Biobanking, part 3: returning research results to participants
Posted Aug 25 2008 3:17pm
So: you've agreed to participate in a genetic study for health purposes, and (with or without your consent--see post #2 on biobanking) the data you've provided has been made available to the broader research community. A sample of your DNA is stored in a biobank, and researchers who have been vetted by the biobank owners are allowed to use that DNA in future studies.
The consent form you were required to sign at the time you agreed to participate in the original study stated that you would not be contacted by the research team with information about the results of the research, or of any testing or other processes they might perform as part of their study. "Ok," you thought--having been informed that most genetic research being done today isn't informative at an individual level and wouldn't be clinically useful anyway--"fair enough. I don't need the researchers to contact me with information I can't act on anyway."
Fast forward 20 years. The promise of genetic research is beginning to deliver. As research uncovers more information about how genetics interacts with environment and behavior, the DNA sitting in biobanks around the world is telling more tales than it used to. The DNA that was formerly mere data is increasingly yielding meaningful information about the health risks of individuals. So, in our imaginary scenario, let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X.
Here are some of the questions this (not terribly far-fetched) scenario brings up for me. Do the researchers have a professional and/or moral obligation to share this information with you? Does it matter that the original consent form, which was written for a single study that the researchers truly didn't expect to provide individually meaningful information, said they would not contact you? What if the researcher contacts you with information that you didn't want? Might the researchers' obligation to re-contact participants depend on whether or not there are good risk-reduction or treatment options for Serious Medical Problem X?
Here's some additional reading for those who want to read more on return of results from genetic studies: here's a paper from the Social Science Research Network; recommendations of a working group at the National Heart, Lung, and Blood Institute; a nice list of refs from Stanford's Center for Clinical Bioethics; and the issue of the American Journal of Bioethics that features a target article and open peer commentaries on this topic.
Wanna read the first 2 posts on this topic? Here they are: 12