NOT-OD-18-115 - Maintaining Integrity in NIH Peer Review: Responsibilities and Consequences - RESCINDED
NOT-OD-15-106 - Applicant Responsibilities in Maintaining the Integrity of NIH Peer Review - RESCINDED
NOT-OD-14-073 - Maintaining Confidentiality in Peer Review - RESCINDED
Office of The Director, National Institutes of Health (OD)
Maintaining security and confidentiality in the NIH peer review process is essential for safeguarding the exchange of scientific opinions and evaluations without fear of reprisal; protecting trade secrets or other proprietary, sensitive and/or confidential information; providing reliable input to the agency about research projects to support; and safeguarding the NIH research enterprise against the misappropriation of research and development to the detriment of national or economic security. In addition, maintaining integrity in the peer review process is important for maintaining public trust in science.
This Notice reminds all participants and stakeholders in the NIH peer review process of federal statutes, regulations, and NIH policies regarding peer review security and confidentiality; their responsibilities for abiding by those rules; and possible actions that the NIH (in coordination with other offices) may take and consequences that may ensue from a violation of those rules. Participants and stakeholders include but are not limited to:
Security of Government Computer Systems
The NIH peer review process is conducted via secure online systems; NIH reviewers and NIH NAC members are provided access through login credentials supplied by the Designated Federal Officer (DFO) in charge of the review meeting. A DFO is a full-time or permanent part-time Federal officer or employee assigned to the committee to ensure compliance with the Federal Advisory Committee Act, 5 U.S.C. App. 2, and other applicable laws, regulations, and NIH policies. The DFO is often referred to as Scientific Review Officer (SRO) for initial peer review meetings or Executive Secretary (ES) for NAC meetings.
Consistent with the agency's responsibility to protect applications, information, and data related to NIH peer review contained in these systems (see the System of Records Notices 09-25-0036 and 09-25-0225), the NIH provides this public Notice that the following activities are prohibited:
With issuance of this Notice, each NIH peer reviewer and NAC member must certify (see Appendix) their understanding of, and compliance with, these rules and consequences for violating them.
In addition, participants and stakeholders in NIH peer review (as defined above) are expected to report, in strict confidence, any known breach of security to the NIH DFO managing the review meeting.
Confidentiality of NIH Peer Review
PD/PIs, Key Personnel, Officials of Applicant Organizations and Offerors, and Other Individuals Acting on Their Behalf
The only acceptable channel for communication about the review of an NIH grant application after submission is through the DFO who is managing the Scientific Review Group (SRG) or NAC; the only acceptable channel for communication about an R&D contract proposal is through the Contracting Officer (CO) in charge of the solicitation. Therefore, PD/PIs, Key Personnel, officials of applicant organizations and offerors, and other individuals acting on their behalf are prohibited from:
Participants and stakeholders (as defined above) who are contacted by an NIH peer reviewer, NAC member, or another individual acting on behalf of an NIH peer reviewer or NAC member, for purposes of obtaining or exchanging information outside of the channels described above, are expected to report the contact to the DFO in charge of the SRG or NAC, or the CO in charge of the solicitation.
NIH Peer Reviewers and NIH Advisory Council Members
Consistent with the NIH peer review regulations at 42 CFR 52h.6, NIH peer review meetings are closed to the public and most documents provided to reviewers are confidential. Therefore, NIH peer reviewers, NIH NAC members, and other individuals acting on their behalf must destroy, delete, and/or return the grant applications, R&D contract proposals, and associated confidential information to the DFO in charge of the review meeting, and are prohibited from:
Each NIH peer reviewer must certify a Security, Confidentiality and Nondisclosure Agreement (see the Appendix) that they fully understand and will comply with the confidential nature of the review process. Members of NIH NACs must submit Confidential Financial Disclosure statements and certify similar Security, Confidentiality and Nondisclosure Agreements.
Each reviewer/NAC member certifies the Security, Confidentiality and Nondisclosure Agreement "with the understanding that any materially false, fictitious, or fraudulent statement or representation may subject me to criminal, civil, or administrative penalties (18 USC §1001)".
18 USC §1001 states:
"Except as otherwise provided in this section, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully-
(1) falsifies, conceals, or covers up by any trick, scheme, or device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement or representation; or
(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry;
Shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2332), imprisoned not more than 8 years or both."
In addition, each reviewer is expected to notify the DFO who is managing the review of the relevant application or the CO in charge of the solicitation if they are contacted for purposes of obtaining or exchanging information outside of the channels described above or in attempts to influence the outcome of the review process.
If the NIH determines that a situation involves a breach of integrity, including confidentiality or security, in the NIH peer review process, the NIH in coordination with other offices may take actions including, but not limited to:
For information on additional, applicable laws, regulations, and policies, as well as possible consequences for violations, see Integrity and Confidentiality in NIH Peer Review.
Please direct all inquiries to:
NIH Review Policy Officer
Certifications for NIH Peer Reviewers
Before gaining access to NIH grant applications, R&D contract proposals or review meeting information, NIH reviewers must certify their understanding of the Security, Confidentiality and Nondisclosure Agreement below. This agreement also is available on the Consolidated List of Reviewer Documents website.
Security, Confidentiality, and Nondisclosure Agreement
With the understanding that any materially false, fictitious, or fraudulent statement or representation may subject me to criminal, civil, or administrative penalties (18 USC §1001), I certify that I fully understand the confidential nature of the NIH peer review process and possible consequences for breaches of confidentiality, and agree:
I understand that confidential information related to NIH peer review includes but is not limited to grant applications, R&D contract proposals, and data and information contained therein; other materials made available to me as an NIH reviewer; information and materials related to the reviewer recruitment process and reviews; individual reviewer assignments, conflicts of interest, and evaluations including scores and written critiques; and discussions and notes taken during review meetings.
I understand that the NIH may take steps in response to a violation of the above rules, in order to preserve the integrity of the NIH review process. Depending on the specific circumstances, such steps may include but are not limited to: