02-19867. Laboratory Animal Welfare: Change in PHS Policy on Humane Care and Use of Laboratory Animals

AGENCY:

National Institutes of Health, DHHS.

ACTION:

Amended Policy Statement.

SUMMARY:

The NIH is changing the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) to permit institutions with PHS Animal Welfare Assurances to submit verification of Institutional Animal Care and Use Committee (IACUC) approval for competing applications subsequent to peer review but prior to award.

DATES:

This change in PHS Policy is effective as of September 1, 2002 (i.e., for all applications submitted for the May-June 2003 Advisory Council dates).

FOR FURTHER INFORMATION CONTACT:

Anthony Demsey, Ph.D., Senior Advisor for Policy, Office of Extramural Research, National Institutes of Health, 301-496-5127, email: [e-mail].

SUPPLEMENTARY INFORMATION:

In the March 28, 2002, Federal Register (67 FR 14956), the NIH proposed to change the PHS Policy to allow institutions to provide IACUC approval for competing applications subsequent to peer review but prior to award. This change would modify the PHS Policy, applicable to all PHS-conducted or -supported activities involving live, vertebrate animals, which currently provides institutions with a PHS-approved Animal Welfare Assurance the option of submitting verification of IACUC approval for competing applications (1) at the time of submission, or (2) subsequent to submission but within 60 days from the receipt date and in any case prior to peer review. Now, with this change in the PHS Policy, IACUC verification is no longer required to be submitted prior to NIH peer review, but instead is simply required prior to award. This process, already adopted as of May 1, 2000, for Institutional Review Board approval of applications involving human subjects, is often referred to as “just-in-time.” The purpose of the change is to enhance the flexibility of institutions and reduce the burden on applicants and IACUCs, allowing resources to be focused on substantive review of applications likely to be funded. The change, however, permits funding components to require verification of IACUC approval at an earlier date if necessary.

Over 200 comments from the research community and institutional officials were received in response to the March 28, 2002, Federal Register solicitation for public comment on the proposed change. The comments were overwhelmingly in favor of the change; some included suggestions for NIH in its implementation of the change. Consequently, NIH emphasizes the following principles and expectations:

• The fundamental PHS Policy requirement that no award may be made without an approved Assurance and without verification of IACUC approval remains in effect. This change only affects the timing of the submission of the verification of that review.
• This change is intended to permit flexibility and discretion on the part of the institution. It is not a requirement that IACUC approval be deferred. Institutional officials retain the discretion to require IACUC approval prior to peer review in certain circumstances of their choosing if they so desire.
• Under no circumstances may an IACUC be pressured to approve a protocol or be overruled on its decision to withhold approval. NIH peer review groups will continue to address the adequacy of animal usage and protections in their review of an application and will continue to raise concerns about animal welfare issues. However, in no way is peer review intended to supersede or serve as a replacement for IACUC approval. An institution that elects to use IACUC just-in-time bears the responsibility for supporting the role of the IACUC.
• It remains incumbent upon investigators to be totally forthcoming and timely in conveying to their IACUCs any modifications related to project scope and animal usage that may result from the NIH review and award process. Should an institution find that one of its investigators disregards his/her responsibilities, the institution may, for example, determine that all animal protocols from that investigator be subject to IACUC approval before it will permit submission of an application from that investigator.
• The existing PHS Policy requirement that modifications required by the IACUC be submitted to the NIH with the verification of IACUC approval remains in effect, and it remains the responsibility of institutions to communicate any IACUC-imposed changes to NIH staff.
• The NIH understands its responsibility to ensure that institutions are given adequate notice to allow for timely IACUC review prior to award and will take appropriate internal measures to fulfill its responsibility to establish timely feedback.

For the reasons stated above, the NIH amends the PHS Policy on Humane Care and Use of Laboratory Animals as set forth below:

Amend the second sentence of Section IV.D.2. of the PHS Policy to delete the words “a time not to exceed 60 days after the receipt deadline date” and replace them with the words “any time prior to award unless specifically required earlier by the funding component” so that the sentence states: “For competing applications or proposals only, such verification may be filed at any time prior to award unless specifically required earlier by the funding component.”

The NIH will modify the NIH Grants Policy Statement and instructions for the 398 Grant Application Form accordingly.

Dated: July 29, 2002.

Elias A. Zerhouni,

Director, National Institutes or Health.