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I. Protocol Review
- How frequently should the IACUC review research protocols?
- The PHS Policy at IV.C.5. states "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three years (3)". The USDA regulations 9 CFR 2.31(a)(5) (4) states "The IACUC shall conduct continuing reviews of activities covered by this subchapter at appropriate intervals as determined by the IACUC, but not less than annually."
- What do I need to do in order to satisfy the continuing review policy?
- What is the SHSU policy of IACUC protocol submissions?
- All IACUC submissions MUST be received by the ORSP by 5:00 pm on the Monday of the week an IACUC meeting is to occur (See IACUC Schedule for meeting dates and times).
- What is the typical timeline for IACUC review and approval?
- Applications are reviewed in the order they are received. The time required for review and approval of an average IACUC application, carefully prepared in accordance with the recommended guidelines, submitted by an applicant who has completed the required Animal Subjects training, is approximately two to three weeks. Full Committee Review (FCR) may take longer depending on when in the meeting cycle the application is received. Final approval is dependent upon requested modifications, if any, being satisfactorily completed. Many low-risk Animal Use Protocols (AUPs) will be processed by the Designated Member Review (DMR) procedures. Please allow for up to 2 weeks for a typical AUP DMR review.
- Is Post-Approval Monitoring required?
Continuing IACUC oversight of animal activities is required and can be accomplished through a variety of mechanisms. (Guide pages 33-34) Monitoring animal care and use is required by the PHS Policy, but the Policy does not explicitly require specific post approval monitoring (PAM) procedures to compare the practices described in approved protocols and SOPs against the manner in which they are actually conducted. IACUCs are charged, however, with program oversight and as such are responsible for program evaluations, reviews of protocols, reporting noncompliance, ensuring that individuals who work with animals are appropriately trained and qualified, and addressing concerns involving the care and use of animals at the institution. The veterinarian with program authority and responsibility for animal activities along with the animal care and technical staff, add another important level of program supervision.
Related components of institutional programs provide monitoring by a multi-disciplinary team of individuals. Examples of such components include daily observation of animals by trained animal care personnel and communication to the veterinary staff for follow-up, facility monitoring by facility maintenance personnel, post operative care by trained personnel, evaluation of outcomes of animal procedures by investigators and staff, hands-on training in animal procedures, and appropriate reporting of incidents involving occupational health and safety. All of these functions and responsibilities imply a level of monitoring. Ultimately the institution has flexibility in how it achieves compliance.
Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement. Whatever methods an institution incorporates, it is important that the authority and responsibility of the IACUC not be contravened by a PAM program, institutional compliance officials, or other mechanism established to monitor animal care and use.
- May the IACUC grant conditional or provisional approval?
- The PHS Policy recognizes that the IACUC may approve, require modifications, or withhold approval. If the IACUC determines that a protocol is approvable, contingent on receipt of a very specific administrative modification or clarification (e.g., a contact telephone number), the Committee may handle the issue as an administrative detail that an individual (e.g., IACUC Chair or Administrator) may verify. Requests for substantive modifications should result in the protocol coming back to the Committee. Protocols that lack substantive information necessary for the IACUC to make a judgment (e.g., justification for withholding analgesics in a painful procedure) should be considered incomplete, and the IACUC should defer review until the requisite information is provided by the investigator. Applying descriptors, such as conditional, provisional or interim, when referring to IACUC approval is not allowed.
II. Records Retention
- What records is the IACUC responsible for maintaining?
- The IACUC is responsible for maintaining:
- minutes of IACUC meetings;
- records of IACUC attendance, activities, and deliberations;
- documentation of protocols reviewed by the IACUC and proposed significant changes to protocols, and whether approval was given or withheld;
- report of semiannual IACUC evaluations and recommendations to the IO, including minority views; and
- accrediting body determinations
- How long are IACUC records to be maintained?
- All records are to be kept for a minimum of 3 years, with the exception of records that relate directly to protocols which must be kept for the duration of the activity and for an additional 3 years after completion of the activity.
Records documenting such activities as the provision of adequate veterinary care, training, and occupational safety, are expected to conform with the recommendations of the Guide and with commonly accepted professional standards.
III. Adverse Events in Animals
- What is an animal adverse event (AE)? Animal protocol deviation?
- An adverse event is any occurrence, usually involving pain, distress or death of an animal, which was not described in the approved IACUC Protocol or its subsequent modifications that has a negative impact on animal welfare. An IACUC protocol deviation is any departure from the methods approved in the IACUC protocol. Note that the IRB further distinguishes between protocol violations and deviations; however, the IACUC does not.
- Why should AEs be reported?
- Reporting AEs assists principal investigators, animal care staff and the attending veterinarian to find the cause and to prevent recurrence. Reporting also helps the IACUC meet its federal requirement to monitor animal activities.
- Who should report AEs?
- PIs and animal facility directors should report to the IACUC as soon as they become aware of an event that may impact animal welfare. An email or phone call is recommended for a preliminary report as soon as possible after the event. The final report should be made on the official form within 7 calendar days and after consultation with veterinary staff.
- What qualifies as an AE?
- When in doubt, call the animal facility director or the IACUC to discuss the event. Unexpected events or problems are considered AEs if they affect greater numbers of animals than anticipated, have a negative impact on other animals or activities, or reflect a situation that could become more severe in the future. A report is not required if the event and its management are described in the approved IACUC protocol.
- What types of events must be reported?
- The following events must be reported:
- Morbidity or mortality resulting from complications not described in the IACUC protocol.
- Greater number of mortalities, more severe responses, or when animals appear to be in more pain or distress than expected/described in the IACUC protocol. For example, a report would be required, if 10 % of animals die following surgery when a 5% fatality rate was indicated in the approved protocol.
- Allergic reaction to a treatment; inadequate anesthesia; development of an unexpected infection following surgery or treatment.
- Facility or equipment failure that has a negative impact on animal welfare. Loss of electrical power impacting HVAC function or water supply; restraint equipment malfunction; biohazard containment failure. Facility design, husbandry or postoperative care that has a negative impact on animal welfare
- Entrapment; overexposure to heat source(s); inadequate analgesia or antibiotic use.
- Off-protocol activity, or Protocol Deviation, i.e., any intentional or unintentional use of animals that was not described in the approved IACUC protocol.
- What events do not need to be reported?
- Injury or illness unrelated to approved procedures and being treated by the attending veterinarian or designee. Events that are described in the approved protocol that occur at rates that are equal or below the rates indicated in the approved protocol.
- What information needs to be reported?
- The Adverse Event and Protocol Deviation Form should be used to submit a report. The form is available on the IACUC website at Application Forms. Information required includes the project title and IACUC protocol number; the principal investigator’s name; the date, time, location and nature of the event; measures taken at the time to minimize impact on animal welfare; the actual or potential impact of the event on animal welfare and study outcomes; and immediate and long-term steps being taken or considered to prevent recurrence of the event. The name and signature of the person reporting the adverse event also are required.
- How should reporting of a typical AE proceed?
- See below:
- In an emergency, contact a staff veterinarian immediately.
- Consult with the animal facility manager to provide any necessary changes in animal care.
- Communicate as soon as possible with IACUC by phone or e-mail to inform them of the situation and receive further instruction as appropriate.
- Work with veterinary staff to complete this report including a Corrective Action Plan, as needed, and submit it by email to IACUC within 7 calendar days of the event.
- The attending veterinarian, or designee, will review the report and seek further clarification or sign off that it has been fully resolved.
- The report will be included in the agenda for the next IACUC meeting and the IACUC chair will seek further clarification or sign off that the event has been documented by the IACUC, thereby closing the issue.
- What will the IACUC do with the report?
- The purpose of AE reporting is to document at the level of IACUC, in accordance with its federally mandated role of oversight, that adverse events have been fully addressed by the research team and veterinary staff as they occur. Timely reporting demonstrates the commitment of the research team to provide the highest quality animal care by engaging all available resources. A subcommittee of the IACUC will review these reports in detail prior to consideration at a convened IACUC meeting. Most of these reports will be informational to the full IACUC; others may require further action. Amendments to approved protocols may be necessary to modify procedures based on knowledge gained from adverse events. In some cases, it will be advisable for principal investigators to voluntarily halt certain animal procedures until an event is fully addressed. If adverse events are not appropriately addressed in a timely manner, the IACUC has the responsibility and authority to protect animal subjects with actions up to and including the suspension of approved protocols. Failure to report adverse events is noncompliance with IACUC policy. As official IACUC documents, these reports are not public because Wake Forest is a private institution. The documents must be available to USDA representatives upon request.