The Peer Review Process

Referral & Review

A Straightforward Description of What Happens to Your Research Project Grant Application (R01/R21) After it is Received for Peer Review

	NOTE: There exists a great deal of official documentation of the rules and regulations governing the conduct of NIH peer review. What follows is meant to be a simpler snapshot of the process for applications reviewed in the Center for Scientific Review (formerly the Division of Research Grants).
	On a major grant application receipt day, delivery trucks unload thousands of packages containing grant applications at the loading docks of the Rockledge 2 Building, the home of the NIH Center for Scientific Review (CSR). Each package is opened; the application is date-stamped and logged into the NIH database for tracking.
	Over a dozen Referral Officers review the contents of some 10,000 applications each grant cycle and, using written guidelines, decide first which Integrated Review Group (IRG) would be most appropriate for assessment of scientific merit. IRGs are clusters of study sections that review similar science. Once the IRG is identified, the application is then assigned to one of the constituent study sections within the IRG. In addition to the IRG assignment, Referral Officers also identify which Institute(s)/Center(s) (I/C) of the NIH would be most suitable to fund the application, should it be considered sufficiently meritorious. Once the I/C is identified, a unique application number is assigned to each application. The Referral Office seriously considers written requests from applicants for both study section and Institute assignments (just include a cover letter with the application). The assignment process is a collegial one, with interaction, when necessary, on a case-by-case basis among Referral Officers, study section Scientific Review Administrators (SRAs), Institute program representatives, and applicants.
	Within 10 days of the completion of application assignment, a computer-generated letter is mailed to each applicant and sponsored research office, listing the study section and potential funding Institute. Upon receipt of this notice, applicants can question the study section or I/C assignments by contacting either the study section SRA or the Referral Office (301-435-0715) . There are official guidelines defining the content and boundaries of the science reviewed in each study section, but there is overlap in the science reviewed by the various study sections. Indeed, because of the broad scope of today's research projects, often a particular application may be appropriate for more than one of the study sections, and CSR staff attempt to refer the application to the single most appropriate committee. The referral of all 10,000 applications for a given review round may take up to six weeks. If applicants have not received notification at that time, they should contact the Referral Office.
	As applications are assigned to a study section, the SRA begins to read through them, analyzing content, checking for completion, and deciding which study section members would be best suited to review each application, or act as discussants. Approximately six weeks before the study section meeting, packages are mailed to members which include all of the applications to be reviewed at the meeting (with the exception of those applications for which a particular member is in conflict.) Typically, two or three members are assigned to provide written reviews of each application, and one or two additional members to serve as discussants.
	NOTE: A chartered CSR study section is composed generally of 18 to 20 individuals, nominated by the SRA from among the active and productive researchers in the biomedical community, to serve for multi-year terms. The goal is to have the group's combined knowledge span the diversity of subject matter assigned to the study section for review. However, this is difficult to accomplish, and the study section's membership is frequently supplemented by temporary members and written outside opinions. In some instances, Special Emphasis Panels (SEPs) are formed on an ad-hoc basis to review applications requiring special expertise, or due to special circumstances (such as when a conflict of interest occurs).
	Because of the multi-month period between submission and review of an application, applicants often wish to submit supplementary materials. However, each study section has policies for acceptance of such additional material (e.g. length; time of submission). SRAs should be contacted prior to submission, both as an alert for the SRA, and to ascertain acceptable content, format, and deadline.
	One week before the convening of a study section, the SRA solicits, from all members, a list of R01 applications believed not to rank in the top half for scientific merit. The individual lists are coalesced, and a final list is established at the outset of the study section meeting. Those R01 applications in the lower half are considered to be "streamlined". They are not scored or discussed at the meeting, but reviewers' written critiques are provided, and the applicant may subsequently revise and resubmit the application. "Streamlining" is not equivalent to disapproval, but rather represents a decision by the study section that the application would not rank in the top half of applications generally reviewed by that study section. With some minor variations, all regular CSR study section meetings follow the same format. The meetings usually last two days. Members convene around a conference table to maximize interaction. The chairperson (a member of the study section) and the SRA sit together and are responsible for jointly conducting the meeting. Representatives from the various NIH Institutes) are encouraged attend, but must sit in chairs set back from the conference table and may not participate in the discussions. After the assigned reviewers and discussants provide their evaluations, any outside opinions are read. After general discussion, members mark their priority scores privately for each application on scoring sheets provided by the SRA. These sheets are collected by the SRA or an administrative assistant at the conclusion of the meeting.
	Within a few days after the meeting, all priority score information is entered into the application database. Computer generated priority scores and percentiles are then automatically mailed to applicants.
	Feedback to applicants is important. However, it requires approximately six weeks to generate an average of 80 summary statements. Once summary statements are produced and transmitted to the appropriate NIH Institute for funding consideration, the SRA's control over the review of those applications ends, and his/her attention turns to the next grant application cycle. At this junction, it is the Institute program officials who become the applicant's link to the NIH with regard to interpretation of the reviews and the disposition of the application.
	There is a flow to the review process, repeated cycle after cycle. For example, applications submitted for the October/November receipt dates will be assigned to CSR study sections by early December, and sent out to members of the study section for scientific review in late December/January.
	Study sections meet between mid-February and mid-March, and summary statements are prepared by late April/May. Institute Advisory Councils, the second step in NIH peer review, meet in May/June to consider the study sections' recommendations, and successful applicants can begin to receive funding several months later.
	While this introduction describes R01/R21 applications, other types of grant applications reviewed in CSR are handled in a similar manner, but there are some differences. Several types of applications (e.g. Small Business Innovation Research (SBIR) and fellowships) receive expedited review and have receipt deadlines one to two months later than R01s. Also, SBIRs are always reviewed by Special Emphasis Panels and fellowships are not "streamlined."

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