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 the 2013 policy announcement (NOT-OD-13-010):
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 are negotiating employment with those entities; and
deletion of the section on management of COI for individuals in multi-component or multi-site applications.
Does the review COI policy apply to the NIH Loan Repayment Program as well? No. The NIH Loan Repayment Program is not a grant program so the policy does not apply.
Does the policy apply to anyone other than those participating in initial peer review? No. Members of NIH National Advisory Councils or Boards, who participate in the second level of peer review, fall under the ethics rules [http://ofacp.od.nih.gov/ethics/index.asp] associated with Special Government Employees.
Which relationships constitute a conflict of interest in initial peer review?
Generally speaking, conflicts of interest in initial peer review result from one or more of the following scenarios:
The potential for financial benefit
Major Professional Roles in the work proposed
Professional associations with individuals listed with Major Professional Roles in the work proposed
Major Professional Roles on an application submitted to a Request for Application (RFA)
Membership on a Standing Study Section or Recurring Special Emphasis Panel
Which relationships do NOT constitute a conflict?
Provision of resources or services that are freely available to the entire scientific community
Co-authorship of a review article, position paper, professional group or conference report
Data donations to a central repository or consortium
Institutional membership in a multicenter network unrelated to the application under review
Can federal staff serve as reviewers? Yes, certain Federal staff may serve as reviewers. Federal employees serving as reviewers in the initial level of NIH peer review also must comply with the ethics rules of their office or agency.
Who is responsible for identifying and declaring conflicts of interest in initial peer review?
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.
What is the cutoff on the number of authors that make a publication “multi-authored”? The NIH policy does not specify a specific number of authors that renders a publication “multi-authored”. Of greater significance are the roles that the authors played in the research that is reported in the publication. The SRO must also be aware of the appearance of a conflict of interest.
What should I know about the Financial Conflict of Interest (FCOI) Final Rule?
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.
Are training faculty listed on a training grant application considered to have Major Professional Roles? For training grant applications, the Principal Investigator(s) or Program Director(s), and members of a curriculum committee or Advisory Committee, and any other personnel who will be involved in administration of the award or training program have Major Professional Roles. Therefore, they cannot serve on the review panel. However, faculty who could potentially gain a student or fellow supported in their laboratories on the training award have Professional Relationships, and therefore can serve on the panel but cannot review the application in question.
When is a collaborator or consultant considered to have a Major Professional Role in a project or application?
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.
Does a “collaborator once removed” create a conflict of interest?
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.