The U.S. Department of Health and Human Services (DHHS), along with 15 other federal agencies, proposes to delay the effective date of sweeping changes promulgated last year regarding protection of human subjects in federally funded research outside of FDA jurisdiction, known as the “Common Rule.” See 83 FR 17595, dated April 20, 2018. The proposal is intended to do three things: (a) give the research community additional time to comply with the numerous new requirements in the new Common Rule; (b) give DHHS and other federal agencies time to issue sub-regulatory guidance; and (c) offer burden-reducing flexibility to research institutions in certain instances. Comments on the proposed rule are due by May 21, 2018.
The proposal would push the effective date of the new Common Rule back from July 19, 2018, until January 21, 2019. The proposal offers the research community several options regarding the timing of implementing the new Common Rule:
1. The default position is that research initiated before January 21, 2019, would continue to be governed by the old Common Rule for its duration even if the research extended beyond January 21, 2019.
2. Alternatively, research institutions could affirmatively opt in writing to transition research begun prior to January 21, 2019, to the new Common Rule in its entirety starting on January 21, 2019. Under this option, research started before January 21, 2019, would be subject first to the old Common Rule and then switch to the new Common Rule midstream.
3. A hybrid alternative is available for research started before January 21, 2019. If the research institution elects at any time between July 19, 2018, and January 21, 2019, to transition the research to the new Common Rule in its entirety as of January 21, 2019, it can also opt to immediately start applying three aspects of the new Common Rule even before January 21, 2019. These three carve-outs are:
- the new Common Rule’s definition of “research,” which deems certain activities not to be research subject to the Common Rule at all;
- the new Common Rule’s elimination of the requirement that an IRB review the grant application related to the research; and
- the new Common Rule’s allowance for no annual continuing review of certain categories of research.
The hybrid alternative is only available if the research institution executes its option to transition to the new Common Rule between July 19, 2018, and January 21, 2019. The research institution can decide to apply the hybrid approach to its whole research portfolio, to only certain classes of research, or only to individual research protocols.
4. Research begun after January 21, 2019, or pre-existing research that is transitioned to the new Common Rule after January 21, 2019, will be subject to the new Common Rule in its entirety for all of its activities.
This complicated set of alternatives is the proposing agencies’ attempt to decrease burden on the research community. In anticipation of the adoption of the proposed changes as a final rule, research institutions should consider which timing option is most advantageous, for which research protocols. These changes are not applicable to research under FDA jurisdiction, such as research to support new drug or medical device applications, but pertain only to other federally funded research, such as those supported by NIH or SAMHSA grants. The proposed approaches give research institutions many options and deserve critical thought.