Principal investigators are responsible for insuring that members of their staffs who work with animals are familiar with relevant procedures and details specified in the protocols. In addition, supervision of work performed on animals must be adequate to insure that approved protocols are being followed and that significant changes are not implemented prior to IACUC approval.
The Central Washington University Use of Animals in Research and Teaching policy [2-2.37] states "It is the policy of Central Washington University to provide the best possible care for animals used in research or teaching, thereby meeting or exceeding accepted guidelines and all applicable federal, state, and local legislation." One of the roles of the IACUC is to review all concerns about the animal care and use program, regardless of origin, and to investigate them as warranted. Furthermore, as an institution that accepts federal funds for research, CWU is legally obligated to report to the appropriate federal agencies (a) any serious or continuing noncompliance with PHS policy or the requirements or determinations of the IACUC, (b) any serious deviation from the provisions of the Guide and (c) any suspension of any activity by the IACUC.
The procedures described below are guided by recommendations in the OLAW Institutional Animal Care and Use Committee Guidebook.
B. NONCOMPLIANCE COMPLAINTS
Several types of noncompliance problems may be brought to the attention of the IACUC, such as:
- Reports that an investigator is not following the research protocol as approved by the IACUC.
- Repeated failure of an investigator to report required or requested information to the IACUC.
- Ongoing research or instructional use of live, vertebrate animals for which there is not an IACUC approved protocol.
- Failure to provide appropriate standard of care.
- Problems causing a funding agency audit regarding an investigator or a research study.
C. NONCOMPLIANCE PROCEDURES
Given the wide range of possible noncompliance events, the procedures and timelines to be followed will depend on the seriousness of the situation and the potential impact on animals involved.
Emergent Situations: The IACUC is authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.
- In an emergent situation where the Attending Veterinarian is on site and veterinary medical intervention is not sufficient, the Attending Veterinarian may immediately suspend an ongoing activity until the IACUC can be convened and consider the matter formally. This is accomplished by personally providing a written statement of suspension to the person in charge of the facility or laboratory. The Attending Veterinarian will immediately notify the IACUC Chairperson of the action.
- Upon receipt of a complaint alleging an emergent situation, the IACUC chairperson will determine with the attending veterinarian if immediate suspension is required for all or part of the project in question as well as the facility. The IACUC chairperson will inform the principal investigator and/or facilities manager as soon as possible. This initial decision will be based on preliminary information and the seriousness of the situation, and a meeting with the PI, if appropriate.
- In either case, the IACUC Chairperson will convene a meeting of the IACUC at the earliest possible opportunity. A majority vote of a convened quorum of the committee will result in the suspension, or continuation of the suspension of the activity.
- If the activity is suspended, the PI will be notified in writing of the suspension and the reasons for it. Notification will also be provided to the PI's department chair or director, facility manager, Office of Grants and Contracts, the Provost and/or other pertinent university officers. All communication regarding the suspension will be documented.
- In consultation with the IACUC, the IO will review the reasons for the suspension, take appropriate corrective action and report that action to OLAW. The IO will also report suspension activity to USDA (APHIS) and any Federal funding agency if required. Follow up reports will be sent at resolution of the concern.
- Upon becoming aware of a non-emergent noncompliance concern, the IACUC Chairperson (or subcommittee) will determine whether to place it on the agenda for the next regular IACUC meeting or to convene a special meeting.
- After initial review of the concern, the IACUC will determine whether it requires further investigation and immediate action (including but not limited to suspension), further investigation but no immediate action, or no action. At that time the IACUC will also determine which individuals or other institutional or noninstitutional offices may require notification. (See procedures for suspension above.)
- Should further investigation be required, the IACUC will outline the information to be gathered and set a completion date. The IACUC Chairperson or appointed designee or subcommittee will conduct the investigation and report back to the IACUC. Care will be taken to avoid actual or perceived conflict of interest.
An investigation will be performed of the research or activity against which the complaint is lodged and may include any or all research at CWU conducted by the principal investigator (PI). The investigation procedures may include but are not limited to:
- Reviewing the research protocol in question.
- Reviewing the principal investigator's IACUC files (i.e., all previous and current projects).
- Reviewing any relevant documentation, including data files, etc., as they relate to the investigator's execution of his or her activities involving animals.
- Interviewing appropriate handlers, and study or university personnel.
The person(s) conducting the investigation will prepare a written report of the investigation findings that will be presented to the full IACUC at its next convened meeting. The report may recommend actions, if appropriate, based on its findings.
4. Possible findings
a. No evidence to support concern or complaint: A finding of no evidence will be signed by the IACUC chairperson. Copies of the communication will be forwarded to appropriate parties.
b. Concern or complaint not supported, but related aspects of animal care and use program or other institutional programs may require further review: A finding of no evidence will be made as above, and the issue will be followed up by the IACUC and/or reported to appropriate institutional officials or committees for their consideration.
c. Nonserious and noncontinuing : If the incident appears to be isolated and, in essence, a miscommunication of a nonserious or noncontinuing nature, the incident will remain internal to the university. A letter from the IACUC Chair to the PI describing a summary of the investigation will be written. A response from the PI describing corrective action, if any, is required. This will be considered the final step if the incident is considered nonserious and continuing noncompliance was not determined. The finding of nonserious and noncontinuing noncompliance will be signed by the IACUC chairperson. Copies of the communication will be forwarded to the PI, the PI's department chair or director, and the IO.
d. Serious or continuing : If the investigation indicates noncompliance that is serious or continuing, the IO will contact OLAW. If applicable, the funding source will also be notified. This notification will consist of an immediate phone call to apprise the office of the incident of serious or continuing noncompliance and will be followed with a formal report including corrective actions for this specific incident as well as for the research program in general at Central Washington University to ensure incidents will not occur again.
A letter to the PI describing a summary of the investigation will be written. This finding of serious or continuing noncompliance will be signed by the IACUC chairperson and may include corrective actions to be taken and/or recommendations to the IO for sanctions. Copies of the communication will be forwarded to the PI, the PI's department chair or director, the appropriate college dean, and the IO. The IACUC and the IO will confer as necessary to resolve the issue. All communication regarding the finding and resolution will be documented.
CWU Noncompliance Procedures Flow Chart