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NIH Conflict of Interest: Identifying & Managing Conflicts in Grants (78 characters), Lecture notes of Management of Health Service

The nih conflict of interest (coi) rules for reviewers of nih grant applications and r&d contract proposals. It covers the federal regulations, the importance of electronic certifications, and the procedures for identifying and managing real or apparent cois. The document also specifies the coi guidelines for grant application reviews and technical evaluation of r&d contract proposals.

What you will learn

  • What are the consequences for reviewers who do not certify COIs before or after the peer review meeting?
  • What are the COI guidelines for grant application reviews and technical evaluation of R&D contract proposals?

Typology: Lecture notes

2021/2022

Uploaded on 09/12/2022

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NIH/OER (Approved for implementation by October 2018)
NIH Conflict of Interest Rules:
Information for Reviewers of NIH Applications and R&D Contract Proposals
The NIH peer review system relies on the professionalism of each reviewer to identify any conflict of
interest (COI) or apparent COI that may affect or appear to affect the integrity of the NIH peer review
process.
The NIH COI rules for initial peer review for grant applications, and technical evaluation of
R&D contract proposals, are based on federal regulations (42 CFR Part 52h) and presented in
detail in NIH Guide Notices NOT-OD-13-010 and NOT-OD-14-069.
Note: Beginning immediately, all reviewer COI certifications, including certifications for
technical evaluation of R&D contract proposals, must go through electronic certifications.
In order to participate in the review meeting, you must:
o Review the appropriate set of rules below and screen the applications or proposals for
real or apparent COI for yourself.
o Notify the Scientific Review Officer immediately:
If you have a COI that prevents you from serving on that review panel (see
below), or
If you are assigned to an application with which you have a COI.
o Electronically certify (see sample certifications):
On the pre-meeting Conflict of Interest Certification that you have
identified any application or proposal with which you have a COI or appearance
of COI, prior to the peer review meeting.
For grant application reviews, if you do not certify the pre-meeting
COI, you will not be able to submit critiques, criterion scores and
preliminary scores.
A recertification will be required if an additional conflict is discovered
before the meeting or under other scenarios (meeting date changes
and certifications reflect the previous date, etc.).
On the post-meeting Conflict of Interest Certification that you recused
yourself from the review of any application or proposal pending review in the
Scientific Review Group where your participation constitutes a real or apparent
COI. In addition, the NIH may determine that a particular situation involves a
COI and require that the potential reviewer not be involved in the review of
the application(s) or proposal(s) in question.
The post-meeting COI certification must be electronically signed at the time
you complete your participation in the study section meeting. Paper
certifications will no longer be accepted.
Federal employees participating in NIH peer review are subject to a comprehensive set of
statutes and regulations governing their conduct, in addition to NIH policy regarding their
selection and use in the peer review process. A Federal employee serving as an NIH peer
reviewer is responsible for obtaining any clearance required by his/her employing institute,
agency, or office.
Reviews of Applications for Grants, Cooperative Agreements, and Fellowships
You may not be on the study section if:
You are named on an application in a major professional role (Program Director/Principal
Investigator [PD/PI], Senior/Key Personnel, Other Significant Contributor, Project/Site/Core
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NIH/OER (Approved for implementation by October 2018)

NIH Conflict of Interest Rules: Information for Reviewers of NIH Applications and R&D Contract Proposals

The NIH peer review system relies on the professionalism of each reviewer to identify any conflict of interest (COI) or apparent COI that may affect or appear to affect the integrity of the NIH peer review process.

  • The NIH COI rules for initial peer review for grant applications, and technical evaluation of R&D contract proposals, are based on federal regulations (42 CFR Part 52h) and presented in detail in NIH Guide Notices NOT-OD-13-010 and NOT-OD-14-069.
  • Note: Beginning immediately, all reviewer COI certifications, including certifications for technical evaluation of R&D contract proposals, must go through electronic certifications.
  • In order to participate in the review meeting, you must:

o Review the appropriate set of rules below and screen the applications or proposals for real or apparent COI for yourself.

o Notify the Scientific Review Officer immediately :  If you have a COI that prevents you from serving on that review panel (see below), or  If you are assigned to an application with which you have a COI.

o Electronically certify (see sample certifications):  On the pre-meeting Conflict of Interest Certification that you have identified any application or proposal with which you have a COI or appearance of COI, prior to the peer review meeting.

  • For grant application reviews, if you do not certify the pre-meeting COI, you will not be able to submit critiques, criterion scores and preliminary scores.
  • A recertification will be required if an additional conflict is discovered before the meeting or under other scenarios (meeting date changes and certifications reflect the previous date, etc.).

 On the post-meeting Conflict of Interest Certification that you recused yourself from the review of any application or proposal pending review in the Scientific Review Group where your participation constitutes a real or apparent COI. In addition, the NIH may determine that a particular situation involves a COI and require that the potential reviewer not be involved in the review of the application(s) or proposal(s) in question.

 The post-meeting COI certification must be electronically signed at the time you complete your participation in the study section meeting. Paper certifications will no longer be accepted.

  • Federal employees participating in NIH peer review are subject to a comprehensive set of statutes and regulations governing their conduct, in addition to NIH policy regarding their selection and use in the peer review process. A Federal employee serving as an NIH peer reviewer is responsible for obtaining any clearance required by his/her employing institute, agency, or office.

Reviews of Applications for Grants, Cooperative Agreements, and Fellowships

You may not be on the study section if:

  • You are named on an application in a major professional role (Program Director/Principal Investigator [PD/PI], Senior/Key Personnel, Other Significant Contributor, Project/Site/Core

Director, collaborator, consultant, sponsor, mentor, or conference organizer).

  • You are a member of an NIH Advisory Council.
  • You have a direct financial interest: You or your close family member would receive a direct financial benefit if an application is funded.
  • You have a Major Professional Role in an application submitted to a Request for Applications (RFA) and the study section will evaluate applications submitted in response to that RFA.

You may be on the study section but may not review certain applications, and must leave the room when:

  • The PD/PI or anyone else on the application with a major professional role is from your institution or for multicomponent institutions, from your institutional component.
  • You are planning a collaboration with anyone with a major professional role on the application.
  • Within the past three years, you have published with, have collaborated with, or have been in a mentoring relationship with any person on the application who has a major professional role.
  • The application includes a letter of support or reference letter from you.
  • You serve as a member of the Advisory Board for the project under review or for a grant held by anyone playing a major professional role on the application.
  • You have an indirect financial interest: You will have received more than $10,000 (in the form of honoraria, stocks, or fees) from the PD/PI or the submitting institution over the period from one year ago through the end of the proposed project.

Technical Evaluation of R&D Contract Proposals

You may not be on the technical evaluation panel if:

  • You are named on a proposal in a major professional role.
  • You have a direct financial interest: You or a close family member would receive a direct financial benefit if a proposal is funded.
  • You are employed by an offerer institution.
  • You are from an institution that is included as a subcomponent of a proposal.
  • Within the past three years, you have been a collaborator or have had any other professional relationship (e.g., served as a mentor) with any person who has a major role on a proposal.
  • A proposal includes a letter of support or reference letter from you.
  • You serve as a member of the Advisory Board for a project under review.
  • Indirect financial interest: You have an indirect financial interest from the offerer institution or person with a major professional role of over $10,000 in honoraria, stocks, and fees during the last year or during the contract period.
  • You have an indirect financial interest: You will have received more than $10,000 (in the form of honoraria, stocks, or fees) from the PD/PI or the offerer institution in the previous 12 months.

Grant and R&D Contract Reviews

You may be on the study section/technical evaluation panel and may review specific applications/proposals if (not considered a COI):

  • An application originates from an institution where you have collaborators, but your collaborators are not listed on the application or proposal.
  • You have an indirect financial interest of less than $10,000.
  • You freely donate reagents or other materials to the proposed project, and these reagents or materials would also be available to other researchers.
  • You, as well as a person with a major role on the proposed project, contribute data, reagents, specimens, etc., to the same repository or database.
  • You are a member of a research network that involves a person with a major role on the proposed project.
  • You are a co-author of a non-research publication (e.g., review, commentary) or a mega- multi-authored publication with a person with a major role on the proposed project.