In January 2017, PRIM&R hosted a webinar titled Reducing Noncompliance While Facilitating Research: Strategies for IACUCs, presented by Barbara Garibaldi, DVM, DACLAM, and Emily Hearne, MS. The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (pdf) and send it to firstname.lastname@example.org.
Through interactive scenarios, this webinar presented strategies for encouraging a culture of compliance and aimed to help attendees understand potential complexities related to noncompliance. It also offered strategies for fostering a culture of compliance without impeding research such as improved communication and training with investigators and animal care staff, interdepartmental partnership, and post-approval monitoring.
After the webinar, speakers answered some of the questions from webinar attendees that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand.
During a recent grant vs. protocol congruency review, we found that a USDA Pain Category E study was not included in the approved protocol. Is this considered noncompliance? If so, is it reportable?
Barbara Garibaldi (BG): If the animal work was conducted, then this is reportable because the IACUC did not review and approve it. If the work has not occurred, then it is not reportable, but it should be submitted as an amendment to the IACUC for review and approval.
You provided some great tips for engaging with your institutional official. My IACUC and my IO sometimes disagree about reporting a noncompliance [incident]. What are some ways to handle this situation?
Emily Hearne (EH): In many cases, it becomes the responsibility of the IACUC and its staff (if applicable) to ‘train’ the IO to recognize incidents that require reporting. If the IACUC is certain that the noncompliance is reportable, then it should use the applicable guidance standard, federal regulation, etc. at hand to ‘prove’ that the issue should be reported. Our IACUC noncompliance reporting form includes a specific section where we include the applicable regulation that applies to the incident.
Also, you could encourage the IO to contact the regulatory body themselves to ask a hypothetical question of the OLAW Compliance Office or your USDA VMO for clarification. If it gets to the point where the IACUC determines that not reporting the incident puts the institution at risk for citation, funding suspension, or is a continuing animal welfare issue, you should involve the institution’s legal counsel.
How can my institution foster more positive relationships with research and husbandry staff to better facilitate communication and understanding?
BG: I have a few suggestions: ask researchers to present a brief overview of their animal research at a convened IACUC meeting and to the husbandry staff during their lunch (and provide food to encourage attendance); have the IACUC chair, IACUC administrator, or the attending veterinarian attend research lab meetings to disseminate new information on new policies, or to provide training; have the animal facility manager or supervisor sit on the IACUC so they represent the husbandry staff and bring back useful information to their group.
An investigator has an approved protocol where the responsibility for monitoring is assigned to the investigative staff as twice per day for the expected clinical signs, but the animal died after their second check. Death as an endpoint is not approved; however, morbidity was expected. Is this reportable?
EH: Not in my opinion, but ask OLAW! If the researcher documented all required monitoring, and the animal died as a result of experimental conditions approved in the protocol, OLAW would likely not require a report. The IACUC should consider increasing the monitoring frequency for this model to decrease the chances of this happening in the future. This is more of an adverse event than noncompliance.
How often does OLAW conduct investigations after a report is made?
EH: This should be answered by an OLAW representative. However, it is not routine practice for OLAW to investigate if the reports they receive illustrate complete investigations conducted by the institution and show adequate measures being taken to prevent future occurrences.
Are there resources for SOP development of institutional policies available that you would recommend?
EH: Start with benchmarking other institutions. Depending on funding source and species, we are all basically governed by the same principles, guidelines, and regulations, so when looking to draft your own policy on a topic, see how others have addressed that same topic. Obviously, there is no one-size-fits all solution, but I always start by looking or asking for examples from others.
[Editor’s note: PRIM&R members have access to PRIM&R’s online Knowledge Center, which provides hundreds of workplace tools that can be used as starting points.]
Also, take advantage of your institution’s policy writing groups, if applicable. Is there a university policy or a company QA group you could work with to develop SOPs that closely mimics your institution’s current guidance documents/SOPs? Find out who writes the other SOPs you are required to follow in your job.
PRIM&R would like to thank our speakers for sharing their expertise!
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (pdf) and send it to email@example.com.