Common Rule Resources and Updates

Latest Updates

August 26, 2022 - AAMC submitted a letter to the Department of Health and Human Services Office for Human Research Protections (OHRP) in response to the OHRP’s request for comments on the draft guidance Use of a Single Institutional Review Board for Cooperative Research. The draft guidance is intended to assist institutions, institutional review boards (IRBs), and human research protection staff to implement the 2018 requirement on the use of a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. Also see AAMC resources and updates: Single IRB for Multisite Trials.

January 20, 2020 - As of January 20, 2020, all cooperative research subject to the revised Common Rule will be required to use a Single Institutional Review (sIRB) to review the research. The NIH sIRB requirement is already in effect and applies to multi-site grant applications and contracts with due dates on or after January 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.

November 22, 2019 - The HHS Office for Human Research Protections (OHRP) announced that research conducted or supported by 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 January 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 January 20, 2020. This decision was in direct response to an AAMC joint letter, expressing concerns about 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 January 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 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:

• 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 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

The AAMC would appreciate your suggestions on the kind of resources, tools, and discussions that would be most helpful to you during the implementation process. Please participate in a brief online survey.

Background

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 Resources

• AAMC Letter to OHRP on Draft Single IRB Guidance (September 9, 2022, Washington Highlights)

• AAMC, AAU, APLU, and COGR Response to NPRM to Further Delay the Common Rule (May 16, 2018)

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

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

• AAMC, AAU, and APLU Joint Letter in Response to the IFR to Delay the Common Rule (March 19, 2018)

• HHS Releases Long Awaited Revisions to the Common Rule (January 19, 2018, AAMC Washington Highlights)

• AAMC Meeting with OMB on the Proposed Delayed Implementation of the Common Rule (December 12, 2017)

• Science Magazine - What Do Revised U.S. Rules Mean for Human Research? The Updated Common Rule Raises Many Questions (August 17, 2017) 

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

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

• AAMC Joint Letter Requesting an Extension to the Compliance Date for the Common Rule (June 21, 2017)

• AAMC News Release - HHS Final Common Rule Updates Address Several Concerns From Research Community (January 31, 2017)

• AAMC Statement on the Release of the Common Rule (January 19, 2017)

• AAMC News Release - National Academies Report Calls for HHS to Withdraw Proposed Common Rule Revisions (September 27, 2016)

• AAMC Comments on the Common Rule NPRM (January 4, 2016)

• AAMC Comments on the Common Rule Advance Notice of Proposed Rulemaking (October 25, 2011)
   

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 )

• Understanding the IFR to Delay the Effective and Compliance Date (January 23, 2018, slides  recording)

• Overview of the Final Rule (January 25, 2017, slides with recording / slides only 

• Previous Education on the NPRM (AAMC Webinars)
   

External 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, January 22, 2018)

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

• Common Rule Final Rule (January 19, 2017)

• HHS Press Release on the Final Rule (January 18, 2017)

• Common Rule NPRM (September 8, 2015)

• HHS Press Release on the Common Rule NPRM

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

• PRIM&R Common Rule Resources and Tools
   

News and Publications

• A Conscious Decoupling of Effective and Compliance Dates (Bloomberg, March 23, 2018)

• Proposed Delay to Research Rule Still Up in the Air (Bloomberg, October 18, 2017)

• Trump Administration Seen Unlikely to Change Human Research Rule (Bloomberg, May 26, 2017)

• Some Social Scientists Are Tired of Asking for Permission (The New York Times, May 22, 2017)

• White House Reviewing Obama-Era Update of Human Research Rule (Bloomberg, May 12, 2017)

• Early Adoption Not an Option for Research Rule Changes (Bloomberg, March 15, 2017)

• Revamping the US Federal Common Rule, Modernizing Human Participant Research (JAMA, April 18, 2017)

• The Common Rule, Updated (New England Journal of Medicine, February 16, 2017)

• Controversial Patient Consent Proposal Left Out of Research-Ethics Reforms (Nature, January 18, 2017)

For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926. You may follow Heather on Twitter at twitter.com/HeatherHPierce.