NOT-OD-14-069: NIH Policy for Managing Conflict of Interest in the Peer Review of Concepts and Proposals for Research and Development Contract Projects

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

Notice Number: NOT-OD-14-069

Key Dates
Release Date: March 20, 2014

Related Announcements
NOT-OD-13-010
NOT-OD-21-019

Issued by
National Institutes of Health (NIH)

Purpose

This announcement presents policies governing the management of conflict of interest (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 peer review of project concepts and proposals submitted to the NIH for research and development (R&D) contract projects, including those submitted under Broad Agency Announcements.

The peer review process at the National Institutes of Health (NIH) involves the consistent application of standards and procedures that facilitate fair, equitable, informed, and unbiased examinations of proposals submitted to the NIH for R&D contract projects. This process is defined in regulation at 42 C.F.R. 52h. [See also Sub-Part 315.303-70 of the Health and Human Services Acquisition Regulation (HHSAR)]. The increasingly multidisciplinary and collaborative nature of biomedical and behavioral research, including multi-site or multi-component projects, consortia, networks, aggregate datasets, and/or multi-authored publications, highlights relationships that could open questions of bias in peer review.

This policy does not apply to:

initial peer review of applications submitted to the NIH for competing research project grants and competing revisions; NIH construction grants; 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;
applications for the Loan Repayment Program;
second-level peer review of grant applications by individuals serving on NIH National Advisory Councils or Boards; and
reviews by individuals serving on Boards of Scientific Counselors or Program Advisory Committees.

I. Definitions:

Close Relative: As defined in the NIH Peer Review Regulation (42 C.F.R. 52h.2) for non-Federal reviewers, a close relative means a parent, spouse, domestic partner, son or daughter.

Conflict of Interest - Appearance:
Non-Federal Reviewer: As defined in regulation (42 C.F.R. 52h.2), appearance of a conflict of
interest means that a reviewer or close relative or professional associate of the reviewer has a financial or other interest in a proposal that is known to the reviewer or the government official managing the review and would cause a reasonable person to question the reviewer’s impartiality if he or she were to participate in the review. The government official managing the review (the Scientific Review Officer or equivalent) will evaluate the appearance of a conflict of interest and determine, in accordance with this subpart, whether or not the interest would likely bias the reviewer’s evaluation of the proposal.

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 contract proposal, 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.

Conflict of Interest - Real:
Non-Federal Reviewer: As defined in regulation (42 C.F.R. 52h.2), real conflict of interest means a
reviewer or a close relative or professional associate of the reviewer has a financial or other interest in a proposal that is known to the reviewer and is likely to bias the reviewer’s evaluation of that proposal as determined by the government official managing the review (the Scientific Review Officer, or equivalent), as acknowledged by the reviewer, or as prescribed by this part. A reviewer shall have a real conflict of interest 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 a proposal under review; (2) Apart from any direct financial benefit deriving from a proposal under review, has received or could receive a financial benefit from the applicant institution, offeror or principal investigator that in the aggregate exceeds $10,000 per year; this amount includes honoraria, fees, stock or other financial benefit, and additionally includes the current value of the reviewer’s already existing stock holdings. The Director, NIH, may amend the dollar threshold periodically, as appropriate, after public notice and comment; or (3) Has any other interest in the proposal that is likely to bias the reviewer’s evaluation of that proposal.

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 contract proposal, 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. 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 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.

From time to time Federal employees participate in the NIH 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. A Federal employee serving as a member of an NIH SRG is responsible for complying with all applicable laws, regulations, and ethical conduct rules and obtaining any clearance for his/her SRG service required by/in his/her employing institute, agency, or office.

Contracting Officer (CO): The CO is a government employee with the authority to enter into, administer, and terminate contracts.

Contract Proposal: A contract proposal means a written offer to enter into a contract that is submitted to the appropriate agency official by an individual or nonfederal organization which includes, at a minimum, a description of the nature, purpose, duration and cost of the project, and the methods, personnel, and facilities to be utilized in carrying it out. A contract proposal may be unsolicited by the federal government or submitted in response to a Request for Proposals (RFP).

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.

Direct Financial Benefit: For purposes of this policy, a direct financial benefit for a non-Federal reviewer is compensation, payment, or other monetary advantage of $1 or more that an individual would receive if a proposal resulted in award of a contract.

Indirect Financial Benefit: For purposes of this policy, indirect financial benefit for a non-Federal reviewer is a financial benefit from the offeror or Principal Investigator (PI) for a proposal, including honoraria, fees, stock or other financial benefit, as well as the current value of the reviewer’s already existing stock holdings.

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.

Offeror: An offeror is an individual or firm responding to a solicitation. For the purposes of this policy, the term offeror includes proposed subcontractors and consultants but does not include collaborators of subcontractors or second or lower tier subcontractors.

Peer Reviewers: Peer reviewers are individuals, primarily non-government, 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 R&D contract project concepts or contract proposals under evaluation. These individuals provide expert advice on the scientific and technical merit of R&D project concepts or contract proposals.

Professional Associate: As defined in regulation (42 C.F.R. 52h.2), 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.

Project Concept: As defined in regulation (42 C.F.R. 52h.2), project concept means the basic purpose, scope and objectives of the project.

Project Concept Reviews: Project concept review is the process by which the basic purpose, scope, and objectives of a proposed biomedical and behavioral R&D contract project are assessed to determine scientific merit and establish the relevance, priority, and need for accomplishing the mission of the NIH. Criteria typically used to evaluate project concept include:

scientific, technical, or program significance of the goals of the proposed R&D activity;
availability of the technology and other resources necessary to achieve the required goals;
extent to which identified, practical scientific or clinical uses exist for the anticipated results; and
adequacy of inclusion of women, minorities and children in clinical research, if applicable.

Request for Proposals (RFP): An RFP is a Government solicitation to prospective offerors, under procedures for negotiated contracts, to submit a proposal to fulfill specific agency requirements based on terms and conditions defined in the RFP. The RFP contains information sufficient to enable all offerors to prepare proposals, and is as complete as possible with respect to the nature of work to be performed; descriptions and specifications of items to be delivered; performance schedule; special requirements clauses, or other circumstances affecting the contract; format for cost proposals; and evaluation criteria by which the proposals will be evaluated.

Research and Development (R&D) Contract Project: An R&D contract project means an identified, circumscribed activity, involving a single contract or two or more similar, related, or interdependent contracts, intended and designed to acquire new or fuller knowledge and understanding in the areas of biomedical or behavioral research and/or to use such knowledge and understanding to develop useful materials, devices, systems, or methods. The CO determines whether the RFP is a solicitation for R&D contract proposals.

Scientific Review Group (SRG): As defined in regulation (42 C.F.R. 52h.2), 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 proposals under review, to evaluate and give expert advice on the scientific and technical merit of contract proposals. No more than one-fourth of the members of any SRG may be Federal employees, as noted in the Public Health Service Act at 42 USC 282(b) and regulation (42 C.F.R. 52h.4). Participation on an NIH SRG does not make an individual an employee or officer of the Federal Government.

Scientific Review Officer (SRO): The SRO is the Designated Federal Official who has the responsibility to ensure that contract proposals receive a competent, thorough and fair review by an SRG, consistent with all relevant NIH review policies. The SRO organizes and provides scientific/technical support to the SRGs, manages conflicts of interest, and is responsible for the completeness and accuracy of the Technical Evaluation Report, including votes on acceptability, scoring of proposals, and other recommendations.

Solicitation means any request to submit offers or quotations to the Government. Solicitations under sealed bid procedures are called invitations for bids. Solicitations under negotiated procedures are called requests for proposals. Solicitations under simplified acquisition procedures may require submission of either a quotation or an offer. (See 48 C.F.R. 2.101)

II. General Policy

A. Responsibilities for managing COI or appearances of COI
The peer review system relies on the professionalism of each reviewer to identify to the Designated Federal Official the existence of any COI that is likely to bias the reviewer's evaluation of a proposal. 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 proposal at issue.

1. NIH Scientific Review Officers (SROs; formerly Scientific Review Administrators)
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 (42 C.F.R. 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 Deputy Director for Extramural Research (DDER), NIH, first grants a waiver.

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 a proposal may not participate as a reviewer on the SRG evaluating that proposal, unless a waiver has been granted consistent with the NIH Peer Review Regulations (42 C.F.R. 52h). As defined in the 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 must certify:

that they will maintain confidentiality of all materials and matters associated with their participation in peer review;
before the SRG meeting that they have identified to the SRO the existence of all known COI and all situations perceived as the appearance of COI; and
after the SRG meeting that they did not participate in the discussion or evaluation of any proposal with which they have a COI or the appearance of COI.

3. Federal Employee SRG Members
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 a proposal 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 about the application of the COI statute and the Standards of Ethical Conduct in the context of their participation in an NIH SRG.

Federal employees are reminded to consider all potential sources of conflict, 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 must certify:

that they will maintain confidentiality of all materials and matters associated with their participation in the review;
before the SRG meeting that they have identified to the SRO the existence of all known COI and all situations perceived as the appearance of COI; and
after each SRG meeting that they have received information regarding the COI rules applicable to Federal employees and did not participate as a reviewer on an SRG where a proposal with which they have a COI or apparent COI was reviewed, unless a waiver or authorization was issued consistent with government ethics requirements.

B. Managing COI
The NIH Peer Review Regulation [42 CFR 52h.5(b)(3)] states that, for contract proposal reviews, an individual with a real conflict of interest in a particular proposal(s) is generally not permitted to participate in the review of any proposals responding to the same RFP.

1. May not serve on the review panel
Through this policy, a reviewer may not serve on the NIH SRG reviewing the proposal in question if:

the reviewer could receive, or the reviewer's close relative could receive, a direct financial benefit of any amount from the proposal, and the conflict is known to the reviewer and/or the SRO managing the review;
the reviewer's employer or institution could encounter direct financial gain deriving from a proposal under review;
the reviewer has received in the twelve months preceding his or her receipt of the proposal an indirect financial benefit from the offeror or the proposed PI that in the aggregate exceeds $10,000 per year; or
the reviewer is listed as participating on a proposal with a major professional role, including:

PI;
Senior/Key Personnel, Project/Site/Core Director, Other Significant Contributor, Subcontractor, Collaborator, and Consultant; and
Advisory Board member for the project or for the offeror.

Waivers (see Section C. Requests for Waivers) for the situations listed above will be considered in extremely rare circumstances.

Federal employees are precluded under the criminal statute, 18 U.S.C. 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.

2. May serve with a waiver
For a non-Federal reviewer, the NIH Peer Review Regulations [42 CFR 52h.5(b)(4)] specify, that, if no other qualified reviewer is available having particular expertise and that expertise is essential to ensure a competent and fair review, a waiver may be granted by the Director to permit an individual to serve as a reviewer of those proposals with which the reviewer has no conflict, while recusing him/herself from the review of any particular proposal(s) in which there is a COI. 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 an R&D contract proposal, 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. The authority to grant such waivers has been delegated to the Deputy Director for Extramural Research (DDER), NIH, and further delegation is prohibited.

Through this policy, a reviewer may serve on the SRG evaluating a proposal, but must be recused from the discussion and evaluation of that proposal through a waiver from the DDER, if he or she has a professional relationship with the offeror or with an individual listed with a major professional role on a proposal being reviewed by the SRG.

Through this policy, such professional relationships include:

Collaborators,
Co-authors,
Mentors, or
Trainees

currently or within the past three years. However, such professional relationships do not include co-authors of review articles, position papers, and professional group or conference reports for the purpose of this policy (see Section 3. Below), and therefore no waiver is needed for these individuals to serve on the SRG and review all the proposals.

3. May serve without a waiver
Through this policy, certain situations, such as those identified below, are considered to present no COI or appearance of COI that could jeopardize the integrity of the review process. Therefore, a reviewer may serve on the SRG and may participate in the discussion and evaluation of all the proposals, without a waiver from the DDER, if he or she:

supplies a resource or service to the offeror, and that resource or service is freely available to anyone in the scientific community;
donates data, specimens, or other resources to a central repository or consortium effort to which an individual(s) named in the proposal also donates data, specimens or other resources, unless he or she plays a major professional role in the consortium;
co-authored a review article, position paper, professional group or conference report (for guidance involving co-authorship of other multi-authored publications see Part B.2. of this announcement) with an individual listed on the proposal;
is from an institution that is part of a multi-center network (e.g., accrual sites for a multi-center clinical trial) or consortium (e.g., Genome Wide Association Study) that includes the offeror, where the SRG member is not involved in the work of the network or consortium.

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.

4. Standing or Recurring Scientific Review Group
According to the NIH Peer Review Regulations [42 CFR 52h.5(d)], an SRG that meets regularly may not be objective as a group about evaluating the work of one of its members. Thus, when a proposal is received in response to an RFP and the proposal lists a member of a standing or recurring SRG as participating with a major professional role, all of the proposals received for that RFP must be reviewed by another qualified SRG to ensure a competent and objective review. The SRO will monitor such situations and appropriately manage the potential COI.

5. Project Concept Reviews
The Peer Review Regulations [42 CFR 52h.5(10)(b]) specify certain situations in which the awarding official may delay carrying out project concept review. Regardless of whether a member of an SRG participates in project concept review for a particular initiative or solicitation before or after release of the solicitation, that member is not considered to have a COI that would prevent him/her from participating in the evaluation of proposals submitted to that initiative or solicitation, as long as no other COI exists.

6. 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 a proposal 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:

the separate campuses of the California State University system are considered separate components in the same way that the separate campuses of the University of California system are;
the separate affiliates of the Harvard system are considered separate components;
the Johns Hopkins Bayview Medical Center and the School of Arts and Sciences, Homewood Campus, are considered separate components;
the Johns Hopkins Schools of Arts and Sciences and of Engineering, Homewood Campus, are considered separate components; but
the Departments of Biology and Chemistry within the School of Arts and Sciences of the same academic institution are not considered separate components.

C. Requests for Waivers
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 waiver. 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 [42 CFR 52h.5(b)].

While the NIH Peer Review Regulations do not apply to Federal employees engaged in peer review, the policy limitations on the selection and use of Federal employees in peer review are modeled on those regulations. In order to facilitate a thorough and competent review of proposals, 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 IC designated official. The justification must explain fully the circumstances for the requested waiver. 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 are disallowed by law, regulation, or designated authority cannot be waived.

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.

III. References

Code of Federal Regulations, 5 CFR Part 2634 - Office of Government Ethics - Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture (http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title05/5cfr2634_main_02.tpl)

Code of Federal Regulations, 5 CFR Part 2635 Office of Government Ethics Standards of Ethical Conduct for Employees of the Executive Branch (http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=06f812f26e7ed9f364bb87944757b912&rgn=div5&view=text&node=5:3.0.10.10.9&idno=5)

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%3A3.0.10.10.12;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 (https://grants.nih.gov/grants/policy/fed_reg_peer_rev_20040115.pdf)

Federal Acquisition Regulation Part 2.101 - Definitions (http://www.acquisition.gov/far/reissue/FARvol1ForPaperOnly.pdf)

Federal Advisory Committee Act, P. L. 92-463 (http://www.gsa.gov/portal/content/100916)

Health and Human Services Acquisition Regulation; Final Rule (http://www.gpo.gov/fdsys/pkg/FR-2009-11-27/html/E9-26948.htm)

18 U.S.C. 208: Acts affecting a personal financial interest (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title18/html/USCODE-2009-title18-partI-chap11-sec208.htm)

Inquiries

Please direct all inquiries to:

NIH Review Policy Officer
[email protected]