New public attitudes about access to medical information, bio tissue for research

Excerpted from “New public attitudes about access to medical information, bio tissue for research,” MedicalXpress. December 13, 2013 -- In this age of surveillance cameras, computer algorithms for tracking website visits and GPS-imbedded cell phones, many people feel their right to privacy is slipping away. This perception extends into the medical realm as well where information gleaned from Electronic Health Records and clinical tissues are being used for medical research purposes with and without patient consent in some situations, though compliant with federal regulations.

With the continued development and importance of the University of Utah's biobank of tissues acquired through research projects and through residual clinical specimens, lead investigator Jeff Botkin, MD, MPH, and his colleagues initiated a study to better understand public attitudes regarding these practices. "There are many technical and financial challenges to establishing a biobank, but we think the largest risk to the enterprise is a loss of public trust if the public is surprised and alarmed by how research is conducted at institutions like ours," says Botkin, associate vice president for research integrity at the University.

The results of the study, published this month in the Journal of Community Genetics, reveal that when the general public is educated about the intricacies involved in collecting and using this information in population-based research—particularly the safeguards and confidentiality measures in place to maintain anonymity—that they support it. "What was surprising is the public is generally not aware of the safeguards in place to assure that research is done in an ethically appropriate fashion," points out Botkin.

"The most important finding from this study was that people, when educated about the safeguards, were fine with their information or tissue being used for research without their signed consent. They were okay with it as long as they had the option to opt out if they wanted," explains co-investigator Erin Rothwell, PhD. The study indicates that once the general public is educated and understands that the risk to their privacy is low, and the option to say "no" (an opt-out) is available, then they are onboard with contributing to the research.

Commentary

Gastroenterologist Jeff Fenyves, MD: -- “While most of practicing clinicians would agree with Dr. Botkin in regard to the importance of public trust, there are many viewpoints as to the best path to take in the case of Biobanks and research. Educating the public, especially given the diversity of types of biobanks, would be impractical. Prior studies already show that the public generally supports the broad goals of genetic research.¹

“Boiled down, the real issue is a widely accepted consent process: opt-in or opt-out, and how much info to go with this? Most agree that formal opt-in, fully explained consent is probably overkill and cumbersome for de-identified specimens. But the public may be rightfully dubious of the assumption of participation, unless they sign an ‘opt-out’ section of a larger document, such as a hospital admission doc or blood draw consent. Or should we find some middle ground, with separate opt-out, or opt-in consent, along with a pamphlet or other informative material?”

¹Kaufman D, Murphy J, Scott J, Hudson K. Subjects matter: a survey of public opinions about a large genetic cohort study. Genet Med. 2008;10:831–839. doi: 10.1097/GIM.0b013e31818bb3ab.

Resources

1. Simon CM, L'Heureux J, Murray JC, Winokur P, Weiner G, Newbury E, et al. Active choice but not too active: Public perspectives on biobank consent models. Genetics in Medicine. 2011;13(9):821–831.
   
2. Project Mkultra: One of the Most Shocking CIA Programs of All Time
   
3. A Biobank for Genomics Research: Do we need Patient Consent?
   
4. Informed Consent for Biobanking
   
5. CMDA Ethics Statement – Human Research Ethics