Responding to proposed changes in the Common Rule

The Department of Health and Human Services has proposed a set of changes to the Common Rule which governs human subject research, and asked for public comment. The Conference on College Composition and Communication (CCCC) Research Committee prepared a response, approved by the CCCC, which was submitted on January 6, 2016. (See the comment on regulations.gov.)

Please direct your questions to Bradley Dilger, the CCCC Research Committee member heading up this effort.

More on the proposed changes and our response

The Office for Human Research Protections (OHRP) proposed a set of changes to the Common Rule which governs human subject research. While many of the changes focus on medical research, including significant changes to the ways “biospecimens” will be handled, there are certainly impacts for writing research. The changes were offered in the form of a “Notice of Proposed Rulemaking” (NPRM) supported by summaries offered on YouTube and in other forms. Changes were published on September 8, 2015, with a 90-day time period for comments extended 30 days. The request for comments closed January 6, 2016.

This NPRM followed a 2011 “Advance Notice of Proposed Rulemaking” (ANPR). A CCCC task force chaired by Karen Lunsford wrote an official response. Because several of the concerns raised by that task force remain relevant, we repeated some of their language in our public comment.

Thanks to Karen Lunsford and Heidi McKee for their assistance here.

Learn more about the proposed changes

Notice of Proposed Rulemaking (NPRM)

The source document as published: 131pp from the Federal Register (PDF); or a more readable 519pp preprint (PDF); or via Regulations.gov with comment interface.

HHS NPRM Portal

Department of Health and Human Services (HHS) portal including links to the Notice of Proposed Rulemaking (NPRM), summaries, and other materials offered by the HHS.

OHRP webinar series

Series of videos explaining the proposed changes. The second video covers the exceptions and exemptions which are most likely to concern writing research, but doesn't discuss them in depth. (All of the videos are captioned.)

PRIM&R descriptive chart of changes (PDF, 30pp)

Public Responsibility in Medicine and Research (PRIM&R), a national professional organization for research ethics administrators, prepared this useful chart which compares the old and new Common Rules.

Verrill Dana LLC: Decision chart mapping new Common Rule process (PDF, 10pp)

Diagram of the way scholarship would move through approval processes, prepared by law firm Verrill Dana.

Verrill Dana LLC: NPRM Redline (PDF, 39pp)

Microsoft Word-style version of the Common Rule showing additions, deletions, and movement in blue, red, and green respectively. Some irregulaties and noise but

Harvard Law School: Bill of Health weblog

Series of weblog posts about the proposed changes from Harvard Law School. Many posts focus on issues unique to medical research, but quite a few other links can be found here.

CCCC task force comment on 2011 ANPR (PDF, 9pp)

A CCCC task force chaired by Karen Lunsford offered this response to the original set of proposed changes.

Got something to add? Let us know.

Bradley Dilger's web stuff