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
Date Written: February 18, 2017
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
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