Update: The following update relating to this announcement has been issued:
Release Date: September 26, 2011
The NIH initial peer review process involves the consistent application of standards and procedures that produce fair, equitable, informed, and unbiased examinations of grant and cooperative agreement applications to the National Institutes of Health (NIH). The process, defined in regulation at 42 CFR Part 52h, is extended by policy to other types of applications submitted to the agency.
This announcement provides revised policy for managing conflict of interest (COI), the appearance of COI, prejudice, bias, or predisposition in the NIH initial peer review process. Given the increasingly multi-disciplinary and collaborative nature of biomedical and behavioral research, the revised policy is intended to facilitate reviews that involve multi-site or multi-component projects, consortia, networks, aggregate datasets, and/or multi-authored publications.
From time to time Federal employees participate in the NIH initial peer review process as part of their official duties. At all times, these Federal officials are subject to the comprehensive body of law governing the conduct of Federal employees. The applicable statutes and regulations include 18 U.S.C. §§ 201-216, the government-wide Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Parts 2634, 2635, and 2640, and agency-specific regulations such as the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services, 5 C.F.R. Part 5501. A Federal employee serving as a member of an NIH Scientific Review Group (SRG) is responsible for complying with all applicable ethical conduct rules and obtaining any clearance for his/her SRG service required by/in his/her employing institute, agency, or office.
This announcement articulates policies governing: (1) the management of conflict of interest (COI), appearance of COI, prejudice, bias, or predisposition in the NIH initial peer review process on the part of individuals who are not Federal employees participating as reviewers; and (2) the selection and use of Federal employees to participate as reviewers, in the initial peer review of:
The revised policy does not apply to:
Conflict of Interest: Regardless of the level of financial involvement or other interest, if a reviewer feels unable to provide objective advice, he/she is expected to recuse him/herself from the review of the application at issue. The peer review system relies on the professionalism of each reviewer to identify to the designated government official the existence of any real or apparent COI that are likely to bias the reviewer's evaluation of an application.
Conflict of Interest – Apparent:
Criterion Scores: Before the review meeting, each reviewer assigned to an application gives a separate numerical score for each of (at least) five established review criteria. These individually scored criteria generally are those that apply to all applications for a particular program or category (e.g., Research Projects), whereas the criteria that are not scored individually generally are those that are included in the determination of the impact score only as applicable for the work proposed. For all applications, even those that are streamlined, the scores of the assigned reviewers for these criteria are reported individually on the summary statement.
Designated Federal Official (DFO): The DFO is the NIH staff member who has legal responsibility under the Federal Advisory Committee Act (FACA) for managing the peer review meeting in a manner consistent with applicable statute, regulation, and policy.
Deviation: In unusual circumstances, a deviation from established NIH policy regarding COI or appearance of COI for non-Federal reviewers, or the selection of Federal employees to serve as reviewers or the assignment of particular review responsibilities to a Federal employee, is warranted in order to facilitate the review of applications and maintain the fairness, timeliness, competitiveness, and impartiality of the review process. A request for a policy deviation must be approved by the NIH DDER in advance of the review meeting.
Fully Participating Reviewer: A fully participating reviewer is one who is formally assigned as a reviewer; is present at the SRG meeting, or for the teleconference or web-based discussion; has reviewed and evaluated the application; and has participated in the deliberation on its scientific and technical merit or in the deliberation to streamline the application at the review meeting, or during the teleconference or web-based discussion. Only fully participating reviewers are eligible to give overall impact scores for an application.
Impact Score: The impact score is the rating assigned to an individual application by an SRG, and designates the reviewers’ assessment of the likelihood for the research project to exert a sustained, powerful influence on the research field(s) involved, in consideration of established review criteria. For certain mechanisms (e.g., Fs and S10s), overall impact may be redefined in terms of merit for the candidate’s career or benefit for the research community. The impact score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application’s scientific and technical merit. Impact scores may be numeric or alphabetical (e.g., ND).
Mail Reviewer: A Mail Reviewer provides written critique(s), criterion scores, and an initial impact score(s) on a particular application or group of applications, by some form of mail, electronic, or internet-assisted communication to the DFO, but does not attend the meeting or participate in the discussion of that application(s) and does not provide a final impact score(s).
Other Significant Contributor (OSC): An OSC is an individual who has committed to contribute to the scientific development or execution of the project, but has not committed to any specified measurable effort (in person months) to the project. These individuals are typically presented at “effort of zero person months” or “as needed” (individuals with measurable effort cannot be listed as OSCs).
Peer Reviewers: Peer reviewers are individuals who are experts qualified by training and experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under evaluation. These individuals provide expert advice on the scientific and technical merit of applications.
Professional Associate: A professional associate is any colleague, scientific mentor, or student with whom an individual is conducting research or other significant professional activities currently or with whom the individual has conducted such activities within three years of the date of the review. See 42 CFR Part 52h.
Request for Applications (RFA): An RFA is an initiative sponsored by one for more NIH Institutes or Centers that stimulates targeted research by requesting grant applications in a well-defined scientific area. RFAs identify funds set aside for the initiative and the number of awards likely to be made..
Scientific Review Group (SRG): An SRG is a peer review committee of primarily non-government experts (peer reviewers), qualified by training or experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under review, to evaluate and give expert advice on the scientific and technical merit of the applications. No more than one-fourth of the members of any SRG may be Federal employees, as noted in the Public Health Service Act and regulation at 42 CFR Part 52h. (Membership on an NIH SRG does not make an individual an employee or officer of the Federal Government.)
Special Emphasis Panel (SEP): A SEP is a chartered federal advisory committee that is authorized under FACA and may be used to perform a one-time only review of a single application or group of applications. The SRG membership of the SEP committee is designated to serve for individual meetings rather than for fixed terms of service.
SRG Member: For purposes of this policy, SRG members include all fully participating reviewers and mail reviewers unless otherwise designated. The term SRG member bears no connotation about appointments, temporary service, or assignments to particular applications.
Scientific Review Officer (SRO): The SRO is the NIH official who serves as the DFO and has responsibility for identifying individuals to serve as peer reviewers, the assignment of review responsibilities, managing the peer review meeting, and the procedures for evaluating the applications assigned to the SRG.
NIH SROs are responsible for managing COI or appearances of COI during the initial peer review process. Their responsibilities include: 1) screening potential and recruited SRG members for COI, apparent COI, and suitability for review assignment(s); 2) providing instructions for reviewers related to applicable regulations and policies regarding COI, apparent COI, and review assignment(s); and 3) managing COI, apparent COI and review assignments otherwise contrary to NIH policy.
Procedures and measures to be taken by the SRO and non-Federal SRG members in advance of, during, and after SRG meetings in relation to COI and appearance of COI are based on the peer review regulations at 42 CFR Part 52h.
NIH SROs may not assign review responsibilities to a non-Federal reviewer or Federal employee that would violate the policy set forth in section B., below, unless the DDER first grants a deviation.
An SRG member who is not a Federal employee and has a real COI or an appearance of a COI with an application may not participate in its review, unless a waiver has been granted consistent with the peer review regulations at 42 CFR Part 52h. As defined in regulation, several bases exist for COI for non-Federal SRG members, including employment, financial benefit, personal relationships, professional relationships or other interests. All non-Federal SRG members, including Mail Reviewers, must:
An SRG member who is a Federal employee and has a COI under the criminal statute, 18 U.S.C. § 208, or an apparent COI under the Standards of Ethical Conduct, 5 C.F.R. § 2635.502 with an application may not participate in its review, unless a waiver or authorization, respectively, has been granted by the appropriate authority at the employing agency, consistent with agency delegations of authority. Federal employees are strongly encouraged to consult with their ethics officials regarding any questions regarding the application of the COI statute and the Standards of Ethical Conduct in the context of their service as NIH peer reviewers.
Federal employees are reminded to consider all potential sources of conflict when engaging in initial peer review, including outside activities, such as clinical practice and teaching, speaking, or writing, spousal employment, and investment interests.
All Federal SRG members and review participants must:
An individual considered to be participating in a project with a major professional role contributes to the scientific development or execution of the project in a substantive, measureable way, whether or not compensation is requested. Even where a Federal employee’s participation in the review would not violate government ethics rules, if s/he is identified as someone who will participate in a project with a major professional role, s/he may not serve as a fully participating member of the SRG where the application in question is reviewed (i.e., “out of the SRG” or "may not serve"). In addition, an individual with a primary appointment in the same component of a multi-component organization as an individual listed on the application with a major professional role may not participate in the review of that application (“out of the room” or "may not review").
Individuals participating with major professional roles include:
An SRG member, including a Federal employee (where participation in the review would not violate government ethics rules), may serve on the SRG but may not participate in the review of an application (“out of the room”), in the absence of a waiver granted by the DDER if the reviewer:
Unless a deviation from a limitation set forth in this Section B is granted by the DDER, an investigator who participates with a major professional role on an application submitted in response to an RFA, or a Federal employee subject to one of the above-stated limitations in relation to an application submitted in response to an RFA, may not serve as a reviewer of that application or other applications submitted in response to the same RFA.
An SRG that meets regularly may not be objective as a group about evaluating the work of one of its members. In such a case, a member’s application or an application that lists the member as participating with a major professional role will be reviewed by another qualified SRG to ensure a competent and objective review. In addition, an application that is from an individual who serves regularly on a recurring SEP, or lists such an individual as participating with a major professional role, may create an appearance of COI for review by that SEP. The SRO will monitor such situations for potential COI.
Multi-component Institutions. For non-Federal reviewers, the DDER has determined that separate organizational components/schools of multi-component academic institutions, hospitals, health centers, and research institutions, as well as different NIH ICs and Federal agencies, are sufficiently independent that an employee of one component serving on an SRG can review an application from another component, if the reviewer has no responsibilities at the institution that would significantly affect the other component and any other real or apparent COI is resolved. For example:
A Federal employee who has, under government ethics rules, a covered relationship with or financial interest in an applicant institution may not participate in the review of an application even if the institution is a multi-component institution.
Applicant Institution. The DDER has determined that an SRG member who is named in an application but has no other affiliation with the applicant institution may participate in the review of other applications from that applicant institution, provided that any other real or apparent COI described in Part B of this announcement is resolved. Federal reviewers must also ensure any real or apparent COI under government ethics rules is resolved by appropriate officials consistent with agency delegations of authority.
Individuals Participating with Minor Professional Roles. An individual listed in an application as participating with a minor professional role does not contribute to the scientific development or execution of the project in a substantive, measureable way and may review the application provided that any other real or apparent COI described in Part B of this announcement is resolved. Federal reviewers also must ensure that any real or apparent COI under government ethics rules is resolved by appropriate officials consistent with agency delegations of authority. Further, an SRG member from the same institution as that of an individual listed with a minor professional role may review the application, provided that any other real or apparent COI is resolved. Similarly, unless there is another unresolved real or apparent COI, an SRG member may review an application if s/he:
Mail Reviewers. COI or the appearance of COI for Mail Reviewers is managed only for those applications that they have been asked to evaluate, not for all applications pending review in the SRG.
Howard Hughes Medical Institute (HHMI). HHMI peer reviewers serving on SRGs may review applications from other HHMI investigators provided they do not work at the same component/school of a multi-component academic institution and no other COI or appearance of COI exists.
The NIH Peer Review Regulations at 42 CFR Part 52h.5(b)(4) specify that in the review of grant and cooperative agreement applications, the Director, NIH (or his/her designee) is authorized to waive the requirement for recusal due to a real COI, as defined in those regulations, when the Director (or his/her designee) determines that there are no other practical means for securing appropriate expert advice to provide a competent review of a grant and cooperative agreement application, and that the COI is not so substantial as to be likely to affect the integrity of the advice to be provided by the reviewer. In addition, the regulations at Part 52h.5(c) authorize the Director, NIH (or his/her designee) to waive the requirement for recusal due to the appearance of COI, when the Director (or his/her designee) determines that it would be difficult or impractical to carry out the review otherwise, and the integrity of the review process would not be impaired by the reviewer’s participation.
The authority to grant such waivers has been delegated to the DDER, NIH, and further delegation is prohibited. The DDER may waive the requirements for recusal in specific instances after review of adequate written justification submitted by an SRO or other official designated by an IC. The justification must explain fully the circumstances for the requested deviation. The SRO or other designated IC official either must exclude the reviewer or obtain advance written approval from the DDER to allow the individual to serve [e.g., 42 CFR Part 52h.5(c)].
While the NIH Peer Review Regulations do not apply to Federal employees engaged in initial peer review, the policy limitations on the selection and use of Federal employees in initial peer review are modeled on those regulations. In order to facilitate a thorough and competent review of applications, the DDER may waive the policy limitations set forth in Section B (above) in specific instances after review of adequate written justification submitted by an SRO or other official designated by an IC. The justification must explain fully the circumstances for the requested deviation. The SRO or other designated IC official either must exclude the reviewer or obtain advance written approval from the DDER to allow the individual to serve.
Situations that may be considered for deviations are of the types that exist between an individual reviewer and an individual application. Requests for deviations involving co-authorship of multi-authored publications (other than review articles, position papers, or professional group or conference reports) within the preceding three years will be considered by the DDER on a case-by-case basis. Situations that involve minor professional relationships generally can be allowed without a deviation. Situations that are disallowed by law, regulation, or designated authority cannot be waived and should never be allowed.
For Federal employees serving as NIH peer reviewers, waivers and authorizations of conflicts of financial interest and appearance concerns under government ethics rules must be obtained from appropriate ethics and agency officials prior to participation.
Please direct all inquiries to:
Sally A. Amero, Ph.D.
NIH Review Policy Officer
 See discussion 3., "Federal Employee SRG Members", for government ethics requirements affecting review assignments.
 A consultant or collaborator who has received or could receive a direct financial benefit of any amount deriving from an application under review, or has received or could receive a financial benefit from the applicant institution or PD/PI that in the aggregate exceeds $10,000/year, is considered to be participating with a major professional role.
 See Discussion 5., "Individuals Participating with Minor Professional Roles", concerning co-authorship of a review article, position paper, or professional group or conference report.
 Members of the NIH Intramural Research Program (IRP) may not participate in the review of an application involving another member of the NIH IRP participating with a major professional role in an application for an allocation from the NIH Common Fund, regardless of IC affiliation, unless a deviation is granted by the DDER.
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