Patients Say Researchers Are Ethically Obligated to Return Study Data
Returning patient-reported outcome data to study participants is a growing priority for researchers.
“Patients want to be more engaged in and informed about their own healthcare,” says Sabrina Mangal, PhD, RN, a postdoctoral fellow at the University of Washington School of Nursing.
Researchers are ethically obligated to return health research data to participants, and to do it in a way that is comprehensible, actionable, and aligned with participants’ preferences, according to Mangal. This is particularly helpful for patients with heart failure, whose care requires rigorous symptom-monitoring and self-management.
Mangal and colleagues found little guidance on best practices for researchers to help them fulfill these obligations. Researchers interviewed 22 patients with heart failure to learn their preferences.1 All patients were part of an eight-week study in which patient-reported outcomes were collected and returned to participants. Some key findings:
• Most participants believe researchers are ethically obligated to return the data to participants.
• Some patients wanted to use the data during discussions with clinicians and to support self-management.
• Many patients were open to sharing their data with outside tech companies, as long as their personal information was not included, they were not identified, and the intent was to help others.
• A few participants did not want access to their health data, and wanted to hear information only from their doctor. (One participant indicated concern that reading the data might exacerbate anxiety).
• Some participants worried about loss of privacy if the data were shared, such as inappropriate access to Social Security numbers, or that it could affect them adversely if health insurers or financial institutions could access the data in the future.
Based on this feedback, Mangal suggests researchers follow these practices:
• Practice transparency by returning data to participants, disclosing intent of data use, and address participants’ concerns about loss of anonymity or privacy. “Researchers can integrate these conversations into the consent process by prompting participants to share their concerns, and by providing them with options of what they want their data to be used for, and who it will be shared with,” Mangal offers.
• Ask study participants what their preferences are for seeing their data. Some participants might prefer to see how their health has changed over time. Others might want to see if their health is better or worse than their last clinical visit.
• Offer multiple options for the format and type of data participants want to see. Simple, colorful visuals like bar graphs or visual analogies (e.g., gas gauges or battery levels) usually are easier to comprehend than line graphs.
• Consider the unique needs of the target audience. Older adults may prefer a paper copy or text message of their health results, whereas younger patients may prefer to access the information through an interactive online portal or mobile application. Likewise, the types of images and data representations that resonate with certain populations differ.
“Allow for customizability and tailoring based on preferences. Everyone’s needs are different,” Mangal says.
1. Mangal S, Niño de Rivera S, Reading Turchioe M, et al. Perceptions of patient-reported outcome data access and sharing among patients with heart failure: Ethical implications for research. Eur J Cardiovasc Nurs 2023; May 12: zvad046. doi: 10.1093/eurjcn/zvad046. [Online ahead of print].
Returning patient-reported outcome data to study participants is a growing priority for researchers. it is important to do it in a way that is comprehensible, actionable, and aligned with participants’ preferences.
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