May 17, 2019 - The NIH announced guidance on where to post clinical trial consent forms for NIH-funded clinical trials. The revised Common Rule requires the posting of IRB approved consent forms to a designated public federal website. The recipients of NIH funding must submit consent forms in accordance with Section 46.116(h) of the revised regulations to ClinicalTrials.gov or to Regulations.gov (Docket ID: HHS-OPHS-2018-0021). Additional information on the consent form posting requirement can be found on the Office for Human Research Protections (OHRP) webpage on posting clinical trial consent forms.
May 1, 2019 -The AAMC, with the AAU, the APLU, and COGR, sent a letter to the HHS Office for Human Research Protections expressing concerns about the office’s assertion that multisite research studies approved by multiple IRBs after the effective date of the revised Common Rule must have a single IRB of record by the delayed compliance date of January 20, 2020. The letter can be found here.
February 15, 2019 - OHRP launched a new webpage on the revised Common Rule's clinical trial informed consent posting requirements (45 CFR 46.116(h)). OHRP will periodically update this webpage with information and guidance.
January 21, 2019 - THE FINAL REVISIONS TO THE COMMON RULE ARE IN EFFECT
OHRP has developed a list of common questions and answers about the revised Common Rule as an education resource, and has developed pictorial representations to help clarify the transition provisions in the Revised Common Rule. On January 10th, OHRP released the draft guidance, The Revised Common Rule Compliance Dates and Transition Provision, which discusses "the regulatory implications of institutional decisions to voluntarily transition research studies initiated before January 21, 2019." Public comments were due on February 11, 2019.
July 20, 2018 - The Department of Health and Human Services (HHS) announced the availability of three draft guidance documents on the revised Common Rule relating to the three burden-reducing provisions that regulated entities are permitted to adopt during the delay period (see below). On July 25, OHRP published the draft guidance in the Federal Register with comments due August 24, 2018. The Federal Register notice can be found here. Draft guidance documents are as follows:
July 19, 2018 - As of July 19, 2018, regulated entities have the option to implement three "burden reducing provisions" of the revised Common Rule during the delay period (July 19, 2018 through January 21, 2019). Studies that decide to implement any of the three provisions during the delay period, must comply with with all of the revised Common Rule's requirements on January 21, 2019 for the full duration of that study. A decision about whether to adopt any of the burden reducing provisions may depend on the nature and progress of the study. The three burden reducing provisions include:
1. Revised definition of "research" which deems certain activities not to be research;
2. Allowance for no annual continuing review of certain categories of research; and
3. Elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
June 19, 2018 - HHS issued a final rule delaying for an additional six months (until January 21, 2019) the general compliance date for the revised Common Rule while allowing the voluntary adoption of three "burden-reducing provisions" of the revised rule during the delay period. On May 16, the AAMC, Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR) submitted a letter to HHS in response the request for comments on the April 19 Notice of Proposed Rulemaking (NPRM).
March 19, 2018 - the AAMC, AAU, APLU responded to HHS' request for comments on January 22, 2018 an IFR to delay the effective and general compliance date of the revisions to the Common Rule until July 19, 2018. The revised final rule was originally scheduled to go into effect on January 19, 2018.
Tell AAMC How We Can Help
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On January 19, 2017, HHS and 15 other federal departments and agencies released the final revisions to the Federal Regulations for the Protection of Human Subjects, also known as the Common Rule. The regulations, which have been in place since 1991, govern federally supported research involving human subjects. Among the changes to the regulations, the most significant include the mandate that a single Institutional Review Board (IRB) review and approve all multi-site research and the extension of the Common Rule to all clinical trials conducted at a U.S. institution that receives federal funding regardless of the funding source. The rule also requires new approaches to the informed consent process such as the publication of informed consent documents.
AAMC Webinars and Presentations
Presentation to the AAMC Compliance Officers' Forum - "The Revised Common Rule: Where Are We Now? What Happens Next?" (June 20, 2018, slides )
Previous Education on the NPRM (AAMC Webinars)
News and Publications
For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at email@example.com or (202) 478-9926. You may follow Heather on Twitter at twitter.com/HeatherHPierce.