June 18, 2018
HHS and 16 Other Federal Departments and Agencies Issue a Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period
The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule).
This policy was originally promulgated as a Common Rule in 1991, and was revised on January 19, 2017 (82 Fed. Reg. 7149) (the revised Common Rule is also known as the “2018 Requirements”). The effective and general compliance date for the 2018 Requirements was delayed to July 19, 2018 by an interim final rule that was published on January 22, 2018 (83 Fed. Reg. 2885). Subsequently, a Notice of Proposed Rulemaking (NPRM) was published on April 20, 2018 (83 FR 17595), which proposed an additional 6-month delay for the general compliance date for the 2018 Requirements and a flexibility that would allow regulated entities to take advantage of three burden-reducing provisions of the 2018 Requirements during the delay period.
The Final Rule adopts the proposals that were described in the April 2018 NPRM. The Final Rule delays the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019. The transition provision in the Final Rule is structured so that regulated entities cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019. As a result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019. The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:
(1) The revised definition of “research,” which deems certain activities not to be research;
(2) The allowance for no annual continuing review of certain categories of research; and
(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the 2018 Requirements beginning on January 21, 2019.
The Final Rule has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/06/19/2018-13187/protection-of-human-subjects-delay-of-general-compliance-date.
January 17, 2018
HHS and 15 Other Federal Departments and Agencies Announce an IFR That Delays the Effective Date & General Compliance Date of the Revisions to the Federal Policy for the Protection of Human Subjects to July 19, 2018
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.
January 16, 2018
CHANGES TO THE FEDERAL REGULATONS THAT GOVERN HUMAN SUBJECTS RESEARCH (“COMMON RULE”)
The Final Rule to update the current regulations at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on 19 January 2017 in the Federal Register. Changes to the Common Rule, the primary rule regulating human subjects research, are currently set to go into effect on January 19, 2018.
On January 19, 2018, OHRE is planning to begin implementation of the revised Common Rule changes into IRBIS. The first step will primarily impact new studies submitted on or after January 19, 2018. As not all federal agencies have signed on to be covered by this new rule, certain studies such as those regulated by the Food and Drug Administration and the Department of Justice, remain subject to the prior regulations. OHRE is in the process of identifying these projects and making sure they are reviewed accordingly.
Two requests to delay the date have been filed, however, both are pending review by the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB). In the event the date is delayed, an announcement on the OHRE website will be made. There will also be an FAQ page available on the OHRE website soon.