A New Approach to Sharing Patient Data and Maintaining Privacy

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Maintaining a balance between patient data-sharing and patient privacy has always been tricky.  Laws and hospital policy require that any shared patient information should be protected from a variety of identifying information given the exquisitely personal nature of health data. Yet, that very same information represents a rich store of clues that could lead to medical advances. And it also holds the promise of a financial win for hospitals willing and able to responsibly share that vast medical and research data. What’s a hospital to do?

To help bridge that sometimes cavernous divide, a team from Michigan Medicine has created a new way for academic health institutions and industry to partner. The patient is, rightly, the heart of the solution. Informed consent has long been standard in medical and research practices where patients are informed prior to treatment, or participation in research studies, about risks and benefits of both. They acknowledge receipt of the information, which usually includes promises by the research institution to keep their personally identifiable information private.

A paper describing the expanded informed consent framework was published in the New England of Medicine.

Additional Patient Consent

In the new approach, which has been in place at the University of Michigan since 2018, patients are provided an additional informed consent document regarding sharing their information that research participants can choose to sign. This additional, or special consent, is additive to the standard informed consent papers required for participating in a research project.

Within the past two years, the framework has been used for about 80,000 thousand patients and research study volunteers, and dozens of projects at Michigan. “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,” says first author 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.

The special consent addresses data sharing head-on, including any body samples, for use outside of the university setting. The document requires that 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.

At the heart of the special consent form is the following text: “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.”

The Michigan experience finds that between 50 percent to 75 percent of those participating in research studies provide that additional level of consent, depending on the project. For those who decline, participation is still welcome and invited. However, those patients’ samples of tissues and blood are designated as off-limits to sharing. Any outside interest will not be given access to them, although the Michigan research teams will still use them for academic research.

A louder, clearer patient voice

While the advantages to outside organizations are obvious, the process gives patients a more prominent role in deciding how involved they want to be in any current or future research projects, both at the university or in industry.

If their samples are being sought for a project with a specific company, they 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.

Specialized Gatekeeper Committee

To make the system work, the Michigan team created a committee to review, approve, and track projects involving patient data or sample sharing with outside interests. While it represents an additional layer of review, it also streamlines the process once established  – a win for all involved parties.

The framework proposes that any such committee review all proposals involving transfer of data or human materials to non-academic entities which are usually companies. 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 shared of information with the company that sponsored the study, do not need committee review either.

Since Michigan put this system in place, its review committee has reviewed about 70 projects, rejecting six mainly because the project started before this additional level of data-sharing consent was applied.

 Unique Challenges

Several issues challenged the framework authors. One involves special circumstances, such as in the study of orphan diseases, or even in the face of global medical emergencies like COVID-19, when patients can no longer be contacted for special consent. In these circumstances the framework provides some balance for making case-specific exceptions to the need for special consent when considering the importance of finding new treatment and prevention options against the individual participant’s right to consent to industry use.

The framework also asks patients to give for special consent for third-party, for-profit companies which occasionally have access to information initially provided to an academic or specialty society.  This requirement is in place given the reality that data or biospecimens are sometimes shared with these third parties.

The Michigan approach also explicitly denies data sharing from patients who previously consented to broad use with standard consent forms but who were not informed of specific companies.

“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,” says Marschall Runge, M.D., Ph.D., U-M executive vice president for medical affairs and dean of the U-M Medical School. “That is why we have adopted our approach, and we hope it will serve as an example for others.”

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