Clinical research compliance alert: Common Rule updated, effective date delayed

The U.S. Department of Health and Human Services has delayed the effective and compliance date for the updates to the Common Rule for six months from January 19, 2018, until July 19, 2018. The updates make significant changes to informed consent that entities involved in government-funded clinical research involving human subjects must heed.

The general requirements for informed consent remain the same, with the addition of a “reasonable person” standard for judging information provided to subjects. In addition, the updates require that the informed consent process (and consent form) begin with “key information,” covering five factors, to assist subjects in understanding the implications of their participation.

The eight “basic elements” of consent still apply, with an additional requirement concerning the collection of identifiable private information (IPI) or identifiable biospecimens for future research. There are also three new requirements added to the six “additional elements” of consent, related to the use of biospecimens for commercial profit, the disclosure of clinically relevant research results to subjects and use of whole genome sequencing.

The updates also include five new subsections. These subsections (1) add a “broad consent” option, allowing prospective consent for unspecified future uses of IPI and identifiable biospecimens; (2) add a new waiver or alteration of consent for qualifying research involving public benefit; (3) include major revisions to the general waiver or alteration of consent conditions, adding new criteria for research involving IPI or identifiable biospecimens; (4) provide an exception to the consent requirement in the context of screening for recruitment purposes; and (5) require that researchers post clinical trial consent forms on a public federal website.

As to the actual consent forms, the updates now allow the use of electronic signatures where a written copy is also provided and include an additional waiver of documentation for subjects that do not sign documents according to cultural norms.

For more information, please contact either of the authors or any member of Bricker's Health Care group.