People want to be asked before sharing genetic data

SEATTLE — People want to be informed and asked for consent before deciding whether to let researchers share their genetic information in a federal database. This is according to a team of investigators at Group Health Research Institute and the University of Washington (UW). The team’s report, called “Glad You Asked,” is in the September 2010 Journal of Empirical Research on Human Research Ethics.

To the team’s knowledge, it is the first to ask research participants’ opinions about the need for informed consent for sharing their own information. The team explored participants’ preferences while collaborating on the Electronic Medical Records and Genomics (eMERGE) Network. The Network involves volunteers enrolled in the joint Group Health-UW Adult Changes in Thought (ACT) study. ACT is a longitudinal cohort study that 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 for this 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, PhD, 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 strongly 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.

For new studies that will enroll participants prospectively, informed consent can — and should — address such sharing. But sharing genetic data raises ethical questions for longitudinal cohort studies, including ACT, which started long before dbGaP was established in 2006. Few existing informed consents address data sharing through this new mechanism. Ideally, Dr. Ludman suggested, research grants would include funding and time to pursue reconsent. In this study, it cost around $50 for each participant who was asked.

“Trust is a two-way street, and human research requires lots of trust,” Dr. 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 have highlighted the issue of consent and trust in research, including the Havasupai tribe vs. Arizona State University and parents vs. the Texas health department over storing newborn blood samples without parental consent. 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.

With funding from the National Human Genome Research Institute (NHGRI), Dr. Ludman’s co-authors were Research Associate Leslie Spangler, VMD, PhD, Executive Director Eric B. Larson, MD, MPH, and Project Manager Monica M. Fujii, MPH, of Group Health Research Institute; Wylie Burke, MD, PhD, UW professor and chair of bioethics & humanities and affiliate investigator at Group Health Research Institute; and Gail Jarvik, MD, PhD, UW professor of medicine and head of the division of medical genetics, Stephanie M. Fullerton, PhD, UW assistant professor of bioethics & humanities, and Susan Brown Trinidad, MA, UW research scientist in bioethics & humanities.

The eMERGE Network

The Electronic Medical Records and Genomics (eMERGE) Network is a national consortium formed to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. The Network brings together researchers with a wide range of expertise in genomics, statistics, ethics, informatics, and clinical medicine from leading medical research institutions across the country: Group Health Cooperative with the UW; Marshfield Clinic; Mayo Clinic; Northwestern University; and Vanderbilt University.

Group Health Research Institute

Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, nonprofit health care system. Group Health Research Institute changed its name from Group Health Center for Health Studies on September 8, 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.

UW Medicine

The UW Medicine health system includes UW Medical Center, Harborview Medical Center, Northwest Hospital, the UW School of Medicine, UW Medicine Neighborhood Clinics, UW Physicians, Airlift Northwest, and the UW’s partnership in the Seattle Cancer Care Alliance with Seattle Children’s and Fred Hutchinson Cancer Research Center. UW Medicine has major academic and service affiliations with Seattle Children’s Hospital, Fred Hutchinson Cancer Research Center, and the Veterans Affairs Puget Sound Health Care System in Seattle and the VA Hospital in Boise. The UW School of Medicine is the top public institution for biomedical research in funding received from the National Institutes of Health. For more information about UW Medicine, visit www.uwmedicine.org.