Conflict of Interest in Peer Review

October 23, 2019

David Kosub: �� Hello and welcome to another edition of NIH�s All About Grants podcast. I�m your host, David Kosub, with the NIH�s Office of Extramural Research. And today we�re going to be talking about an issue that�s important to maintaining the integrity of our peer review process, and that�s managing conflicts of interest. And we have with us Dr. Sally Amero, she is NIH�s Review Policy Officer.

And for our discussion today it�s important to note that we�ll be focusing on grants and not contracts, as well as the first round of peer review, not the advisory council stage. And with that, thank you very much for being with us, Sally.

Sally Amero: �� Well thank you for having me.

David Kosub: �� Let�s start by just having you explain why is it important to manage conflicts of interest?

Sally Amero: �� I want to make sure we understand we�re talking about conflicts of interest between reviewers and grant applications. These policies are separate from the financial conflict of interest policy, which applies to recipient organizations.

�� So, for the peer review process, it�s essential for NIH to make sound funding decisions, fund scientifically meritorious research, and maintain public trust in research. So, one way we do that is by managing conflicts of interest in peer review.

David Kosub: �� And what are some examples of conflicts of interest that may arise during peer review?

Sally Amero: �� So, in broad terms, they fall into four categories. Two of them are based on financial benefit, so the regulations and policy differentiate between direct financial benefit and indirect financial benefit. Another category is having a major role on the project that�s being reviewed. And then the final category would be professional associations, including employment.

�� I should point out that federal employees serving as reviewers in NIH peer review have additional conflict regulations and rules that they must follow as well.

David Kosub: �� And, how do we manage these conflicts during study section?

Sally Amero: �� So we have several different approaches for managing conflicts of interest in peer review. Depending on the severity and the category of the conflict, we might decide that the reviewer who�s presenting the conflict cannot serve on that study section, or alternatively, we accomplish the same goal by taking the application out of that study section and assigning it elsewhere for review. So those would be what we call �out of the study section� conflicts.

�� Then we have another category called �out of the room� conflicts, and in that situation, the person, the reviewer, could continue to serve on the study section, but when that application comes up for discussion and evaluation, that person must recuse themselves and leave the room so they cannot evaluate that particular application.

David Kosub: �� And now that we have a better idea of what is a conflict, can you describe what is not considered a conflict of interest?

Sally Amero: �� Well, that�s kind of a broad universe, but let me try a few examples. So one situation that we encounter frequently is when an investigator is donating reagents, cell lines, whatever, to a project freely without expectation of authorship or financial benefit. And in those cases, we decide that if the investigator would make that resource available to anyone under the same conditions, it�s not really a conflict of interest.

�� We get asked often about individuals who contribute to the same database or repository. And as long as there is no oversight function among the people involved, we say that donating to the same database or repository does not create a conflict of interest.

�� And another frequent one, a popular one, is when individuals coauthor a publication that is not a research publication. And we do not view those as conflicts of interest either. So those might include editorials, those might include meeting reports, and so forth, and we do not view those as creating conflicts of interest.

David Kosub: �� Alright, well who is involved with managing conflict of interest during peer review?

Sally Amero: �� Well, broadly, each participant in the process has a responsibility to uphold the integrity of the process and to declare conflicts when they see them. So these include officials of applicant organizations, investigators listed on applications, reviewers, of course, and NIH staff.

�� I will say that reviewers are responsible for declaring conflicts of interest that are known to them, and Scientific Review Officers here at NIH also screen for potential conflicts of interest, which the reviewers must then certify.

David Kosub: �� So, along those lines of the NIH staff, the Scientific Review Officers that you mentioned, can you tell us more about their specific role?

Sally Amero: �� Well, so Scientific Review Officers, or SROs as we call them here, would be responsible for instructing reviewers in the conflict of interest policy, providing materials and documents for them to read, answering questions about potential conflicts, ensuring that each reviewer signs two different certifications that they have declared all of the relevant conflicts of interest and did not participate in the review of any application where they did have a conflict.

They examine incoming applications for conflicts for their reviewers and they recruit reviewers and assign them so as to avoid conflicts of interest, and to manage them appropriately.

David Kosub: �� Alright, let�s say that I am a reviewer, how would I go about disclosing potential conflicts?

Sally Amero: �� So, a reviewer must fill out a certification as I mentioned, which is now online and electronic, and they must do this in advance of the review meeting, or they get locked out of the system. Also, after the meeting is over, they must sign a post-meeting certification, that again they declared all their known conflicts of interest and did not participate in the review of any application where they had a conflict of interest.

David Kosub: �� What about if there�s a situation where the reviewer identifies a conflict during the study section itself, what would they have to do then?

Sally Amero: �� So that does happen, I�ve had it happen to me when I was running a meeting. In those cases, the reviewer must notify the SRO immediately and the SRO must recuse the individual from the evaluation of that particular application. Or, it has happened where either we send the reviewer home or we defer the application for review in another panel.

David Kosub: �� Alright, thank you very much, Sally. This has been a great opportunity to hear more about how NIH manages conflicts of interest in the peer review process.

�� For those who would like more information, please do visit our peer review website, as well as check out NIH Guide Notice NOT-OD-13-010. This has been David Kosub with NIH�s All About Grants. Thank you!