of applications recommended for funding are actually funded in any given fiscal year.
In addition to their responsibilities for assessing scientific merit, IRGs also are asked to identify ethical concerns associated with proposed research in relation to the rights and welfare of human research subjects, care and use of laboratory animals, and scientific misconduct. If an IRG or an NIH staff person raises an ethics concern, a bar to funding is entered into the computerized grant-tracking system. No award can be made in support of a barred project until and unless the concern has been resolved. Most grant applications also are reviewed by a national advisory council or board that considers program relevance and the public importance of the application. Boards and councils also have authority to raise ethical concerns that place a bar to funding. Ethics concerns raised by IRGs are reviewed and resolved by national advisory boards or councils.
Contract proposals and cooperative agreements for biomedical and behavioral research are reviewed in a manner similar to that utilized to review grant applications. Technical Evaluation Groups (TEGs) carry out assessment of the proposal in a manner analogous to that of IRGs. As is the case for IRGs, TEGs are expected to identify any ethics concerns associated with proposals for contracts or cooperative agreements. No contract or cooperative agreement can be finalized until and unless ethics concerns have been resolved.
In making awards, NIH and other PHS agencies operate under the general authority of the Public Health Service Act, which requires the secretary of DHHS to operate a wide variety of health-related regulatory, research, demonstration, and service programs. Responsibility for these programs is delegated by the secretary, or in some cases directly by the Congress, to the agencies and program directors throughout PHS.
Regulatory responsibility for protecting the rights and welfare of human research subjects has been delegated to the Office for Protection from Research Risks (OPRR). Although that office is located within NIH for organizational purposes, it acts on behalf of the secretary of DHHS. The primary instrument that OPRR uses in meeting its responsibility is the promulgation and implementation of regulations codified in the Code of Federal Regulations (C.F.R.) for the protection of human subjects. Those regulations require that, before awardee institutions are permitted to carry out research involving human subjects, they must provide adequate assurance to OPRR that they will comply with the regulations. The primary requirement of the regulations is that before work is begun and at intervals of no more than one year during the conduct of research involving human subjects, each research project shall be reviewed and approved by an institutional review board (IRB). The U.S. Food and Drug Administration (FDA) has also issued regulations at 21 C.F.R. 50 & 56 that include congruent require-