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Section 493 provides certain conditions with respect to the proper care and treatment of animals used in research which must be met by institutions that conduct research supported by NIH.

For the past twenty years, institutions receiving NIH grants and contracts have been required to meet NIH guidelines regarding the treatment of laboratory animals. These guidelines are presently based on the 'guide for the care and use of laboratory animals' developed by the institute of laboratory resources of the national research council.
It is important to provide statutory authority and recognition for these requirements. In order to ensure professionally appropriate direction for these conditions, the guidelines should remain under the control and direction of the director of the NIH.

Subsection (b) requires entities that receive NIH support for research involving animals to establish and maintain animal care committees to monitor care and treatment of animals used in research. The membership of these committees would consist of at least three members, of which one must be a veterinarian and one an individual with no financial ties to the institution. This 'outside' member is intended to provide representation for the general community interest in the proper care and treatment of animals.

The animal care committees are responsible for reviewing semiannually the care and treatment of animals in all animal study areas and facilities for compliance with NIH guidelines, for keeping appropriate records of such reviews, and for certifying to NIH that such reviews have been conducted. Animal care committees must report violations of NIH guidelines first to their institutions and, if a violation continues, then to NIH. The committees must only certify to NIH that reviews have taken place. Paperwork and reporting requirements are therefore minimal.

The requirement to establish animal care committees is intended to provide the most constructive assurance that NIH guidelines for the care and treatment of animals are met. It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive federal inspections as is presently the case. Testimony presented to the subcommittee on health and the environment indicates that the cost of complying with this requirement would be minimal because service on animal care committees in many institutions is voluntary.

Under subsection (b)(2), the chief executive officer of each research institution is charged with the authority to appoint all members of the animal care committees. As a result, the committees will serve as a constructive element within their institutions. The animal care committees' role will be to assure compliance with the NIH guidelines. The animal care committees have no authority to interfere with research decisions, goals or methods. The committees have no authority to 'second guess' or review the appropriateness of research. The authority of the committees is limited to review of the care and treatment of animals pursuant to guidelines established by the NIH.

The animal care committees are important because their presence will create an ongoing discussion within the nation's research institutions of sensitivity to the care and treatment of research animals. This ongoing process recognizes that such sensitivity cannot be captured in any set of rules, that standards of care will change in the future as science advances, and that the value of medical research requires such judgments to be professionally and scientifically sound. The consultation inherent in the review of the care and treatment of animals by animal care committees is essential. Within such a framework, the public can have confidence that the proper sensitivity, whatever the sensitivity may be, to the care and treatment of animals will occur.

Two out of three research institutions receiving NIH funds already have animal care committees. Further, many of the nation's most respected research institutions already include a veterinarian and an 'outside' member on their animal care committees. Under subsection (c) the secretary, acting through the NIH director, shall issue regulations requiring applicants for NIH funds to provide assurances that the applicant will meet the NIH guidelines for the care and treatment of animals and that the applicant's institution has an animal care committee. Applicants must also assure NIH of the availability of instruction at their institution in humane practices of animal care and in research methods that minimize the use of animals and limit animal distress. All applications for NIH support will include a statement of the reasons for using animals in the research project in order to allow peer review committees to consider possible alternatives to or duplication of research.

If NIH determines that a research entity is not meeting the guidelines, and if after notification of its noncompliance, no action is taken, subsection (d) provides that the director of NIH shall suspend or revoke a grant or contract. Since all institutions will make a commitment to meet the guidelines, effective animal care committees will virtually eliminate the possibility of revocation of funds. Animal care committees and NIH should give research institutions and grant recipients maximum opportunity to correct any instances of noncompliance. However, if after appropriate notification and consultation, inappropriate activities continue, NIH is authorized to suspend funds or revoke grants and contracts under such conditions as the director of NIH determines are appropriate. Subsection (e) provides that no guideline or regulation promulgated under subsection (a) or (c) may require a research entity to disclose trade secrets or commercial or financial information which is privileged or confidential. This provision is intended to prevent the improper disclosure of trade secrets and other confidential information.

Guidelines established by the secretary under subsection (a) and regulations promulgated by the director of NIH under subsection (c), should affirm the authority of the secretary to assure compliance with guidelines on the proper care and treatment of laboratory animals and assure that trade secrets or proprietary research information in the possession of a research entity is protected. The conferees do not intend that subsection (e) be applied so as to restrict effective functioning of the animal care committees or inhibit authorized NIH investigations into allegations of improper care or use of laboratory animals involved in research supported by the NIH.

These requirements are consistent with both the values of humane treatment of animals and criteria for high quality scientific research. Both are already common practices in many research institutions.