If passed, the changes to the Common Rule (also known as the Federal Policy for the Protection of Human Research Subjects) would include “a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.” The documents will be published after trial enrolment has closed.
Additionally, consent forms would be shortened, with extra information available in appendices:
“Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find.
“They would need to give appropriate details about the research that is most relevant to a person's decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information.
Most pharma companies have yet to respond to the planned changes, although BIO (Biotechnology Industry Organization) and PhRMA (Pharmaceutical and Research Manufacturers of America) say they “applaud” HHS for trying to modernise the Common Rule and have asked for a two-month extension to the December 7 comment deadline.
A clinical trials expert told Outsourcing-Pharma.com he expects the pharma industry to request the final rule to allow redactions of parts of consent with proprietary information.
David Borasky, a VP at the institutional review board Copernicus Group IRB, told us he also has concerns that publishing consent documents alone “won’t tell you the whole story” about the consent “process” and may pose some challenges with increased uptake of electronic consent forms.
Timeline: six months?
It is possible HHS and a coalition of other government departments may decide whether to make their proposals a final rule within six months. The agency “seems under pressure to publish before the end of the Obama administration,” Borasky told us; incoming governments of either party tend to temporarily halt many planned regulations.
The FDA is not involved in rewriting the Common Rule but has said if the changes pass it will issue its own Notice of Public Rule-Making as similar as possible to HHS’s.