Common Rule Changes - NEW

From OHRP website

Delay in Common Rule Implementation

On Jan 17, HHS announced an interim Rule that would delay the effective and compliance dates of the Revised Common Rule to July 19, 2018. This will allow time for the regulatory agencies to develop more guidance around the Rule, and they will also work wtih stakeholders to determine when the Rule should ultimately go into effect. eIRB changes related to the revised Rule were implemented, but will be "turned off" until the Rule becomes effective. Note that the NIH policy changes related to clinical trials and single IRB review are still in place.

Here is the official announcement from HHS:

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. 

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf . This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule (found at §__114(b)), which remains January 20, 2020.

Federal departments and agencies listed in the IFR are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019).  If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.

Final Revisions to the Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.


Related Information

  • The Common Rule, Updated
    By Jerry Menikoff, Julie Kaneshiro, and Ivor Pritchard
    New England Journal of Medicine, January 19, 2017 (Vol. 376 No. 3)

Emory IRB Implementation

Information forecoming.