Request for Information: Invitation to Comment on Proposed Guidance Regarding Significant Changes to Ongoing Animal Activities

Notice Number: NOT-OD-14-063

Key Dates
Release Date: March 11, 2014
Response Date: May 15, 2014

Related Announcements
NOT-OD-03-046

Issued by
National Institutes of Health (NIH)

Purpose

The NIH Office of Laboratory Animal Welfare (OLAW) is seeking comments and suggestions on guidance to awardee institutions concerning implementation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). This guidance on significant changes further supports the use of performance standards and professional judgment by Institutional Animal Care and Use Committees (IACUC) in meeting the standards of the PHS Policy and is intended to reduce the burden on investigators and institutions by facilitating greater autonomy within local IACUCs.

Background

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy. The PHS Policy requires that IACUCs “review and approve, require modifications in (to secure approval) or withhold approval of proposed significant changes regarding use of animals in ongoing activities.” (IV.B.7.) In 1995, the NIH published guidance regarding examples of significant changes to approved research protocols (Lab Animal 24 (9):24-26, 1995). This guidance was intended to assist IACUCs in determining when IACUC review is required under the provisions of the PHS Policy. The guidance was amended in 2003 to allow changes in personnel, other than the Principal Investigator, to be handled through an administrative process (NOT-OD-03-046). 

Information Requested

OLAW is seeking input on the following proposed guidance regarding what is considered a significant change to an ongoing animal activity that requires IACUC review.

Proposed Guidance on Significant Changes
Significant changes must be approved by one of the valid IACUC approval methods described in the PHS Policy IV.C.2., full committee review or designated member review.

The IACUC has the authority to approve ranges of variables as long as it can determine that the range does not interfere with the welfare of the animal or the range is scientifically justified. If the investigator chooses to use a single value rather than a range, he or she is required to adhere to that standard.

The IACUC has discretion to add to the following sections A. and B. or to establish a mechanism for determining significance on a case-by-case basis while remaining consistent with A. and B. It is the responsibility of the IACUC to clearly define and communicate to investigators its policy for determining significance.

A. Significant changes are those changes that have or may have a direct impact on animal welfare including but not limited to changes:

  • that have the potential to increase the level of pain or distress of the animal and includes all changes that involve anesthesia, analgesia, sedation, or euthanasia;
  • in frequency, interval, type, number, or anatomical location of:
    • procedures; and
    • substances delivered to the animal.

B. Some activities that may not have a direct impact on animal welfare are also significant. These include but are not limited to changes:

C. Changes that are not significant may be handled by the IACUC staff without IACUC review and approval. However, the IACUC is to be informed of changes handled by the IACUC staff. This information may be provided after the change has been reviewed and initiated. Such minor changes include but are not limited to:

  • total increase in animal number for animals not regulated by USDA that does not exceed 10% of the number reviewed and approved by the IACUC;
  • change that would result in less discomfort or invasiveness to the animal, except the changes described in section A.;
  • change in stock, strain, or genetic modification, unless the new stock, strain, or modification results in abnormalities that require special support;
  • change to house or use animals in a location that is currently used for the same purpose and is part of the animal program overseen by the IACUC;
  • change in personnel other than the Principal Investigator (An appropriate administrative review must be conducted to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in applicable occupational health and safety programs, and meet other criteria as required by the IACUC. The IACUC should have a procedure in place to ensure that this review is conducted.);
  • correction of typographical errors;
  • correction of grammar; and
  • contact information updates.

How to Submit a Response

All comments must be submitted electronically at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=36 by May 15, 2014. You will receive a confirmation acknowledging receipt of comments but will not receive individual feedback on any suggestions. 

Responding to this request for comments is voluntary. Submitted comments are considered public information; do not include any information that you wish to remain private and confidential.  Comments may be posted on the NIH website; personally identifiable information (except for organizational affiliations and addresses) will be removed by NIH prior to making comments publicly available.

This Request for Information is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government.

Inquiries

For questions or further information, contact:

Office of Laboratory Animal Welfare
Phone: 301-496-7163
Email: olaw@od.nih.gov
Web: http://olaw.nih.gov/

 

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.