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Research Misconduct |
The National Science Foundation Act of 1950
42 U.S.C. § 1861 et seq.; 45 C.F.R. § 617.1 et seq. (non-discrimination), 45 C.F.R. § 689.1 et seq. (misconduct) and 45 C.F.R. § 690.101 et seq. (protection of human subjects).
Institutions receiving research money from the National Science Foundation (NSF) must maintain and enforce a written conflict of interest policy and take steps to prevent scientific misconduct. An awardee institution must have a policy for investigating and acting on suspected or alleged misconduct. In certain situations the NSF must be immediately notified of the apparent misconduct. The conflict of interest policy must identify, evaluate and resolve conflicts of interest, and if they cannot be resolved, report them to the NSF. Financial disclosures must be updated annually. Records of same must be kept for three years after the expiration of an award or grant (42 C.F.R. §§ 6.04 and 6.05). The institution must also set up an Institutional Review Board (IRB) for all research involving human subjects.
Responsible Conduct of Research, 74 Fed. Reg. 42126 (August 20, 2009)
Standardized Research Performance Progress Report, 72 Fed. Reg. 63629 (November 9, 2007)
The NSF is soliciting public comment on a standardized Research Performance Progress Report (RPPR) format. Although different Federal agencies utilize a variety of formats for reporting progress on activities supported by research grants, similar information is usually collected. These variations increase administrative effort and costs for recipients of Federal awards and make it difficult to compare research programs across government. Development of standard reporting categories will facilitate the development of a common electronic solution for collecting the information in lieu of collecting it through numerous agency-unique reporting forms currently used. Comments due January 8, 2008.
Final Regulations Implementing Federal Policy on Research Misconduct
67 Fed. Reg. 11936, March 18, 2002
NSF issued a final rule to revise its existing misconduct in science and engineering regulations. The new rule implements the Dec. 2000 Federal Policy on Research Misconduct. The preamble notes that the rule has been amended to include language stating that consistent with federal policy, NSF will continue to protect research misconduct investigative and adjudicative files as exempt from mandatory disclosure under the Freedom of Information and Privacy Act, to the extent permitted by law. The rule has as a standard “preponderance of the evidence” for a finding of research misconduct. Institutions have the discretion to apply a higher standard of proof in their internal misconduct proceedings, but if the higher standard is used, and the institution wishes NSF to defer its investigation, then the institution should also evaluate whether the allegation is proven by a preponderance of the evidence.
Federal Policy on Research Misconduct
The Federal Research Misconduct Policy can be found at 65 Fed. Reg. 76,260 (Dec. 6, 2000). The policy applies to research supported by the federal government and performed at research institutions, as well as to research conducted by federal agencies. Under the final policy, research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
The policy is limited to addressing misconduct related to the conduct and reporting of research, as distinct from misconduct that occurs in the research setting but does not affect the integrity of the research record. Thus, falsification of data would be covered by this policy, but misallocation of funds would not. The standard of proof will be a preponderance of the evidence. In most cases, federal agencies will rely on the researcher’s home institution to make the initial response to allegations of research misconduct. Research institutions will notify the funding agency (or agencies) of an allegation of research misconduct if: (1) the allegation involves federally-funded research (or an application for federal funding); (2) it meets the federal definition of research misconduct given above; and (3) the institution's inquiry into the allegation determines there is sufficient evidence to proceed to an investigation. When an investigation is complete, the research institution will forward to the agency a copy of the evidentiary record, the investigative report, recommendations made to the institution's adjudicating official, and the subject's written response to the recommendations (if any). When a research institution completes the adjudication phase, it will forward the adjudicating official's decision and notify the agency of any corrective actions taken or planned.
Immediate notification of the funding agency is required under the following circumstances:
public health or safety is at risk;
agency resources or interests are threatened;
research activities should be suspended;
possible violations of the law;
federal action required to protect the interests of those involved in the investigation;
the research institution believes the inquiry or investigation may be made public prematurely (and the agency needs to take steps to safeguard evidence, etc.); or
the research community or the public should be informed.
The federal agency will make the final decision about whether to make an agency finding of research misconduct.
Required Education for the Protection of Human Research Participants
Beginning October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects.
Office of Human Research Protections:
The federal government has recreated the Office for Protection from Research Risks as the new "Office of Human Research Protections." The newly created office will lack the enforcement authority of the old office, but will still be charged with overseeing compliance with federal regulations regarding research that involves human subjects. For detailed information, see 65 Fed. Reg. 37,136 (June 13, 2000).
National Science Foundation Research Administrator Workshop PowerPoint Presentation(May 2007)
This is a comprehensive Power Point by Crystal LaCore, Special Agent, and William J. Kilgallin, Head of Investigative Legal and Outreach, Office of Inspector General, National Science Foundation. Topics covered include a Compliance Program for Research Risks, Effort Reporting, Cost Accounting, Conflict of Interest, Research Misconduct, and Certification for Federal Grants and Contracts.
Cites:
59 Fed. Reg. 33,308 (June 28, 1994) (the second of two documents within this cite) contains the NSF Investigator Financial Disclosure Policy. The NSF policy applies only to grantee institutions that employ more than 50 persons.
45 C.F.R. § 689 sets forth the institutional requirements for policies and procedures on misconduct in science and engineering.
45 C.F.R. § 684 contains the conflict of interest regulations for professors that are also NSF board members.
45 C.F.R. § 690 deals with the protection of human subjects in research.
60 Fed. Reg. 35,820 (July 11, 1995) contains the amendments to the Grants Policy Manual. Section 930 of the manual contains the scientific misconduct rules, and Section 510 contains the conflict of interest rules.
61 Fed. Reg. 34,839 (July 3, 1996) contains a useful guide to the Public Health Service (PHS)/NSF investigator conflict of interest rules.
All of the above can be accessed on the NIH web page.
Other Resources
Office for Human Research Protections (OHRP)
OHRP IRB Registration and Assurance Filing (information and materials for registering an Institutional Review Board and filing an Assurance of Compliance) (Procedures for Registering Institutional Review Boards and Filing Federalwide Assurances of Protection for Human Subjects (FWAs))
Instructions for Filing Assurances of Protection for Human Subjects
NIH computer-based training module for researchers on the protection of human subjects.
See the AAU Report on University Protections of Human Beings Who Are the Subjects of Research, dated June 28, 2000.
See the Secretary of Health and Human Services announcement on new initiatives to further strengthen protections of human research subjects in clinical trials, including those involving gene transfer.
See also Required Education in the Protection of Human Research Participants, NIH guidance, June 5, 2000.
Updated 03/18/2009 PK
updated 5/13/09 by mlo to add compliance partner, check links
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updated by mlo 6/21/09 to add related policy
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