Common Rule Resources and Updates

The Department of Health and Human Services (HHS) and 15 other federal departments and agencies Jan. 19, 2017, released 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 multisite 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.

Latest Updates

Aug. 26, 2022. The AAMC submitted a letter to the HHS Office for Human Research Protections (OHRP) in response to the agency’s request for comments on the draft guidance Use of a Single Institutional Review Board for Cooperative Research. The draft guidance is intended to assist institutions, institutional review boards (IRBs), and human research protection staff to implement the 2018 requirement on the use of a single IRB for cooperative research projects (Subpart A of 45 CFR part 46.114). This requirement is included in the revised Common Rule. For more information, refer to Single IRB for Multisite Trials.

Jan. 20, 2020. As of Jan. 20, 2020, all cooperative research subject to the revised Common Rule will be required to use a single Institutional Review Board (sIRB) to review the research. The NIH sIRB requirement is already in effect and applies to multisite grant applications and contracts with due dates on or after Jan. 25, 2018. Additional resources can be found on the NIH sIRB webpage, including a September 2019 report by CTTI, Evaluation Framework for the NIH Single IRB Policy.

Nov. 22, 2019. The HHS OHRP announced that research conducted or supported by the HHS under the revised Common Rule may continue to use multiple IRBs in lieu of a single IRB for cooperative research if (1) the IRB approved the research before the Jan. 20, 2020, delayed compliance date for the single IRB requirement, or (2) the NIH single IRB policy does not apply, and the research was approved by an IRB or the NIH excepted the research from the single IRB policy before Jan. 20, 2020. This decision was in direct response to an AAMC joint letter expressing concerns about the HHS’ assertion that multisite research studies approved by multiple IRBs after the effective date of the revised regulations must have a single IRB of record by Jan. 20, 2020.

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 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 OHRP 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 Jan. 20, 2020.

Feb. 15, 2019. The OHRP launched a new webpage on the revised Common Rule's clinical trial informed consent posting requirements [45 CFR 46.116(h)]. The OHRP will periodically update this webpage with information and guidance.

Jan. 21, 2019. The final revisions to the common rule are in effect.

Jan. 10, 2019. The OHRP has developed a list of common questions and answers about the revised Common Rule as an educational resource and has developed pictorial representations to help clarify the transition provisions in the revised Common Rule. On Jan. 10, the 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 Feb. 11, 2019.

July 20, 2018. The 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, the OHRP published the draft guidance (PDF) in the Federal Register with comments due Aug. 24, 2018. Draft guidance documents are as follows:

• Scholarly and Journalistic Activities Deemed Not to be Research

• When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018, through January 20, 2019

• Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals

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 Jan. 21, 2019). Studies that decide to implement any of the three provisions during the delay period must comply with all of the revised Common Rule's requirements Jan. 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:

• Revised definition of "research" that deems certain activities not to be research.

• Allowance for no annual continuing review of certain categories of research

• 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 (PDF) delaying for an additional six months (until Jan. 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, the Association of American Universities (AAU), the Association of Public and Land-Grant Universities (APLU), and Council on Governmental Relations (COGR) submitted a letter to the HHS in response to the request for comments in the April 19 Notice of Proposed Rulemaking (NPRM).

March 19, 2018. The AAMC, the AAU, and the APLU responded to the HHS' request for comments on Jan. 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 Jan. 19, 2018.

AAMC Comments and Letters 

• “AAMC Joint Letter to Further Delay Implementation of the Common Rule” (March 23, 2018, Washington Highlights). 

• AAMC, AAU, and APLU joint letter in response to the IFR to delay the common rule (March 19, 2018, PDF).  

• AAMC letter to OHRP on draft single IRB guidance (Sept. 9, 2022, Washington Highlights). 

• AAMC joint letter requesting an extension to the compliance date for the Common Rule (June 21, 2017, PDF). 

• AAMC comments on the Common Rule NPRM ( Jan. 4, 2016, PDF). 

• AAMC comments on the Common Rule Advance NPRM (Oct. 25, 2011, PDF). 

Meetings and Webinars  

• Presentation to the AAMC Compliance Officers' Forum, "The Revised Common Rule: Where Are We Now? What Happens Next?" (June 20, 2018, PDF slides). 

•  AAMC meeting with OMB on the proposed delayed implementation of the Common Rule (Dec. 12, 2017, PDF). 

News and Publications  

• “HHS Proposes for Comment a Further Delay to the Common Rule" (April 20, 2018, Washington Highlights). 

• “HHS Releases Long Awaited Revisions to the Common Rule” (Jan. 19, 2018, Washington Highlights) 

• AAMC, AAU, APLU, and COGR response to NPRM to further delay the Common Rule (May 16, 2018, PDF). 

• Special Issue on the Common Rule (June 29, 2017, The American Journal of Bioethics). 

• "Opportunities Missed and Created by the New Common Rule" (June 29, 2017, Heather H. Pierce, JD, MPH, and Ross E. McKinney Jr., MD, The American Journal of Bioethics). 

• "HHS Final Common Rule Updates Address Several Concerns From Research Community" (Jan. 30, 2017, AAMCNews). 

• "National Academies Report Calls for HHS to Withdraw Proposed Common Rule Revisions" (Sept. 27, 2016, AAMCNews). 

General Resources 

• HHS Q&As about the revised Common Rule (Last updated: July 24, 2018). 

• Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period (Final Rule, June 19, 2018). 

• Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period (New NPRM, April 20, 2018). 

• Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects (Interim Final Rule, Jan. 22, 2018). 

• The Secretary's Advisory Committee on Human Research Protection (all committee recommendations). 

• Common Rule final rule (Jan. 19, 2017). 

• Common Rule NPRM (Sept. 8, 2015). 

• HHS press release on the Common Rule NPRM. 

• Optimizing the Nation's Investment in Academic Research (National Academies report, 2016)