8/12/2016

According to the Office for Human Research Protections, the Common Rule, which began circulating in 1991, is undergoing an upgrade of sorts in order to ensure the better protection of human subjects involved in research conducted through clinical trials. The U.S. Department of Health and Human Services has propositioned the revision of the Federal Policy for the Protection of Human Subjects. The goal of the Common Rule’s revision would be to strengthen the overall policy through modernization and an increase and focus on efficiency. On September 8, 2015, a Notice of Proposed Rulemaking (NPRM) was published in the Federal Register. It addresses the need to offer better protection for subjects, while decreasing ambiguity and lessening the burden for investigators.
One of the key areas of focus and revision for the Common Rule surrounds informed consent and the confusion that often surrounds this crucial part of the research process. Informed Consent Forms (IFCs) can often present a challenge to subjects and their loved ones in terms of the difficulty the overall length of the document and the heightened medical jargon poses. IFCs should not need to be excavated in order to find the elements that really matter to the subject. The details most relevant to the subject and the study’s information need to be presented in a clear, concise manner – all while in a logical progression within the document. Clinical trials will be required to fulfill “a one-time posting” of the ICF. This places the trial’s ICF in the eyes of the public and holds them to a standard of critical analysis they may be unaccustomed to.

The NPRM focuses largely on removing any unnecessary experiences for the subject and investigator while engaged with the ICF. The NPRM aims to make “the level of review more proportional to the seriousness of the harm or danger to be avoided.” This is excellent news, since research that poses a potentially greater risk to the subjects than research that holds a lower risk-level should be required to face a longer and more rigorous review process. Requirements that inhibit the efficient processing and comprehension of the ICF will be avoided by the NPRM, as best as possible, especially if they “do not enhance protection.”

As a result of these new proposals, certain studies that require IRB review would become exempt and other studies that are already exempt would be excluded from further IRB review. A study’s exemption will be determined by “a web-based decision tool.” Investigators would be able to use the tool themselves, thus negating the need for further review.

These changes the NPRM has proposed to the Common Rule are working towards improving the subject’s understanding of ICFs, through creating ICFs that are less lengthy and convoluted. The Common Rule is based on ethical principles and these will be upheld, while the overall rule itself is strengthened and made more widely applicable across our society.

Thank you!

-The Clinical Pathways team