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On Improving Oversight and Enhancing Protections

For this theme issue, we invited leading experts and scholars in research ethics to identify and reflect on some of the important changes that the U.S. Department of Health and Human Services made to the Common Rule in a final regulation the agency released in January 2017. The authors draw on their experience as institutional leaders, members of national research ethics advisory bodies and institutional review boards, and scholars with deep knowledge of the ethical issues that human biomedical and behavioral research raises.

It is too soon to know whether the changes to the Common Rule will, as intended, improve the effectiveness of oversight of human subjects research and enhance protections for research participants. What we do know is that government regulations are not value neutral and that the rule-making process is not as transparent or as conducive to eliciting a wide range of public perspectives as it could be. Moreover, what protecting research participants ought to mean and what policies and practices can best ensure such protection requires more sustained discussion than is possible in the rule-making process.

The authors of the commentaries identify several issues ripe for discussion—some old and some new. Carl Coleman and Barbara Bierer point out that the revision of the Common Rule does not change the definition of research. Coleman addresses some of the implications of the definitional ambiguities that remain in the revision, including the distinction between research and quality assessment and quality assurance activities. In Bierer’s view, the generalizable knowledge definition of research should not be the criterion for distinguishing research from clinical care. The other two commentaries highlight new issues that warrant in-depth discussion. Holly Fernandez Lynch, Emily Largent, and Deborah Zarin raise important issues about what kind of research could be conducted on and with the consent forms that the revised Common Rule requires be posted on a publicly accessible website. And Suzanne Rivera identifies several concerns about the new blanket requirement that multisite studies cede authority to one single IRB to review the protocols for all the study sites.

We don’t need a crystal ball to know that more issues will emerge as researchers, institutions, and regulatory agencies sort out how to interpret and implement the rule change. For now, it’s important to reflect on what the revision did and did not change and what needs to be done to ensure that its implementation improves oversight effectiveness and enhances protections for individuals who agree to participate in biomedical and behavioral research.