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:

1. Realize that proposed rules are not final and often change. This is especially true of complicated or controversial rules like this one. Each and every comment will be read and considered by agency staff who are responsible for the final rule. So make your comments count.
2. Don’t just state a position. Make a case. Agency staff do not count votes or base their decisions on the number of comments for or against a particular position. They must be persuaded to change a position.
3. Support your case with facts, data, and/or expert opinion. Provide new information, cite sources, and make well-reasoned policy arguments.
4. Explain what qualifies you to comment authoritatively on this topic. Are you an expert? Do you have personal experiences that are relevant? When considering comments, agency staff take into account their source.
5. Be constructive. If you disagree with something in the proposed rule, offer alternative language and explain why the alternative is better than what was originally proposed. Agency staff are looking for win-win solutions.
6. Read the proposed rule carefully. Your comments will not be taken as seriously if it appears you have only a superficial understanding of the issues.
7. Demonstrate that you understand all sides of an issue. Explicitly address competing viewpoints and trade-offs between alternatives.
8. You can comment on one or more specific elements, on more general topics, or both. Just be sure to clearly identify what you are commenting on. If you are commenting on a specific sentence, reference the page number and paragraph where it appears in the Federal Register.
9. Bear in mind that your comments will be publicly viewable and identifiable. If you wish, you can review and comment on other people’s comments.
10. Feel free to contact the agency contact listed in the announcement to ask questions. Agency staff will be happy to discuss the issues or clarify their thinking.

Additional information about the Federal rulemaking process and how to submit effective comments can be found here, here, and here.

Comments on the Federal Policy for the Protection of Human Subjects are due by December 7, 2015 at 11:59 PM EST.

Make your voice heard!