People want to be asked to share their genetic data

Researchers at the Group Health Research Institute and the University of Washington (UW) has published their study in which they discovered that peopled want to be informed and asked for their consent to share their coded, de-identified genetic information in a federal database.  This study, published in the September 2010 Journal of Empirical Research on Human Research Ethics (JERHRE), involved research participants who were enrolled in the longitudinal “Adult Changes in Thought” (ACT) study. When asked as to whether their genetic and medical record information could be shared in the database, 86 percent said “yes.”  Also, of the 365 ACT study participants who had agreed to let their genetic information be shared, 90 percent of participants said they thought it was important to have been asked for this consent – what researchers call “re-consent.”

Since 2008, the National Institutes of Health (NIH) has encouraged many studies to submit genetic information to the federal database of Genotypes and Phenotypes (dbGaP). The reason for this request is that genomic research on large numbers of people can yield insights that aren’t possible with smaller numbers.  For new studies that will enroll participants, informed consent for such data sharing in a national registry can be asked prospectively.  However,  for ongoing studies or completed studies in which biological samples or medical data had been collected previously for other purposes, the issue is whether retrospective or re-consent from the research participants is ethically necessary if the original informed consent did not address the issue of data sharing in a federal registry.

According to the federal regulations governing human research,  key issues for Institutional Review Boards (IRBs) that review such research to consider regarding a requirement for re-consent  is the risk level associating with such data sharing (i.e., risks due to a breach in the confidentiality of the data) and the practicableness of approaching research participants for their re-consent, which often be time consuming and expensive.   If the risks are minimal and re-consent is impracticable, then one can argue that the public good of data sharing in a federal repository outweighs the rights of individual participants to choose whether to participate.  IRBs will differ in their determinations based on their assessment of whether the data sharing represents minimal risk and the impracticableness of obtaining re-consent.  It is interesting to note that in the study published in the JERHRE journal, the participants in the  ACT study were receiving biennial examinations and hence, one could argue that it was not impracticable for the investigators to seek their re-consent.  However, for studies that had previously collected tissue samples and have been closed for years, one could argue that re-contact of the research participants would not be practicable.  Despite such uncertainty in the determining levels of risk and practicableness, one thing is certain, IRBs and investigators need to be mindful of recent high-profile legal cases that have highlighted the issue of consent and trust in research.  These include the Havasupai tribe vs. Arizona State University in which there were group harms; the Parents vs. the Texas health department, in which newborn blood samples were collected and stored without parental consent; and the the story of Henrietta Lacks (The Immortal Life of Henrietta Lacks), in which the highly profitable HeLa cell line was established without the consent of Ms. Lacks.




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