The Final Rule in the U.S. and Its Implications for Biobank Research

Since the Common Rule was developed in the 1990s, the landscape and volume of research activities have changed dramatically. This growth and expansion of human subject research led to questions whether the regulatory framework was adequate and appropriate. Under the Obama Administration in 2011, revision of the Common Rule started, with the goal of updating it to better protect human subjects while least burdening researchers.

In this report, Hilde Eikemo and Berge Solberg evaluate the implications for Europe of the United States’ development of a risk-based ethical review system for medical research aimed at replacing their federal policy for protecting human research subjects (informally known as the Common Rule).  Eikemo and Solberg describe the new legislation and review system in the US and how this affects biobanking and research on health data. They further look at the American research ethical debate on the revised “Final Rule” and, finally, discuss pros and cons of the American research regulation compared to the typical European one.

Although a comparison of systems is challenging due to the fundamental structural, constitutional and practical legal differences, it seems that the US and Europe are moving in different directions. The strengths and weaknesses of each regulatory system are discussed. In addition Eikemo and Solberg investigate the implications for biobank research and cooperation across the Atlantic.

To find out more, read the full article here:

• Eikemo, H. & Solberg, B.  (2018). Rulemaking in the U.S. BBMRI-ERIC Common Service ELSI.