Under The Poliscope: Bringing Science Policy Into Focus

The Revised Common Rule: A Tribute to the Past and a Promise for the Future

January 18, 2017

As humans living longer, healthier lives than at any point in history, we all owe a great deal of thanks to the countless volunteers who have served as research participants. These are people who have given of their time, of their bodies, who have accepted risks from the very small to the very large, and who have done so knowing that they might receive no personal benefit. Lifesaving vaccines, cancer therapies, cardiovascular treatments, and every drug, diagnostic, and cure in our modern medical pantheon have been made possible thanks to the willingness of research volunteers; real people with real lives and real loved ones.

And we owe it to those willing to volunteer to ensure that we have the best possible safeguards in place to ensure that research involving humans is conducted ethically, safely, and equitably.  In 1978, the Belmont Report was published, outlining the principles and guidelines for protecting human research participants, built on the foundations of respect, beneficence and justice. This led to the regulation now known as the “Common Rule,” whose purpose was to ensure that research involving humans was conducted in line with the highest ethical standards and practices. Today, the U.S. government has announced revisions to the Common Rule, the culmination of nearly a decade of rulemaking aimed at improving our system of oversight and facilitating research.

In the world of science policy geeks, there are few Eureka! moments or end zone dances. It is not every day that landmark rules are released. Furthermore, it is rare for significant policy changes to take place in the absence of a crisis, but rather in recognition of the evolution of science, our increased understanding of what works and what doesn’t in research oversight, and the changing nature of participant engagement in research. The revision of the Common Rule is the endpoint of years of discussion, debate, thousands of public comments, and, most importantly, a dedication to the very people who it is designed to protect and to the researchers who serve as their partners in discovery.

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Comments

The revisions of the 26 year old Common Rule is being hailed as a promise for the future. On the other hand, this revision can be viewed as a failure to protect the privacy of individuals who have participated in research. The view that the "future is promising" appears to be based on the notion that researcher burden will be reduced because individuals would not need to be re-consented to have their biological specimens and associated personal information used for purposes other than what they had originally consented to do. Another alternative would have been to uphold the autonomy, privacy and confidentiality of data that research participants offer to particular researchers for particular research projects by excluding such data from the NIH sharing requirement in instances where the participant cannot be located for reconsent or if found refuses to take part in any new initiative. This would reduce researcher burden but also would protect the personal information of those who have so generously given of their time and shared with researchers their most private and sometimes stigmatizing information. We should keep in mind that "de-identified" data can relatively easily be re-identified if publicly available putting individuals who volunteer for research at risk. It should be the research participant's decision to take that risk given the importance of the particular research project in which they have agreed to participate.
Promise for the Future!!!!

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Under The Poliscope: Bringing Science Policy Into Focus
Dr. Carrie D. Wolinetz

Carrie D. Wolinetz, Ph.D.
Associate Director for Science Policy, NIH

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