With patients increasingly concerned about their privacy and with more health data being shared between medical centers and industry partners, meaningful informed consent is becoming a higher profile issue. Researchers at Michigan Medicine, the University of Michigan’s academic medical center, have developed a framework for expanding patient consent for sharing their information, and any samples taken from them, outside the university.
U-M launched the framework in 2018, and the approach is already applied to thousands of U-M patients and research study volunteers, and dozens of projects. More than half of research volunteers asked for such consent have given it, the researchers say.
In a news item on the U-M website, the researchers describe their approach. “We believe our approach provides an ethical way to advance medical discovery and innovation while also respecting the trust patients and research participants put in the University of Michigan,” said Kayte Spector-Bagdady, J.D., M.Bioethics, chief of the research ethics service of the Center for Bioethics & Social Sciences in Medicine and faculty at Michigan Medicine.
Spector-Bagdady co-authored an article in the New England Journal of Medicine along with fellow members of a special U-M committee that oversees the university’s process, including Sachin Kheterpal, M.D., M.B.A., associate dean for research information technology and a co-leader of U-M Precision Health; Ray Hutchinson, M.D., active emeritus professor of pediatrics and former associate dean for regulatory affairs; and Erin Kaleba, M.P.H., director of the office that oversees clinical research data.
Before they sign any such consent, patients must first discuss the special outside-sharing consent form with research staff, who assess each participant’s understanding of what giving the additional consent means.
The critical passage in the form reads: “You give permission to share your samples and information with researchers around the world including those working for companies. Researchers and their organizations may potentially benefit from the sale of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.”
If their samples are being sought for a project with a specific company, patients will be told about the project and company, though their consent applies to all approved industry use. They are told they can revoke their consent in future, stopping their data from being shared further.
But, if they don’t consent, the samples of tissue and blood taken during their care and research participation, and the contents of their health record, will be marked as off-limits for sharing with industry. U-M teams may still use it for academic research, under a broader consent document and ethics board approvals. The authors of the NEJM article are all members of a committee that must review, approve and track any projects that involve patient data or specimen sharing with companies.
The article in NEJM lays out the decision process followed by the Michigan Medicine Human Data & Biospecimen Committee, which reviews all proposals involving transfer of data or human materials to non-academic entities, mostly through partnerships between a U-M researcher and an outside company. There are a few exceptions. Aggregated summaries of data, which do not disclose individual participant information, do not need to be reviewed. Data and specimens collected under industry-sponsored clinical trials that already include sharing of information with the company that sponsored the study, do not need committee review either.
The committee, which meets every other week, has on average of three new proposals to review each time. Only a few have been rejected outright – mainly because the project proposed to use samples acquired before the new consent process, and there was no easy way to reach back to the people those samples had come from to ask for their consent.
The U-M news story quotes Marschall Runge, M.D., Ph.D., U-M executive vice president for medical affairs and dean of the U-M Medical School, as saying that even in the face of COVID-19 and the pressing need to seek answers to a global pandemic, the framework is crucial. “The temptation has never been greater to take shortcuts around health data protections to vie for huge federal grants or to develop and monetize intellectual property,” said Runge. “That is why we have adopted our approach, and we hope it will serve as an example for others."