NIH Grants and Funding
Streamlining IACUC Review for Animal Activities
One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research as part of the 21st Century Cures Act is for OLAW to review and revise the current guidance on streamlining the IACUC protocol review process for animal activities.
On this page:
Request for Information
The NIH Office of Laboratory Animal Welfare (OLAW) proposed updates to NOT-OD-09-035 between July 11, 2023 and October 11, 2023.
The proposed changes can be found here: NOT-OD-23-152
The comment period is now closed.
The final guidance will be published along with a new webpage once comments have been considered. Until comments have been considered and new guidance has been finalized, OLAW expects institutions to comply with the Guide Notices listed in the Guidance section, below.
Policies and Laws
PHS Policy IV.B.6.: As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities...review and approve, require modifications in (to secure approval), or withhold approval of those PHS-conducted or supported activities related to the care and use of animals as specified in IV.C.
PHS Policy IV.B.7.: As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities...review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities
PHS Policy IV.C.2.: Prior to the review, each IACUC member shall be provided with a list of proposed research projects to be reviewed. Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval), or request full committee review of those research projects. If full committee review is requested, approval of those research projects may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest(e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
PHS Policy IV.C.3.: The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.
PHS Policy IV.D.1.a.: All Institutions: Applications and proposals (competing and noncompeting) for awards submitted to the PHS that involve the care and use of animals shall contain the following information: a. identification of the species and approximate number of animals to be used
Guidance
| Notice Number | Description | Date |
|---|---|---|
| NOT-OD-14-126 | Guidance on Significant Changes to Animal Activities | August 26, 2014 |
| NOT-OD-11-053 | Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates | March 18, 2011 |
| NOT-OD-09-035 | Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR) | January 8, 2009 |
| NOT-OD-03-046 | Revised Guidance Regarding IACUC Approval of Changes in Personnel Involved in Animal Activities | June 6, 2003 |
| OPRR Reports 90-01 | Use of Expedited Protocol Reivew Procedures by IACUCs | May 21, 1990 |
Resources
Webinars
| Webinar Link | Webinar Date |
|---|---|
| Implementing Guidance on Significant Changes: One Institution's Experience | September 8, 2016 |
| OLAW Online Office Hours | December 3, 2015 |
| Guidance on Significant Changes to Animal Activities | August 21, 2014 |
| IACUC Review of Proposed Animal Activities | December 9, 2010 |
Questions?
Call (301-496-7163) or e-mail (olaw@mail.nih.gov) OLAW for answers to your questions.