NIH’s Office of Laboratory Animal Welfare (OLAW) seeks public comment on two separate requests for information (RFIs) as an initiative of the 21st Century Cures Act to reduce burden on investigators:
- Request for Information (RFI): Flexibilities for Streamlining IACUC Review of Protocols and Significant Changes
- Request for Information (RFI) on an Update to the Current OLAW Guidance Disclaimer
In response to the 21st Century Cures Act, section 2034(d), and feedback from stakeholders, NIH conducted a review of regulations and policies applicable to the care and use of laboratory animals. The goal was to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. One of the actions identified in the resulting report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, encourages assured institutions to use flexibilities that streamline review of protocols and significant changes, such as designated member review (DMR), DMR subsequent to full committee review (FCR), veterinary verification and consultation (VVC), and administrative handling of increases in previously approved animal numbers.
Information Requested
OLAW seeks input from the scientific extramural community on the following proposal encouraging the use of DMR, DMR subsequent to FCR, VVC, and administrative handling of increase in previously approved animal numbers.
Proposed Guidance for Streamlining DMR
Although FCR and DMR are equally valid methods of Institutional Animal Care and Use Committee (IACUC) review for protocols and significant changes, DMR may reduce administrative burden and enhance review efficiency by decreasing the turnaround time for IACUC review and approval since it does not require a quorum of the IACUC at a convened meeting. The guidance proposes criteria for a reduced time frame (e.g., 3 instead of 7 business days) for obtaining concurrence to call for FCR from all members, routing submissions to allow the DMR initiation process while providing the opportunity for the IACUC to call for FCR and expediting the 3-year complete review by DMR. The IACUC chairperson may designate only one qualified member to conduct the review. The IACUC has the flexibility to determine the best way for the chairperson to assign the designated reviewer.
Refer to the RFI linked above for a full list of additional flexibilities as well as a list of examples of criteria that may be flagged for DMR based on types of research or significant changes.
Proposed Guidance for Streamlining DMR subsequent to FCR
To avoid temporal delays and reduce the burden on investigators, DMR subsequent to FCR provides proposed guidance for IACUCs to have the revised protocol reviewed and approved when modifications are required to secure approval. The DMR subsequent to FCR policy requires the IACUC chairperson to designate the DMR and may be implemented as soon as all members agree to it. However, it does not require:
- A convened meeting
- A vote
- Signing the policy
- Provision of a written statement at meetings
Proposed Guidance for Streamlining VVC
OLAW is proposing guidance to streamline veterinary verification and consultation (VVC) to reduce the burden of developing new references when established references that meet IACUC needs are already available. IACUCs may authorize more than one veterinarian, who need not be an employee, to conduct VVC and place in effect appropriate requests immediately.
Proposed Guidance for Streamlining Administrative Handling of Increase in Previously Approved Animal Numbers
An additional proposed OLAW guidance is aimed at administratively handling an increase in previously approved animal numbers, in accordance with an IACUC-approved policy. The study objectives and the rationale for using animals must be unchanged by the proposed increase, but if the rationale or study objectives change, DMR or FCR is required to conduct an IACUC review. The increase may be expressed as a percentage, an exact number, or a number relative to the original number approved and the IACUC has flexibility to determine the most appropriate individuals and means of handling and documenting this process.
Refer to the RFI above for the full list of proposed guidelines.
Provide Input on Proposed OLAW Guidance Disclaimer
In addition to the requesting feedback on proposed IACUC review of protocols, OLAW is also seeking input on a proposed revision to the current OLAW guidance disclaimer, which does not impose legally binding requirements on constituents, unless specific statutory or regulatory requirements are cited. However, an institution may use an alternative approach for outcome-based requirements in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.
The proposed guidance requires compliance not only with the PHS Policy, but also with the Animal Welfare Act, other federal statutes and regulations related to animals, and any state or local laws which impose more stringent standards for the care and use of laboratory animals.
Read the RFI for more information on the proposed revision to the OLAW guidance disclaimer.
How to Submit a Response
Submit your response to the streamlining IACUC review RFI electronically on the RFI webpage by October 11, 2023, at 11:59 p.m. Eastern Time.
Submit responses to the revised guidance disclaimer RFI electronically on the RFI webpage by October 22, 2023, at 11:59 p.m. Eastern Time.
Responses to both RFIs are voluntary and may be submitted anonymously. Do not include any personally identifiable-proprietary, classified, confidential, or sensitive information in RFI responses. OLAW may make the comments available online.
Direct all inquiries to OLAW at olaw@mail.nih.gov or 301-496-7163.