Mary Anderlik Majumder, JD, PhD and Christi J. Guerrini, JD
Amendments to the Common Rule and Health Insurance Portability and Accountability Act (HIPAA) raise questions about broad consent and sale of health data.
AMA J Ethics. 2016;18(3):288-298. doi:
10.1001/journalofethics.2016.18.3.pfor5-1603.
Rebekah Davis Reed, PhD, JD and Erik L. Antonsen, PhD, MD
Though the National Aeronautics and Space Administration’s collection of disaggregated genetic data for occupational surveillance and research raises numerous privacy concerns, the Genetic Information Nondiscrimination Act of 2008 allows genetic information to be used to develop personal pharmaceuticals.
AMA J Ethics. 2018;20(9):E849-856. doi:
10.1001/amajethics.2018.849.
Cynthia E. Schairer, PhD, Caryn Kseniya Rubanovich, MS, and Cinnamon S. Bloss, PhD
Questions about data privacy need to be addressed when research institutions negotiate with companies developing mobile health applications. Commercial terms of use and data sharing notifications should be reviewed before use in human subject research settings.
AMA J Ethics. 2018;20(9):E864-872. doi:
10.1001/amajethics.2018.864.
Specific advocate guidelines are needed for the protection of children in state custody who are potential research subjects in trials that would expose them to greater-than-minimal risk but also hold the prospect of direct benefit.
In “Ethics of International Research: What Does Responsiveness Mean?” Christine Grady explains how developing countries are vulnerable to exploitation by researchers and explores what “responsiveness” to the needs of those populations might entail.
Susanne Sheehy, BM BCh, MRCP, DTM&H and Joel Meyer, BM BCh, MRCP
The decline in numbers of healthy volunteers who participate in clinical trials has the potential to become a key rate-limiting factor in vaccine development.
Qualifying conscience protections for institutions with requirements that they minimize hardship caused to the patient would prevent religious institutions from acting as a choke point on the path to services.