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

Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of the Bioethics Commission’s response to the corresponding advance notice of proposed rulemaking (ANPRM) in 2011.

The July 2011 ANPRM sought public comment on several potential changes to research regulations. In Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission reviewed federal and international protections for participants in human subjects research. As a part of that review, the Bioethics Commission commented on the considerations highlighted by the ANPRM.

The Bioethics Commission has long espoused the principle of regulatory parsimony—calling for only as much oversight as necessary to uphold ethical standards. Applying this principle to human subjects research, the Bioethics Commission asserted that research oversight should be restructured to appropriately calibrate the level and intensity of review with the level of risk posed to participants. Calibrating the intensity of review to the level of risk allows IRBs to give more attention to higher-risk research. The Bioethics Commission supported specific changes to the Common Rule to help foster regulatory parsimony, in particular, regularly updating the list of research categories eligible for accelerated review processes and eliminating follow-up requirements for certain lower-risk studies.

The NPRM proposes several changes that would reduce unnecessary regulation of low-risk research. Under the proposal, several low-risk activities and categories of research would no longer be deemed human subjects research under the Common Rule. Other categories of research would be assigned to accelerated review processes. Further, some studies would no longer be required to undergo annual follow-up review. Together, these changes proposed by the NPRM constitute a move towards a review system that better matches the level of research regulation to the level of risk to participants.

The Bioethics Commission supports the principle of regulatory parsimony, advocating only as much regulation as is necessary to protect participants. The NPRM proposes several changes to the Common Rule that embody the principle of regulatory parsimony. These changes are an important part of modernizing human subjects research protections.

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1 Comment to Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

  1. David Resnik's Gravatar David Resnik
    September 24, 2015 at 10:19 am | Permalink

    Regulatory parsimony? Maybe and maybe not. Yes, the NRPM increases the types of studies that are declared not to be research or are exempt research, which reduce regulation in these areas. But it also adds a lot of extra requirements concerning research with biological samples, informed consent, and confidentiality. These requirements are complex and difficult to follow, as they are full of various exceptions and twists and turns. I think it will take IRBs quite a while to learn how to apply the revised Common Rule and that there may some unexpected adverse consequences, as is often the case when you revise regulations.

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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.

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