ORO Town Hall Meeting Updates & Guidance Summary

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Updates from the recent ORO Town Hall meeting presented by Kristina Borror, Ph.D., Director of Policy & Education, on May 4, 2020, include expanded access for sites without FWAs, flexibility in remedial action plans, ORO reporting guidance, directives, and more. Guidance on COVID-19 incidents and reporting, audit practices during the pandemic, and flexibility in compliance reviews were also discussed.

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ORO Town Hall meeting Updates Presented by: Kristina Borror, Ph.D. Director, Policy & Education, ORO Date: May 4, 2020 1

Overview Expanded access for sites without FWAs Audit Guidance Flexibility for remedial action plans ORO reporting guidance ORO Directives 1058.01 & 1058.03 Facility Director s Certification (FDC) ORO site visits Field Questions

Expanded Access for COVID-19 Treatment Worked with ORD to develop a special assurance, MOU and procedures to allow VA facilities without a research program or an FWA to treat COVID-19 patients with investigational drugs under an expanded access program

ORO Audit Guidance If an RCO s auditing practices require in-person interaction with study staff, counter to recommendations for slowing the spread of COVID-19, completion of such audit activities should be postponed until further ORO notice, or alternative methods can be implemented that would enable the RCO to conduct the audit activity without in-person interactions with study staff No need to audit expanded access protocols

Remedial Action Plans for ORO Compliance Reviews Unless there is imminent risk of harm to human research subjects, employees, or research animals, ORO will exercise flexibility re timelines for remediation of ORO compliance findings. Facility COVID-19 responses take precedence. Let ORO know if you need flexibility on RAP timeframes.

ORO Guidance on COVID-19 Incidents and Reporting to ORO In most cases, modifications/holds/stops of research activities due to COVID-19-related concerns not related to a research-specific risk will NOT need to be reported to ORO. A temporary stop of research or research activities for the same reasons, such as outlined in ORD s ADMINISTRATIVE HOLD would not be reportable to ORO under VHA Handbook 1058.01 6.h.

1058.01 1058.01: Research Compliance Reporting Requirements --proposed major changes: Handbook being revised into a Directive Provides added flexibility for reviewing and reporting requirements where a facility relies upon an external research review committee Provides additional flexibility with regard to the individuals in VA medical facility senior leadership to whom an RCO may report.

1058.03 1058.03: Assurance of Protection for Human Subjects in Research-- proposed major changes: Handbook being revised into a Directive Only VA medical facilities engaged in non-exempt human subjects research must hold a recognized assurance of compliance. Only IRBs operated by the VA medical facility must be designated on the FWA or, in the absence of an IRB operated by the facility, only the primary external IRB relied upon must be designated. Elimination of requirement for facilities to report IRB roster changes to ORO. Responsibility for approving the restriction or suspension of an FWA or VA FWA Addendum, based on a recommendation by the ORO Executive Director, has been assigned to the USH.

Facility Directors Certification (FDC) ORO is continuing to assess the COVID-19 situation and is considering options for the FDC, including: Delay implementation and/or submission deadline Limit data collection (e.g., collection of only RCO audit data)

When will ORO oversight visits resume? ORO is continuing to monitor the pandemic situation and will adhere to travel-related guidance that is issued by the Department.

HRP Questions From the Field to ORO ORO will answer Qs related to ORO policies (1058 series policies) When ORO receives a question related to an ORD human subjects protection policy, we will direct the questioner to the relevant ORD policy/guidance/website and note that if the Q is not answered by review of said policy, the questioner should direct their Q to VHACOORDRegulatory@va.gov