Human Subjects Research Regulations During COVID-19 Pandemic

Dial in (Main): (213) 929-4232 Dial in (Alt): (702) 489-0006 Access Code: 995-488-255 Slides in Handout Tab Office of Research Protections, Policy, and Education Spring Research Town Hall C. Karen Jeans, PhD Director, Regulatory Affairs ORPP&E May 4, 2020

Conducting Human Subjects Research During the COVID-19 Pandemic Conducting human subjects research during the COVID- 19 pandemic is challenging Health needs and constraints Personnel and resource constraints Time constraints Pressure to produce results 2

Applicability of Human Subject Protection Regulations During the COVID-19 Pandemic Adaptations have been made in how human subjects research is conducted: Conduct of study visits Conduct of study monitoring Delays in non-COVID related clinical trials Adaptations have not been made in the federal humans subjects protections regulations. 3

Informed Consent for Human Subjects Research: The Informed Consent Human Subject Regulations Have Not Changed Because of the Pandemic 4

Informed Consent for Clinical Procedures is Not the Same as Informed Consent for Human Subjects Research Activities Informed Consent for Clinical Procedures Informed Consent for Human Subjects Research VHA Handbook 1004.01: Informed Consent for Clinical Treatment and Procedures VHA Directive 1200.05: Requirements for the Protection of Human Subjects in Research 5

VHA Handbook 1004.01: Informed Consent for Clinical Treatment and Procedures Policies do not supersede human subject protection regulations for informed consent VHA Directive 1004.01 does not apply to research consents as per Paragraph 4.d.: . . . Specific consent for any aspect of the recommended treatment or procedure that involves research sponsored by VA, as well as any human subjects research conducted on VA premises, must meet requirements of 38 CFR Part 16 and must be obtained in accordance with VHA Handbook 1200.05, VHA Handbook 1058.03, or superseding regulation and policy. . . IRB-approved informed consents do not replace any clinical consents that the VA patient is also required to sign for purposes of having the clinical procedure. 6

Informed Consent for Human Subjects Research: Important Reminders A waiver of documentation of informed consent cannot be used for greater than minimal risk humans subjects research under FDA regulations or the Common Rule. IRBs cannot approve a method of documenting informed consent that violates human subjects research regulations. Researchers cannot sign a VA subject or VA subject s legally authorized representative (LAR) on a written informed consent document approved by the IRB. Researchers cannot alter how informed consent is documented as approved by the IRB. ORD is in alignment with FDA for obtaining informed consent in clinical trials as published in their guidance: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards located at https://www.fda.gov/media/136238/download 7

Use of COVID-19 Convalescent Plasma All uses of COVID-19 Convalescent Plasma are Investigational and regulated by FDA. There are three FDA-regulated pathways for administering or studying the use of COVID-19 convalescent plasma: Clinical trials using a traditional Investigational New Drug (IND) pathway, Expanded access using a treatment IND, such as with the Mayo Clinic Convalescent Plasma EAP, and, Expanded access using a single patient emergency use IND. 8

Use of COVID-19 Convalescent Plasma ORD is reinforcing that any use of COVID-19 Convalescent plasma requires an IND approved by FDA. Any non-emergency use requires prospective IRB approval and VA Facility R&D Committee approval. More information about FDA s regulatory pathways on COVID-19 convalescent plasma can be found at reviewing: FDA s Recommendations for Investigational COVID-19 Convalescent Plasma. 9

Source of COVID-19 Convalescent Plasma for VA Facilities The supply source of COVID-19 convalescent plasma for your VA Facility is from your hospital blood blank or whatever source the VA Facility is using for blood products. The Mayo Clinic is not supplying COVID-19 convalescent plasma for VA Facilities conducting the Mayo Clinic Expanded Access Program for COVID-19 Convalescent Plasma. For VA Facilities that do not have local availability, please work with your VA Facility s Blood Bank/Transfusion Service to order through the Red Cross: https://plasma.app.redcross.org/ConvalescentPlasmaDonorRequest/ Order/Create 10

VA Innovation and Research Review System: (VAIRRS) Tier 2 Sites Tier 1 Sites Tier 3 Sites Training has been moved to the end of the summer. We will be reaching out to the Tier 2 sites in July. 4 of the Tier 2 sites are onboarding early. Still opportunity to onboard early. 14 sites currently active 6 additional sites scheduled to go-live in May IRBNet is working with remaining sites to schedule go-live date before the end of June Training has been moved to the end of the FY. ORPP&E will be contacting the Tier 3 sites in October. 11

VA Central IRB Priorities The VA Central IRB s priorities are: 1. New COVID protocols approved by the ORD COVID steering committees 2. Amendments and reportable events for CIRB approved protocols related to COVID 3. Continuing reviews, amendments and reportable events for ongoing CIRB approved protocols involving critical interactions 4. New critical interaction protocols 5. Continuing reviews of non-COVID protocols 6. New non-COVID protocols 12

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