by Ellen Fox, MD
Yesterday, the Federal Register published a long-awaited Notice of Proposed Rulemaking to “modernize, strengthen, and make more effective” the Federal Policy for the Protection of Human Subjects known as “the Common Rule.” The proposed changes are endorsed by 16 Federal agencies, plus several others that “intend to adopt the proposed rule” through a separate rulemaking. This event is momentous for several reasons. First, there have been almost no changes to the Common Rule for over 30 years. Most of the current language in the Common Rule was first published by the Department of Health, Education, and Welfare in 1981. Second, the proposed changes are far-reaching. They include, for example, improvements to the informed consent process, new exclusions for activities that will no longer be covered under the Common Rule, and the addition of categories of exempt research. Third, achieving consensus among this many Federal agencies is an amazing feat. Trust me on this. And perhaps most importantly, this event is momentous because it affords the public an extraordinary opportunity to shape Federal policy.
If you have an interest in the protection of human research subjects, I urge you to take advantage of this opportunity. To do so, go to this page and click on the green box labeled “Submit a Formal Comment.” You will be asked for your contact information. You can then upload your comments as an attachment, or type them directly into a box provided on the screen.
As someone with inside experience with this process, I offer the following tips for submitting public comments on a proposed rule:
- Realize that proposed rules are not final and often change.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.