14
Jul2016

On May 24, PRIM&R hosted a webinar titled Making Good Meetings Happen for IACUCs and IRBs, presented by Melissa Frumin, MD, MS, and Rachel Murray, MS, CPIA, RLATG. This webinar was complimentary for PRIM&R members as part of Member Appreciation Month and is now available for members to watch at no cost in the Knowledge Center.

For those involved with the ethical oversight of research involving animals or human subjects, committee meetings are a regular part of the job. IACUC and IRB staff and chairs are tasked with ensuring that those meetings run smoothly and are conducted in accordance with federal regulations. During this webinar, presenters shared recommendations and best practices for preparing for, conducting, and following up on committee meetings from the perspectives of a chair and coordinator. Consideration was also given to procedural and interpersonal aspects of IACUC and IRB meetings.

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 readers of Ampersand:

What do you do about an IRB member who gets lost in the weeds at the meeting?
Melissa Frumin, IRB Chair (MF): I have tried various strategies, with varying degrees of success! If they are new to the panel, I try to give them gentle feedback after their first few reviews, in private. If they are old-timers, like me, and have a sense of humor, I remind them that the attention span of young people is much shorter than us old-timers. If a member is going on way too long, I will ask them to turn in their comments and just focus on what other committee members need to know to be able to vote intelligently on the protocol.

We have a Principal Investigator (PI) who continues to send in sloppily-prepared protocols, bogging down discussion, despite being told of the problem. What do you suggest?
Rachel Murray, IACUC Coordinator (RM): If I continuously came across a PI who was sending in sloppily-prepared protocols, my first course of action would be to contact the PI the next time a protocol was submitted and to actually meet with that individual one-on-one and do a complete pre-review of the protocol. You do not need to be an expert in the science to be able to assist with formatting and input of information. As a coordinator, I have become very familiar with what our IACUC expects in regards to how a protocol should be written. I can easily meet with a person by myself and go over their protocol and give them suggestions for how to improve it. These are things such as making sure all the information is in the correct place, that there is the right amount of detail in each protocol, and even ensuring that the formatting is correct. If you have a veterinarian (or doctor) who could go with you to these meetings and discuss the protocol from a medical/veterinary perspective, that is even better. If, despite your attempts at a pre-review, the PI continues to miss the mark and submit poorly prepared protocols, this may be an opportunity for your chair to step in and talk with the PI as well.

What do you do when you cannot get the expertise you need to review a protocol?
MF: I will contact a committee member who is not attending, and ask them to review, in absentia.  If that does not work, I will ask a chair from a different panel who does have expertise to give me their thinking. Very rarely, I will pull the protocol off the agenda.

What do you do if you have one committee member who consistently disagrees and seems to argue just for the sake of arguing?
RM: As a coordinator it is important to remember that it is ultimately the responsibility of the chair to guide discussion and disagreements at meetings. If you are able to provide educational material (references to regulations, guidelines, interpretations of regulations, etc.) to the committee prior to discussion it may help alleviate some of the disagreements, particularly if it is a black-and-white issue according to the regulations. Otherwise, let your chair handle the member.

How common is it to have PIs attend meetings to provide summary? This is the practice at an institution I just joined.
RM: At my institution we rarely have PIs attend meetings. It is not common practice to have them provide a summary of their research for any committee (IACUC, IRB, or IBC). If there are questions, our reviewers reach out to them ahead of time, and if there were significant concerns our chair would make the decision as to whether or not that person should be invited to the meeting. If the PI is only presenting a summary of their research and then promptly leaving the meeting it may not be an issue. However, if they are sticking around for the discussion or the vote you may want to have your institution look at this process (and remember, they cannot be present for the vote). Also, it is important to remember that you have scientists, doctors, nurses, etc. on your committee for a reason: they are intelligent people who have knowledge and expertise in a wide variety of areas and are capable of understanding the protocol and completing reviews without the PI present.

How would you handle a PI who is angry with the decision of the committee?
RMI feel that often coordinators take the brunt of researcher frustration as we are often the ones communicating between our committee and the research community, and more often than not, that frustration is misplaced. The phrase, “don’t shoot the messenger,” is applicable in most of these cases; however, it is important to remember that these responses are commonly knee-jerk reactions and the PI does know that it's not you making the decisions. However, if the PI comes to you upset about a decision, make sure that you explain to him/her that you are not the one making the decision and that this is what the committee decided. Try to explain the decision further or differently than originally presented. If he or she is still unhappy, inform your chair and have the chair reach out to that PI for a discussion. This often goes much further than back-and-forth emails, which can increase frustration.

Procedurally, what is your recommended process for running the meeting? Do you use Robert’s Rules of Order? Our biggest problem with Robert’s Rules is when additional contingencies are identified for an existing motion to “approve with contingencies”.
MF: We don’t use Roberts Rules of Order. If another issue comes up after we have already voted, and it is an important issue to discuss (not just pointing out a funny typo!), I open up the discussion again and we decide whether it changes our original vote. I care that we give the best thinking to our work.

As a coordinator, I'm hesitant to have committee members directly contact PIs with questions/comments. I'm worried that we won't be able to keep track of changes that occur to the protocols, or whether the committee member's comments were fully addressed. Do you have any suggestions? Should I just let the changes happen, or have everything funnel through me?
RM: I have all formal communications filter through me as the coordinator. Any questions or comments that need to be addressed by the PI are put into our electronic protocol system and documented. However, our IACUC members will contact the PI directly, often via email, and offer to meet with the PI and/or lab manager and go over the questions or comments they submitted and assist the PI with how to answer appropriately. The committee members explain to them exactly the response they are looking for and the amount of detail they want to see. This typically occurs via phone conversations or in-person meetings. Our IACUC members are very willing to meet with PIs, but all revisions are tracked electronically. We have found this to be a very positive experience for committee members as well as for researchers. It increases trust, transparency, communication, and has even resulted in a few collaborations between our committee members and our researchers.

If there are revisions requested to a protocol at the meeting, do you extend a deadline to the investigator for when the revisions need to be made?
RM: If revisions are requested at the meeting (which happens at every single one of our IACUC meetings) the PI receives the requested revisions within 24 hours of the meeting. While there is no “formal” deadline to submit a response, often the PIs are working up against a looming expiration date, so their deadline has been determined for them. Typically, if I do not hear back from them within about 10 business days I send them an email and remind them they have outstanding questions or comments that need to be addressed. I remind them of their upcoming expiration date and the importance of submitting their revisions in a timely manner to ensure approval prior to expiration. Our researchers are generally good about responding quickly, as they are often as eager as we are to get their renewal approved (or new work started) and to avoid the stress of potentially halting their research due to a lapse in protocol approval.

How do chairs control discussion by reviewers that seem to focus on their opinions of the investigator rather than the protocol itself (i.e., personal attacks)?
MF: I am very direct and talk about not punishing difficult investigators by holding them to a higher standard. There are so many important issues to discuss in a protocol, so it is not too difficult to redirect the discussion back to the research study.

Would your recommendations differ for investigator-initiated trials as compared to industry-sponsored/cooperative group trials where there is often resistance to recommended changes?
MF: Yes, we are aware that for industry–sponsored protocols, it is not easy to ask for substantive changes. We will ask for site-specific changes, such as tightening exclusion criteria. It is rare, but it has happened that we have required modifications that are too strict, and our site cannot participate. However, that is unusual.

PRIM&R would like to thank our presenters for sharing their experience and expertise!

If you’re interested in viewing the entire webinar, it is now available for PRIM&R members to watch by logging into the Knowledge Center. Not a PRIM&R member? Individuals can purchase this webinar in our online store. To purchase a recording at the group rate, please download the order form and email it to webinars@primr.org.

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