Announcer: ������������������ From the National Institutes of Health, in Bethesda, Maryland, this is All About Grants.

David Kosub: ��������������� Hello, and welcome to another edition of NIH's All About Grants podcast. I'm your host David Kosub with the NIH office of extramural research. All right, so you've spent many months working with your institution on developing an application seeking NIH support. You're likely aware that the next step is for NIH to empanel a group of experts to evaluate your application's scientific merit and provide us a score for which we can use, consider to use for making funding decisions. But did you know that there's another round of review that your application must go through before we finally award? And that's what brings us here today, we're gonna talk about the second round of peer review. We have with us Doctor Sally Amero, she�s the NIH's review policy officer, and we also have Doctor Rebekah Rasooly, who is a branch chief in program at the National Institute of Nursing research. So, let's jump right in, Sally, can you briefly describe the two-tier NIH peer review process, and how advisory councils fit in?

Dr. Sally Amero: ����������� Sure, thank you David. The two-stage peer review process for NIH is mandated by the public health service act, that means that with limited exceptions, an application must be recommended by both levels of peer review, initial peer review, and advisory council review, in order for the NIH to make an award. In the first level of peer review, applications are evaluated for scientific merit, in the second level of peer review, what we call council review, that is perform by NIH, national advisory councils or boards. They make recommendations on which applications too fund, as well as priority areas of research and pending policy.

David Kosub: ��������������� And who exactly sits on councils and how are they selected, or are they same folks that are in the study section?

Dr. Sally Amero: ����������� So, council members are both scientific experts and public representatives, who are chosen for their expertise, interest, or activity in matters related to health and disease. Appointed members usually serve a four-year term, or in NCI a six-year term.

David Kosub: ��������������� Great, and just to clarify, even if an application scores exceptionally well during the first round of review, it still has to go through the second round?

Dr. Sally Amero: ����������� Yes, that�s correct.

David Kosub: ��������������� Okay great, I also think it's important to reiterate that, as we just mentioned during the first two rounds of peer review, they provide funding recommendations for us to consider, but it's up to the discretion of the director of the specific funding institute or center to actually make, or whether or not to make an award. Rebekah, turning to you, you've experienced a lot of these advisory councils up close and personal, can you give us a little bit of your experience at NINR, how these councils generally work?

Dr. Rebekah Rasooly: � Well, advisory council meetings have two parts. Much of the meeting is what's called an open session, meaning it's open to members of the public, and it's intended to inform the council about important NIH wide, and institute specific issues, and changes. The council members of an institute's council are ambassadors who convey significant information about NIH back to their respective research communities. Now councils do not discuss every single submitted application. Instead, when they discuss applications, they discuss a small subset of them, and that discussion happens in what's called the closed session, and there they typically discuss applications that require council input for some specific reason, such as a foreign application or an appeal. Each council follows the procedures that were setup by the institute or center, and those procedures outline which applications will be discussed.

David Kosub: ��������������� That's very interesting, you mentioned the closed sessions, you briefly discussed a little bit about that, can you dive into that just a bit more?

Dr. Rebekah Rasooly: � Well, in general I think it's important to know that council discussions tend to remain at a very high level in the closed session, and do not engage in detailed scientific re-review of applications. So, for example, it's if an appeal of an initial peer review that they're discussing, the council will discuss the appeal letter. If there is an application involving an investigator who already has substantial funding, that is to say, more than one million dollars in active grants, the council will look for overlap in already funded applications, and that helps us manage resources efficiently, at NIH. If an application asks for more than 500,000 per year of direct costs, the council might be charged with considering its relevance to IC, the institute or center's mission, the potential value of the knowledge to be gained, and the complimentarily with other supported research activities. Sometimes councils consider foreign applications in their discussions, and there they discuss whether the application represents a unique research opportunity. If the council is considering applications that would be funded out of priority score order, or ones that the IC wants to skip within the priority score order, then the council will typically focus on the public health relevance of the application, and how it fits into the portfolio balance of the funding institute, or center.

David Kosub: ��������������� Okay great, can you also go a little bit further into the general decision-making processes that they make, perhaps even using your experiences at NINR?

Dr. Rebekah Rasooly: � So, in a typical situation, in the closed session, when the council is discussing one of the small number, specific applications. Two or more council members will be assigned to the application in question, and they will present their opinions. And then the remaining members or council are invited to discuss the application. Often, I would say, there's really excellent consensus among the members. I wanted to say that at NINR council one of the categories of applications that are brought are those in the funding, when the study section has identified human subjects� concerns, and it's very interesting at NIRN council to hear the voices of the members, most of whom were, or still are practicing nurses. When they comment on human subjects and research, and they have such insightful views, which are invariable informed both by policy as well as by their personal expertise.

David Kosub: ��������������� Going a little further, some of our listeners may have heard about expedited council review, can you briefly describe what that means?

Dr. Rebekah Rasooly: � So that refers to the fact that most applications are not discussed individually at council meetings. Only that small subset that fall into specific categories identified in council procedures are actually discussed. For the remaining applications, the councils generally consider them as a group, and vote to concur with the study section recommendation as a single expedited action.

David Kosub: ��������������� Fantastic, and Sally, turning to you for some final thoughts, do you have anything that you'd like to leave with our listeners regarding the second round of council review?

Dr. Sally Amero: ����������� Well sure, both levels of NIH peer review strive to seek and maintain the highest standards of excellence. Both stages tend to promote a fair equitable and timely framework for our funding decisions. Each institute or center has the responsibility of selecting meritorious applications for payment. Whether by establishing a pay line or by priority criteria. The second level of review by council provides crucial input during this process, especially on the small number of applications where specific council relevant issues need to be discussed. However, council review is just advisory, and funding decisions are not made at council meetings or by council members.

David Kosub: ��������������� Fantastic, thank you very much Sally and Rebecca, I truly appreciate this opportunity to speak to you both about the second round of review here at the NIH. This is David Kosub with NIH's All About Grants, thank you.

Announcer: ������������������ For more information on the second round of review at NIH, please visit the office of extramural research�s webpage at grants.nih.gov/grants/peer-review.htm. Once again that's grants.nih.gov/grants/peer-review.htm