Institutional Animal Care and Use Committee (IACUC) Policy for Review and Investigation of Animal Welfare Concerns

Purpose: The purpose of this policy is to describe the procedures that will be followed for addressing animal welfare concerns at the University of Pennsylvania.

Background: Congress amended the Animal Welfare Act (AWA) in 1985 in Public Law 99-198. The Secretary of Agriculture was directed to promulgate new rules governing the humane handling, care, and treatment, and transportation of animals by dealers, research facilities, and exhibitors. A requirement under the AWA is that the IACUC, as an agent for the research facility, "review and if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees [Federal Register Vol. 54, No. 168, Thursday, August 31, 1989, final rule 2.31[c][4]:p. 36152]. "The research facility must maintain documentation of the Committee's reviews and investigations conducted in response to complaints received in order to demonstrate its compliance with these regulations." The research facility determines the form and method of such documentation [ibid. p. 36128].

Reporting: Animal welfare concerns can be expressed in writing, by telephone or in-person. They can be sent anonymously. Concerns can be made to the Office of Regulatory Affairs (ORA), (215) 898-2614, the University's Corporate Compliance Office (UCCO) 1-888-236-8477, the Chairperson or members of the Institutional Animal Care and Use Committee (IACUC). All concerns will be reviewed regardless as to how they are received. The two recommended ways of reporting a concern are:

1. An animal welfare concern can be reported and the individual will be known to the IACUC and will be part of the investigation process.

2. An animal welfare concern can be anonymously submitted. An individual can approach any IACUC member, the ORA office or the UCCO. The person approached will act as the complainant or employee's representative throughout the process. The rest of the IACUC, ORA, or UCCO will not know the individual's name.

Procedures: The procedures when any concern involving the care and use of animals at the University of Pennsylvania is received by the IACUC, ORA, or UCCO is as follows:

1. The Director of ORA will be responsible for bringing the concern to the attention of the IACUC Chairperson and to the Vice Provost for Research. The IACUC Chairperson will be responsible for the review and if warranted the investigation.

2. The IACUC Chairperson will notify both IACUC Committee of the pending review and investigation. The IACUC Chairperson will keep the IACUC Committee informed on the progress of the review and the investigation (if warranted) on the preparation of action steps and recommendations and on the completion of the welfare concern.

3. An investigation, if warranted, will proceed immediately (normally no later than 5 working days). The investigation will involve the participation of the IACUC Chairperson and the Director of ULAR (University Laboratory Animal Resources). The investigation will include contacting the Principal Investigator for the animals which the animal welfare concern was raised, along with others, if warranted. Consultants and others may assist in the investigation.

4. Generally, within 10 working days after completion of the investigation, the IACUC Chairperson and the Director of ULAR [including consultants and additional designated resources, if deemed appropriate] will meet to discuss the review/investigation and preparation of action steps/recommendations. The results of this meeting will be provided to ORA and to the Vice Provost for Research.

5. The results of the investigation/resolution of the concern will be shared with the person reporting the animal welfare concern by ORA. This may take the form of a meeting, letter, or other communication. If the concern is anonymous, the University member (IACUC, ORA, UCCO) representing the person reporting the concern will meet as above and then inform the person of the resolution.

Record Retention: A report of the animal welfare concern and the appropriate documents from the IACUC investigation and the action steps/recommendations process will be maintained by the ORA for a period of 3 years. The AWA stipulates that "the research facility must maintain documentation of the Committee's reviews and investigations in response to complaints received in order to demonstrate its compliance with these regulations" [ibid. p. 36128].

Public Notification: On an annual basis, the Director of ORA will submit this policy to Almanac for publication. Within the animal facilities, informational signage regarding this policy will be posted.

-- Joseph R. Sherwin, Director, Office of Research Administration