Science and technology are at a fortuitous crossroads: As we’re learning more about how variations in human genetics affect health and disease, we’re expanding our use of the electronic medical records systems that make it easier to gather, store, sort, and analyze genetic data. And growing right alongside clinical and technological medical advances: The importance of informed consent and its kissing cousin, re-consent.
So, how many times do you have to get permission from patients before you use their medical data for research? From the patients’ point of view, the answer is “every time,” a new study suggests. It doesn’t matter if the data is de-identified or if they’ve already approved its use for one purpose. If you want to use it again, they want you to ask them again, say investigators at Group Health Research Institute and the University of Washington (UW) in a report called “Glad You Asked,” which was published in the September 2010 Journal of Empirical Research on Human Research Ethics.
Genomic research on large numbers of people can yield insights that aren't possible with smaller numbers. So, since 2008 the National Institutes of Health (NIH) has encouraged researchers to submit genetic information to the federal database of Genotypes and Phenotypes (dbGaP). But researchers must respect their study participants. And that means going back to those who may have signed up for a study on diabetes or heart disease and asking them to share their medical data for genomic research projects, as well.
It’s not that people don’t want to share their data. When researchers asked volunteers who were already enrolled in a joint Group Health-UW longitudinal study on aging if it would be OK to share their de-identified genetic and medical record information in the database, 86% said yes. Then researchers went back to a subset of those who gave permission mostly because of a “desire to help others.” Of those, 90% said they thought being asked for re-consent was important.
Alternatives to re-consent were not popular with the participants, either. Opting out was unacceptable to 40% of respondents and notification was unacceptable to 67%. When asked what they thought about their data being used for a new purpose without individual permission or notification, 70% gave researchers the thumbs down.
"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."
Asking permission is a sign of respect, after all. And that’s particularly important when researchers are asking for genetic samples and related medical data. "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. 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."
As luck would have it, there are tools to help manage and document the informed consent process. The University of Texas Health Science Center at Houston is using one such solution, called iMedConsent, to manage its research consents. The program can be integrated with an organization’s EMR so that it can automatically populate consent forms with patient and provider information. It can capture signatures from digital pads, send images of signed documents to document management systems, and post comprehensive notes to the patient’s medical record. And automating a traditionally paper-based process saves money by eliminating scanning costs and the need to manage and archive paper documents.