HHS Issues Draft Guidance on Transitioning Studies to Revised Common Rule Requirements

J.W. Schomisch
January 19, 2019 at 10:43 AM EST
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The Department of Health and Human Services released a draft guidance on the regulatory implications of transitioning existing studies to the revised Common Rule requirements. The guidance, issued by HHS’ Office for Human Research Protections, deals with studies started before the revised Common Rule took effect on Jan. 21.

“HHS recommends that institutions carefully consider the implications of transitioning a study (or set of studies) before any transition determination is made,” the guidance said. “Such an analysis could include consideration of whether there will be administrative benefit or administrative burden created by transitioning a study, and whether there might be additional protections or benefits to subjects participating in a research activity.”

HHS noted the decision to transition is voluntary, but that once a study is transitioned to the new requirements, it cannot be transitioned back to the old rules. “A decision to transition a study may not be reversed,” the guidance said.

The guidance added individual institutions have “the flexibility to determine who makes the transition determinations on the institution’s behalf” and that an institution can decide to transition individual studies, classes of studies, or all studies.

Either the institution or the institutional review board (IRB) can document transition determinations. “The institution and the IRB have the flexibility to determine who will document these determinations on the institution's or IRB's behalf. Remember: If the institutional determination occurs prior to the documentation of that determination, the date of the documentation is the transition date.”

The guidance also noted that when a study is transitioned, the new requirements “apply only to future actions or activities (i.e., prospectively) beginning on or after the transition date.”

Flexibility Detailed

HHS added institutions also have the flexibility to implement provisions of the new requirements that do not conflict with the old requirements on non-transitioned studies through institutional or institutional review board (IRB) policy without transitioning the study. For example, “without transitioning a study, it is permissible to incorporate the new elements of consent because the [old] requirements do not prohibit such information in an informed consent document,” the guidance said.

“Similarly, institutions and IRBs may retain or implement institutional policies related to the [old] requirements for studies that are subject to the [new revised] requirements, as long as the policies do not conflict with the [new] requirements. Examples of institutional or IRB policies that could be voluntarily implemented or retained for studies subject to the [new] requirements include:

  • Implementing a periodic administrative check-in with investigators conducting exempt and nonexempt research to verify that no changes have been made to the research activity during a specified time period;
  • Implementing administrative review of protocols involved in cooperative research when a different IRB of record is used;
  • Requesting a copy of the grant application from investigators (when available) and reviewing that application as part of the protocol review process.

In addition, “if an institution or IRB determines that it wants to conduct continuing review of research that is not otherwise required to undergo such review by the [new] requirements, there are two pathways available:"

  • Pathway 1 – Review required by institutional policy. “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. Such reviews could mirror the continuing review process described in the [new] requirements or could be different. Notwithstanding institutional policy, if an IRB determines that continuing review is otherwise required, as set forth in 45 C.F.R. §46.109(f)(1) of the [new] requirements, then continuing review must be conducted in accordance with the [new] requirements, including documentation of the IRB's rationale for requiring continuing review. Such continuing reviews will be subject to OHRP compliance oversight.”
  • Pathway 2 – Regulatory continuing review. “If an IRB determines that continuing review is warranted for a study (even if continuing review would not otherwise be required under 45 C.F.R. §46.109(f)(1) of the [new] requirements), continuing review will be required for the study. Such continuing reviews will be subject to OHRP compliance oversight. The determination and documentation requirements set forth in 45 C.F.R. §46.109(f) and 45 C.F.R. §46.115(a)(3) of the [new] requirements must also be satisfied. These requirements can be satisfied as long as an IRB determines that continuing review is warranted, either on a study-specific basis or with respect to broader categories of research, and the rationale for this determination is documented. Given that the regulatory language refers to an IRB's determination, an institutional policy would not satisfy this requirement without the involvement of an IRB. However, an IRB could make a determination at a convened meeting that certain research at the institution or all research at the institution warrants continuing review and that determination could be documented in an institutional or IRB policy. The rationale for why continuing review is required should be specific to the review of a particular study or group of studies. For example, a rationale that a study is using new or novel analytical techniques is an appropriate reason for why continuing review for a particular study or group of studies would be appropriate.”

The guidance noted that “protocol amendments must be reviewed and evaluated under the version of the Common Rule to which a study is subject, regardless of when the amendment is made, the guidance said. For example, if an institution transitions an ongoing research activity on April 5, 2022, before April 5, 2022, any protocol amendment for this activity would be reviewed under the [old] requirements. On and after April 5, 2022 (i.e., the study's transition date), amendments would be evaluated under the [new] requirements.”

Informed Consent Issues Examined

“There is no need to automatically seek a new consent from subjects who have already provided informed consent” when a study is transitioned, the guidance said. “However, if after a study's transition date, the IRB approves a new or amended informed consent (either based on an IRB determination that this is required by the regulations or is an advisable action), such a new or amended consent form must comply with the [new] requirements (e.g., must incorporate any 45 C.F.R. §46.116 provision of the [new] requirements that was not included in the original consent).”

The guidance added that “as long as the IRB records include documentation that an IRB has determined (in accordance with 45 C.F.R. §46.111(a)(4) and (5)) that the study's informed consent satisfies the [new] requirements, the IRB or institution need not take additional steps to verify that an informed consent form complies with the [new] requirements on or after the study's transition date.”

In cases where a study initiated before Jan. 21, 2019, was approved using the waiver of informed consent criteria found in the [old] requirements is transitioned, the study may have to follow the waiver of informed consent criterion in the new requirements. “The [new] requirements include a new criterion for waiver of informed consent: if the research involves using identifiable private information or identifiable biospecimens, the IRB must determine that the research could not practicably be carried out without using such information or biospecimens in an identifiable form (45 C.F.R. §46.116(f)(3)(iii)). While a study must comply with the [new] requirements on and after its transition date an IRB does not need to review actions that occurred prior to a study's transition date for compliance with the revised Common Rule,” the guidance said.

“Thus, the [new] requirements' new waiver criterion is only relevant if subjects are still being enrolled in the study on and after the study's transition date. If all subjects have been enrolled in a study before the study's transition date, then the new waiver criterion at 45 C.F.R. §46.116(f)(3)(iii) is not relevant because this element of waiver did not apply at the time that subjects were enrolled. If subject enrollment is ongoing on or after the study's transition date, an IRB must ensure that such enrollment complies with all of the waiver criteria outlined in the [new] requirements (including 45 C.F.R. §46.116(f)(3)(iii)),” the guidance said.

“This will mean that, before these new subjects are enrolled, the IRB must review and approve the study in light of the [new] requirements' waiver of informed consent criteria, in order to make the determination that the research could not be practicably carried out without using the identifiable information or identifiable biospecimens. In order to streamline the study's transition to compliance with the [new] requirements, the IRB could have made such a determination during a review conducted prior to the study's transition date.”

In cases where an institution transitions an ongoing study to comply with the new requirements and the study's investigator modifies the consent form to be consistent with them, “IRBs may consider whether modifying the consent form to satisfy the [new] requirements represents a minor change to the research. If such a determination is made, the IRB may use the expedited review procedure to evaluate the consent form changes, as permitted under 45 C.F.R. §46.110(b)(1)(ii),” the guidance said.

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