NIH All about Grants Podcast

Maintaining Confidentiality in the Peer Review Process��

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. NIH strives to exemplify and promote the highest levels of scientific integrity, public accountability, and social responsibility in the conduct of science. As part of this, the integrity of the peer review process is critical for us to make the most informed funding decisions. This also helps us maintain the public's trust. However, breeches in confidentiality in the peer review process are thus unacceptable and consistent with our guiding principles for scientific excellence, research integrity, and fair competition. And that's what brings us here today. We have with us Dr. Sally Amero. She's NIH's Review Policy Officer and will be talking to us about how NIH strives to maintain confidentiality and security in the peer review process. Thank you for being with us.

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

David Kosub:����������������� All right, Sally, let's begin by first hearing a bit about the intent behind NIH protecting the research ideas submitted in grant applications.

Sally Amero:������������������ Well, let me start by saying NIH takes the integrity of peer review seriously, and we appreciate that the vast majority of individuals also take the integrity of peer review seriously. Maintaining the confidentiality and security of grant applications in the peer review process is essential for protecting trade secrets or other proprietary, sensitive, and/or confidential information.

David Kosub:����������������� Great. So, which statutes, laws, regulations, what-have-you are in place to ensure confidentiality in grant applications?

Sally Amero:������������������ Well, there are a number of them. So I would refer you to the core values of peer review which include confidentiality and security and drives the NIH to seek the highest levels of scientific and ethical standards. They also form the foundation for the laws, regulations, and policies that govern the NIH peer review process. Listeners may view the applicable statutes, policies, and regulations governing confidentiality in the peer review process on our integrity and confidentiality websites.

David Kosub:����������������� You've briefly mentioned both confidentiality and security. Can you tell us the difference?

Sally Amero:������������������ So, "security" refers to our ability to keep unauthorized people out of the NIH systems that support the peer review process and to protect the applications and review information from inappropriate access. Inappropriate access is a breach of security. Physical security is a key component to control information. "Confidentiality," on the other hand, refers to the agreement that reviewers sign that they will not disclose confidential information from or about applications or the review meeting to individuals who are not authorized to participate in the review meeting. Portions of NIH review meetings, either initial peer review or advisory council meetings are closed or partially closed to the public if grant applications are being reviewed or discussed. Only federal employees with a need to know, reviewers, and support contractors are allowed to attend NIH review meetings.

David Kosub:����������������� All right, let's jump to the applicants. When they submit an application, whom are they allowed to speak to at NIH about its review?

Sally Amero:������������������ That's a great question. So the proper communication channels are to talk to the program officer at NIH or the scientific review officer at NIH managing the study section. You may contact the scientific review officer�we tend to call them SROs�if you have any questions about the review process for your application or in general or if you have any post-submission materials you wish to submit. The process for submitting post-submission materials for applications is outlined in our guide notice NOT-OD-17-066. You should not send post-submission information or data directly to a reviewer on the study section evaluating your application.

David Kosub:����������������� So, you can't reach out to any study section member at any time?

Sally Amero:������������������ No. It is not appropriate to reach out to a study section member at any time to discuss anything about the review of your application. That includes when the meeting is over too. PIs, advocate institutions, or third parties should not contact reviewers on the study section to request or provide information or materials related to the review. This may be seen or interpreted as you introducing or trying to influence or bias the outcome of the review. You can, however, discuss the peer review process in general with someone you know who has served on a study section outside the field you are applying to. This will allow you to avoid any potential conflicts while still learning about the general peer review process.

David Kosub:����������������� All right. Well, now, let's turn to reviewers. What should they do if they're contacted by someone outside the study section interested in learning more about review of a particular application or the reviewers themselves?

Sally Amero:������������������ So, the reviewers are instructed to contact the scientific review officer assigned to their study section immediately, preferably in writing, not necessarily, though, with as much information as possible. Such information would include things like who contacted them, the date of the contact, the time of the contact, the information requested, and so forth. This information will help us to determine if any grant application information or the integrity of the review process may have been compromised. We greatly appreciate our reviewers who tell us when something is amiss. They may not necessarily know it, but we do act in response to the information they give us.

David Kosub:����������������� So, what may reviewers share outside the study section, and when can they share it?

Sally Amero:������������������ So, a reviewer may share general information about the peer review process with their colleagues but cannot discuss anything related to specific projects, applications, or the deliberations of individual study sections. Reviewers may not share study section materials, including applications with their post-docs or students at any time, not even for training purposes. This ensures security of the proprietary information in a research application that is shared with the federal government as well as the confidentiality of the review process.

David Kosub:����������������� Are these rules spelled out for reviewers somewhere, that people can find out more information?

Sally Amero:������������������ So, everybody has a responsibility here. Each NIH peer reviewer must read the NIH confidentiality and non-disclosure rules. And before gaining access to information about the applications or meetings, must certify a confidentiality agreement that he or she understands and will comply with the confidential nature of the review process. One may refer to the appendix in NOT-OD-18-115. When certifying the confidentiality agreements, each peer reviewer agrees with the understanding that any materially false, fictitious, or fraudulent statement or representation may subject them to criminal, civil, or administrative penalties under 18USC10001 to maintain confidentiality in peer review.

David Kosub:����������������� So, listeners probably recognize that we've been talking about the first round of peer review, but, of course, there is the second round, the advisory council round. Do the members in advisory councils�do these rules pertain to them?

Sally Amero:������������������ Yes, they do. In addition, because council members are appointed as special government employees, additional rules apply to them. Members of NIH advisory councils must submit confidential financial disclosure statements and certify a similar confidentiality agreement.

David Kosub:����������������� And what happens in cases of breaches of confidentiality? Are there any consequences that NIH can do or have?

Sally Amero:������������������ Consequences for breaches in the integrity of the peer review system are serious and spelled out on our integrity and peer review website and in guide notices like NOT-OD-18-115. For example, applications may need to undergo re-review. In addition, or instead, we can do the following: we may disinvite a person who committed the breach from peer review service. We may contact their institutional officials and inquire about reassigning the principal investigator designated on the grant. We may refer them to the NIH office of Management Assessment and/or the HHS office of the Inspector General to determine their ability to perform research, and, if necessary, lead to criminal penalties, fines, and or imprisonment. We may also pursue a referral for government-wide suspension or debarment.

David Kosub:����������������� And, finally, as these are confidential deliberations, are any information, records, et cetera releasable under the Freedom of Information Act?

Sally Amero:������������������ The following information may be released under FOIA: the date of the study section, the rosters of certain study sections, but not all of them, and the general area of science for the standing study sections. All discussions, application materials, except those in the public domain such as publications, and information about conflicts of interest and assignments of individual reviewers to particular applications are strictly confidential and may not be released in order to protect the integrity of the peer review process.

David Kosub:����������������� Well, thank you very much, Sally. This has been wonderful. And just to echo some of the points that you made earlier, it's incredibly important to maintain confidentiality and security of the grant applications submitted to NIH, ensure the integrity of peer review is maintained. And for more information, please do check out the NIH grants websites on confidentiality and integrity where you will also find core values documents as well as some other information related to the peer review process. This has been David Kosub with NIH's All About Grants. Thank you.

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