Online Issues

Journal Vol 47(2)

Verification of IACUC Approval and the Just-in-time Process

Michael D. Mann and Ernest D. Prentice

Michael D. Mann, Ph.D. is a Professor of Cellular and Integra-tive Physiology and the Executive Chair of the University of Nebraska Medical Center IACUC. Ernest D. Prentice, Ph.D. is a Professor of Genetics, Cell Biology, and Anatomy and the Associate Vice Chancellor for Academic Affairs. Both authors are at the University of Nebraska Medical Center, Omaha, Nebraska.

Address correspondence to M.D. Mann, Cellular and Inte-grative Physiology, UNMC, Omaha, NE 68198-5850 (E-mail: mmann@unmc.edu).

Abstract

Abstract Public Health Service Policy requires institutional animal care an d use committees (IACUCs) to review and approve the animal care and use aspects of grant proposals submitted for funding. Initially, submission of verification of approval was required with submission of the proposal; however, in 2002, a “just-in-time” (JIT) process was begun to allow submission when it appeared that the proposal would be in the fundable range. After 3 yr, no evaluation of JIT and its impact on the IACUC has been published. An online survey designed by the authors to determine this impact is described. Invitations to participate in the survey were sent to 1002 IACUC chairs and administrators, and responses were received from 168. Surprisingly, 30% of respondents indicated that they did not review grant proposals at all. The majority of those respondents reported that they rely on principal investigator assurance that approved IACUC protocols match grant proposals. In the authors’ experience, this procedure is not safe 23% of the time, and several respondents described the same experience. Most respondents indicated that they use JIT whenever possible for all investigators. Of those who reviewed grant proposals, most indicated that each review consumes 20 to 29 min, and most respondents indicated that the granting agency does not allow enough time for a JIT verification to complete a de novo submission and review of a protocol. Instead, the protocol must have been submitted and reviewed prior to the JIT request. Respondents indicated that there is considerable uncertainty about what the granting agency would do when an IACUC requires changes in a protocol during the JIT process.

Key Words: grant proposals; IACUC; just in time; PHS Policy; protocols