IACUC: Committee Function

IACUC Composition

Federal regulations require that the membership of the IACUC include at a minimum a veterinarian, a scientist experienced in research involving animals, a member whose principal expertise is in a nonscientific field of study, and an individual not affiliated with WCM.

Because WCM is a large institution, additional members are included to provide ample representation of investigators, to reflect the diversity of the institution's research portfolio, and to accommodate the workload associated with reviewing a large number of protocols and conducting facility inspections. Membership beyond the minimum required by regulation is drawn from faculty and staff of the institution.

The IACUC will:

1. Review at least once every six months the institution's program for humane care and use of animals, using the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation. Semiannual program evaluations will include components of the animal care and use program, inspections reports, and compliance issues which are discussed at each monthly IACUC meeting and recorded in the monthly meeting minutes. Additionally, a complete program evaluation is conducted at a convened meeting of the IACUC using the "Sample Semiannual Program Review checklist", provided by OLAW, semi-annually (every six months).

2. Inspect at least once every six months all of the institution's animal facilities, including satellite facilities, using the Guide as a basis for evaluation. The IACUC process for developing reports and submitting them to the Institutional Official is:

IACUC facility inspections are performed monthly and components of the animal care and use program are also discussed at each monthly IACUC meeting. The animal facility and laboratories using animals are divided into six areas. A sample checklist which covers the major topics of the Guide, and the requirements of the Public Health Service (PHS) Policy, is provided to the inspectors for each area as a tool to assist them in conducting the semiannual inspection. In addition to at least two IACUC members, and a Facility Manager also participates in the inspection of RARC-managed facilities. Each area is inspected at six-month intervals. The IACUC meets and reviews the inspection findings monthly and conducts a final programmatic review according to the Guide, which contains the standards and benchmarks to be used as a basis for evaluation.

3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3 and submit the reports to the Institutional Official (IO).

4. Review concerns involving the care and use of animals at the institution. Facility employees, laboratory personnel, or other WCM staff members with questions or concerns regarding the welfare, care and/or treatment of animals used at WCM are instructed to contact the IACUC. If concerns are reported, the IACUC would conduct an investigation and report its findings and actions to the IO. All reports are held in strict confidence and no employee shall be subject to discrimination or reprisal for reporting such concerns. Instructions regarding this process are posted in all animal facilities, on WCM's website and described in the RARC User's Guide.

5. Issues of non-compliance reported to the IACUC by RARC or noted during IACUC semi-annual inspections are recorded in a Compliance and Inspection Log which is reviewed at each monthly IACUC meeting. Dependent upon the nature and/or scope of the issue, the issue could be addressed directly by the PI and/or RARC without requiring direct IACUC intervention. If IACUC involvement is required, the issue is discussed by a sub-committee of the IACUC and an appropriate course of action is decided. In these cases, the final resolution is reported at the next convened IACUC meeting. All items noted during semi-annual inspections and the course of action and/or resolution is recorded in the log. Issues resolved since the prior IACUC meeting are presented at the following scheduled IACUC meeting.

6. Make written recommendations to the Institutional Official, regarding any aspect of the institution's animal program, facilities, or personnel training.

7. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C. The IACUC procedures for protocol review are:

• Investigators planning to use animals for research, training, or teaching, including those that do not involve a formal grant proposal, must complete and submit for review, in advance of the IACUC's scheduled monthly meeting, a description of their proposed activities using EnCCoMPass, the web internet-based IACUC management application. Based on the nature of the research or teaching to be conducted with animals, the protocol is subject to either designated member review (DMR) or full committee review (FCR). There is no distinction made for pilot studies. Investigators submitting proposals funded internally must also obtain approval from their department chair.

• Full Committee Review (FCR) - Upon receipt of the protocol, it is assigned to two or three IACUC members, one of which must represent the Research Animal Resource Center (RARC), for preliminary review. These reviewers may provide comments/questions to which the PI must provide response by the prescribed deadline. When answers to questions generated during the preliminary review are incorporated in a revised protocol is received, the protocol is placed on the next meeting agenda for discussion and made available to all members. At the meeting, the possible decision for the protocol can be as follows:

1. Approved - the IACUC has determined that the proposal indicates scientific significance and that the PI has provided justification for the use of animals to determine its aims.
2. Approved with caveats - the proposal has scientific merit and the PI has provided justification for the use of animals to determine its aims; however, there are minor changes that need to be made to the text of the document or directives that need to be followed.
3. Non-substantive technical issues raised - response to questions and/or revised protocol does not need to be discussed at a Committee meeting; the response will be reviewed by the IACUC Chair who is able to provide final approval on the project.
4. Substantive issues raised - response to questions and/or revised protocol and must be discussed at a Committee meeting; the response will be reviewed by the assigned reviewers however the decision is determined by the members at the meeting.
5. Disapproved - the IACUC has determined that the proposal does not have scientific significance and/or justification for the use of animals to determine its aims; the Committee will provide comments and questions that led the members to this decision; if the PI chooses to resubmit the proposal, the critique can be of assistance.

Designated Member Review (DMR) - All IACUC members are notified of protocols subject to DMR and have access to the protocol for review. Each member has the authority to request the protocol be subject to FCR. DMR is conducted by at least two members of the IACUC who are selected by the Chair, with at least one member representing RARC. Protocols subject to DMR can be recommended for approval; approval with caveats; non-substantive technical issues raised; non-substantive with re-review; or FCR. All responses to questions resulting from DMR must be reviewed and approved by the reviewers prior to approval. This process is only used in cases where investigators require IACUC approval between scheduled IACUC meetings.

8. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are:

Changes/amendments to protocols must be approved by the IACUC. Changes/amendments are requested by submitting an amendment. Depending on the nature of the change the amendment may be approved administratively (personnel changes only excluding change in the Principal Investigator of a protocol) or are evaluated by the DMR procedure. All amendments approved administratively or by DMR are listed on the agenda at the next convened IACUC meeting.

9. Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy at IV.C.4.

10. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C. 1-4 at least once every three years. The IACUC procedures for conducting continuing review are:

a. All protocols must be resubmitted and reviewed every three years by completing a new activity description using EnCCoMPass.

11. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. If the IACUC suspends a previously approved activity, the IO in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.

Protocol Development Overview

The use of animals for biomedical research, testing, or training must be conducted in a manner which prevents, minimizes, or eliminates pain and distress, while using the minimal number of animals needed to address the stated goals. The principal questions that the IACUC must address are:

1. Are the proposed studies, testing, teaching exercises of sufficient importance to warrant the use of animals?
2. Are the studies designed to cause the least harm possible in order to answer the proposed question?
3. Does the staff utilizing the animals have sufficient experience and training to execute the studies/training?

It is essential that the use of animals described in the approved protocol be followed. Written records that document when and how animals are monitored during and after experimental procedures must be maintained. Performing unapproved procedures is a violation of WCM Policy, as well as federal and state laws and/or policies and will be addressed by the IACUC. The IACUC is mandated to report unapproved activities to the NIH. Staff who become aware of violations, particularly violations which can cause harm or unnecessary pain to animals, are strongly encouraged to report the violations to the IACUC or other appropriate institutional officials. The IACUC can be informed anonymously. Notifications will be handled confidentially.