Integrity and Confidentiality in NIH Peer Review

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Brenda, a reviewer for an upcoming NIH study section, is assigned to review a grant application that cites the work of a colleague in her department. Brenda thinks that feedback from her colleague would be helpful in writing her critique of the application. Can Brenda give the application to her colleague?

No! Brenda must contact the Scientific Review Officer (SRO) who is managing the review, and discuss the situation. If input from Brenda's colleague would be helpful, the SRO would need to check for conflicts of interest, obtain a confidentiality certification from Brenda's colleague, and grant permission for the colleague to participate.

Maintaining confidentiality throughout the peer review process is essential to allow for the candid exchange of scientific opinions and evaluations; and to protect trade secrets, commercial or financial information, and information that is privileged or confidential. NIH has multiple safeguards to protect the integrity of and to maintain confidentiality in peer review. See Guide Notice NOT-OD-14-073 and NOT-OD-15-106.

NIH understands that some professional interactions between applicants and reviewers often continue while an application is undergoing peer review, but discussions or exchanges that involve the review of that application are not allowed.

Reviewers

Prohibitions

Confidentiality in NIH peer review prohibits a peer reviewer member from:

  • Sharing applications, proposals, or meeting materials with anyone who has not been officially designated to participate in the peer review process.
  • Granting access to any NIH secure computer system or advisory committee meeting to anyone who has not been officially designated to participate in the peer review process .
  • Disclosing, in any manner, information about the committee deliberations, discussions, evaluations, or documents to anyone who has not been designated to participate in the peer review process or who has a declared conflict of interest.
  • Using information contained in an application or proposal for his/her personal benefit or making such information available for the personal benefit of any other individual or organization.
  • Disclosing procurement information prior to the award of a contract.
  • Participating in NIH peer review without signing a confidentiality certification.

Signing Certification

Reviewers must sign, under penalty of perjury, 18 U.S.C. §1001, a confidentiality certification before gaining access to applications, proposals, and meeting materials.

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 2331), imprisoned not more than 8 years, or both."

Consequences

If NIH determines that a situation involves a breach of confidentiality in the peer review process on the part of a reviewer, the NIH may:

  • notify the reviewer in question and/or his institutional Research Integrity Officer or other similar, senior, institutional official.
  • terminate the reviewer's term of service in peer review.
  • refer the matter to the NIH Office of Management Assessment and possibly to the Department of Health and Human Services Office of the Inspector General.
  • Pursue a referral for government-wide suspension or debarment.

Applicants

Prohibitions

An official of an applicant institution, Program Director/Principal Investigator (PD/PI), or individual named in an application (or “applicants”), unless contacted by a government official:

  • Should not contact reviewers on the study section evaluating his or her application to request or provide information about the review or to otherwise attempt to influence the outcome of the review or the reviewer(s).  The only acceptable process for such communication is through the Scientific Review Officer (SRO) who is managing the study section.
  • Should not send information or data directly to a reviewer on the study section evaluating his or her application.  The only acceptable processes for submitting post-submission materials are outlined in NOT-OD-10-115, NOT-OD-12-141, and related notices.
  • Should not attempt to access information related to the review of that application in secure NIH computer systems.

An official of an applicant institution, PD/PI, or individual named in an application who is contacted by a reviewer for purposes of obtaining or exchanging information outside of the channels described above should contact the SRO who is managing the review of his or her application.

Consequences

Depending on the specific circumstances, the NIH may take additional steps to ensure the integrity of the peer review process, including but not limited to:

  • notifying or requesting information from the applicant institution or the individual’s institution.
  • pursuing a referral for government-wide suspension or debarment
  • notifying the NIH Office of Management Assessment with possible referral to the U.S. Department of Health and Human Services Office of Inspector General.

Applicable Laws and Regulations

1. Privacy

The Privacy Act specifies that no agency shall disclose any record which is contained in a system of records, such as NIH Systems Listing 09-025-0036 (which contains NIH grant applications, summary statements, R&D contract proposals and related documents), by any means of communication to any person, or to another agency, except pursuant to a written request by, or with the prior written consent of, the individual to whom the record pertains, unless certain conditions apply. Agencies may disclose Privacy Act records to employees (including Special Government Employees) of the agency which maintains the record who have a need for the record in the performance of their duties. Disclosures may also be made pursuant to a routine use identified in the applicable System of Records Notice. Systems Listing 09-025-0036 provides for routine use disclosures to peer reviewers of grant applications and contract proposals as follows: "to qualified experts not within the definition of Department employees as prescribed in Department regulations for opinions as a part of the application review process."

The Privacy Act also prohibits employees of an agency (including Special Government Employees), who by virtue of their employment, have possession of, or access to Privacy Act protected records, from willfully disclosing the material in any manner to any person not entitled to receive it.

2. Meeting Access

Many NIH advisory committee meetings are closed or partially closed to the public under the Government in the Sunshine Act, 5 U.S.C. § 552b.

3. Procurement Integrity

The Federal Acquisitions Regulation (FAR) is the primary regulation for use by all Federal Executive agencies in their acquisition of supplies and services with appropriated funds, and governs the NIH's procurement of research and development through R&D contracts. According to Section 3.104-3 "Statutory and Related Prohibitions, Restrictions, and Requirements" of the FAR, a person who is advising or has advised the United States with respect to, a Federal agency procurement must not, other than as provided by law, knowingly disclose contractor bid or proposal information or source selection information before the award of a Federal agency procurement contract to which the information relates. (See Section 3.104.4) Criminal and civil penalties, and administrative remedies, may apply to conduct which violates the Act (see 3.104-3)."

4. Confidentiality Agreements

When signing the Confidentiality Agreements, each peer reviewer agrees, under penalty of perjury, 18 U.S.C. §1001, to maintain confidentiality in peer review. 18 U.S.C. § 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 2331), imprisoned not more than 8 years, or both."

5. Federal Employees

Federal employees involved in peer review, including NIH employees, Federal employees serving as reviewers or Council members, and Special Government Employees (SGEs) are subject to:

  • the Standards of Ethical Conduct for Employees of the Executive Branch (5 C.F.R. 2635), which state that an employee has a duty to protect and conserve Government property and to not use such property, or allow its use, for other than authorized purposes. Government property in this context includes Government records. 5 C.F.R. 2635.704. Employees are also prohibited from using nonpublic information, or allowing the improper use of nonpublic information, to further their own private interests or that of another, whether through advice or recommendation, or by knowing unauthorized disclosure. Non-public information includes confidential information gained in peer review. 5 C.F.R. 2635.703. Appropriate corrective or disciplinary action may be taken under applicable Government wide regulations or agency procedures, for a violation. 5 C.F.R. 2635.106.
  • the Privacy Act, which, as discussed above, prohibits employees from willfully disclosing Privacy Act records in any manner to any person not entitled to receive it. Violations may be subject to criminal penalties, including fines of not more than $5,000. 5 U.S.C. Sec. 552a(i).
  • the Trade Secrets Act (Title 18, U.S.C., Sec. 1905), which provides that an employee of an United States agency who publishes, divulges, discloses, or makes known information that comes to him in the course of his employment or official duties and concerns or relates to trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association shall be fined, or imprisoned not more than one year, or both; and shall be removed from office or employment.
 

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