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Extramural Research Program Funding Policies and Procedures

Overview

The peer review process at OPHPR consists of three steps: initial scientific peer review, secondary peer review and the Director's Briefing. CDC and Department of Health and Human Services policy on scientific peer review is intended to ensure that applications for funding submitted to CDC are evaluated on the basis of a process that is fair, equitable, timely, and conducted in a manner free of bias.

The first level of review is carried out by a Scientific Review Group (SRG) composed primarily of non-federal scientists who have expertise in relevant scientific disciplines and current research areas. In the secondary review, meritorious applications from the initial peer review process are evaluated for programmatic balance and mission relevance. Only applications that are favorably recommended by both the SRG and the secondary review committee may be recommended for funding. In the Director's Briefing, funding decisions are made by the OPHPR Director based on the results and recommendations from the initial and secondary review processes. See additional information on CDC review procedures.

The solicitation process at OPHPR involves obtaining applications submitted in response to a funding opportunity announcement, program announcement or request for applications. Applications received are reviewed for completeness by the CDC/Procurement and Grants Office (PGO) and then forwarded to OPHPR. After applications have been processed into OPHPR, the Scientific Review Officer (SRO) for OPHPR Initial Review Group, along with a subject matter expert and Science Program Administrator (SPA), review each application for responsiveness to the announcement. Incomplete applications and applications that are non-responsive to the eligibility criteria do not advance through the review process. These applicants are notified that their applications did not meet submission requirements. Applications that are complete and responsive to the announcement are evaluated for scientific and technical merit by an appropriate initial peer review panel convened by OPHPR in accordance with the review criteria listed in the announcement.

Initial Scientific Peer Review Process

The initial scientific peer review is conducted by a OPHPR SRG. This procedure involves a closed meeting and a rigorous process where the methods and scientific quality of applications are evaluated to identify applications most likely to successfully contribute to the research goals of the announcement. The review process is modified from the National Institute of Health (NIH) peer review process. Applications may be subjected to a preliminary evaluation (streamlining or triage review) by the SRG to determine if the application is of sufficient technical and scientific merit to warrant full discussion and scoring at the meeting.

In the streamlining process, reviewers identify the applications deemed to have the highest scientific merit, generally the top half of the applications under review. These applications will be discussed at the Scientific Review Group meeting, assigned a priority score, and receive a second level review. Applications in the lower half are not discussed or scored at the Scientific Review Group meetings. This process allows the reviewers to focus their discussion on the most meritorious applications.

SRG members will be instructed to evaluate research applications by addressing five review criteria (see below) and assigning a single, global score for each scored application. The score will reflect the overall impact that the proposed research could have on the field. Requests for Applications (RFAs) and other types of grants may have different and/or additional review criteria.

As part of the initial merit review and regardless of whether an application is scored or unscored (streamlined), all applicants will receive a written critique, called a Summary Statement. The Summary Statement represents a combination of the reviewers' written comments and, for non-streamlined applications, it includes the SRO's summary of the members' discussion during the study section meeting as well as the recommendations of the study section, a recommended budget, and administrative notes of special considerations.

CDC currently employs a scoring system that uses a 100-500 point scientific merit impact scale in which 100 is the most meritorious and 500 is the least meritorious. This scoring system is currently undergoing extensive review and revision. The status of this process of changing and enhancing peer review can be followed at the NIH website.

Each application is evaluated on its own scientific merit and not in comparison to other applications submitted in response to the program announcement or request for applications. Information related to this project not provided in the application cannot become a part of the panel discussion. Panel members can only evaluate information in the written application. All applications are evaluated in depth by a minimum of three assigned reviewers followed by discussion by the entire panel. Each panel member not in conflict with the application votes individually on each of the applications. Upon completion of this process, the scores of individual panel members are averaged to determine the final priority score. The priority score, the written critiques of the reviewers, and the resume and summary of discussion (if any) are provided to applicants in the form of a summary statement. Summary statements are available to applicants at the eRA Commons website, usually 30-60 days following the SRG meeting. Scored applications proceed to secondary review where they are assessed for programmatic relevance and balance. After summary statements are released, applicants may contact the scientific program administrator or project officer assigned to the announcement for the status of the application.

Research Project Evaluation Criteria

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
In conducting an evaluation of the scientific assessment of Approach criterion, SRGs will also evaluate the involvement of human/animal subjects, the proposed plans for inclusion of minorities and members of both sexes/genders. The evaluation will be factored into the overall score for scientific and technical merit of the application.

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigator: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

While these review criteria are intended for use primarily with unsolicited research project applications (e.g., R01 or P01), to the extent reasonable, they will also form the basis of the review of solicited applications and non-research activities. However, for some activities (e.g., construction grants), use of these criteria as stated may not be feasible.

Note: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score.

Protection of Human Subjects: In conducting peer review for scientific and technical merit, SRGs also will evaluate the involvement of human subjects and proposed protections from research risk relating to their participation in the proposed non-exempt research plan according to the following five review criteria: (1) Risk to subjects, (2) Adequacy of protection against risks, (3) Potential benefits of the proposed research to the subjects and others, (4) Importance of the knowledge to be gained, and (5) Data and safety monitoring for clinical trials.

When human subjects are involved in research that involves one of the six categories of research that are exempt under 45 CFR Part 46, the SRG will evaluate the justification for the exemption and (1) Human Subjects Involvement and Characteristics and (2) Sources of Materials.

Inclusion of Women, Minorities, and Children: When human subjects are involved in the proposed clinical research, the SRG will also evaluate the proposed plans for inclusion of minorities and members of both sexes/genders, as well as the inclusion of children in clinical research, as part of the scientific assessment of Approach criterion.

Vertebrate Animals: As part of the peer review process, the SRG will evaluate the proposed involvement and protection of vertebrate animals as part of the scientific assessment of Approach and Environment criteria and according to the following five points: (1) detailed description of the proposed use of the animals, (2) justification for the use of animals and for the appropriateness of the species and numbers proposed, (3) adequacy of proposed veterinary care, (4) procedures for limiting pain and distress to that which is unavoidable, and (5) methods of euthanasia.

Secondary Review

Secondary Review Committee (SRC) members are external experts invited to attend the secondary review and receive modified briefing books (i.e., abstracts, the summary statements from the initial review, and project officer's briefing materials). SRC members participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared. Only SRC members vote on funding recommendations in a closed meeting and their recommendations are submitted to the Director of the funding organization.

The Extramural Research Program (ERP) Director develops funding recommendations for the OPHPR Director based on the results of the primary review, the relevance and balance of proposed research relative to OPHPR programs and priorities, and assures that unwarranted duplication of federally-funded research does not occur. The secondary review committee has the latitude to recommend to the OPHPR Director to reach over better ranked proposals in order to assure maximal impact and balance of proposed research.

Director's Briefing

At the Director's Briefing, the results from the review processes are presented in the form of staff analysis. All awards are determined by the Director of OPHPR based on priority scores assigned to applications by the primary scientific review panel (IRG), recommendations by the secondary review committee and the availability of funds.

Award Process

Based on the results from the Director's Briefing, ERP staff develops funding packages that are submitted to CDC's Procurement and Grants Office (PGO).

After awards are made by PGO, an announcement is made notifying the public of the new projects funded by our Center. Public announcement of awards is prohibited until PGO makes the official notification of award to the recipient. The description (abstract) of the grant is placed on OPHPR website.

Post-Award Administration

ERP is responsible for monitoring awards. The Scientific Program Official (SPO) is responsible for the continuous monitoring of the programmatic performance of the particular project. Monitoring is accomplished through the review and assessment of information gathered from audit reports, progress reports, financial reports, site visits, correspondence and peer review. SPO may also visit the institution to evaluate scientific progress, especially when problems or weaknesses are identified. When problems or weaknesses are found, SPO works with the recipient institution to resolve or begin the resolution of the troublesome issues. When additional scientific expertise is needed invite for monitoring, review of reports or site visits, it may become necessary to appropriate intramural scientists to provide assistance with this task.

The Grants Management Specialist is primarily responsible for the business and other non-programmatic areas of grant award and administration. This includes ensuring that CDC staff and recipients fulfill applicable statutory, regulatory, and administrative policy requirements for pre- and post-award actions. View for more information.



 
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