THE SCIENTIFIC REVIEW PROGRAM TRAINING PROGRAM

(SRPTP)

CONFLICT OF INTEREST

August, 2015

Disclaimer: The National Institute of Allergy and Infectious Diseases (NIAID) Scientific Review Program (SRP) makes its training documents available to NIH staff as a service. In return for their use we request that you do not share or transmit any of the materials to anyone outside of the NIH. We do our best to keep these documents current, but we do not guarantee the content to be correct or up to date. Documents are reviewed periodically or as needed. If you have any questions or comments, please contact us at .

Goals for This Module

  • Define Conflicts of Interest (COIs) in the context of peer review for reviewers and NIH staff.
  • Explain the difference between real and apparent conflict of interest.
  • Explain the procedures and tools used to identify conflicts of interest during administrative review.
  • Provide guidance on how to handle unexpected conflicts prior to or at the review meeting.

Acronyms Used in this Document
BC / Branch Chief / IC / Institutes and Centers
CFR / Code of Federal Regulations / NAC / National Advisory Council
CO / Contract Officer / NHLBI / National Heart, Lung and Blood Institute
COI / Conflict of Interest / OA / Office of Acquisitions
CS / Contract Specialist / OER / Office of Extramural Research
CSR / Center for Scientific Reviews / PI / Principal Investigator
DEA / Division of Extramural Activities / R&D / Research and Development
DEAS / Division of Extramural Activities Support / RFA / Request for Applications
DUNS / Data Universal Numbering System / RFP / Request for Proposals
EIN / Employer Identification Number / RSS / Reviewer Support Site
EMPC / Extramural Program Management Committee / SEP / Special Emphasis Panel
ESA / Extramural Staff Assistant / SOP / Standard Operating Procedure
FACA / Federal Advisory Committee Act / SRO / Scientific Review Officer
FCOI / Financial Conflict of Interest / SRG / Scientific Review Group
FOA / Funding Opportunity Announcement / SRP / Scientific Review Program
IAR / Internet Assisted Review

Table of Contents

Goals for This Module

NIH Policy and Guidance

Advance Notice: Revised Policy for Managing Conflict of Interest in the Initial Peer Review of NIH Grant and Cooperative Agreement Applications

Notice of Correction to NOT-OD-13-010 "Advance Notice: Revised Policy for Managing Conflict of Interest in the Initial Peer Review of NIH Grant and Cooperative Agreement Applications"

NIH Policy for Managing Conflict of Interest in the Peer Review of Concepts and Proposals for Research and Development Contract Projects

Managing Conflicts of Interest for NIH Staff Handling Activities that Span the Intramural/Extramural Boundary

Blanket Waiver for Individuals from Applicant Organizations to Serve on Initial Scientific Review Groups Evaluating Requests for Applications

NIH’s responsibility in addressing COI issues for non-FACA committees

Training and Guidance

NIAID SOPs

Managing Staff Conflicts of Interest for Cooperative Agreements

Conflict of Interest in Peer Review SOP - Program Officers

Issues frequently confused with COI in Peer Review

Financial Conflict of Interest (FCOI)

NIH Policy on Intramural Scientists as Reviewers

HHS Policy on Committee Service

SRP Practice

Types of COIs

Special COI Considerations for Chartered Study Sections

Special COI Considerations for Conference Grant (R13) Applications

Special COI Considerations for Loan Repayment Applications

How NIH COI Protections are Implemented by SRP

Recruitment Phase tool in IMPAC Peer Review - grant reviews

The Scientific Review Data Management System (SRDMS) – grant and contract reviews

e-Reviewer Support System (RSS) – contract reviews

Conflict of Interest Pack

What to do in Cases of Apparent (or Real) COI

Links to COI and NIH Policy Documents

SRP COI Pack

Contract Reviewers

Other Important Documents

NIH Policy and Guidance

Advance Notice: Revised Policy for Managing Conflict of Interest in the Initial Peer Review of NIH Grant and Cooperative Agreement Applications

See

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:

  • definitions of COI specified in the NIH peer review regulations (42 CFR Part 52h) with respect to direct and indirect financial benefit; and
  • managing COI for individuals participating in multi-component or multi-site applications.

Following an assessment of the 2011 policy by the NIH Office of Extramural Research, the following changes are reflected in this 2013 policy announcement:

  • addition of new language to clarify the regulatory requirements concerning COI involving direct and indirect financial benefit;
  • addition of new language to clarify the regulatory requirements concerning COI involving reviewers who are salaried employees of the applicant institution or investigator, or is negotiating employment with those entities; and
  • deletion of the section on management of COI for individuals in multi-component or multi-site applications.

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:

  • on the part of individuals who are not Federal employees participating as reviewers, and
  • in the selection and use of Federal employees to participate as reviewers,

in the initial peer review of:

  • all applications submitted to the NIH for competing research project grants and competing revisions of any complexity; program projects; resources, including but not limited to instrumentation; center grants and cooperative agreements; institutional and individual National Research Service Awards (NRSAs); and academic, clinical investigator, and career development awards. Hereafter “application” refers to all these types of applications; and
  • such applications submitted for the January 25, 2013 due date and thereafter.

The revised policy does not apply to:

  • the review of applications for NIH construction grants; and
  • individuals serving on NIH National Advisory Councils or Boards, Boards of Scientific Counselors, or Program Advisory Committees.

I. Definitions:

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.

  • Non-Federal Reviewer: COI in scientific peer review exists when a non-Federal reviewer has an interest in an application that is likely to bias his or her evaluation of it. A non-Federal reviewer who has a real COI with an application as defined in 42 CFR Part 52h may not participate in its review unless a deviation is granted by the NIH Deputy Director for Extramural Research (DDER). (See the definitions of Direct Financial Benefit and Indirect Financial Benefit below.)
  • Federal Employee: A Federal employee has a conflict of interest (COI) when he/she participates in a particular matter, such as the review of a funding application, that will have a direct and predictable effect on his or her personal or imputed financial interests, unless a statutory or regulatory exemption or exception applies, or a waiver of the COI is granted by the individual responsible for the employee’s federal employment (the appointing authority), consistent with agency delegations of authority. Imputed interests include those of the employee’s spouse, dependent children, general partner, and any non-federal entity the employee serves as officer, trustee, director, or employee. See 18 U.S.C. § 208; 5 C.F.R. Part 2640.

Conflict of Interest – Apparent:

  • Non-Federal Reviewer: The appearance of COI occurs when a reviewer or close relative or professional associate of the reviewer has a financial or other interest in an application that is known to the reviewer or the government official managing the review, and this circumstance would cause a reasonable person to question the reviewer's impartiality if he or she were to participate in the review. The Scientific Review Officer (SRO) or equivalent managing the review will evaluate the appearance of COI and determine, in accordance with the regulations at 42 CFR Part 52h, whether or not the interest would likely bias the reviewer's evaluation of the application. A non-Federal reviewer who has an apparent COI with an application may not participate in its review.
  • Federal employee: An appearance of a COI arises when a Federal employee is involved in a particular matter involving parties, such as the review of a grant application, and a reasonable person with knowledge of the relevant facts would question the employee’s impartiality in the matter. This may happen when the matter is likely to have a direct and predictable effect on the financial interests of a member of the employee’s household or involves a person with whom the employee is deemed to have a covered relationship as a party or the representative of a party to the matter. Federal employees have a covered relationship with, among others, the following: a person or organization with whom he or she seeks a business or financial relationship; a close relative; an entity that employs the employee’s spouse, parent, or dependent child; an organization in which the employee’s spouse serves as an officer, director, or other position; and, any organization in which the employee is an active participant. Where an appearance of a COI arises, an employee should not participate in the official matter unless he or she is authorized to do so by the appropriate designee of his or her employing agency (often the ethics official). See 5 C.F.R. § 2635.502.

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.

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[1] .

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:

  • certify that they have identified to the SRO before the SRG meeting the existence of all known COI and all situations perceived as the appearance of COI; and
  • certify after the SRG meeting that they did not participate in the discussion or evaluation of any application with which they have a COI or the appearance of a COI.

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.