The National Institutes of Health's Office for Protection from Research Risks (OPRR) is responsible for development, interpretation and oversight of compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). This letter is meant to provide assistance to your institution in complying with reporting requirements of the PHS Policy.
The 1986 revision of the 1985 PHS Policy was made necessary by certain provisions of the Health Research Extension Act of December 1985. To meet the provisions of this law, institutions that had submitted Animal Welfare Assurances (Assurances) to OPRR before the law was passed were required to submit a one-time only amendment for approval by this office.
Section IV.B. of the PHS Policy requires the Institutional Animal Care and Use Committee (IACUC) to conduct semiannual evaluations of the institution's animal care and use program and semiannual inspections of animal facilities. This section also requires that the IACUC prepare and submit to the Institutional Official, reports of these program evaluations and facility inspections. These reports are to be retained by the institution and should only be submitted to OPRR upon request.
Section IV.F. of the PHS Policy describes the annual reporting requirements for institutions to maintain compliance with the Policy. Specifically, the IACUC each year must submit to OPRR, through the Institutional Official, information pertaining to: (1) change in the institution's AAALAC accreditation status; (2) change in the institution's current Assurance or in the program for animal care and use, as required by Section IV.A.1 of the PHS Policy; (3) changes in IACUC membership; and (4) the dates that the IACUC conducted its semiannual evaluations and inspections of the institution's program and facilities. If there are no changes to report in (1) through (3) above, a statement to that effect must be submitted along with the information (dates) required in item (4). Please note that the annual report must be initiated by the IACUC and must represent the consensus of the membership. If minority views are filed, they must also be included in the report.
With the number of Animal Welfare Assurances on file in this office approaching 1,000, we are attempting to minimize staff time spent dealing with routine correspondence. Standardization of correspondence to OPRR is one method for achieving this goal. To this end we have prepared the attached SAMPLE INSTITUTIONAL ANNUAL REPORT. Although the use of this sample is not required, preparation of your institution's report according to this format will meet all PHS Policy annual reporting requirements while allowing more expeditious handling of these reports by OPRR.
A separate but related item of information deals with the recent reorganization of the Office for Protection from Research Risks. As a result of an internal management survey, OPRR has been reorganized along functional lines, with the creation of a Division of Human Subject Protections and a Division of Animal Welfare. Each division has two branches, Assurance and Compliance, as well as a Special Assistant for Education. The Division of Animal Welfare is directed by Dr. John G. Miller, with Mr. Denis J. Doyle as Chief, Assurance Branch and Dr. Nelson L. Garnett the Chief, Compliance Branch. Ms. Roberta Sonneborn serves as Special Assistant for Animal Welfare Education and Ms. Agnes Richardson is the Division Secretary. Please note that annual reports should be mailed to the Chief, Assurance Branch, Division of Animal Welfare.
If you have any question regarding the above information or any other aspect of the PHS Policy, please feel free to contact OPRR at NIH, Building 31, Room 5B59, 9000 Rockville Pike, Bethesda, MD 20892; (301) 496-7163.
Charles R. McCarthy, Ph.D.
Director, Office for Protection
from Research Risks
John G. Miller, D.V.M.
Director, Division of Animal