|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
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