The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”  While the guidance is draft, it provides insight into OHRP’s interpretation of the rule, including that:

  • Institutions do not have to transition studies approved or determined exempt before January 21, 2019 to comply with the revised rule. The default position of the rule is that such studies remain subject to the pre-2018 requirements unless an institution voluntarily decides to transition the study to comply with the 2018 requirements.
  • Institutions may make the determination to transition on a per-protocol basis or with respect to a broader category of research conducted at an institution.
  • When an institution decides to transition a study and documents the decision, including adoption of the three burden-reducing provisions during the delay period, that decision may not be reversed. The study must comply with the 2018 requirements for the remainder of its ‘lifespan”.
  • For transitioned studies, the 2018 requirements apply to prospective activities, not activities that have already occurred, for example:
    • Already enrolled participants do not need to be reconsented for the sole purpose of providing them with consent compliant with the 2018 requirements. However, if reconsent is necessary for another purpose (e.g., new risk information), the new consent must comply with the 2018 requirements
    • Data or specimens obtained under an existing waiver of consent do not need to be withdrawn if the research doesn’t qualify for a waiver under the new criterion (that the research could not practicably be carried out without using such information or biospecimens in an identifiable form). However, for any prospective collection of information or specimens (on or after the study’s transition date), all of the criteria for a waiver of consent in the 2018 rule must be satisfied or consent must be obtained.
  • “Consistent with the principle that the Common Rule establishes a regulatory floor, an institution can implement any kind of additional review that it wants as a matter of institutional policy for research conducted at that institution.” For example, an institution can establish that continuing review is required for all (or a subset) of research conducted at the institution even when it is not required by regulation.  Institutional policy would be the rationale that must be documented for research subject to the 2018 requirements.

Comments on the draft guidance will be accepted through 2/11/2019 and may be submitted, identified by docket ID number HHS-OPHS-2019-0001, via http://www.regulations.gov or by Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Lauren Hartsmith, J.D., OHRP 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.