“The irony is, if you had asked me, I probably would have consented.”(1) So said Andrea Beleno, a plaintiff suing the Texas Department of State Health Services over its use of newborn screening blood samples in research. Carletta Tilousi, a plaintiff in the Havasupai tribe’s lawsuit against the Arizona Board of Regents, expressed similar sentiments: “I’m not against scientific research. I just want it to be done right. They used our blood for all these studies, people got degrees and grants, and they never asked our permission.”(2)

Many potential harms that might arise from participation in genomic research, and how likely they are to occur, are not well known. This should not imply, however, that harms to dignity have not occurred. Claims of harm include breaches of autonomy and privacy, stigmatization or other negative social consequences, and uninvited challenges against deeply held beliefs. Financial settlements, restrictions on research, and the destruction of samples have been used to make amends, but they cannot undo the injury to individuals and their communities. Such “solutions” may bring their own negative consequences if they delay scientific advances that could improve human health.

Recent studies at Group Health, a non-profit health care system based in Seattle, provide new data about participant views. As one of five sites participating in the electronic MEdical Records and GEnomics (eMERGE) Network, Group Health planned to use data from an existing cohort, the Adult Changes in Thought (ACT) Study,(22) to investigate the accuracy of phenotypes derived from electronic medical records. ACT participants – unlike those enrolled in general-purpose biobanks established at other eMERGE sites – had volunteered for a particular study. Although the original ACT consent covered data sharing among colleagues of the study investigators, it did not address wider sharing. For this reason, and because dbGaP was new and its possible risks largely undefined, the institutional review board (IRB) determined that re-consent was needed for Group Health to use ACT data for the eMERGE project.

For ACT participants, the re-consent process documented researchers’ respect. Being given a choice about uses of their data that were not contemplated at the time of original consent was important not because they found particular kinds of studies objectionable, but because the request represented a tangible demonstration of the researchers’ trustworthiness and regard. It should be noted that, demographically, the ACT participants represent the type of people most willing to take part in research: they are older, mostly white, and relatively well educated. If the majority of this population favors re-consent for wide data sharing, others may be more likely to want an opportunity to weigh in.

Insights from Group Health/ACT point toward the need for re-consent when researchers wish to move existing data into a general-use repository. They also suggest the need to reassess how biobanks relate to volunteers who have donated samples. Current practices presumingthat study participants do not wish to hear from researchers, or that participants find general, one-time consent acceptable, may be contrary to participant preferences. Establishment of repositories using de-identified, clinically collected samples – often authorized through a generic statement in the consent to treat form – may threaten trust in the research enterprise, potentially derailing research efforts if they receive public attention. As one commentator recently wrote, “[w]e are only one scandal away from legislation that will regulate or even prohibit the use of de-identified data for research purposes.”(25)The positive message is that many participants view themselves as having an ongoing stake in research to which they have donated samples and data. They want to be asked (or at least kept informed) about changes in that research. Reframing research practice to align with this interest is an important step toward ensuring long-term success of genomic investigation.