On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of exempt research. We also reviewed the NPRM’s proposed changes related to informed consent, to biospecimens research, and to institutional review board (IRB) review.

In today’s post, we examine issues related to the NPRM’s scope and to harmonization. We conclude with the proposed implementation timeline and some practical suggestions for drafting and submitting effective comments.

NPRM proposes to extend the Common Rule to cover more clinical trials

The NPRM proposes to extend the Common Rule to cover all clinical trials conducted at an institution in the United States if the institution receives any federal funding for non-exempt human subjects research and regardless of the funding source of any specific clinical trial. The stated purpose of this “clinical trial extension” is to ensure that all clinical trials, the type of studies likeliest to pose significant risks, are covered by human subject protection measures. Clinical trials already subject to FDA oversight but not the Common Rule would not be affected by this change.

As a result of this change, institutions would no longer have the option of not extending the Common Rule regulations to their non-federally funded clinical trials. In the past, institutions seeking flexibility within regulatory compliance may have “unchecked the box” on their Federalwide Assurance (FWA), thereby limiting federal oversight to research funded and regulated by a Common Rule agency. The preamble of the NPRM points out that OHRP’s database shows that 25% of institutions with active FWAs already extended the Common Rule to all research at their institutions (DHHS 2015, 53982).

It is important to remember that the FDA is not a signatory to the Common Rule, and thus is not one of the agencies involved in the NPRM. Once the new Common Rule is finalized, the FDA will go through a separate rulemaking process to harmonize its regulations as closely as possible with the Common Rule’s regulations. The FDA and the Office for Human Research Protections (OHRP) will continue to collaborate on harmonization of their respective guidance documents to the extent possible (DHHS 2015, 53981).

NPRM implementation timeline

The final revised Common Rule will go into effect one year after it is published in the Federal Register, with the exception of two provisions. The compliance date for the new provisions concerning consent for storage and secondary use of biospecimens is three years after publication of the final rule [§__.101(k)]. The three-year compliance deadline also applies to the mandate that any institution located in the U.S. that is “engaged in cooperative research” rely upon approval by a single IRB for the portion of the research that is conducted in the United States [§__.114(b)(1)].

However, it is important to remember that the NPRM is just a proposal. It is possible that a final rule will not include all of the provisions outlined here. It would thus be premature for IRBs, researcher teams, or institutions to start implementing any of these provisions, or make changes with respect to how they conduct and review human subjects research in light of these proposals.

The final rule may have new provisions or changes made in response to the comments currently being accepted. There is still time to provide your input on the proposed changes and potentially have an impact on the final rule. We strongly encourage you to do so. Below we offer some practical guidance on how to draft effective comments.

How to draft effective comments

The American Bar Association offers some helpful tips to make your comments stand out. To effectively write your comments, propose regulatory language but make sure to address DHHS’s stated concerns. If you offer an alternative, make sure your request is something DHHS has the power to do (i.e. no changes need to be made by Congress) and is consistent with the scope of the NPRM. Consider providing an executive summary if your comments are lengthy. After you submit your comments, consider sending “courtesy copies” to the relevant DHHS staff and Congressional offices (especially if your Congressional delegation includes members that sit on committees that oversee DHHS).

Here is how to submit comments electronically to OHRP:

• Use the link: www.regulations.gov
• Enter the docket number: HHS–OPHS–2015–0008 into the regulations.gov box that is labeled “Search.”
• The second result will be the DHHS Federal Register notice.
• Click on the “Comment Now” button that is to the right of the notice title.
• DHHS prefers that your comments be in Microsoft Word.

Comments are being accepted on the proposed rule through January 6, 2016 at 5:00 PM ET.

PRIM&R recently completed a draft of our comments to DHHS in response to their NPRM. We invite your reflections on our draft comments and welcome you to quote it in your own comments.

References

Department of Health and Human Services (DHHS). 2015. Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects. Federal Register 80 (173): 53981-53982.

Conrad, James W., Dailey, Joan P., and Andrew Emery. (2013, Apr. 3). Rulemaking 101 – The APA & Rulemaking Process. Retrieved from http://www.americanbar.org/content/dam/aba/events/administrative_law/2013/04/administrative_lawandregulatorypracticeinstitute/rulemakinghandout.authcheckdam.pdf