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Frequently Asked Questions
Initial Peer Review Conflict of Interest Policy
Initial Posting: October 19, 2011
Last Revised: April 2, 2013
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 the 2013 policy announcement (NOT-OD-13-010):
Generally speaking, conflicts of interest in initial peer review result from one or more of the following scenarios:
The NIH peer review regulations (42 CFR 52h) state the following:
(b) 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 an application or 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 Administrator 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 application or proposal.
(q) Real conflict of interest means a reviewer or a close relative or professional associate of the reviewer has a financial or other interest in an application or proposal that is known to the reviewer and is likely to bias the reviewer’s evaluation of that application or proposal as determined by the government official managing the review (the Scientific Review Administrator, or equivalent), as acknowledged by the reviewer, or as prescribed by this part.
Unlike members of NIH Advisory Councils or Boards, reviewers in the initial level of NIH peer review are not appointed as Special Government Employees and do not submit financial disclosure forms. Therefore, SROs are not in the position to collect financial information from reviewers, but can ask about professional relationships and roles and make determinations about potential bias in the initial peer review process.
Reviewers may be looking up financial information about investigators on the websites of the investigators’ institutions. Although this fCOI information is available publicly, SROs should instruct reviewers not to consider fCOI information about applicants in their reviews, discussions, or evaluations of applications. See Financial Conflict of Interest (FCOI) Final Rule.
Similarly, applicants may be looking up financial information about reviewers on their institutions’ websites and submitting appeals of initial peer review on the basis of that information. Therefore, it is important that SROs clearly explain the conflict rules for initial peer review to their reviewers.
The revised policy defines an individual with a Major Professional Role as an individual who contributes to the scientific development or execution of the project in a substantive, measurable way, whether or not compensation is requested.
A “collaborator once removed” does not create a conflict of interest. For example, if Dr. X were a potential reviewer of an application from Dr. Y, but both Dr. X and Dr. Y collaborate with Dr. Z, who is not involved in the application, then Dr. X may review the application from Dr. Y, provided that all other conflicts of interest are resolved.