Clinical Research Review Committee (RIRG-G)

CTSA Review Committees

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CRRC FAQs - September 22, 2008 •
Management of Conflict of Interest •
Peer Review Committee Logistics

CRRC FAQs - September 22, 2008

What is the CRRC and what does it do?

The CRRC is a standing study section administered by the NCRR to conduct peer review of grant applications.

What types of applications does the CRRC typically review?

As of February 2008, the CRRC review portfolio was shifted from review of the General Clinical Research Centers (GCRC) to review of the Clinical Translational Science Award (CTSA) applications. For the February 2008 meetings, about one-third of the CTSA applications received were reviewed by the CRRC.

What other committees review the CTSAs?

From the inception of the CTSA program in 2006, all CTSAs had been reviewed by Special Emphasis Panels (SEPs). In February 2008, about two-thirds of the CTSAs were reviewed in SEPs and the remainder in the CRRC. Prior to February 2008, all CTSAs were reviewed by SEPs.

What is the difference between SEPs and standing study sections, such as the CRRC?

For SEPs:

Reviewers are recruited for each SEP meeting.
Reviewer status is considered temporary.
Reviewers are not appointed for more than one meeting; a reviewer's commitment is to that meeting only.
SEP rosters reflect only those members who actually participate in the meeting.
"Participation" is defined as those reviewers who attend, participate by teleconference, or submit mail reviews; if a recruited reviewer does none of these activities, then the reviewer's name is removed from the roster since they did not materially participate in the meeting.

For standing study sections (CRRC):

Members must undergo an appointment process.
Reviewer status is considered permanent for the term of appointment.
Reviewer commitment typically is for at least one year and can be up to four years.
Rosters of standing study sections list all permanent members whether they attend each meeting or not.

NEW: What is the current status of the Clinical Research Review Committee (CRRC)?

An administrative decision has been made to suspend use of the CRRC to better manage appearances of conflicts of interest (COI).

Management of Conflict of Interest

What guidance is followed in management of COI related to peer review of grant applications?

COI management is governed by federal regulations, see Section 52h.5 at http://grants.nih.gov/grants/policy/fed_reg_peer_rev_20040115.pdf external link, opens in new window . These rules describe procedures for handling real COIs (financial or other interests that may bias a reviewer) as well as appearances of COI.

How have COIs been managed for the CTSAs reviewed in SEPs?

In each round, COIs were managed to avoid inclusion of CTSA applicants as reviewers for any of the three CTSA SEP meetings. There is no requirement that COI be applied across several meetings; however, to avoid potential appearances of COI, a more conservative decision was made in regards to the SEP reviews of the CTSAs. No applicant or key personnel of an applicant institution was invited as a reviewer for any of the SEP meetings held in the same council round.

Are the regulations that apply to management of COIs different for standing study sections, such as the CRRC, as compared to SEPs?

The short answer is, yes. In addition to the COI regulations that apply to all peer review meetings, the regulations assume that members of a standing study section have a long-standing relationship that may create a situation in which the review of a member application could be biased; this typically is considered an appearance of COI as long as there are no other COIs, such as co-publications. The regulations require that applications from standing study section members be reviewed in a separate, appropriately constituted panel (i.e., SEPs).

Why not just ask the member who has an application not to attend the standing study section meeting?

Rosters for standing study sections are permanent and the relationship is considered to apply even if the person is not present for the meeting. Having the reviewer not attend the meeting is not an appropriate solution. The application must be reviewed by a SEP whether or not the member attends the standing study section review meeting.

How were COIs handled for the CRRC reviews?

All regulations were followed, including the regulation that applications from CRRC members are to be reviewed in a SEP.

Why stop using the CRRC to review CTSAs?

Given the circumstances of the far-reaching and high competitiveness of the CTSA program, we continue to support the conservative decision as the best to manage COIs for this particular program. Therefore, after discussion with the NCRR leadership, including the Director and Deputy Director of the NCRR as well as Directors of Division of Clinical Research Resources and the Office of Review, we conclude that the most straightforward solution is to suspend use of the CRRC.

Peer Review Committee Logistics

Will only SEPs be used to review CTSA applications beginning October 2008?

Yes.

What will be the status of current CRRC members?

The current members will be officially retired from the CRRC and no new members will be recruited for the CRRC.

Will current CRRC members be able to serve on the SEPs that review CTSAs?

Yes. Even though CRRC members will no longer have a commitment as permanent reviewers appointed to the CRRC, it is our hope that current members will agree to continue to serve as CTSA reviewers when invited for the SEPs, as long as apparent or real COIs are managed.

How will continuity of review be maintained with SEPs?

We routinely recruit reviewers who have experience in these types of reviews, who are current CTSA awardees, and/or who have related experience, e.g., principal investigators of other large, complex centers and/or lead training grants themselves. Our experience over the past several years with this program and others provides assurance that such reviewers will continue to serve and provide the type of continuity that would be expected. It is important to note that even with a standing study section, there is no way to guarantee that the same reviewers are assigned to revised applications. Most importantly, the outcome of a review depends on a committee process. Therefore, continuity depends on the experience and commitment of the review group as a whole, not on an individual reviewer.

If a potential reviewer also has a CTSA application to be reviewed, will that person be invited to any of the SEP meetings for that round?

No.

Do you anticipate any effects on the quality of the review?

No. This decision is fundamentally an administrative matter to better manage potential appearances of COI. We expect no impact on the actual substance of the review process, which, to date, has been uniformly of high quality and well respected by the community and this is true whether the review has been done in the CRRC or in the SEPs. We remain grateful to the commitment of all reviewers to maintain a superlative quality standard for review and we will continue to recruit the very best reviewers for this program.

What if I have more questions?

Any questions about the review process can be directed to Sheryl Brining, Director, Office of Review, NCRR, 301-435-0809, sb44k@nih.gov or Mohan Viswanathan, Deputy Director, Office of Review, 301-435-0829, viswanam@mail.nih.gov.