Human Subjects Research Rule Revisions Finally Proposed

More than four years after the federal government introduced an advanced notice of proposed rulemaking on federal regulations on human subjects research (called the Common Rule), there has been another regulatory step (H/T ScienceInsider).

The Federal Register has a draft edition of the notice of proposed rulemaking it will publish on September 8.  Comments will be due in 90 days from the date of publication, which would be around December 6.  The draft notice is over 500 pages, so I will have additional posts on the subject once I have the chance to review this in more detail.

Quick thoughts on a first glance.

If this is implemented as written, it will affect researchers in a number of different fields (16 federal agencies are listed in the proposed rules, but not the Office of Science and Technology Policy), and it seeks to define areas of activity that would or would not be covered under the proposed rules.

(Two agencies – the Department of Housing and Urban Development and the Consumer Product Safety Commission – will update their Common Rule regulations through separate proceedings.  The Department of Labor is not currently covered by the Common Rule, but has joined this rulemaking in order to adopt those regulations.)

The proposed changes are necessary to do the heavy lifting required to update a 24 year-old rule.  With the continued changes in technology, whatever final rule that emerges will become dated quickly.  Having a means of effectively assessing and adapting to future changes in technology and research capabilities would be nice to have.

Even if you don’t think work you’re engaged with isn’t covered by federal human subjects research regulations, read the notice.  You might be surprised.


One thought on “Human Subjects Research Rule Revisions Finally Proposed

  1. Pingback: Deadline Extended For Comments On Human Subjects Protection Regulations | Pasco Phronesis

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