by Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB
PRIM&R is pleased to share a post from Jim Gearhart, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening December 4-7 in Baltimore, MD.
My experience at the 2014 AER Conference began with an exceptional pre-conference program titled Contemporary Issues in Biobanking: Governance, Consent, and Practical Approaches to Current Challenges. The space allotted for this blog post doesn’t allow me to do justice to the speakers, the topic, or the discussions, but I’ll do my best to share the highlights and spirit of this session. Over lunch, one attendee said, “This is about the best I’ve been to—and I’ve been to a lot of these.”
While this wasn’t the first time that PRIM&R held a pre-conference program on collecting, processing, storing, and sharing biological specimens from study participants, its popularity surpassed all expectations. The room was packed to capacity with attendees who stayed until the very last minute of the session.
The full-day workshop featured a lineup of speakers who have extensive and varied experience with the myriad challenges associated with biorepositories, including:
- Mark Barnes, JD, LLM, Partner, Ropes & Gray, LLP
- Marianna Bledsoe, MA, Adjunct Assistant Professor, George Washington University School of Medicine and Health Sciences
- Lynn Dressler, DrPH, Director of Personalized Medicine, Fullerton Genetics Center at Mission Health
- William (Bill) Grizzle, MD, PhD, Professor of Pathology, University of Alabama at Birmingham (“Father of Biobanking” since 1981)
- Michele Russell-Einhorn, JD, Senior Director, Office for Human Research Studies, Dana-Farber Cancer Institute
The morning sessions provided background on the concerns around biorepositories: what they are, what consenting issues they present, and what administrators, researchers, and representatives of research participants need to know. In the afternoon the speakers drilled down into the practicalities of running a biorepository: rules of access, strategic priorities, and measurements of success. The audience remained engaged and asked questions that prompted lively discussions among the panelists. One of the panelists remarked, “As you can see, most of the people on this panel have known each other for a while.”
Dr. Dressler presented a real-life example of dealing with these issues. For example, she was involved in a request to provide biological sessions to a new government database, one that had not existed when the specimens were collected. The researchers and the IRB grappled with the question of what was ethical in light of what participants had consented to, and what was best for science. That decision process was detailed in a published article titled “Ethical Aspects of Participation in the Database of Genotypes and Phenotypes of the National Center for Biotechnology Information: The Cancer and Leukemia Group B Experience,” by Jeffrey Peppercorn MD, MPH, et al. For anyone interested in biorepositories, this article is a great resource on the complicated issues faced in biobanking.
There will be several additional sessions about biobanking at the 2014 AER Conference, and if the caliber and quality of this pre-conference program is any indication, I fully expect that the other sessions will prove enlightening and thought-provoking.