by Sylvia Baedorf Kassis, MPH
Happy New Year! Although one of the characteristics of the Year of the Rabbit, according to the Chinese Zodiac, is supposedly a decrease in rules and regulations, I don’t see any shortage of discussion of research ethics and regulations in my future.
In fact, since my return from the 2010 Advancing Ethical Research Conference, it was not long before I put my conference experience, especially what I learned about biobanks, to good use. Four investigators have already contacted me for guidance on how to proceed with their research projects that include the use of previously stored samples or the prospective storing of samples for future research.
Repositories also seem to be on the minds of regulatory and ethical professionals at academic institutions funded by the NIH’s Clinical and Translational Science Awards (CTSA). I just participated in a national teleconference where more discussions about biobanks took place; repositories seem to be a hot topic—both at my institution, and beyond.
Post-AER, I have become particularly concerned by the banks that house "discarded" clinical samples without any kinds of approvals for research use in place. We are hearing more and more about physicians storing biospecimens collected for clinical purposes during routine care (without necessarily having any research intent) rather than discarding them when clinical testing is finished. It is hard enough to create guidances and policies for the repositories we know about; how can we even begin to uncover all the informal, unregulated 'banks' in hospital freezers around the country?
Over the past year and half, two cases related to the storing of biospecimens for research purposes have had very different outcomes. At the end of 2009, the Texas Department of State Health Services (DSHS) settled a lawsuit by agreeing to destroy more than five million stored newborn blood spots because parents did not give consent to do so. Consider, however, that similar litigation took place in Minnesota and that case was dismissed by the court in 2010. If it hasn’t already, it won’t be long before this issue of researchers wanting to access stored samples hits an IRB near you.
There are many factors that your institution will have to consider when deciding whether to approve tissue banking-related research. I simply want to leave you with the reminder that repositories are made up of samples and data collected from people who may or may not have been informed that their samples were going to be used in future research.
The aforementioned cases, as well as the story of Henrietta Lacks' family and the Havasupai tribe, prove that people have very strong feelings about the storage of their samples. As noted by PRIM&R's education director Elisa Hurley, in our efforts to advance ethical research, it is essential that we listen to the voices of research participants. Only then can research guidances, policies, and regulations be meaningful, relevant, and protective of the research participants who enable the promise of scientific progress to become a reality.
by Sylvia Baedorf Kassis, MPH