By Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB
If one quote sums up the usefulness of PRIM&R’s annual Advancing Ethical Research (AER) Conference, I think it’s one I heard over the lunch table: “This is why you come to PRIM&R: to hear what’s coming up for the next year.”
And I know I already used that line, in my last Blog Squad post from the 2014 AER Conference, but it came back to me again this week. Not even two months have passed since the AER Conference, and the observation is already proving true. Just this month I have reflected on insights from the conference that illuminated events around us. Here are two articles, from both our specific realm of ethics and research and the general news services, which brought to mind some of PRIM&R’s most memorable sessions.
23andMe marketing its trove of genetic data: Since 2006, 23andMe has been offering genetic analysis and reports to customers for $99 each. Slate’s Future Tense blog recently discussed another aspect of 23andMe’s business: aggregating, anonymizing, and selling the genetic information it has collected. The blog immediately recalled for me highlights from PRIM&R’s pre-conference program, Contemporary Issues in Biobanking: Governance, Consent, and Practical Approaches to Current Challenges. At that pre-conference we heard firsthand about the ethical and research challenges that result when setting up biobanks.
The Future Tense blog indicated that 23andMe has no “institutional review mechanisms”, but a quick read of 23andMe’s consent and privacy documents suggests they do have some research participant protections in place. By my reading, the closest these documents come to addressing the sale of aggregated data to others was a rather anodyne: “We may share anonymized and aggregate information with third parties.” As we heard from numerous speakers at PRIM&R, assurances that any genetic data can remain anonymous seem increasingly suspect. And AER14’s closing presentation, Living Room Conversation: An Update on the Henrietta Lacks Case put human faces on the prospect of supposedly private health information becoming public. I was surprised at how many of the conference’s topics came to mind while reading just that one news story.
FDA Guidance on mobile health devices: In mid-January the FDA issued two guidance documents on wearable health devices. The initial articles and comments about the proposed regulations also brought to mind a number of PRIM&R sessions. Anyone who heard John Wilbanks’ keynote address, Informed Consent in the Mobile Era, came away with a better appreciation of the evolution of monitoring devices, as well as the issues facing researchers and regulators. These guidance documents aim to define what devices remain outside of the FDA’s regulatory purview, an important step toward framing a future where these monitoring devices will play an ever greater role. Mr. Wilbanks’ (and others’) observations provided perspective I would not have had otherwise.
2015 is only a month old, but already I have been struck by how many PRIM&R sessions resonate in current news stories. So to my lunch companion’s assertion that we come to the AER Conference to hear what’s “coming up for the next year,” I would add that we come not only to hear what’s on the horizon, but also to learn what questions to ask ourselves and others about these new development and how they fit within our ethics framework. I’m sure both aspects will continue in the months to come.
If you are interested in viewing the Henrietta Lacks Living Room Conversation session or John Wilbanks’ keynote address, you can do so via the conference proceedings. To access the conference proceedings, you will need the conference access key. If you attended the conference, this access key was emailed to you and was also on the back of your conference name badge. If you are unable to locate it, please call the PRIM&R office at 617.423.4112, ext. 0. If you did not attend the conference, please download the proceedings order form to purchase access.