Top Takeaways from the Common Rule Amendments

Hodge, JG, Arnold S, Wetter S. Top take-aways from the Common Rule amendments. Jurist; Feb. 19, 2017

5 Pages Posted: 27 Feb 2017

See all articles by James G. Hodge

James G. Hodge

Arizona State University (ASU) - Sandra Day O'Connor College of Law

Sarah Arnold

Arizona State University (ASU), Sandra Day O'Connor College of Law, Students

Sarah Wetter

Center for Health and Homeland Security, University of Maryland

Date Written: February 18, 2017

Abstract

On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), and multiple federal agencies published final amendments to the Federal Policy for the Protection of Human Subjects (aka the “Common Rule”). Introduced in 1991 based on research ethics principles dating back to the early 1970s, the Common Rule was viewed by many as antiquated given shifts in research practices over decades.

Research enterprises previously based largely in academic and medical institutions expanded exponentially into private sector entities. Conducting research moved far beyond clinical trials to extensive assessments of biospecimens, genetic data, and private health information.

In amending the Common Rule, OHRP attempts to simultaneously enhance protections for human subjects while limiting administrative burdens for researchers. While many of the changes to the Common Rule will not take effect until January 2018, essential themes already impact researchers, subjects, administrators, and attorneys representing their interests. We lay out below 10 premier “takeaways” from the amended Common Rule including major changes to come and opportunities foregone.

Keywords: research, ethics, Common Rule, amendments, privacy, human subjects

Suggested Citation

Hodge, James G. and Arnold, Sarah and Wetter, Sarah, Top Takeaways from the Common Rule Amendments (February 18, 2017). Hodge, JG, Arnold S, Wetter S. Top take-aways from the Common Rule amendments. Jurist; Feb. 19, 2017. Available at SSRN: https://ssrn.com/abstract=2923147

James G. Hodge (Contact Author)

Arizona State University (ASU) - Sandra Day O'Connor College of Law ( email )

Sandra Day O'Connor College of Law
111 E. Taylor Street
Phoenix, AZ 85004-4467
United States
480-727-8576 (Phone)

HOME PAGE: http://https://law.asu.edu/degree-programs/public-health-law-policy

Sarah Arnold

Arizona State University (ASU), Sandra Day O'Connor College of Law, Students ( email )

Box 877906
Tempe, AZ 85287-7906
United States

Sarah Wetter

Center for Health and Homeland Security, University of Maryland ( email )

Baltimore, MD 21230
United States

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