Overview

The National Institutes of Health (NIH) is the principal health research agency of the Federal Government; it is a component of the Department of Health and Human Services. With headquarters in Bethesda, Maryland, the NIH is a large, complex organization composed of 27 distinct institutes and centers, hereafter called "institutes" or "ICs."

Mission

The Office of Extramural Research (OER) serves as the focal point for policies and guidelines for extramural research grants administration. This office has primary responsibility for the development and implementation of NIH Grants Policy, monitoring of compliance with PHS policy on Humane Use and Care of Laboratory Animals, coordination of program guidelines, and development and maintenance of the information systems for grants administration.

OER staff have expertise in the complete range of issues associated with program, grants management, and review. For example, staff in the OER's Office of Policy for Extramural Research Administration (OPERA) have expert knowledge of grants policy issues such as Facilities & Administrative costs (indirect costs), allowable and allocable costs as specified in OMB Circular A21, roles and responsibilities of grantee institutions, and compliance. OER staff with expertise in program administration have developed NIH policies for data sharing, clinical research and clinical trials including policies related to data and safety monitoring and protection of human subjects, and an online education module on bioethics.

OER also coordinates communications with the extramural communities. For example, OER is responsible for the NIH Guide for Grants and Contracts, which publishes all NIH policy notices, Program Announcements, and Requests For Applications. In collaboration with the ICs, the OER is responsible for the development and implementation of eRA, the electronic system for conducting grants business of the NIH enterprise. The eRA system includes IMPACII for grants administration, iEdison for invention reporting, and the NIH Commons, a web-based, secure interface that allows grantee institutions to exchange information with the NIH. OER also provides a number of data resources that are accessible to the public, including CRISP and the award data page.

Mechanisms of Support

The NIH awarding institutes use three major instruments to provide funds to organizations outside the NIH to accomplish program goals--grants, cooperative agreements, and contracts. With grants and cooperative agreements, the applicant investigators are responsible for developing concepts, methods and approaches for their research projects. With contracts, the awarding institute is responsible for establishing plans, protocols, and detailed requirements.

Grants for health-related research and research training projects or activities make up the largest category of funding provided by the NIH. Research project grants are awarded to institutions on behalf of a principal investigator to facilitate the pursuit of a scientific objective when the idea for the research is initiated by the investigator and the funding institute anticipates no substantial program involvement. The NIH awards research grants for terms ranging from one to five years. Institutional sponsorship assures that the awardee organization will provide the facilities and the financial stability necessary to accomplish the research, and be accountable for the funds.

Cooperative Agreements are similar to grants in that they are awarded to assist and support research and related activities. However, they differ from grants in that the awarding institute or center has substantial involvement in carrying out the project's activities. Since the terms and conditions of the award are above and beyond those required for the normal stewardship of grants, the rights, responsibilities, and authorities of the prospective awardee and the NIH institute are developed in advance. The awarding institute typically issues a specific request for applications (RFA) describing the program, functions, and activities as well as the nature of the shared responsibilities.

Most applications for support are unsolicited and originate with the individual investigators who develop proposed plans for research or research training within an area of interest to the NIH. Occasionally, to hasten the development of a program or to stimulate submission of applications in an area of high priority or special concern, an institute will issue a Program Announcement (PA) to describe new, continuing, or expanded program interests, or issue an RFA inviting grant applications in a well-defined scientific area to accomplish a scientific purpose.

Research and development (R&D) contracts are awarded to academic institutions and other non-profit and commercial organizations to procure specific activities for scientific inquiries in particular areas of research and development needed by the NIH. Contract performance is monitored closely by the NIH staff to ensure accomplishment of the research goals.

The Peer Review System

As mandated by law, and with few exceptions, the review of grant and cooperative agreement applications involves two sequential levels of review for each application. In this system, the scientific assessment of proposed projects is kept separate from policy decisions about the scientific areas to be supported and the level of resources to be allocated. The first review, the evaluation of scientific and technical merit, is conducted by one of many chartered scientific review groups, referred to as SRGs, managed by the Center for Scientific Review or by the institutes. The group or panel, established according to scientific disciplines or medical specialties, may consist of as many as 16 to 20 members who are primarily non-Federal scientists with expertise in various disciplines and areas of research.

The primary requirement for serving on an SRG is competence as an independent investigator in a scientific discipline. Other factors such as respect among peers and quality of research accomplished are also important. The reviewers study each application individually before the meeting; and for each application, some reviewers are assigned to prepare written critiques. Those projects deemed most competitive, approximately the upper half, are fully discussed and given a priority score based on the scientific merits of the project.

The second review is performed by National Advisory Boards or Councils, hereafter "councils," of the NIH funding components. This panel of 12-18 members consists of scientists and laypersons chosen for their interest in matters related to health and disease. Council members review the applications against a broad background of considerations including relevance, program goals, and available funds of the institute; they also consider the appropriateness of the scientific review conducted previously by the SRG.

The review process for solicited R&D contracts differs from that for grants in that all offerors are responding to a Government-defined statement of work contained in the Request for Proposal (RFP). Contract projects are subject to a multifaceted review process prior to the award. Usually institute program staff develop the concept for a project which must be cleared by an outside advisory panel. The concept for a planned project is then translated by NIH program staff into an RFP, which clearly specifies the work that must be done by the contractor. To reach all segments of the scientific community, contract opportunities are advertised as widely as possible, usually in the Commerce Business Daily and other appropriate channels.

The proposals responding to the solicitation are evaluated against the evaluation criteria specified in the RFP by technical evaluation groups composed typically of non-Federal scientists. The recommendations of peer reviewers and the results of separate NIH staff reviews provide the basis for discussions with offerors deemed in the competitive range. At the conclusion of these discussions, offerors are requested to submit their best and final offer. The award is made on the basis of the best final offer judged to be most advantageous to the Government. The institute may occasionally make an award in response to an unsolicited proposal if it meets specific NIH program needs and can be adequately justified as a non-competitive award.

The evaluation of NIH intramural research programs, projects, and investigators is performed by Boards of Scientific Counselors, hereafter "boards," composed of non-Federal scientists with outstanding achievement and expertise in the areas of research pertinent to each of the NIH categorical disease institutes. They assess the research in progress, proposed research, and the productivity and performance of staff scientists. The boards serve a dual function; they not only provide expert scientific advice to institute Scientific Directors regarding particular projects and employees, they also assess the overall quality of the institute's intramural efforts.

Funding the Highest Quality Research--Coordination, Priority Setting, and Accountability

Because of the magnitude, diversity, and complexity of the NIH mission, the NIH draws on a national pool of scientists actively engaged in research for advice on the selection of the most promising research projects for support. These scientists review and rate applications for grants and proposals for contracts and attend review meetings at the NIH to discuss and make final recommendations on those applications. In Fiscal Year 2002, over 30,000 applications for research projects were reviewed. Only the very best -- the top 31 percent -- were funded.

The institute program staff play an important role in the funding of high-quality research projects. Their responsibilities within an institute may be allocated according to grant award mechanisms, medical disciplines, or disease areas. These may be determined by the legislation that authorized the institute, by the language of budget authorizations, by specific delegations of authority from the institute directors or the NIH director, or, within broad limits, by the actions of the appropriate councils.

The extramural program staff of the institutes are charged with planning and implementing scientific programs and consulting with the councils about future program developments. They are responsible for keeping up with scientific developments in certain areas. They may also convene task forces, workshops, or conferences to assess scientific progress in a field or identify new initiatives for an institute. Implementation of these program responsibilities varies from providing advice to interested investigators to organizing extensive collaborative projects requiring a multidisciplinary approach by investigators in one or several research institutions. Special consideration for funding projects may be based on institute priorities, portfolio balance, innovativeness, as well as investment in highly productive groups, promising new investigators, and high-risk but exciting research.

Finally, the members of the statutorily-mandated National Advisory Councils, besides making recommendations on funding to the institute director and the program staff, play a significant role in advising on the overall program of the institute they serve.

Institutes are making increased use of the World Wide Web as a vehicle for sharing their program priorities with their constituencies and for disseminating health information that is derived from their research. As the locus for extramural policies, the Office of Extramural Research takes advantage of its Home Page as one means of advising the extramural community. The electronic medium is becoming the basis of transactions with our applicant and grantee community, providing better service for them and their institutions and fulfilling our need to streamline our administrative processes.