IRB Advisor asked Irene Stith-Coleman, director of the division of policy and assurances at the Office for Human Research Protections (OHRP) in Washington, DC, to answer questions about recent OHRP guidance related to the revised Common Rule and the recent frequently asked questions (FAQs) in the following interview:
IRB Advisor: The FAQs state: “However, the first set of revisions to the 1998 list as contemplated in this commitment has not occurred yet.” Would you please explain what has changed for 2019 with expedited review per the revised Common Rule? Specifically, are IRBs/research institutions in a holding pattern on expedited review changes until the U.S. Department of Health and Human Services (HHS) evaluates the list of research activities eligible for expedited review? (http://bit.ly/2CUSZe4)
Stith-Coleman: There exists a “holding pattern” in terms of changes to the list but not in terms of using the list. IRBs and research institutions may use the expedited review procedure, as provided for in 45 CFR 46.110(b); i.e., an IRB may use the expedited procedure to review the following:
• some or all of the research on the HHS secretary’s established list of categories of research that may be reviewed by an IRB through an expedited review procedure;
• minor changes in research previously approved during the period for which approval is authorized;
• research for which IRB review is a condition of exemption under 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
The context of that statement in the above-cited FAQ is the following:
• The 2018 requirements at 45 CFR 46.109(f)(1)(i) eliminate the continuing review requirement for research that is eligible for expedited review unless an IRB determines otherwise.
• Reference in 45 CFR 46.109(f)(1)(i) of the 2018 requirements to “research eligible for expedited review” refers to research that appears on the 1998 list since the list has not yet been evaluated. The 2018 requirements include a commitment for the HHS secretary to evaluate the list of research activities eligible for expedited review at least every eight years, and to amend it, as appropriate.
• Research that is subject to the 2018 requirements and that is eligible for expedited review, including research that falls into categories 8(b) or 9 of the 1998 list, would not require continuing review unless an IRB determines otherwise.
• However, OHRP recommends that IRBs use their discretion “to determine otherwise” under 45 CFR 46.109(f)(1) of the 2018 requirements to determine that continuing review of studies that are subject to these requirements and that meet the criteria for expedited review categories 8(b) or 9 should be conducted at the same frequency as required in the pre-2018 requirements; that is, at intervals appropriate to their degree of risk, but not less than once per year (pre-2018 requirements at 45 CFR 46.109(e)).
IRB Advisor: Regarding your eight new FAQs on the revised Common Rule: Why were the three newest questions about the compliance date added? Were these questions created to address issues IRBs/research institutions have often raised since the new Common Rule was published? (The FAQs can be found at: https://bit.ly/2IeMTtt.)
Stith-Coleman: These new questions and answers were added because of the volume of queries from the research community. OHRP does not have evidence that there has been a significant increase in compliance issues.
• What is the general compliance date of the revised Common Rule and what does it mean? OHRP answers, in part: “The compliance date of the 2018 Common Rule remains Jan. 21, 2019. This means that HHS-conducted or supported research initiated on or after Jan. 21, 2019, will need to comply with the revised Common Rule.”
• If the IRB discussed a study before Jan. 21, 2019, but did not approve the study until after Jan. 21, 2019, may that study be conducted under the pre-2018 Common Rule?
OHRP’s short answer is “no.” Expanding on that answer, OHRP says, “If an IRB discussed a study before Jan. 21, 2019, but did not approve the study (either as submitted without any conditions, or with conditions, as described in OHRP’s ‘Approval of Research with Conditions’ guidance document) before Jan. 21, 2019, then the study is subject to the revised Common Rule once approved.”
• If an IRB approves a study with conditions before Jan. 21, 2019, but verification that the conditions are satisfied occurs after Jan. 21, 2019, is that study subject to the pre-2018 Common Rule?
OHRP responds: “As per OHRP’s guidance on ‘Approval of Research with Conditions,’ the date the IRB approves the research with conditions is the date of IRB approval. The effective date of the IRB’s approvals is the date that is verified that the investigator has satisfied all conditions related to the approval. That is also the date on which the research may actually begin. The IRB is not required to verify that the conditions are satisfied; this verification may be completed by anyone who has been designated by the IRB to do so.”
Irene Stith-Coleman, director of the division of policy and assurances at the Office for Human Research Protections, answers questions about recent guidance related to the revised Common Rule and the recent frequently asked questions.
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