SACHRP Recommendations Approved May 26, 2017
Final Rule §_.101(l) Compliance Dates and Transition Provisions
Section_.101(l) of the final rule addresses compliance dates and transition provisions. The entire language of §_.101(l) is as follows:
(l) Compliance dates and transition provisions:
(1) For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations.
(2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The compliance date for §__.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.
(3) Research initially approved by an IRB, for which such review was waived pursuant to §__.101(i), or for which a determination was made that the research was exempt before January 19, 2018, shall comply with the pre-2018 Requirements, except that an institution engaged in such research on or after January 19, 2018, may instead comply with the 2018 Requirements if the institution determines that such ongoing research will comply with the 2018 Requirements and an IRB documents such determination.
(4) Research initially approved by an IRB, for which such review was waived pursuant to §__.101(i), or for which a determination was made that the research was exempt on or after January 19, 2018, shall comply with the 2018 Requirements.
SACHRP has identified several issues that would benefit from clarification by the Common Rule agencies regarding these transition provisions. Specific examples are discussed below.
SACHRP recommends that the agencies clarify that for research approved under the pre-2018 requirements for which an IRB has decided to transition to the 2018 requirements, the transition may not be piecemeal or selective, but rather must be complete. However, SACHRP recommends that the 2018 requirements only need to be applied prospectively to IRB determinations and consent forms, to compliance deadlines, and to any other requirements applicable to the research arising subsequent to the transition. It is not necessary to revisit decisions that were made under the pre-2018 requirements.
Transition to 2018 Continuing Review Provisions under 101(l)
SACHRP commends the flexibility provided in .101(l)(3), allowing an IRB to continue to oversee research approved prior to January 19, 2018 under the pre-2018 Requirements or alternatively to determine and document that the research will be overseen under the 2018 Requirements. Institutions and IRBs will need to consider the implications of adopting the 2018 Requirements.
For instance, for research that meets the conditions not to be subject to continuing review under .109(f)(1)(i) and (iii), the IRB may wish to determine and document transition to the 2018 Requirements, as this will remove the requirement for continuing review. SACHRP’s recommendation is that if an IRB documents this decision (to eliminate continuing review in accordance with the new 2018 Requirements), then the IRB would not perform continuing review of the protocol, and thereby would not be in a position to incorporate other parts of the 2018 Requirements such as the revised equitable selection of subjects provision at .111(a)(3) and new informed consent requirements at .116 (including the new organization and presentation requirements at.116(a)(5)(i) and (ii), the new requirement for disclosure regarding future research at .116(b)(9), and the requirement to post a version of the consent form from a clinical trial at .116(h)). If instead, such other parts of the 2018 Requirements were to be followed, then a new, reorganized and revised consent form and process would need to be adopted, with likely need to obtain new consent from participants, yet this would directly conflict with the planned elimination of the study from continuing IRB review. To avoid this illogical result, and to respect the preamble’s explicit intent to enhance flexibility and reduce administrative burden, SACHRP’s recommendation is that an IRB’s choice to apply the .109(f) continuing review flexibility would not trigger other 2018 Requirements.
This recommendation is grounded in several parts of the preamble that emphasize additional flexibility and reduction of burden on the regulated community. See, e.g., 82 FR at 7210, 7161 and 7205. Additional support comes from the Regulatory Impact Analyses (RIA) of costs and benefits, which describe the anticipated ways in which the new continuing review and new consent requirements will apply. The RIA predicts a reduction of over 40,000 continuing reviews, for a cost savings of as much as $148 million over 10 years. (“It is estimated that 40,773 … reviews will be discontinued under .109(f)…,” 82 FR at 7245.) In addition, the RIA calculates costs ($4.6 million) of complying with the new .116 consent requirements based on their application to “new protocols.” (82 FR at 7248.) If, in opposition to the interpretation described above, the regulatory intent instead had been for IRBs to start applying the new consent and consent form standards to old protocols that under the revised Common Rule no longer need continuing review, then the RIA would have described this and taken into account reduced benefits and increased costs.
The regulatory text also supports this interpretation. First, section .109(f) establishes a bright-line rule: “[C]ontinuing review is not required” for certain defined research. If an IRB does not adhere to this new federal “regulatory baseline,” as the continuing review requirement is termed (82 Fed. Reg. at 7210), then the IRB has the burden to develop a record setting forth “the rationale for conducting continuing review of research that otherwise would not require it.” (.115(a)(3)). The overall text makes clear that the new human subjects protection standard is to focus on higher-risk research, and this section reinforces that by directing IRBs not to perform continuing review in narrowly defined, low-risk protocols.
Also, section .101(l)(3) states that research that pre-dates the 2018 Requirements may follow those requirements in any given study if an IRB documents such determination. The reference to “2018 Requirements” inherently assumes “applicable” requirements for the study. If it instead meant all 2018 Requirements (i.e., “all or nothing”), then a study would need to comply with new waiver criteria as well as new informed consent criteria, and every other section of the 2018 Requirements. This would be a highly confusing and problematic regulatory approach for any given study. Instead, the more appropriate approach would be to recognize the new continuing review standard in the text and interpret the 2018 Requirements to allow an IRB to follow the new continuing review standard applicable to a given study.
This interpretation also ensures respect for persons. We are concerned that if applying the new continuing review standard were to trigger new 2018 Requirements for informed consent, then researchers likely would need to recontact participants, who may not have expected recontact or who even explicitly requested no recontact. Such an approach would lessen human subjects protections, not enhance them. Further, even if participants were contacted without complaints, questions likely would be raised about why they were receiving principally the same information in a newly reorganized form for procedures already performed and data already collected. If a participant did not understand the purpose of this, did not want to be bothered, or declined for any reason to provide consent, the study already has been conducted, and ongoing use of identifiable data for the integrity of the study is permissible (at least at HIPAA covered entities). This overall result does not meaningfully contribute to human subjects protections and actually may reduce them.
For all the above reasons, grounded in the regulatory text, the preamble, and the research community’s practice of meaningfully protecting participants, SACHRP recommends that for purposes of the transition provision, the HHS makes clear that it interprets the final rule to mean that IRBs in fact have flexibility to eliminate continuing review of pre-existing studies (.109(f)) without triggering all 2018 Requirements. If the agencies are concerned about studies in which obtaining consent from subjects is anticipated, then SACHRP asks that consideration be given to clarifying that the provisions recommended by SACHRP can apply to studies where obtaining consent from subjects is not anticipated. SACHRP believes this was, and should be, the intended result.
Posting Consent Forms for Research Transitioned to the 2018 Requirements
SACHRP recommends that HHS issue clarification regarding the requirement for posting of consent forms for clinical trials under .116(h). The new requirement states at .116(h)(3) that, “The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.” SACHRP asks that the agencies provide guidance on the requirement for posting the consent form for research originally approved under the pre-2018 Requirements, but which is still open, and for which the 60 day timeframe has passed. Does a consent form need to be posted at all, or should it be posted “promptly” or within some other time frame? SACHRP recommends that if the 60 day timeframe has passed, then there should not be a requirement that the consent form be posted. According to the preamble comments, the purpose of posting the consent forms is to improve the quality of consent forms and to provide useful models for others. Given that there are new consent provisions, particularly at .116(a)(5), posting consent forms approved under the pre-2018 Requirements could introduce confusion. In addition, most laws are passed with prospective enactment rather than retrospective, and SACHRPs approach falls within that tradition. Finally, it will lower administrative burden, which is a central rationale for the final rule.
Transition to 2018 Requirements Prior to Effective Date
SACHRP notes that institutions and IRBs may start to implement provisions of the 2018 Requirements prior to the transition date, as long as those provisions do not conflict with the pre-2018 Requirements. For instance, institutions and IRBs can start to add the new consent requirements to consent forms being approved prior to the transition date so that no changes are necessary to the form when the research is transitioned to the 2018 Requirements and that decision is documented. SACHRP recommends that HHS expressly support this interpretation. However, SACHRP also notes that the meaning and practical outcome of the new elements of consent at .116(a)(5)(i) and (ii) is unclear, and that the agencies should as quickly as possible issue guidance on the meaning and the effects on drafting consent forms so that the regulated community can start to implement those elements in a compliant manner.
Closure of Minimal Risk Research Not Undergoing Continuing Review
SACHPR also notes that research that qualifies as not needing continuing review under 109(f) does still require reporting of changes in research and unanticipated problems. In section D “Response to Comments and Explanation of the Final Rule: Review of Research,” at FR 7206, the preamble states;
The final rule does not require investigators to provide annual confirmation to the IRB that such research is ongoing and that no changes have been made that would require the IRB to conduct continuing review. Institutions that choose to require some accounting of ongoing research not subject to continuing review have significant flexibility in how they implement their own requirements. Note that under the final rule, investigators would still have the current obligations to report various developments (such as unanticipated problems or proposed changes to the study) to the IRB.
SACHRP recommends that IRB record systems be designed and operated to ensure that records for a study approved as exempt or through expedited review be available for the processing of amendments or reports of unanticipated problems or other new information while the study is ongoing.
Ability for Institutions to Continue to "Check the Box" and Voluntarily Apply the Federal Regulations to Non-Federally Funded Research
In at least New York and Virginia, there are state laws regarding human subjects research that only apply to research that is not conducted under and subject to the federal research regulations. In those states, institutions may determine that it is preferable to maintain their current practice to apply the federal regulations to non-federally funded by “checking the box” in order to avoid the application of inconsistent legal requirements. In order to allow an orderly transition, and to provide time for institutions to approach state governments regarding interpretation of state human research laws that have been lightly enforced to date, SACHRP recommends that the agencies allow institutions to continue to apply the federal regulations to non-federally funded research for another five years after the effective date of the final rule. The current term of an FWA is five years, so extension of this provision from the effective date forward would satisfy this request. SACHRP notes that when the FWA form is updated by OMB, it might not contain “the box” any longer, and therefore it would not be possible for an institution to “check the box” for its FWA renewal. SACHRP recommends that the agencies anticipate this, and develop an alternate approach – for example, allowing institutions conducting research subject to the research laws of any state that apply when federal research regulations do not, to file a letter with OHRP opting, for up to a five year period after the final rule’s effective date, to put all of its human subjects research under the jurisdictional coverage of the final rule.
Extension of Effective Date Due to Pending Reviews
SACHRP recommends that the Secretary take notice of considerable uncertainty in the research community about whether the final rule will take effect on January 19, 2018, as published, or will be delayed or modified by executive or congressional action. This uncertainty arises from several sources, including the Congressional Review Act (CRA), the Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs(issued on January 30, 2017), and the Memorandum for the Heads of Executive Departments and Agencies (issued on January 20, 2017) (“White House Memorandum”). As one example, the White House Memorandum temporarily postpones, for 60 days, the effective date of regulations that were published in the Federal Register but have not yet taken effect. Clarity on the effective date is important to institutions and IRBs that have to revise and implement new SOPs, forms, and computer system modifications; for researchers who will have to be trained on the new SOPs and submission systems: and for the federal agencies who have to write and publish guidance. SACHRP recommends that HHS publish in the Federal Register a new effective date (and similarly modify the transition terms of the Rule) to reflect a date one year and three years, respectively, after the date the final rule is released from Executive Review or the possibility of disapproval under the CRA.