Category: NPRM Symposium

The HHS has issued a Notice of Proposed Rule Making (NPRM) with significant changes to the U.S. regulation of human subjects research. Bill of Health will be hosting a mini-symposium on the topic getting some of the most important thinkers about human subjects research to weigh in on the NPRM and what it means for the field. Watch this space for more over the coming days and weeks.

NPRM Symposium: Freedom for Historians, If They Can Keep It

The Petrie-Flom Center Staff 1 Comment

[Cross-posted from the Institutional Review Blog, as part of the Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.]

By Zachary Schrag

The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.

Organizations representing anthropologists, sociologists, political scientists, and other social scientists have largely tried to make peace with IRB regulations, often counseling members to submit to IRB review and serve on IRBs. Historians, by contrast, have been almost uniform in our opposition to regulation, and since 2000, we have argued that our work should not be subject to rules written for “generalizable research.” In 2003, OHRP endorsed that position, but then distanced itself at the first challenge from IRB offices. Read More

Introducing NPRM Symposium Guest Blogger Zachary Schrag

The Petrie-Flom Center Staff Leave a comment

Zachary Shrag 3Zachary M. Schrag, editor of the Institutional Review Blog, will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.

Zach is a professor of history at George Mason University. He has been involved with human subjects regulations’ impact on the humanities and social sciences since 2004, working as both an advocate and scholar.

Representative publications:

Mini-Symposium: The NPRM and the Future of Human Subjects Research Regulation

I. Glenn Cohen Leave a comment

As discussed in other posts, HHS has issued a Notice of Proposed Rule Making (NPRM) with significant changes to the U.S. regulation of human subjects research. Bill of Health will be hosting a mini-symposium on the topic getting some of the most important thinkers about human subjects research to weigh in on the NPRM and what it means for the field. Watch this space for more over the coming days and weeks.