|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.
January 12, 1994
Greetings from the National Institutes of Health, Office for Protection
from Research Risks (OPRR), Division of Animal Welfare.
This letter provides Public Health Service (PHS) awardee institutions
with information and clarification in the area of animal welfare-related
prompt reporting requirements.
The PHS Policy on Humane Care and Use of Laboratory Animals (Policy)
identifies three areas that require prompt reporting to OPRR (Section
IV.F., paragraph 3): (a) any serious or continuing noncompliance
with the PHS Policy; (b) any serious deviation from the provisions
of the Guide for the Care and Use of Laboratory Animals;
and (c) any suspension of an activity by the IACUC. Determination
that a problem at an awardee institution falls within the meaning
[letter or spirit] of either (a) or (b) requires a degree of judgment
by the IACUC. The language used in the Policy was chosen purposely
to permit the judicious application of professional judgment by
the IACUC in determining what incidents should be reported to
OPRR. In an effort to assist IACUCs in making such judgments,
we offer the following examples of occurrences that we have determined
meet these reporting criteria:
(a) serious or continuing noncompliance with the PHS Policy
(b) serious deviation from the provisions of the Guide
NOTE to (a) and (b): SERIOUS NONCOMPLIANCE WITH THE PHS POLICY
AND DEVIATIONS FROM THE GUIDE MUST BE REPORTED, EVEN IF IDENTIFIED
INITIALLY BY OTHER AGENCIES, SITE VISITORS OR CONSULTANTS.
(c) suspension of an activity by the IACUC
As a reminder, reports of IACUC semiannual evaluations are intended to be tools for institutional selfidentification and correction of facility and program deficiencies and therefore are not required to be submitted to OPRR unless specifically requested by this Office. However, as noted above, serious problems may be identified during the course of a semiannual evaluation that also qualify for prompt reporting.
As a general rule, reports to OPRR of noncompliance with the PHS
Policy and deviations from the Guide should be made if
the IACUC believes that the situation might meet the provisions
of Section IV.F. of the Policy. In some cases, it may be advantageous
to report preliminary findings and actions by telephone, pending
the results of a full IACUC investigation and final report. Final
reports of deviations/noncompliance must be accompanied
by specific and reasonable corrective plans and schedules. This
approach aids in demonstrating that the Institutional Animal Welfare
Assurance mechanism of "enforced selfregulation"
is an effective method of promoting the welfare and wellbeing
of laboratory animals.
Please call OPRR at (301) 4967163 if you have any questions
regarding the above information.
Gary B. Ellis, Ph.D.
Director, Office for Protection from Research Risks
Nelson L. Garnett, D.V.M.
Director, Division of Animal Welfare, OPRR
Director, Office of Laboratory Animal Welfare
Office of Extramural Research,
Office of the Director, National Institutes of Health
RKL 1, Suite 360
6705 Rockledge Dr.
Bethesda, MD 20892-7982
(For express or hand-delivered mail use zip code 20817)
Telephone (301) 496-7163