OLAW replies:

In response to the issues raised by the American Physiological Society's Animal Care and Experimentation Committee, OLAW offers the following clarification.

The Public Health Service Policy on Humane Care and Use of Laboratory Animals1 requires the IACUC to “review and approve, require modifications in (to secure approval) or withhold approval of proposed significant changes regarding the use of animals in ongoing activities.” OLAW's FAQs (http://grants.nih.gov/grants/olaw/faqs.htm) provide OLAW's responses to general questions from institutions and IACUCs as they implement the PHS Policy. Information in the FAQs is updated frequently.

Owing to the great diversity of research performed at Assured institutions, the OLAW FAQ on the subject of protocol changes that require IACUC review provides a list of examples of the types of changes that OLAW considers to be significant and explains that the IACUC has “discretion to define what it considers a significant change, or to establish a mechanism for determining significance on a case-by-case basis.”

OLAW agrees with the APS Animal Care and Experimentation Committee's statement that “IACUC review is needed in certain cases where fewer procedures than planned are performed.” It is incumbent on PIs, when they have doubts about a change in an animal research activity, to communicate with their IACUC. As stated in the FAQ, it is also critical that the IACUC clearly define and communicate to investigators what it considers to be a significant change, or its mechanism for determining significance.

OLAW welcomes comments on any of its guidance. Comments may be submitted to OLAW by email (olaw@od.nih.gov). All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents or development of new guidance documents.