The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Commission Work Will Dovetail Nicely with HHS’ ANPRM

The Presidential Commission for the Study of Bioethical Issues today discussed how its current work assessing the contemporary rules and regulations that protect human subjects in research will nicely dovetail with the Department of Health and Human Service’s Advanced Notice of Proposed Rulemaking (ANPRM), which was released last summer. The ANPRM is entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

In August, at its last public meeting in Washington, the Commission heard from Zeke Emanuel, Former Chief of the Clinical Center Department of Bioethics at the National Institutes of Health, regarding the importance of this reconsideration of the regulations governing human subjects research. Indeed, it’s the first time the topic has been revisited in 20 years.

Today the Commission commended the drafters of the ANPRM for their thoughtful treatment regarding the revision of what has come to be known as the “Common Rule,” i.e. the rules for human subjects research protection ostensibly common across the government. The opportunity for the Commission to comment on the ANPRM is particularly valuable in light of their current charge from the President to “determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal government.” Indeed, the ANPRM itself commits to taking into account “the deliberations of the Presidential Commission for the Study of Bioethical Issues.”

Commission Member John Arras introduced the idea that the Commission has the opportunity to recommend the proper “pruning” and allow for the proper “budding” of professional standards of ethical requirements for researchers. In other words, prune where excessive regulations should be cut back, and encourage budding where further creative methods to achieve ethical standards could be developed.

“There’s an opportunity for us to be very specific about some places we think there should be pruning,” Chair Amy Gutmann said. However, she cautioned that one can prune well and “something more vigorous can prosper, or you can prune and kill.”  Gutmann added that obviously the Commission does not “want to kill important rules, we want them to actually be stronger as a result.”

Commission Member Barbara Atkinson emphasized that when revisiting regulations, it is of primary importance not to lose sight of what the rules were intended to achieve, namely creating a regulatory structure to enact the ethical principles behind human subjects protection. In particular, the Commission considered the ANPRM discussion on the importance of “harmonization” and improving the consistency of guidance on the protections of human subjects across federal departments and agencies.

Indeed, the Commission’s subcommittee, the International Research Panel, in its publication, “Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues,” recommended to the Commission in August that “continued efforts to harmonize and guide interpretation of rules should be made a priority over creating new rules.” The International Research Panel acknowledged that new rules may be needed to harmonize existing U.S. rules, but any additions must be clear, sound, and streamlined. The Commission agreed that harmonization across the federal government would add clarity to the U.S. oversight process, particularly for international clinical trials.

“We should put forward a standard that maintains the highest level of protection,” Atkinson concluded.

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About blog.Bioethics.gov

This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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