Dial in (Main): (562) 247-8422 Dial in (Alt): (702) 489-0006 Attendee

Dial in (Main): (562) 247-8422 Dial in (Alt): (702) 489-0006 Attendee Access Code: 376-069-593 Slides in “Handout” Tab VAIRRS How-To Series #1: Tracking Studies that do not Require Continuing Review Regulatory Primer on Continuing Review Soundia Duche, MA, MS Director, Education & Training ORPP&E September 23, 2020

Continuing Review Requirements pre-January 21, 2019 Pre-2018 Common Rule: “An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year ” (38 CFR 16.109(e)) Common Rule FDA Regulations FDA Regulations: “An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year ” 2 (21 CFR 56.109(f))

3 Continuing Review Requirements on/after January 21, 2019

FDA Regulated Research: CR Required Continuing Review Requirements on/after January 21, 2019 Non-Exempt Research subject to 2018 Rule: CR Required for SOME Research Non-Exempt Research subject to pre-2018 Rule: CR Required 4

Continuing Review Requirements for Research Subject to the 2018 Requirements IRBs shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, but not less than once per year, except in the instances described below: Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: Research eligible for expedited review Research reviewed by the IRB in accordance with the Limited IRB Review provisions (Exempt categories 2(iii); 3(i)(c); 7; and 8) 5

Continuing Review Requirements for Research Subject to the 2018 Requirements (Continued) Research that has progressed to the point that it involves only one or both of the following: Data analysis, inclusive of analysis of identifiable private information or identifiable biospecimens, or Access to follow-up clinical data obtained from procedures that subjects undergo as part of clinical care IRBs must document the rationale for conducting continuing review of research that does not require Continuing Review. 38 CFR 16.109(f)(1) and 38 CFR 16.115(a)(3) 6

Don’t Forget about Research under the Sole Oversight of the R&D Committee Research under the sole oversight of the R&D Committee (to include exempt research) requires continuing review by the R&D Committee. The time frame for continuing review by the R&D Committee may not exceed 365 days (VHA Directive 1200.01 paragraph 9d(1)(d)). 7

When Must Continuing Review Occur When continuing review is required, it must occur on or before the date when approval expires. No provision exists for any grace period to extend the conduct of research beyond the expiration date of IRB or R&D Committee approval. 8 VHA Directive 1200.05 paragraph 5g(19)

Lapses in IRB or R&D Committee Approval If Approval Expires: Local research office must promptly notify the investigator Investigator must stop all research activities including, but not limited to Enrollment of new subjects Continuation of research interventions or interactions with currently participating subjects Data analysis Analysis of identifiable data for IRB-approved studies 9

Additional Steps for Lapses in IRB Approval Investigator must immediately submit to the IRB Chair a list of research subjects who could be harmed by stopping study procedures IRB Chair, with appropriate consultation with the Chief of Staff, determines if subjects on the list may continue participating in the research interventions or interactions 10

Lapses in IRB or R&DC Approval Once study approval has expired, re-review and re-approval must occur by the oversight committee before the study can resume. The committee cannot retrospectively grant approval to cover a period of lapsed approval. Lapses in approval are not considered reportable events as they are not suspensions or terminations of committee approval. However, patterns of non-compliance with the requirements of continuing review should be reviewed to determine if such patterns represent serious or 11 continuing non-compliance.

Resources ORD’s Guidance on Continuing Review for IRBs: https://www.research.va.gov/resources/policies/gu idance/ContinuingReview.pdf R&D Committee FAQs: https://www.research.va.gov/programs/orppe/poli cy/faq/VHA-Directive-1200-01-faq.pdf 12

Contact Information Soundia Duche, MS, MS Director, Education and Training Office of Research Protections, Policy, and Education [email protected] 13