The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.

January 12, 1994

Subject: Requirements for Prompt Reporting of Problems to OPRR

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

• failure to correct situations identified in previous semiannual evaluations as significant deficiencies
  
• conducting animal-related activities without appropriate IACUC review and approval
  
• failure of animal care and use personnel to adhere to IACUC - reviewed and approved institutional policies and procedures
  

(b) serious deviation from the provisions of the Guide

• conditions that jeopardize the health or well­being of animals, including accidents, natural disasters and mechanical failures resulting in actual harm or death to animals
  
• shortcomings in programs of veterinary care, occupational health or training, identified during semiannual program review and not corrected within the institutionally determined time frame.
  

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

• an IACUC intervention that results in the temporary or permanent interruption of an activity involving animals
  

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.

Sincerely,

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
olaw@od.nih.gov