Are there any reporting requirements? You have always been required to keep your protocol current as to changing activities and to request prior approval for modifications. You are also required to complete an Annual Report (previously called a Continuing Review) for each protocol. Once your projects are in IRBNet you will receive automated notifications at 60, 30, and 7 days prior to expiration. Failure to submit your annual report by the deadline will result in the system automatically issuing a closure notice. Also, once a year UAF must submit a report to USDA on our activities involving species covered under the Animal Welfare Act. This means listing species used and providing the number of animals used as categorized by the level of invasiveness or pain induced. Some funding agencies also have reporting requirements related to the use of animals.
I am doing surgery in the field. Is there a reporting requirement for this? Yes. In the Animal Welfare Regulations, a field study means any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study. So, a field study is not subject to the Animal Welfare Regulations if it adheres to the above definition. However, many of our field surgical procedures that involve implantation of telemetry devices are subject to the Animal Welfare Act and these activities must be reported to USDA on an annual basis.
When are problems with my approved IACUC protocol reported to federal regulatory agencies? The Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), has issued guidance for Public Health Service (PHS) awardee institutions regarding the requirements for prompt reporting of animal welfare issues. Essentially, institutions are expected to inform OLAW and the funding agency of "serious non-compliances" involving animal welfare. In addition, the UAF Office of Grant & Contract Administration is required to report any actions that significantly delay progress on an award. One example of such action would be suspension or revocation of an IACUC Protocol.