Notice Number: NOT-OD-13-010
Update: The following update relating to this announcement has been issued:
Release Date: November 30, 2012
National Institutes of Health (NIH)
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.
Last year, given the increasingly multidisciplinary and collaborative nature of biomedical and behavioral research, the NIH issued revised policy (NOT-OD-11-120) for managing conflict of interest (COI), the appearance of COI, prejudice, bias, or predisposition in the NIH initial peer review process. Since that time, questions arose concerning:
Following an assessment of the 2011 policy by the NIH Office of Extramural Research, the following changes are reflected in this 2013 policy announcement:
For these reasons, this announcement replaces the 2011 policy (NOT-OD-11-120) and articulates policies governing the management of COI, appearance of COI, prejudice, bias, or predisposition:
in the initial peer review of:
The revised policy does not apply to:
Applicant Institution: The applicant institution is the one organization that will be legally and financially responsible for the conduct of activities supported by the award.
Close Relative: As defined in the NIH Peer Review Regulation (42 CFR Part 52h) for non-Federal reviewers, a close relative means a parent, spouse, domestic partner, son or daughter.
Conflict of Interest - Real:
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 Federal Official the existence of any real or apparent COI that is likely to bias the reviewer's evaluation of an application.
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. 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 (waiver) must be approved by the NIH DDER in advance of the review meeting.
Direct Financial Benefit: As indicated in the Peer Review Regulation (42 CFR Part 52h) for non-Federal reviewers, a direct financial benefit is compensation, payment, or other monetary advantage of $1 or more that an individual would receive if an application were to be funded. Direct financial benefit usually will be listed in the budget request in the application.
Fully Participating Reviewer: A fully participating reviewer is an SRG member who 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 for research applications 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.
Indirect Financial Benefit: As indicated in the Peer Review Regulation (42 CFR Part 52h) for non-Federal reviewers, indirect financial benefit is a financial benefit from the applicant institution or Program Director/Principal Investigator (PD/PI) for an application, including honoraria, fees, stock or other financial benefit, as well as the current value of the reviewer’s already existing stock holdings.
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).
Major Professional Role: 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.
Minor Professional Role: An individual considered to be participating in a project with a minor professional role does not contribute to the scientific development or execution of the project in a substantive, measureable way.
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 or 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 the Federal Advisory Committee Act (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, with responsibility during the initial peer review process for, among other duties: 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.
II. General Policy
A. Responsibilities for managing COI or appearances of COI
1. NIH Scientific Review Officers (SROs)
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.
2. Non-Federal SRG Members
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:
3. Federal Employee SRG Members
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 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.
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. In the event any applicable legal requirement imposes greater restrictions than NIH policy, employees must abide by the legal requirement.
All Federal SRG members and review participants must:
B. Managing COI or Appearance of COI
1. Financial Benefit
The NIH Peer Review Regulation (42 CFR Part 52) states that a non-Federal reviewer has a real COI if he/she or a close relative or professional associate of the reviewer 1) has received or could receive a direct financial benefit of any amount deriving from an application or proposal under review; or 2) has received or could receive an indirect financial benefit from the applicant institution or Principal Investigator of an application that in the aggregate exceeds $10,000 per year. The NIH Peer Review Regulation further states that if a reviewer has a real or apparent COI, he/she must recuse him/herself from the review of the application.
Through this current policy, regardless of the role he/she plays in the application and regardless of the complexity of the application:
the reviewer is in conflict with the review and is "out of the SRG” or "may not serve", unless a waiver is granted by the DDER in advance of the meeting.
In addition, through this current policy, in connection with an application of any complexity, a reviewer who has received in the twelve months preceding his or her receipt of the application, or who could receive, an indirect financial benefit from the applicant institution or any of the multiple Program Director(s)/Principal investigator(s) [PD(s)/PI(s)] of an application of any complexity, that in the aggregate exceeds $10,000 per year, may not review the application ("out of the room").
Federal employees are precluded under the criminal statute, 18 USC § 208, and the ethical conduct regulations, at 5 C.F.R. § 2635.502, from participating in any review that would affect a personal or imputed financial interest or that involves an entity with which they have a covered relationship, including close relatives, household members, and others.
The NIH Peer Review Regulation (42 CFR Part 52) states that a reviewer who is a salaried employee, whether full-time or part-time, of the applicant institution or Principal Investigator, or is negotiating for employment, shall be considered to have a real conflict of interest with regard to an application from that organization or Principal Investigator. Through this policy announcement, a reviewer who is a salaried employee, whether full-time or part-time of any of the multiple Program Director(s)/Principal Investigator(s)(PDs/PIs) and any of the institutions of an application of any complexity, will be considered to have a real conflict of interest with that application. Provided that any other real or apparent COI is resolved, a reviewer who has a COI due to their current or pending employment may not participate in the review of the application in question (“out of the room” or "may not review") but may review other applications under consideration in the SRG (however, see the exception for multi-component organizations below; Section 7). Federal reviewers are subject to such restrictions under applicable government ethics standards.
3. Individuals Participating with Major Professional Roles
An individual participating in a project with a major professional role may not serve as a member of the SRG where the application in question is reviewed (“out of the SRG” or "may not serve") unless a waiver is granted by the DDER in advance of the meeting.
Even where a Federal employee’s participation in the review would not violate government ethics rules, if she/he is identified as someone who will participate in a project with a major professional role, she/he may not serve as a member of the SRG where the application in question is reviewed (“out of the SRG” or "may not serve").
Individuals participating with major professional roles include:
4. Professional Associates
Provided that any other real or apparent COI is resolved, professional associates may not participate in the review of the application in question (“out of the room” or "may not review") but may review other applications under consideration in the SRG.
In addition, an SRG member, including a Federal employee (even where participation in the review would not violate government ethics rules), may serve on the SRG but may not, in the absence of a waiver granted by the DDER, participate in the review of a specific application (“out of the room” or "may not review") if the reviewer:
5. Applicants to an RFA
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 (“out of the SRG” or "may not serve"). Federal employee reviewers seeking a deviation based on limitations 1 or 2 must also seek a waiver or authorization through their ethics official.
6. Standing Study Section or Recurring Special Emphasis Panel (SEP)
According to the NIH Peer Review Regulation (42 CFR Part 52h), an SRG that meets regularly may not be objective as a group about evaluating the work of one of its members. When a peer review group meets regularly (e.g., standing study section or recurring SEP), 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 that lists such an individual as participating with a major professional role, may create an appearance of COI for review in that SEP. The SRO will monitor such situations and appropriately manage the potential COI.
Applicant Institution.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 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.
Multi-component Institutions. For non-Federal reviewers, separate organizational components/schools of multi-component academic institutions, hospitals, health centers, and research institutions, as well as different NIH Institutes and Centers (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 (“out of the room” or "may not review"). 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.
Individuals Participating with Minor Professional Roles. An individual listed in an application as participating with a minor professional role may review the application and other applications in the SRG without a waiver, provided that any other real or apparent COI is resolved. Situations involving minor professional roles will be assessed by the SRO on a case-by-case basis.
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.
Examples of a minor professional role include an individual who:
Mail Reviewers. COI or the appearance of COI for mail reviewers is managed primarily for those applications that they have been asked to evaluate, not for all applications pending review in the SRG. However, a mail reviewer may not review an application pending review in the same SRG where another application is pending review that lists him/her as participating with a major professional role.
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 any other real or apparent COI is resolved.
C. Requests for Deviations
For non-Federal reviewers, 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, and co-authorship of multi-authored publications (other than review articles, position papers, or professional group or conference reports) within the preceding three years. 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.
Code of Federal Regulations, 5 CFR Part 2635 – Office of Government Ethics – “Standards of Ethical Conduct for Employees of the Executive Branch” (http://www.usoge.gov/laws_regs/regulations/5cfr2635.aspx)
Code of Federal Regulations, 5 CFR Part 2640 – Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest) http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr;sid=cbc7425f9cf4949f6e219b8737e5b2b2;rgn=div5;view=text;node=5%3A126.96.36.199.12;idno=5;cc=ecfr
Code of Federal Regulations, 5 CFR Part 5501 – Office of Government Ethics – “Supplemental Standards of Ethical Conduct for Employees of DHHS” http://www.access.gpo.gov/nara/cfr/waisidx_07/5cfr5501_07.html)
Code of Federal Regulations, 42 CFR Part 52h - Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects (http://grants.nih.gov/grants/policy/fed_reg_peer_rev_20040115.pdf)
Federal Advisory Committee Act, P. L. 92-463 (http://www.gsa.gov/portal/content/100916)
Please direct all inquiries to:
Sally A. Amero, Ph.D.
NIH Review Policy Officer
 See discussion on Federal Employee SRG Members for government ethics requirements affecting review assignments. See Section II(a)(3).
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