This past January, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the “Common Rule,” was published in the Federal Register. Although there has been talk of pushing back the compliance date, the bulk of changes made by the Revised Common Rule are still currently set to go in effect on January 19, 2018.
The Common Rule is the set of regulations governing clinical research involving human subjects conducted or sponsored by the federal government agencies and departments that have adopted the rule (including the U.S. Department of Health and Human Services and the Food and Drug Administration among others). The revisions were the first in well over a decade and were intended to modernize the rule.
These revisions touch on many areas of interest. Of note, the revised rule adds new definitions and revises existing definitions in the rule, including a new definition of “clinical trial,” an expanded definition of “human subject” to cover the collection of identifiable biospecimens, and a revised definition of “research” to carve out four additional categories of excluded activities. The Revised Common Rule adds new elements of informed consent and updates the exemptions to the rule (both revising the existing exemptions and exempting secondary research under set conditions). Also among the changes is the elimination of the requirement of continuing review for many minimal risk studies.
To comply with the Revised Common Rule, entities engaged in covered research will need to train their staff and make operational changes affecting their IRBs, informed consent, secondary research, and possibly Federalwide Assurances (FWAs) among others. With the exception of revisions relating to cooperative research, the implementation date for the changes is currently January 19, 2018. Even if that date is delayed as is rumored, it is important to start evaluating what needs to be done to comply as soon as possible if the organization has not already done so.