Watch the Webinar On-Demand

About the Webinar

One of the questions the IRB receives most frequently is “does this require review?”

In this webinar we’ll talk about changes in research in all their various forms (protocol amendments, administrative letters, notes to file), safety reports, study committee reports, recruitment plans and unanticipated problems. We’ll discuss the history that has created confusion for sites, sponsors, and even IRBs, the problems of over-reporting, and how to assess whether an event meets the guidelines for being promptly reportable to the IRB.

Meet the Speakers

Photo of Dawn Flitcraft

Dawn Flitcraft (Moderator)

President, WCG IRB

Photo of Dave Borasky

David A. Borasky, MPH, CIP

Vice President, Compliance, WCG IRB

Questions and Answers from the Audience

Q: Flitcraft: In terms of reporting a change in research to the IRB, who typically takes the lead, the sponsor or the site?

A: Borasky: Usually in multi-site studies, sites really shouldn’t be instigating changes without working with the sponsor first. From the IRB’s perspective, if a site reaches out to us and says they’re going to implement this change and it’s a sponsored study, the first thing we’re going to ask is, “Did the sponsor sign off on this? Do you have documentation that the sponsor said you can go ahead and submit it?” However, if we’re talking about a change in research, we’re usually looking at them in multi-site studies as, “Isn’t this going to apply to all the sites?” And in that case, it’s more centralized to come through the sponsor or CRO. Again, the site can initiate the CIR submission, but we’re going to ask whether the sponsor signed off on it.

Q: Flitcraft: If a sponsor or a site moves forward with a change due to safety concerns, how soon should they get this information reported to the IRB?

A: Borasky: Fortunately, I don’t think it happens that often. But when it does, we expect reasonable timeliness, and we want to know about it even if there’s not a formal amendment ready yet. As the IRB, we need to know: is this something that affects everybody in the study or everybody in a certain arm? And if either is the case, what’s going to be done to manage that, whether it’s simply informing them or bringing them back in for additional visits. Our advice to clients is to implement that change, and in real time you should be reaching out to the IRB and presenting them with whatever the site received or whatever the sponsor created to tell sites about that change. For example, a Dear Investigator Letter (DIL), is a great way to manage communication. We receive these often and they articulate the point, “Remember to do this, or not do that, or start doing this.” Often, it is something that needs to be dealt with quickly. And that’s why a DIL has been issued. We want those to come to the IRB and we’ll figure out downstream what needs to happen with consent forms or protocol amendments. So, again, report these instances as soon as possible to the IRB.

Q: Flitcraft: What’s the IRB’s stance on general correspondence from a sponsor to their study participants, like a birthday card or just keeping in touch? Is that required to be reviewed by an IRB?

A: Borasky: We get a lot of questions about those types of communications, or “informal reach outs”, as I would call them. And at WCG IRB we do review and approve a lot of those communications because they’re subject facing. In fact, we expect to see, review, and approve them. That said, this is an unregulated area. There’s nothing in the regulations that talks about birthday cards. And you might say, “Why in the world is the IRB looking at that?”. And part of it is the concern that the IRB wouldn’t want to find out down the road that there were these things going out that overstated the benefits or the value of the research or emphasizing things that the IRB felt should not be emphasized. So yes, we want to see those and look at those types of communications.

Q: Flitcraft: Let’s talk about unplanned deviations and CIRs. If a patient misses their study visit by two days due to a holiday, does that require follow up to the IRB?

A: Borasky: An example like that does not require a notification to the IRB. We’ve had people report deviations, like blood drawn 15 minutes out of window or an hour out of window. There are very few studies where that level of detail impacts subject safety at the macro level. On the other hand, we’ve also received reports – and this is a real example – where the site reached out and said, “We’re reporting that 10 people missed their follow-up visit because our clinic was understaffed. We didn’t open that day.” And that’s a bigger compliance issue that the IRB is likely to be more concerned about. Why aren’t you able to keep your clinic open? What is going on at the site that might impact collection of important safety data or labs?