SEATTLE – People want to be informed and asked for consent before deciding whether to share their genetic information in a federal database, according to a Group Health study that bills itself as the first to ask patients about sharing their data.

The study "Glad You Asked," conducted by researchers at Group Health Research Institute and the University of Washington (UW), is published in the September 2010 Journal of Empirical Research on Human Research Ethics.

The team explored participants' preferences while collaborating on the Electronic Medical Records and Genomics (eMERGE) Network. The network is made up of volunteers enrolled in the joint Group Health-UW "Adult Changes in Thought" (ACT) study. ACT tracks aging-related changes in thousands of older Group Health patients over time.
 
When the team asked Group Health patients who participate in ACT whether their "de-identified" (anonymous) genetic and medical record information could be shared in the database, 86 percent said "yes." Then the team surveyed 365 ACT study participants who had agreed to let their genetic information be shared, mostly because of a "desire to help others." In the survey, 90 percent of participants said they thought it was important to have been asked again for this consent - what researchers call "reconsent."

Reconsent means getting additional informed consent from research participants before using their information for a purpose beyond what they agreed to originally. Alternatives to reconsent – including opting out, being notified, or neither individual permission nor notification – were unacceptable to 40 percent, 67 percent, and 70 percent of the surveyed participants, respectively.

"We were surprised that so many people felt it was important for us to ask them, even though they decided to give their consent," said lead author Evette Ludman, a senior research associate at Group Health Research Institute. "This indicates that even if most of a study's participants would agree to data sharing, it's still crucial to ask them."

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 is that genomic research on large numbers of people can yield insights that aren't possible with smaller numbers.

"Trust is a two-way street, and human research requires lots of trust," Ludman said. "People have an understandable feeling of ownership over their bodies and medical records, including their genetic information," she added. "Researchers show we're worthy of trust when we ask research participants for permission to use their information in a way that they haven't already agreed to."

Recent high-profile legal cases – including Havasupai Tribe vs. Arizona Board of Regents, and Beleno v. Tex. Dept. of State Health Services – have highlighted the issue of consent and trust in research. So too has the bestselling book, "The Immortal Life of Henrietta Lacks," about the history surrounding the HeLa cell line, the world's most widely grown human cells.