Governments and research organizations around the world are conducting large long-term precision medicine projects to understand how genetic and lifestyle factors cause disease. Longitudinal projects such as the UK Biobank and the Precision Medicine Initiative in the US collect biological samples and healthcare data from hundreds of thousands or millions of participants (1). These samples and data must be securely biobanked to protect patient privacy.
Any biobanking organization that collects and stores healthcare data must abide by regulations such as Health Insurance Portability and Accountability (HIPAA) Act and the Health Information Technology for Economic and Clinical Health (HITECH) Act in the US, and the General Data Protection Regulation in the EU (2-4). These regulations are designed to protect the privacy and security of sensitive patient data, and are particularly important in precision medicine studies that collect and store large amounts of data.
Despite these regulations, some potential precision medicine study participants may be worried about the security of their biological samples and healthcare data. This could be a particular concern in large-scale studies that store samples and data in a centralized biobank and share these resources with multiple research teams. Furthermore, attitudes to medical research and data privacy may differ between community groups which could make it difficult to enrol participants from all ethnic and socioeconomic groups.
To better understand whether patients would be willing to participate in large government-funded precision medicine studies, a group of researchers surveyed 134 chronic kidney disease patients at the MetroHealth Medical Center in Ohio, USA (5). These patients had already agreed to participate in a local research study and had consented to donate biological samples and allow researchers to access their electronic health records. More females than males responded to the survey (54% versus 46%), and most respondents were African American (50.5%) or White (45.6%). Latinos (0.97%), Asians (0.97%) and Native Americans (1.94%) were all under-represented in this study.
Survey answers were the same across all sex and race groups. Over 70% of respondents said they would be willing to participate in a national project that biobanked their electronic health records and genetic information. However, less than half of the respondents were willing to track their lifestyle behaviors on a free phone app.
Most respondents were interested in receiving research results. More than 60% felt it was very important to have access to results from research studies that used their samples and data. Over half of respondents wanted access to all their genetic and health results. Only 11.7% said it was not important to receive those results and 10.6% said they did not want to receive any results.
These survey results suggest that most patients who participate in a local research study are also willing to participate in a large government-funded precision medicine study where samples and data are centrally biobanked. The results also show that most participants want access to research study results.
This survey has several limitations. It was a small survey of patients already participating in research and while African American and White participants were well-represented, Latinos, Asians and Native Americans were under-represented. Also the paper did not report on the socioeconomic status of participants.
However, the results suggest that patients might be more likely to participate in precision medicine research if they have access to research results. This information is important for researchers designing and implementing precision medicine studies.
- Sankar, PL and Parker, LS. The Precision Medicine Initiative’s All of Us Research Program: an agenda for research on its ethical, legal, and social issues. Genetics in Medicine. 2017.
- Summary of the HIPAA Security Rule. HHS.gov
- HITECH Act Enforcement Interim Final Rule. HHS.gov
- The EU General Data Protection Regulation. GDPR Portal.
- Bailey et al. Willingness to Participate in a National Precision Medicine Cohort: Attitudes of Chronic Kidney Disease Patients at a Cleveland Public Hospital Pers. Med.2018.