NICHD Animal Care and Use Committee (ACUC)
- Legal Basis for ACUC Activities
- Hints on Preparing an Animal Study Proposal (ASP)
- NICHD ACUC Significant Changes to Animal Study Proposals
Public Health Service Policy and federal regulations require that all animals used in research be covered by active Animal Study Proposal (ASPs) that are approved by an Institutional Animal Care and Use Committee. An NICHD Investigator must complete an NICHD Animal Study Proposal(ASP) form that completely describes any planned experiment that will use vertebrate research animals. This form must be submitted to the NICHD Animal Care and Use Committee electronically to NICHD ACUC Committee firstname.lastname@example.org or brought to the ACUC Coordinator, Building 6A/B1A05,, 301-496-9733) . The original copy with signatures and attachments need to be submitted in order to be considered for review at the ACUC meeting. Electronic forms with digital signatures are acceptable and encouraged. For pre-review purposes, copies of the form and attachments should be emailed to the ACUC inbox, email@example.com. ACUC Coordinator is Maria Publico, firstname.lastname@example.org. Investigators should contact her or Dr. Schech for questions and guidance about submitting ASPs or modifications.
It is strongly suggested that you consult with the NICHD Animal Program Director prior to submitting proposals to the NICHD Animal Care and Use Committee (ACUC). He can provide assistance to you that may facilitate the ASP review process.
The ACUC is comprised of nine voting members. The membership includes a non-scientific member who is not affiliated with the NICHD or the NIH. The ACUC members also include the NICHD Animal Program Director (veterinarian), and scientists from various laboratories in the NICHD.
The ACUC generally meets monthly (third Wednesdays); ASPs received by the first Friday of any given month will be reviewed by the ACUC during that month. The form should be complete, including all required signatures, or it may not be reviewed by the ACUC that month. Each ASP is reviewed in its entirety at the ACUC meeting. The investigator may be requested to appear before the committee to answer specific questions that arise. There is no process for expedited review of ASPs in the NICHD.
Proposals are reviewed by the ACUC with regard to NIH policies, the Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals, Public Health Service Policy on Humane Care and Use of Laboratory Animals, and other pertinent references. The ACUC is also required to utilize the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research and Training in its review. ASPs must contain sufficient information to allow for full ACUC evaluation on the basis of these principles.
The ACUC determines that an Animal Study Proposal may be approved, tabled for designated review, tabled for full committee review, or disapproved:
- Proposals which are approved are signed and assigned a number.
- Proposals which are tabled for designated review are returned to the Principal Investigator to prepare a response to specific questions or concerns held by the ACUC members. The revised ASP is returned for review by the ACUC Chair and NICHD Animal Program Director or other designees of the ACUC. If, in the opinion of these members, the questions or concerns have been fully addressed, the ASP is approved, signed, and assigned a number. If either individual not satisfied that the stipulations have been fully addressed, the ASP is referred back to the Principal Investigator or to the full committee for further consideration.
- Proposals which are tabled for full review are returned to the Principal Investigator to prepare a response to specific questions or comments. The revised ASP is referred back to the full committee for further consideration.
- Proposals which are disapproved are returned with an explanation of the reasons for disapproval; these may be modified and submitted for reconsideration by the full committee.
- On the first and second annual anniversary of approval of an ASP, an Animal Study Proposal Annual Review form is sent to the Principal Investigator inquiring as to whether the ASP is still in use and whether any changes in the ASP are proposed for the coming year. The Instructions for Emergency Animal Care and Treatment form should also be updated as part of this review. Every three years the ASP must be resubmitted on the current NICHD Animal Study Proposal form for re-review by the full ACUC.
Proposed changes to an ASP must be described on a Modification to Animal Study Proposal formand submitted to and approved by the ACUC. This includes, but is not limited to, additions or deletions of personnel; any modification of previously approved animal procedures; increases in the number of animals needed; changes in the species, strain, or sex or animals required; and changes in research objectives. Minor changes, such as adding or deleting personnel to the ASP, can be approved by designated review prior to the next meeting if requested at the time of submission and if ACUC designees are available.
Significant changes to an ASP require a review by the full ACUC. Thus, they need to be received by the ACUC coordinator by the first Friday of the month in order to be considered at that month's meeting.
Significant changes include, but are not limited to:
- Changes which increase the levels of pain, distress and discomfort of the animals;
- Change from non-surgery to surgery, minor to major surgery, non-survival to survival surgery, or from single to multiple survival surgery;
- A greater than 10% increase in the number of animals used;
- Change in the species of animals used;
- Change in principal agent;
- The addition of the use of hazardous agents in animal procedures.