Comment on Proposed Rules for Protection of Human Subjects

UPDATE: The proposed rulemaking comment period has been extended to January 6, 2016.

I would like to draw your attention to proposed revisions to the federal policy for the protection of human subjects exit icon, often referred to as the Common Rule. Even if you’re not currently involved in human subjects research activities, your research might be affected by the proposed changes.

The modifications are intended to enhance the ability of individuals to make informed decisions about participating in clinical research and also to modernize and streamline the regulatory approval process. One of the major reforms would expand the definition of human subjects research to include the secondary use of human biospecimens, regardless of identifiability. Some of the other proposed changes would affect the processes for obtaining informed consent and for determining the exemption status of human subjects research activities.

I encourage you to review the notice of proposed rulemaking and submit comments by the December 7, 2015, deadline. Please note that each proposed change described in the document includes specific questions for public comment.

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