement debarment and
suspension regulations, as well as the requirements for a fact-finding
hearing as described in the FAR.
III. Public Comment Procedures
Interested persons are invited to participate by submitting data,
views or arguments with respect to the new regulation in this
rulemaking. Five copies of written comments should be submitted to the
address indicated in the ADDRESSES section of this notice of
rulemaking. All comments received will be available for public
inspection as part of the administrative record on file for this
rulemaking in the Department of Energy Freedom of Information Reading
Room, Room 1E-090, Forrestal Building, 1000 Independence Avenue, SW.,
Washington, DC 20585, (202) 586-
[[Page 37012]]
3142, between the hours of 9 a.m. and 4 p.m., Monday through Friday,
except Federal holidays. All written comments received by the date
indicated in the DATES section of this notice of rulemaking and all
other relevant information in the record will be carefully assessed and
fully considered prior to the publication of the final rule. Any
information or data considered to be exempt from public disclosure by
law must be so identified and submitted in writing, one copy, as well
as one complete copy from which the information believed to be exempt
from disclosure is deleted. DOE will determine if the information or
data is exempt from disclosure.
IV. Procedural Review Requirements
A. Review Under Executive Order 12866
This regulatory action has been determined to be a ``significant
regulatory action'' under Executive Order 12866, ``Regulatory Planning
and Review,'' (58 FR 51735, October 4, 1993). Accordingly, this action
was subject to review under that Executive Order by the Office of
Information and Regulatory Affairs of the Office of Management and
Budget (OMB). OMB has completed its review.
B. Review Under Executive Order 12988
With respect to the review of existing regulations and the
promulgation of new regulations, section 3(a) of Executive Order 12988,
``Civil Justice Reform,'' 61 FR 4729 (February 7, 1996), imposes on
Executive agencies the general duty to adhere to the following
requirements: (1) Eliminate drafting errors and ambiguity; (2) write
regulations to minimize litigation; (3) provide a clear legal standard
for affected conduct rather than a general standard; and (4) promote
simplification and burden reduction. The review required by section
3(a), section 3(b) of Executive Order 12988 specifically requires that
Executive agencies make every reasonable effort to ensure that the
regulation: (1) Clearly specifies the preemptive effect, if any; (2)
clearly specifies any effect on existing Federal law or regulation; (3)
provides a clear legal standard for affected conduct while promoting
simplification and burden reduction; (4) specifies the retroactive
effect, if any; (5) adequately defines key terms; and (6) addresses
other important issues affecting clarity and general draftsmanship
under any guidelines issued by the Attorney General. Section 3(c) of
Executive Order 12988 requires Executive agencies to review regulations
in light of applicable standards in section 3(a) and section 3(b) to
determine whether they are met or it is unreasonable to meet one or
more of them. The Department has completed the required review and
determined that, to the extent permitted by law, the regulations meet
the relevant standards of Executive Order 12988.
C. Review Under the Regulatory Flexibility Act
The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., requires that
a Federal agency prepare a regulatory flexibility analysis for any rule
for which the agency is required to publish a general notice of
rulemaking. Today's rule consists of a general statement of policy,
amendments to financial assistance regulations, and amendments to
procurement regulations. Each part of today's rule is exempt from the
requirement to publish a general notice of proposed rulemaking under
the Administrative Procedure Act (5 U.S.C. 553) or any other law.
Therefore, the Regulatory Flexibility Act does not apply to this
rulemaking.
D. Review Under the Paperwork Reduction Act
No new information collection requirements subject to the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., are imposed by today's
regulatory action.
E. Review Under the National Environmental Policy Act
The Department has concluded that promulgation of this rule falls
into a class of actions which would not individually or cumulatively
have significant impact on the human environment, as determined by
Department of Energy regulations (10 CFR part 1021, subpart D)
implementing the National Environmental Policy Act (NEPA) of 1969 (42
U.S.C. 4321 et seq.). Specifically, this rule is categorically excluded
from NEPA review because the rule and amendments to the Department of
Energy Acquisition Regulation (DEAR) would be strictly procedural
(categorical exclusion A6). Therefore, this rule does not require an
environmental impact statement or environmental assessment pursuant to
NEPA.
F. Review Under Executive Order 13132
Executive Order 13132 (64 FR 43255, August 10, 1999) requires
agencies to develop an accountable process to ensure meaningful and
timely input by State and local officials in the development of
regulatory policies that have ``Federalism implications.'' As defined
in the Executive Order, policies that have Federalism implications
include regulations that have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. The Department has examined this rule and has
determined that it would not have a substantial direct effect on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. No further action is required by
Executive Order 13132.
G. Review Under the Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally
requires a Federal agency to perform a detailed assessment of costs and
benefits of any rule imposing a Federal Mandate with costs to State,
local or tribal governments, or to the private sector, of $100 million
or more. This rulemaking affects private sector entities, and the
impact is less than $100 million.
H. Review Under the Treasury and General Government Appropriations Act,
1999
Section 654 of the Treasury and General Government Appropriations
Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family
Policymaking Assessment for any proposed rule or policy that may affect
family well-being. Today's rule does not impact on the autonomy or
integrity of the family institution. Accordingly, the Department has
concluded that it is not necessary to prepare a Family Policymaking
Statement.
I. Review Under the Treasury and General Government Appropriations Act,
2001
The Treasury and General Government Appropriations Act, 2001 (44
U.S.C. 3516, note) provides for agencies to review most disseminations
of information to the public under guidelines established by each
agency pursuant to the general guideline issued by OMB. OMB's
guidelines were published at 67 FR 8452 (February 22, 2002) and DOE's
guidelines were published at 67 FR 62446 (October 7, 2002). DOE has
reviewed today's rulemaking under the OMB and DOE guidelines and has
concluded that it is consistent with applicable policies in those
guidelines.
[[Page 37013]]
J. Review Under the Small Business Regulatory Enforcement Fairness Act
As required by 5 U.S.C. 801, DOE will report to Congress on the
promulgation of today's interim final rule prior to its effective date.
The report will state that the rule is not a major rule under 5 U.S.C.
804(2).
List of Subjects
10 CFR Part 600
Administrative practice and procedure.
10 CFR Part 733
Investigations, Reporting and recordkeeping requirements, Research,
Science and technology, Scientists.
48 CFR Parts 935, 952, and 970
Government procurement.
Issued in Washington, DC on June 20, 2005.
Raymond L. Orbach,
Director of Science.
0
For the reasons set out in the preamble, Chapters II and III of title
10 and Chapter 9 of title 48 of the Code of Federal Regulations
respectively, are to be amended as set forth below:
PART 600--FINANCIAL ASSISTANCE RULES
0
1. The authority citation for 10 CFR part 600 continues to read as
follows:
Authority: 42 U.S.C. 7101 et seq.; 31 U.S.C. 6301-6308; 50
U.S.C. 2401 et seq., unless otherwise noted.
0
2. Add Sec. 600.31 to subpart A to read as follows:
Sec. 600.31 Research misconduct.
(a) A recipient is responsible for maintaining the integrity of
research of any kind under an award from DOE including the prevention,
detection, and remediation of research misconduct, and the conduct of
inquiries, investigations, and adjudication of allegations of research
misconduct in accordance with the requirements of this section.
(b) For purposes of this section, the following definitions are
applicable:
Adjudication means a formal review of a record of investigation of
alleged research misconduct to determine whether and what corrective
actions and sanctions should be taken.
Fabrication means making up data or results and recording or
reporting them.
Falsification means 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 means a determination, based on a
preponderance of the evidence, that research misconduct has occurred.
Such a finding requires a conclusion that there has been a significant
departure from accepted practices of the relevant research community
and that it be knowingly, intentionally, or recklessly committed.
Inquiry means information gathering and initial fact-finding to
determine whether an allegation or apparent instance of misconduct
warrants an investigation.
Investigation means the formal examination and evaluation of the
relevant facts.
Plagiarism means the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
Research means all basic, applied, and demonstration research in
all fields of science, medicine, engineering, and mathematics,
including, but not limited to, research in economics, education,
linguistics, medicine, psychology, social sciences statistics, and
research involving human subjects or animals.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results, but does not include honest error or differences of
opinion.
Research record means the record of all data or results that embody
the facts resulting from scientists' inquiries, including, but not
limited to, research proposals, laboratory records, both physical and
electronic, progress reports, abstracts, theses, oral presentations,
internal reports, and journal articles.
(c) Unless otherwise instructed by the contracting officer, the
recipient must conduct an initial inquiry into any allegation of
research misconduct. If the recipient determines that there is
sufficient evidence to proceed to an investigation, it must notify the
contracting officer and, unless otherwise instructed, the recipient
must:
(1) Conduct an investigation to develop a complete factual record
and an examination of such record leading to either a finding of
research misconduct and an identification of appropriate remedies or a
determination that no further action is warranted;
(2) Inform the contracting officer if an initial inquiry supports
an investigation and, if requested by the contracting officer
thereafter, keep the contracting officer informed of the results of the
investigation and any subsequent adjudication. When an investigation is
complete, the recipient will forward to the contracting officer a copy
of the evidentiary record, the investigative report, any
recommendations made to the recipient's adjudicating official, and the
adjudicating official's decision and notification of any corrective
action taken or planned, and the subject's written response to the
recommendations (if any).
(3) If the investigation leads to a finding of research misconduct,
conduct an adjudication by a responsible official who was not involved
in the inquiry or investigation and is separated organizationally from
the element which conducted the investigation. The adjudication must
include a review of the investigative record and, as warranted, a
determination of appropriate corrective actions and sanctions.
(d) The Department may elect to act in lieu of the recipient in
conducting an inquiry or investigation into an allegation of research
misconduct if the contracting officer finds that:
(1) The research organization is not prepared to handle the
allegation in a manner consistent with this section;
(2) The allegation involves an entity of sufficiently small size
that it cannot reasonably conduct the inquiry;
(3) DOE involvement is necessary to ensure the public health,
safety, and security, or to prevent harm to the public interest; or,
(4) The allegation involves possible criminal misconduct.
(e) DOE reserves the right to pursue such remedies and other
actions as it deems appropriate, consistent with the terms and
conditions of the award instrument and applicable laws and regulations.
However, the recipient's good faith administration of this section and
the effectiveness of its remedial actions and sanctions shall be
positive considerations and shall be taken into account as mitigating
factors in assessing the need for such actions. If DOE pursues any such
action, it will inform the subject of the action of the outcome and any
applicable appeal procedures.
(f) In conducting the activities in paragraph (c) of this section,
the recipient and the Department, if it elects to conduct the inquiry
or investigation, shall adhere to the following guidelines:
(1) Safeguards for information and subjects of allegations. The
recipient shall provide safeguards to ensure that individuals may bring
allegations of research misconduct made in good faith to the attention
of the recipient without suffering retribution. Safeguards include:
protection against retaliation; fair and objective procedures for
examining and resolving allegations;
[[Page 37014]]
and diligence in protecting positions and reputations. The recipient
shall also provide the subjects of allegations confidence that their
rights are protected and that the mere filing of an allegation of
research misconduct will not result in an adverse action. Safeguards
include timely written notice regarding substantive allegations against
them, a description of the allegation and reasonable access to any
evidence submitted to support the allegation or developed in response
to an allegation and notice of any findings of research misconduct.
(2) Objectivity and expertise. The recipient shall select
individual(s) to inquire, investigate, and adjudicate allegations of
research misconduct who have appropriate expertise and have no
unresolved conflict of interest. The individual(s) who conducts an
adjudication must not be the same individual(s) who conducted the
inquiry or investigation, and must be separate organizationally from
the element that conducted the inquiry or investigation.
(3) Timeliness. The recipient shall coordinate, inquire,
investigate and adjudicate allegations of research misconduct promptly,
but thoroughly. Generally, an investigation should be completed within
120 days of initiation, and adjudication should be complete within 60
days of receipt of the record of investigation.
(4) Confidentiality. To the extent possible, consistent with fair
and thorough processing of allegations of research misconduct and
applicable law and regulation, knowledge about the identity of the
subjects of allegations and informants should be limited to those with
a need to know.
(5) Remediation and sanction. If the recipient finds that research
misconduct has occurred, it shall assess the seriousness of the
misconduct and its impact on the research completed or in process. The
recipient must take all necessary corrective actions. Such action may
include but are not limited to, correcting the research record and as
appropriate imposing restrictions, controls, or other parameters on
research in process or to be conducted in the future. The recipient
must coordinate remedial actions with the contracting officer. The
recipient must also consider whether personnel sanctions are
appropriate. Any such sanction must be consistent with any applicable
personnel laws, policies, and procedures, and must take into account
the seriousness of the misconduct and its impact, whether it was done
knowingly or intentionally, and whether it was an isolated event or
pattern of conduct.
(g) By executing this agreement, the recipient provides its
assurance that it has established an administrative process for
performing an inquiry, mediating if possible, investigating, and
reporting allegations of research misconduct; and that it will comply
with its own administrative process and the requirements and
definitions of 10 CFR part 733 for performing an inquiry, possible
mediation, investigation and reporting of allegations of research
misconduct.
(h) The recipient must insert or have inserted the substance of
this section, including paragraph (g), in subawards at all tiers that
involve research.
PART 733--ALLEGATIONS OF RESEARCH MISCONDUCT
0
3. Part 733 is added to Chapter III of title 10 of the Code of Federal
Regulations to read as follows:
PART 733--[ADDED]
Sec.
733.1 Purpose.
733.2 Scope.
733.3 Definitions.
733.4 Research misconduct requirements.
733.5 Allegations received by DOE.
733.6 Consultation with the DOE Office of the Inspector General.
733.7 Referral to the contracting officer.
733.8 Contracting officer procedures.
Authority: 42 U.S.C. 2201; 7254; 7256; 7101 et seq.; 50 U.S.C.
2401 et seq.
Sec. 733.1 Purpose.
The purpose of this part is to set forth a general statement of
policy on the treatment of allegations of research misconduct
consistent with Federal Policy on Research Misconduct established by
the White House Office of Science and Technology Policy on December 6,
2000 (65 FR 76260-76264).
Sec. 733.2 Scope.
This part applies to allegations of research misconduct with regard
to scientific research conducted under a Department of Energy contract
or an agreement.
Sec. 733.3 Definitions.
The following terms used in this part are defined as follows:
Contract means an agreement primarily for the acquisition of goods
or services that is subject to the Federal Acquisition Regulations (48
CFR Chapter 1) and the DOE Acquisition Regulations (48 CFR Chapter 9).
DOE means the U.S. Department of Energy (including the National
Nuclear Security Administration).
DOE Element means a major division of DOE, usually headed by a
Presidential appointee, which has a delegation of authority to carry
out activities by entering into contracts or financial assistance
agreements.
Fabrication means making up data or results and recording or
reporting them.
Falsification means 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.
Financial assistance agreement means an agreement the primary
purpose of which is to provide appropriated funds to stimulate an
activity, including but not limited to, grants and cooperative
agreements pursuant to 10 CFR Part 600.
Finding of research misconduct means a determination, based on a
preponderance of the evidence, that research misconduct has occurred.
Such a finding requires a conclusion that there has been a significant
departure from accepted practices of the relevant research community
and that it be knowingly, intentionally, or recklessly committed.
Plagiarism means the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
Research means all basic, applied, and demonstration research in
all fields of science, engineering, and mathematics, such as research
in economics, education, linguistics, medicine, psychology, social
sciences, statistics, and research involving human subjects or animals.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results, but does not include honest error or differences of
opinion.
Research record means the record of all data or results that embody
the facts resulting from scientists' inquiries, including, but not
limited to, research proposals, laboratory records, both physical and
electronic, progress reports, abstracts, theses, oral presentations,
internal reports, and journal articles
Sec. 733.4 Research misconduct requirements.
DOE intends to apply the research misconduct policy set forth in 65
FR 76260-76264 by including appropriate research misconduct
requirements in contracts and financial assistance awards that make
contractors and financial recipients primarily responsible for
implementing the policy in dealing with allegations of research
[[Page 37015]]
misconduct in connection with the proposal, performance or review of
research for DOE .
Sec. 733.5 Allegations received by DOE.
If DOE receives directly a written allegation of research
misconduct with regard to research under a DOE contract or financial
assistance agreement, DOE will refer the allegation for processing to
the DOE Element responsible for the contract or financial assistance
agreement.
Sec. 733.6 Consultation with the DOE Office of the Inspector General.
Upon receipt of an allegation of research misconduct, the DOE
Element shall consult with the DOE Office of the Inspector General
which will determine whether that office will elect to investigate the
allegation.
Sec. 733.7 Referral to the contracting officer.
If the DOE Office of the Inspector General declines to investigate
an allegation of research misconduct, the DOE Element should forward
the allegation to the contracting officer responsible for
administration of the contract or financial assistance agreement to
which the allegation pertains.
Sec. 733.8 Contracting officer procedures.
Upon receipt of an allegation of research misconduct by referral
under Sec. 733.7, the contracting officer should, by notification of
the contractor or financial assistance recipient:
(a) Require the contractor or the financial assistance recipient to
act on the allegation consistent with the Research Misconduct
requirements in the contract or financial assistance award to which the
allegation pertains; or
(b) In the event the contractor or the financial assistance
recipient is unable to act:
(1) Designate an appropriate DOE program to conduct an
investigation to develop a complete factual record and an examination
of such record leading to either a finding of research misconduct and
an identification of appropriate remedies or a determination that no
further action is warranted; and
(2) Make the appropriate findings consistent with the Research
Misconduct requirements contained in the contract or financial
assistance award, in order to act in lieu of the contractor or
financial assistance recipient.
Title 48
PART 935--RESEARCH AND DEVELOPMENT CONTRACTING
0
4. The authority citation for 48 CFR part 935 continues to read as
follows:
Authority: 42 U.S.C. 7101 et seq.; 41 U.S.C. 418b; 50 U.S.C.
2401 et seq.
0
5. Sections 935.070 and 935.071 are added to read as follows:
935.070 Research misconduct.
(a) Applicability. The DOE research misconduct policy set forth at
10 CFR part 733 addresses research misconduct by individuals who
propose, perform or review research of any kind for the Department of
Energy pursuant to a contract. The regulation applies regardless of
where the research or other activity is conducted or by whom.
(b) Definition. Research misconduct means 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. A finding of
research misconduct means a determination, based on a preponderance of
the evidence, that research misconduct has occurred, including a
conclusion that there has been a significant departure from accepted
practices of the relevant research community and that it be knowingly,
intentionally, or recklessly committed.
935.071 Contract clause.
The contracting officer must insert the clause at 952.235-71,
Research Misconduct, in contracts, including management and operating
contracts, that involve research.
PART 952--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
0
6. The authority citation for part 952 continues to read as follows:
Authority: 42 U.S.C. 2201, 2282a, 2282b, 2282c, 7101 et seq.; 41
U.S.C. 418b; 50 U.S.C. 2401 et seq.
0
7. Section 952.235-71 is added to read as follows:
952.235-71 Research Misconduct.
As prescribed in 48 CFR Part 935.071, insert the following clause:
Research Misconduct (JUL 2005)
(a) The contractor is responsible for maintaining the integrity
of research performed pursuant to this contract award including the
prevention, detection, and remediation of research misconduct as
defined by this clause, and the conduct of inquiries,
investigations, and adjudication of allegations of research
misconduct in accordance with the requirements of this clause.
(b) Unless otherwise instructed by the contracting officer, the
contractor must conduct an initial inquiry into any allegation of
research misconduct. If the contractor determines that there is
sufficient evidence to proceed to an investigation, it must notify
the contracting officer and, unless otherwise instructed, the
contractor must:
(1) Conduct an investigation to develop a complete factual
record and an examination of such record leading to either a finding
of research misconduct and an identification of appropriate remedies
or a determination that no further action is warranted;
(2) If the investigation leads to a finding of research
misconduct, conduct an adjudication by a responsible official who
was not involved in the inquiry or investigation and is separated
organizationally from the element which conducted the investigation.
The adjudication must include a review of the investigative record
and, as warranted, a determination of appropriate corrective actions
and sanctions.
(3) Inform the contracting officer if an initial inquiry
supports a formal investigation and, if requested by the contracting
officer thereafter, keep the contracting officer informed of the
results of the investigation and any subsequent adjudication. When
an investigation is complete, the contractor will forward to the
contracting officer a copy of the evidentiary record, the
investigative report, any recommendations made to the contractor's
adjudicating official, the adjudicating official's decision and
notification of any corrective action taken or planned, and the
subject's written response (if any).
(c) The Department may elect to act in lieu of the contractor in
conducting an inquiry or investigation into an allegation of
research misconduct if the contracting officer finds that:
(1) The research organization is not prepared to handle the
allegation in a manner consistent with this clause;
(2) The allegation involves an entity of sufficiently small size
that it cannot reasonably conduct the inquiry;
(3) DOE involvement is necessary to ensure the public heath,
safety, and security, or to prevent harm to the public interest; or,
(4) The allegation involves possible criminal misconduct.
(d) In conducting the activities under paragraphs (b) and (c) of
this clause, the contractor and the Department, if it elects to
conduct the inquiry or investigation, shall adhere to the following
guidelines:
(1) Safeguards for information and subjects of allegations. The
contractor shall provide safeguards to ensure that individuals may
bring allegations of research misconduct made in good faith to the
attention of the contractor without suffering retribution.
Safeguards include: protection against retaliation; fair and
objective procedures for examining and resolving allegations; and
diligence in protecting positions and reputations. The contractor
shall also provide
[[Page 37016]]
the subjects of allegations confidence that their rights are
protected and that the mere filing of an allegation of research
misconduct will not result in an adverse action. Safeguards include
timely written notice regarding substantive allegations against
them, a description of the allegation and reasonable access to any
evidence submitted to support the allegation or developed in
response to an allegation and notice of any findings of research
misconduct.
(2) Objectivity and Expertise. The contractor shall select
individual(s) to inquire, investigate, and adjudicate allegations of
research misconduct who have appropriate expertise and have no
unresolved conflict of interest. The individual(s) who conducts an
adjudication must not be the same individual(s) who conducted the
inquiry or investigation, and must be separate organizationally from
the element that conducted the inquiry or investigation.
(3) Timeliness. The contractor shall coordinate, inquire,
investigate and adjudicate allegations of research misconduct
promptly, but thoroughly. Generally, an investigation should be
completed within 120 days of initiation, and adjudication should be
complete within 60 days of receipt of the record of investigation.
(4) Confidentiality. To the extent possible, consistent with
fair and thorough processing of allegations of research misconduct
and applicable law and regulation, knowledge about the identity of
the subjects of allegations and informants should be limited to
those with a need to know.
(5) Remediation and Sanction. If the contractor finds that
research misconduct has occurred, it shall assess the seriousness of
the misconduct and its impact on the research completed or in
process. The contractor must take all necessary corrective actions.
Such action may include but are not limited to, correcting the
research record and as appropriate imposing restrictions, controls,
or other parameters on research in process or to be conducted in the
future. The contractor must coordinate remedial actions with the
contracting officer. The contractor must also consider whether
personnel sanctions are appropriate. Any such sanction must be
considered and effected consistent with any applicable personnel
laws, policies, and procedures, and shall take into account the
seriousness of the misconduct and its impact, whether it was done
knowingly or intentionally, and whether it was an isolated event or
pattern of conduct.
(e) DOE reserves the right to pursue such remedies and other
actions as it deems appropriate, consistent with the terms and
conditions of the award instrument and applicable laws and
regulations. However, the contractor's good faith administration of
this clause and the effectiveness of its remedial actions and
sanctions shall be positive considerations and shall be taken into
account as mitigating factors in assessing the need for such
actions. If DOE pursues any such action, it will inform the subject
of the action of the outcome and any applicable appeal procedures.
(f) Definitions.
Adjudication means a formal review of a record of investigation
of alleged research misconduct to determine whether and what
corrective actions and sanctions should be taken.
Fabrication means making up data or results and recording or
reporting them.
Falsification means 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 means a determination, based on a
preponderance of the evidence, that research misconduct has
occurred. Such a finding requires a conclusion that there has been a
significant departure from accepted practices of the relevant
research community and that it be knowingly, intentionally, or
recklessly committed.
Inquiry means information gathering and initial fact-finding to
determine whether an allegation or apparent instance of misconduct
warrants an investigation.
Investigation means the formal examination and evaluation of the
relevant facts.
Plagiarism means the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
Research means all basic, applied, and demonstration research in
all fields of science, medicine, engineering, and mathematics,
including, but not limited to, research in economics, education,
linguistics, medicine, psychology, social sciences statistics, and
research involving human subjects or animals.
Research Misconduct means fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results, but does not include honest error or
differences of opinion.
Research record means the record of all data or results that
embody the facts resulting from scientists' inquiries, including,
but not limited to, research proposals, laboratory records, both
physical and electronic, progress reports, abstracts, theses, oral
presentations, internal reports, and journal articles.
(g) By executing this contract, the contractor provides its
assurance that it has established an administrative process for
performing an inquiry, mediating if possible, or investigating, and
reporting allegations of research misconduct; and that it will
comply with its own administrative process and the requirements of
10 CFR part 733 for performing an inquiry, possible mediation,
investigation and reporting of research misconduct.
(h) The contractor must insert or have inserted the substance of
this clause, including paragraph (g), in subcontracts at all tiers
that involve research.
(End of Clause)
PART 970--MANAGEMENT AND OPERATING CONTRACTS
0
7. The authority citation for part 970 continues to read as follows:
Authority: 42 U.S.C. 2201, 2282a, 2282b, 2282c; 42 U.S.C. 7101
et seq.; 41 U.S.C. 418b; 50 U.S.C. 2401 et seq.
0
8. Section 970.5204-3 is amended by revising paragraph (b)(1) to read
as follows:
970.5204-3 Access to and ownership of records.
* * * * *
(b) * * *
(1) Employment-related records (such as worker's compensation
files; employee relations records, records on salary and employee
benefits; drug testing records, labor negotiation records; records on
ethics, employee concerns; records generated during the course of
responding to allegations of research misconduct; records generated
during other employee related investigations conducted under an
expectation of confidentiality; employee assistance program records;
and personnel and medical/health-related records and similar files),
and non-employee patient medical/health-related records, except for
those records described by the contract as being maintained in Privacy
Act systems of records.
* * * * *
[FR Doc. 05-12645 Filed 6-27-05; 8:45 am]
BILLING CODE 6450-01-P