Monday, May 19, 2014

Managing Conflict of Interest in NIH Peer Review of Grants and Contracts

Below is some important information regarding: Managing conflict of interest in NIH peer review of grants and contracts per the National Institutes of Health's website.

If John is a paid employee of Science University, which has submitted a research application to NIH, can he serve on the panel that reviews the application? Since John has a conflict of interest with the application, he may not review that particular application and will have to be out of the room during the discussion and evaluation of that application, but may serve on the panel to review other applications.

The core values of impartiality, fairness, and integrity are fundamental to the NIH peer review process. NIH Scientific Review Officers (SROs) spend considerable time and energy identifying appropriate reviewers and managing reviewer conflicts of interest (COI).
Application of the Rules

The rules for managing COI addressed on this page apply to peer reviewers participating in:
  • initial peer review for all types of grant programs, with the exception of construction grants, and
  • peer review of proposals for Research and Development (R & D) contracts.
When does COI arise?

What are the types of conflicts that raise red flags? Check out the many types below. Note that COI is handled differently for reviewers of grants and R&D contracts.
  • Direct financial benefit: A reviewer may not serve on a particular study section if he/she or his/her close relative could receive direct benefit from any application or proposal reviewed in that study section's meeting.

  • Indirect financial benefit: A reviewer may not serve on a particular study section if he/she or his/her close relative could receive indirect financial benefit, from any of the multiple Program Directors/Principal Investigators with applications or proposals in the meeting, that in the aggregate exceed $10,000 per year.

  • Major professional roles: A reviewer may not serve on a particular study section if he or she is contributing to the scientific development or execution of any project under review in the meeting in a substantive, measurable way (Senior/Key Personnel, Project/Site/Core Directors, Other Significant Contributors, collaborators, and consultants).

  • Employment: A reviewer who is a salaried, full or part-time employee of any of the multiple Program Directors/Principal Investigators, or any of the institutions submitting an application or proposal:
    • May not participate in the evaluation of that grant application, or
    • May not serve on the study section evaluating that contract proposal.
  • Professional Associates: A reviewer whose professional associate (colleague, scientific mentor, student, collaborator, etc., within the last three years) plays a major professional role:
    • On a grant application may not participate in the evaluation of that application.
    • On an R&D contract proposal may not serve on the study section evaluating that proposal.
  • Appearance of a COI: Any situation that could cause a reasonable person with all the relevant facts to question the impartiality of the reviewer or that leads a reviewer to question his or her objectivity means that the reviewer:
    • May not participate in the evaluation of that grant application.
    • May not serve on the study section where that R&D contract proposal is evaluated.
  • Study section membership: An application from a member of a study section that meets regularly may not be reviewed by that member's study section.

  • Applications in response to a Request for Applications (RFA): An individual who is listed on an application submitted to an RFA with a major professional role may not serve on a study section evaluating any applications from that same RFA.
Certifying COI

Each NIH peer reviewer must certify, under penalty of perjury (US Code Title 18 chapter 47 section 1001), that to the best of his or her knowledge he/she has disclosed all conflicts of interest that he or she may have with the applications or R&D contract proposals; he or she fully understands the confidential nature of the review process and agrees:

(1) to destroy or return all materials related to it;
(2) not to disclose or discuss the materials associated with the review, the evaluation, or the review meeting with any other individual except as authorized by the Scientific Review Officer (SRO) or other designated NIH official;
(3) not to disclose procurement information prior to the award of a contract; and
(4) to refer all inquiries concerning the review to the SRO or other designated NIH official.

Osprey COI RiskManager™ (a powerful web-based solution) conflict of interest software, efficiently captures, tracks and reports the required disclosures for thousands of researchers, post-docs, fellows, board and faculty members, for any industry. The system also protects organizations by ensuring compliance with the new regulations set forth by the Public Health service (PHS) funds from the National Institutes of Health (NIH) 
 
Osprey COI RiskManager™

  • Easy to use and deploy
  • Reduces risk and costs
  • Proven in world-class organizations
  • Improves organizational effectiveness
Contact information:

For more information about Osprey COI RiskManagerTM, call Osprey at 518-203-3995 or michael.vidoni@ospreysoftware.com

No comments:

Post a Comment