24
Feb2020

Just by reading this title you probably have guessed that I am a big Star Wars Fan. We are a special breed, one that grew up with the movies and who like to complain about changes to the original saga. I will save you from my opinion on whether Han truly shot first or not, but as the last movie of the Star Wars franchise was released, I cannot help but notice some parallels between the journey of a Jedi and the work of an IRB professional working with single IRB studies.

A Jedi in these movies is a reluctant student, one forced to learn the ways of the Force due to the circumstances, but who appreciates the need and enjoys the hard work. Similar to a Jedi, a lot of single IRB professionals are placed on their roles to fill a void and have to gain a high level of expertise really fast! The movies show that one of the main issues of a Jedi during training is lack of clear information, in their case because their mentor gets killed in the first of three movies. Hopefully, this is not a parallel we share in common with the Jedi, but an sIRB professional may feel as though "their mentor has died" if they do not have a lot of experts around to rely on; as the field is relatively new, they may even find they are, effectively, the "expert" at their institutions. Communication is important in general, but it is crucial for single IRB professionals, who have to navigate different laws from (sometimes) several states and consider different ways to review the same study, as it varies per institution polices and procedures.

As in the case of a Jedi, sometimes there are other impediments for effective communication. For example, a Jedi may encounter a faulty robot or a broken communication device. The single IRB professional may get their information through a research coordinator who, despite not being new to research, is new to the sIRB arena. As explained by John Heldens and Carissa Minder during their presentation at the 2019 Advancing Ethical Research Conference (AER19) ("The Etiquette and Necessity of Communication in the Single IRB World"), sometimes it is important to just take control and contact the other IRB directly to avoid additional confusion with the process. You could easily be involved in a Catch-22 scenario when (as was the example in this presentation) a relying IRB will not provide local context information until the reviewing IRB issues a site approval memo, but the reviewing IRB cannot provide the memo without local context information from the relying IRB. This is so easily resolved with clear communication!

A Jedi is always encountering challenges along the way. I think we can all agree that this is the experience for single IRB professionals. This started early with the release and application of the single IRB mandate at each institution. The regulation and the transition provision caused some concerns, especially for studies that have been ongoing for some years. Thankfully, OHRP released an exception document, to our  great relief as alleviates administrative burden. Other challenges involve the study team themselves; some study teams and principal investigators may not want to “delay the process”, as they see it, by having IRBs communicate with each other. They may not understand why the IRB is asking a lot of questions or asking them to fill out form after form. A Jedi is resourceful, finding ways to improve their environment and ensuring that they are following the right path. As we are all still learning these new ways of the single IRB process, IRB professionals have found better ways to get the information they need to create their approval memos—by creating databases to ensure they save the information in a more effective way, among other initiatives.

I, for one, am a fan of the single IRB professionals who are helping all of us being complaint with changing regulations, and who are brave in taking on these tasks with what I can only describe as a Jedi’s determination! It was great to meet so many other professionals at AER19 and to learn from them, with the goal of all of us being successful in facilitating human subjects research.

Are you also a Star Wars fan? Did you enjoy exploring human subjects protections challenges through the lens of pop culture? Check out the SBER19 session that covered a similar topic, A08 - May the Revised Common Rule Force Be With You: How to Become a Review Jedi.

Maria G. Davila MD, CCRC, MA (Bioethics), is the Associate Director for Emory University IRB. She joined the IRB in August 2010. Maria is the team leader of the QA and Education team, which is in charge of auditing Emory IRB approve research studies and reviewing reportable events applications. Her team is responsible for providing federal regulations and P&P education to the Emory research community, IRB Staff, and IRB members. Under Maria's leadership, the IRB Education and QA team have developed several guidance documents and worksheets and started educational, monthly webinars to provide up-to-date information to the Emory research community.

Before joining the IRB, she worked as a research associate for the Department of Orthopaedics for six years. During this time, Maria worked in a diverse range of studies, going from minimal risk studies up to Phase I research trials; helped with the development of quality assurance procedures for their research projects; and was the microsurgery instructor for residents and fellows. Maria has a foreign medical degree from Ecuador and a Master’s in Bioethics at Emory University.

 

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