The Final Rule to update the current regulations at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (the Common Rule) was published by the U.S. Department of Health and Human Services (DHHS) on 19 January 2017 in the Federal Register. The general compliance date of the revised Common Rule is 21 January 2019, while the revisions to cooperative research and use of single Institutional Review Boards compliance date is 20 January 2020 ( to prepare, view our guide to the revised common rule).
There are several revisions to 45 CFR 46.116, which focus on the process of obtaining subject informed consent. These changes include revisions and additions to the general requirements and basic elements, as well additional elements. For example, researchers conducting clinical trials will now be required to post trial consent forms on a federal website, “after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.” For a multi-site study, only a single consent form from the entire study is required to satisfy the posting requirement – not a consent form from each participating site.
The Office for Human Research Protections (OHRP) has just identified “two publicly available federal websites that will satisfy the consent form posting requirement” in the revised Common Rule: http://ClinicalTrials.gov and a docket folder on http://Regulations.gov. More may be identified in the future.
Check back to the Pearl IRB blog or further updates.