New NIH Rules for Human Subjects Research in Effect

[Michael Oberdorfer]

Effective today, NIH has issued new rules for all studies involving human subjects it will consider for funding. This in effect changes NIH’s definition of a clinical trial which has been under discussion since last year.
The details can be found in the New Human subjects and clinical trial information form issued by NIH today.

This change has stirred significant pushback from the research community and professional societies as reported in Washington Post.

Dr. Michael Lauer, NIH’s Deputy Director for Extramural Research, responded to these concerns earlier this month.

What do you think?