A Researcher Perspective on Working with the Institutional Review Board (IRB)
Some human subject research protocols achieve timely IRB approval while other, similar protocols face setbacks and delays. To discover potential reasons for the two outcomes, we spoke with several people who are experienced in IRB submissions.
Linda Tickle-Degnen, PhD, is professor and chair of the Department of Occupational Therapy and director of the Health Quality of Life Lab. She has been the principal investigator or co-investigator of eight human subject studies over a period of four years. She says the major thing she and her research group do is to check with Yvonne Wakeford (SBER IRB Administrator) via email if they have special concerns or questions about an application, or whether or not an application is warranted for some types of projects. “Our motto is: ‘If in doubt—ask,’” says Tickle-Degnen. “We email her our specific questions and she is great at responding to us quickly. We find her and the IRB to have very reasonable responses to our applications and we revise quickly according to their feedback, if needed. We very much take the approach of this being a collaborative research process and treat the IRB proposal stage accordingly. All of our RA’s [research assistants] of course go through the CITI [Collaborative Institutional Training Initiative] course. We also make sure to carefully follow IRB templates on the website. I have found the website to be very helpful.”
Kathleen Bogart, MA, is a member of Tickle-Degnen’s research group. She says she has found it helpful just to make a quick phone call to the IRB office if in doubt. “I can make a call and ask a complicated question about an application, have someone carefully consider my problem and explain my options—all in about five minutes,” says Bogart. “I have been very pleased with the fast response of the IRB when making determinations.”
Julia Bloom, MPH, is a project manager for Christina Economos, PhD, an associate professor at the Friedman School and the School of Medicine, the New Balance Chair in Childhood Nutrition, and the associate director of the John Hancock Research Center on Physical Activity, Nutrition, and Obesity Prevention. Economos has been the principal investigator or co-investigator of 48 human subject studies over a period of seven years. Bloom has been assisting Economos with protocols for more than three years. She has managed two human subject projects that required multiple IRB protocol submissions. “As a project manager, I have the role of finding out what the principal investigator wants,” says Bloom. “But before we start to write out an IRB submission, to write out a research protocol, I talk with Yvonne [Wakeford], the IRB administrator, and that may shift the way we decide to do something. The conversation is about meeting the needs of the study in a way that protects human subjects, so it’s a problem-solving conversation.”
Bloom says that Wakeford helps her fine tune the research protocol, and saves them time by advising where they need to provide more detail, and where less detail is warranted. “For example, when you’re designing a consent form, don’t be overly complicated; be straightforward. If there’s too much information, the major points could get hidden in there,” says Bloom. To keep up to date on changes to regulations and forms, Bloom pays attention to the emails sent out by the IRB office. And because of possible changes to forms, whenever she needs one she always returns to the IRB website to download the current form.