Is Oversight and Outreach a part of the IACUC?
The Oversight & Outreach Office is independent of the IACUC and reports directly to the Assistant Dean of Regulatory Affairs and Research Integrity.
Should you have a concern or question about the welfare of any animal, contact your supervisor
and/or the principal investigator of the research project. You may also contact the:
Oversight & Outreach Office: 336-716-4127
IACUC Office: 336-716-3540
ARP Main Office: 336-713-7394
A confidential Concern Line is also available. WFU Concern Line at 1-877-880-7888 or www.tnwinc.com/Reportline
What is a "PAM" Review?
A Post Approval Monitoring review (PAM review) is a review of the work being done on an approved IACUC protocol. It is performed to provide assurance to regulatory agencies that studies are conducted in a manner that is consistent with the approved protocol. These reviews are used by the IACUC to ensure that animal activities approved by the IACUC are conducted according to applicable external regulatory rules and Wake Forest SOPs (SOP 23). A PAM review is also a good time for O&O staff to provide one-on-one training/updates on regulatory or policy changes to your team as well as answer any of your questions. In addition, procedures that are currently being done as part of the protocol will be observed to confirm that they are being done as described in the protocol.
For specific information about how protocols are chosen for review and how to prepare, visit the Post Approval Monitoring (PAM) page on the Oversight & Outreach web site of the CTSI.
What do I do if there are health complications (anticipated or unanticipated) affecting the animals in my research?
The Animal Resources Program provides clinical veterinary assistance for any animal health and welfare concerns. Vet staff is available 24 hours daily for clinical emergencies. Contact information is posted next to all phones in vivarium hallways. O&O staff can assist you with any required reporting of unexpected adverse events or protocol deviations involving animal health/welfare. Detailed information, including FAQs for specific AE guidance, can be found on the Reporting Procedures page on the Oversight & Outreach web site of the CTSI.
What is AALAC and why do we need AAALAC certification?
AAALAC International (AAALAC) is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. While mandated external oversight is provided by the USDA, OLAW and AAALAC, nearly 1,000 companies, universities, hospitals, government agencies and other research institutions in 46 countries have chosen to become AAALAC accredited, demonstrating that they meet the minimum standards required by law, and are also going the extra step to achieve excellence in animal care and use.
Many funding agencies, including the DOD, VA, NASA and NIH, consider AAALAC accreditation a sign of commitment to excellence.
Why do the regulations and policies keep changing?
Federal regulations and policies actually have not changed all that frequently. However, publications such as The Guide for the Care and Use of Laboratory Animals are periodically revised and updated. Guidance on the interpretation of regulations by governmental agencies such as OLAW and USDA will change over time as areas of interest shift and priorities change. O&O and the IACUC monitor these changes and accordingly the IACUC will adjust our institution’s policies to maintain compliance and high standards. The IACUC Board votes on any changes in standard operating procedure.
How will I be notified of any policy changes?
All animal users should receive the quarterly IACUC Animal Welfare Newsletter. This contains announcements and instruction on a variety of topics. In addition, the IACUC Director sends out emails notifying animal users of any important or impactful information.
Do I need to scrub and wear surgical gloves if I am doing rodent surgery?
Yes. IACUC SOP 13a specifically addresses surgical procedures in rodents. Aseptic technique requires that the surgeon scrub and wear a fresh pair of sterile surgical gloves for surgery on each rodent (SOP 13a, page3).
Which forms do I use to keep surgery or procedural notes?
For surgical procedures-
- A Surgical Record Form must be used
- An Intraoperative Monitoring Form (if applicable)
- A Post-surgical Observation Form which includes pain scores must be used until the animal is at Stage 0
For procedures which result/ may result in pain or distress, or involve humane endpoints (tumor bearing, infectious disease, radiation studies, etc.)-
- An Animal Welfare Assessment Form and/or a Scoring Rubric must be used.
SOP 13 and 13a indicate which essential information must be recorded. We have a selection of form templates in our Study Management Tools section for both rodent and non-rodent users. Rodent users can also review the Record Keeping presentation. If in doubt, please call the O&O staff.
What do I do with expired drugs?
Expired controlled substances should be stored in the same place as other controlled substances until disposed of through a reverse distributor or DEA agent. Expired controlled substances must be labeled as expired and kept separate from “in date” drugs. This can be as simple as a plastic bag or a box. Contact Environmental Health and Safety for more information (Bill Crouse, 336.716.3029).
Other expired drugs should be disposed of in a timely manner by contacting EH&S
Why do I count pre-weanling rodents?
At WF, any animal that exists counts against the animal number approved in the protocol. Thus, if an animal is ordered or is born here, even if it may not survive until experimentally used (due to illness, breeding problems, or not suitable genotype/sex), or is used prior to weaning, it is counted as part of your approved animal numbers.
How do I get specialized training for specific biomethodology procedures like tail vein injections, gavage, anesthesia or intubation?
Animal Laboratory Training is required and provided through online training modules, hands-on training and periodic presentations. Specialized training can be arranged through WF Training Coordinator, Amanda Dillard (email@example.com). She can meet with researchers or arrange veterinary assistance with new techniques or refresher training.
What is the purpose of the Oversight & Outreach Program
The purpose of the Oversight & Outreach Program (O&O) is to improve the quality of the human subjects’ protection program through education, training, and post approval monitoring of research studies. This program is intended to be proactive, not punitive, and focuses on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research.
What is the relationship between the IRB and the Oversight & Outreach Program (O&O)?
The IRB and O&O are both components of the HRPP. The O&O is charged with evaluating and enhancing human research protections through education, training, and monitoring. The IRB is charged with reviewing and overseeing human research to ensure protection of research participants. The feedback received from Oversight & Outreach reviews provides a way for the IRB to improve these activities.
What activities comprise the Oversight & Outreach Program?
The Oversight & Outreach Program (O&O) is responsible for reviewing activities associated with human research protections and for providing related education and monitoring. Examples include, but are not limited to:
- Routine, random reviews
- For Cause reviews
- Investigator-initiated reviews (post approval monitoring of research studies requested by the investigator or study team)
- Conflict of interest reviews
- Pre-study site or investigator assistance
How are individuals notified when their studies are selected for routine Oversight & Outreach review?
The Principal Investigator is notified electronically via e-mail or in writing that a particular study has been selected for a review. (Note: Individuals listed as study team members in e-IRB may also be copied on the notification.) The study team and Oversight & Outreach will arrange a date/time for the review, typically within 2-4 weeks of notification.
What can an investigator or research staff member do to prepare for a routine QI review?
Organizing study related records (even without an Oversight & Outreach review) can help to track your study’s progress. Some helpful tips include:
- Conducting your own internal monitoring review and including notes to file in research records where discrepancies are found or clarification is needed.
- Performing inventories of items that require accountability (e.g., drugs, devices).
- Ensuring that documents are organized and can be made available for review.
- Using the helpful tools on the O&O website to review your files for the appropriate contents.
What is a “For Cause” review?
A “For Cause” review is an in-depth examination of a research study to determine if the safety, rights, and welfare of research subjects are being upheld according to federal regulatory, IRB, and institutional requirements. For Cause reviews are conducted in response to:
- Requests from the IRB
- Subject Complaints
- Sponsor Complaints
- Requests from institutional officials or other institutional contacts
- Requests/concerns from government agencies (e.g. FDA, NIH, OHRP, etc.)
What is a “Random” review?
A “Random” review is conducted as a normal part of the Oversight & Outreach program to ensure that the safety, rights and welfare of research subjects are properly protected and to identify any educational and/or training needs the study team might have as related to the research. This type of review includes, but is not limited to, all research records and documents, observations of processes, and interviews with research team members
How are protocols randomly selected for a review?
Protocols are randomly selected for a review by performing a query of the IRB database.
What studies can be reviewed?
Any study that has WFUHS IRB approval can be reviewed.
Do I need to be present for the entire review?
No, you do not need to be present during the entire review. The research team, however, should be readily available to answer any questions that may arise during the review.
How long will the review take?
The length of time a review takes depends on many factors such as:
- The complexity of the study
- The number of subjects enrolled
- The length of time the study has been active
- The organization of the research records and regulatory files
How many research records are reviewed?
The number of records reviewed depends on the type of review (random vs. for cause) and the number of subjects enrolled. Generally, all signed consent forms are reviewed along with a random sampling of 10% of the research records/source documents. If deficiencies are identified, then additional research records may be reviewed.
What materials should I have available for the review?
The following items should be available for review:
- The regulatory binder
- All signed consent forms
- Source documentation and research records for all enrolled subjects.
What is a regulatory binder?
A regulatory binder contains all the essential documents for the conduct of the study and demonstrates compliance with the standards of good clinical practice and all applicable regulatory requirements. All investigators are expected to maintain regulatory binders that contain all vital study documentation.
What are the most frequently identified issues found during a review?
- Utilization of an outdated informed consent
- Incomplete regulatory files
- Failure to document the consent process
- Failure of subjects to initial optional procedures on consent form
- Failure to follow protocol as written
- Consent obtained by individuals not IRB approved and/or CITI certified
- Inadequate documentation to verify study eligibility
- Site responsibility/delegation log not maintained
Who receives a copy of the Oversight & Outreach report?
A copy of the Oversight & Outreach report is shared with the Assistant Dean for Research, the IRB Director, and the IRB Executive Chair. A follow-up letter is sent to the principal investigator and study coordinator outlining all findings as well as any corrective actions required by the study team. The investigator should provide a written response to the follow-up letter within 30 days documenting the corrective actions taken and study revisions made in order to eliminate future recurrences of the problem.
In cases where major deficiencies are identified, a meeting with the Principal Investigator, study coordinator, IRB Director, IRB Executive Chair, and Oversight & Outreach may be scheduled to clarify discrepancies/deficiencies and to develop a corrective action plan to prevent further recurrences.