The Catholic University of America

Summary of Federal Laws

Research

National Science Foundation (NSF) 

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)
Effective January 4, 2010 each institution that applies for financial assistance from the Foundation for science and engineering research or education must describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project. See the RCR Frequently Asked Questions, updated March 3, 2010.

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. See also Grants Policy and Guidance on Research Misconduct
 

Required Education for the Protection of Human Research Participants

NIH requires 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.

Notification of Requirements Regarding Findings of Sexua Harassment, Other Forms of Harassment, or Sexual Assault, 83 Fed. Reg. 47940, Sept. 21, 2018. 

Effective Sept. 21, 2018, NSF awardee organizations must notify NSF of any findings and determinations of sexual harassment, sexual assault, or other forms of harassment committed by an NSF-funded principal investigator (PI) or co-principal investigator (co-PI). The new term and condition will further require the awardee organizations to notify NSF if a PI or co-PI is placed on administrative leave or if any administrative action is imposed on the PI or co-PI related to harassment or sexual assault. After notification, NSF will consult with the awardee organization to determine what action is necessary. 

 Resources

NSF Proposal and Award Policies and Procedures Guide, Jan. 2019, posted 11-2-18

Office of Human Research Protections

RCR Frequently Asked Questions, updated March 3, 2010.

University of Louisville  RCR policy

NIH Web page Update on the Requirement for Instruction in the Responsible Conduct of Research (dated 11-24-09)

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))

NIH computer-based training module for researchers on the protection of human subjects.

 

 

 

updated 11-7-18 mlo