United States Department of Health and Human Services to review regulation of study participation

First review of ethics rules for study participants in almost a quarter century announced

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Sep 04, 2015
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The world of large-scale studies has changed over the past quarter century, with genomic technology representing the biggest shift. With this in mind, the Department of Health and Human Services (HHS)has announced its suggested changes to regulation of individuals participating in studies.

Large genomics studies can require that dozens of sites seek ethical approval to recruit thousands of individuals to donate tissue. This tissue can then be utilized in dozens of other studies. Much of the current ethical infrastructure in the Common Rule was not created to cater to these large distributed studies. Patients are more engaged (and perhaps more skeptical) about medical studies in particular and they want to be informed at most stages of the process.

The HHS wants to update the Common Rule to reflect current sensibilities and work within the modern research environment. Four years after announcing their intention to begin a review, they have announced their proposed changes to the regulation.

The main changes proposed in the review are:

  • Streamlined ethical approval of low-risk research allowing for reduced burden on Institutional Review Boards.
  • Studies would only face requirement for approval at one Institutional Review Board for multisite studies.
  • Changes to consent rules including the introduction of a requirement of written consent for use of biological samples, but allowance for participants to consent to future unspecified use.
  • New requirements for data and information protection.

While the reduced requirements for low-risk studies will be welcomed, it is likely that these proposed changes will spark a lively debate on bioethics, as many of the changes will create challenges for larger studies involving biological samples and sharing of large datasets. Special attention will likely be paid to these changes as the debate over the place of bioethics was reignited by Steven Pinker’sincendiary comments that bioethicists should “get out of the way” of biomedical research.

The HHS will be taking comments on its suggestions for 90 days from September 8th.


HHS press release: HHS announces proposal to update rules governing research on study participants

Boston Globe article: The moral imperative for bioethics

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