Patient Data Access News

E-Consent Forms Useful for Patient Data Sharing in Research

E-consent tools for patient data sharing in research need more assurances of health data security, researchers found.

e-consent patient data sharing

Source: Thinkstock

By Sara Heath

- Electronic consent (e-consent) forms are useful for  offering patient consent for sharing health data with medical researchers, according to a recent study published in the Journal of the American Medical Informatics Association.

Facilitating patient consent for data sharing is essential given the growing uses for patient data. Medical researchers are increasingly using bio specimens, genomic data, and social determinant of health data to make scientific discovery, the research team said.

Medical researchers require patient consent to access these types of data, highlighting a need for better protocol surrounding patient consent and data sharing.

“In general, as long as permission is obtained and individual privacy is protected, patients are highly supportive of using health information for research purposes,” the researchers explained.

However, there is a lot of variability related to how researchers obtain patient consent, and different consent strategies yield different levels of patient satisfaction and buy-in. Healthcare professionals need to develop effective strategies for collecting patient consent that do not disrupt clinical or administrative workflows.

“What are best practices for obtaining broad consent in a way that informs patient choice without placing an undue burden on researchers and clinical staff?” the researchers question. “Some evidence suggests that multimedia applications allow patients to better control the pace of information delivery and may reduce the intensity of staff oversight as compared to paper consent documents.”

E-consent tools allow patients to better understand health data sharing, learn about potential research opportunities, and give permission for data sharing on an electronic device, typically a tablet. These tools must follow the Common Rule, which establishes ethical and clinical guidelines for collecting informed patient consent, the researchers said.

Currently, the Common Rule calls for focused information for patient consumption followed by more in-depth information.

Through a series of 42 interviews with 32 adult patients, the researchers determined that e-consent tools are effective in obtaining patient consent. Specifically, these tools allow patients to learn more about potential medical research that will use their own health data.

E-consent tools are modeled in such a way that patients see the bare bones information that they ethically and legally must see prior to granting access to patient data. The tools also allow patients to choose to continue reading for more information. Because the read more functions are optional, these tools do not bombard patients with information.

However, information about data security hosted on e-consents leave something to be desired, the researchers found.

“For many participants in this study, it was insufficient to simply indicate that their EHR data would be kept secure,” the study authors said. “These participants desired specifics about what information is contained in their EHR, where their data are stored, which safeguards are applied, who has access to their data, and how breaches or misuses will be addressed.”

Additionally, patients had questions about how long their data would be accessible to researchers.

E-consent tools may prove useful for medical researchers going forward, the study authors said. However, more changes to these tools are necessary before broad implementation. Foremost, medical researchers must underscore the data security assurances in these tools to foster patient trust.

Additionally, the tools must deliver patient education for multiple types of information-seekers. Information regarding how patient data might be used should be available to those patients who seek it, but not in such a way that it bombards other users.

“Overall, these findings point to an ongoing challenge for broad consent implementation, namely the ability to carefully balance the delivery of information that is specific enough to satisfy patients’ information needs but also general enough to allow broad future research uses,” the researchers concluded. “Again, electronic platforms may help strike this balance through interactive capabilities and other functionalities.”


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