IACUC approval of SOPs

There is a burning desire within the hearts of some animal facility managers to have the IACUC approve each of the facility's Standard Operating Procedures (SOPs), every informal operating policy, every food ration used, and so forth. This is balanced by an equally strong desire of other facility managers to work cordially but at an arm's length from the IACUC. In the latter managers' opinions, the job of the IACUC is to oversee the program of animal care and use as it relates to federal regulations, and nothing more. Not surprisingly, both groups have trouble seeing the other's viewpoint.

At Great Eastern University, the difference in opinion was not among animal facility managers but between the facility director and the IACUC chairman. Dr. Bernard Koul, the animal facility director, believed that the IACUC had an obligation to assure that husbandry and veterinary care for laboratory animals met or exceeded the minimum standards of the Guide for the Care and Use of Laboratory Animals (the Guide)¹ and the Animal Welfare Act regulations². He had no problem with the IACUC reading the animal facility's SOPs and offering suggestions for improvements, but he did not believe that the IACUC had any authority to approve those SOPs or require changes that went beyond federal regulations. He quoted the section of the Animal Welfare Act regulations that states that an IACUC is to evaluate the care, treatment, housing and use of animals and to certify compliance with the Animal Welfare Act³. Koul also said that section 495 of the Health Research Extension Act of 1985 (which requires an IACUC for research funded by the Public Health Service)⁴ said nearly the same thing and was focused on compliance with the Act, not on the approval of SOPs by the IACUC.

Dr. Larry Covelli, the IACUC chairman, disagreed with Koul. Covelli said the Health Research Extension Act and the Guide required the IACUC to oversee and evaluate animal care and use activities. The Animal Welfare Act regulations, he said, required a similar review and also referred to animal activities, not just research protocols. In his opinion, approving SOPs that focused on animal activities were well within the scope of the IACUC's responsibility and authority.

Both Koul and Covelli concurred that the IACUC had an oversight and evaluation responsibility for husbandry and veterinary care issues but, using the same documents for their justification, they disagreed on the issue of the IACUC's authority to approve SOPs. What is your opinion and how would you resolve this impasse?

Response to Protocol Review Scenario: Review animal welfare SOPs

Response to Protocol Review Scenario: Self-control and institutional culture

Response to Protocol Review Scenario: Does approval add value?

Response to Protocol Review Scenario: A word from OLAW and USDA