Conducting Human Subjects Research during the COVID-19 Pandemic: Guidance for Hackensack Meridian Health Investigators Tamara Friedman, PhD, Clinical Research Education Specialist Avery Freed, CIP, Director, Human Research Protection Program Daniel Alderson, MS, CIP, Manager, Office of Research Integrity
COVID-19 Research and Treatment
COVID-19 Initiatives • All hands on deck for COVID-19 efforts All COVID-19 new trials should utilize a commercial • Institutional Review Board (IRB) [ex. WIRB, Advarra], regardless of sponsorship/funding When enrolling patients into COVID-19 • trials/Emergency/Compassionate Use products, keep efficacy discussions honest with regard to benefit.
COVID-19 Steering Committee • Every new study/trial that is COVID-19 (minimal risk or greater than minimal risk) must first be submitted to the Steering Committee before IRB. Once the Steering Committee has approved the study, it may be submitted to an IRB (HMH or external). The deadlines for this week (midnight tonight for submission and Friday, 3/27 • for a response) are rolling deadlines. If you miss tonight’s deadline, submit and it will be reviewed in the next group. • The BioR protocol will be amended to include COVID-19 and COVID-19 enrollment will be prioritized. All questions about this process should be directed to Drs. Aschner and Gourna • Paleoudis
Emergency/Compassionate Use The Process: (Outlined in more detail: Emergency Individual Patient IND Process) 1. Contact the manufacturer 2. Prepare the patient/family in advance that the company could say “no”. 3. If yes, notify the FDA via email at DAVPEINDREQUEST@fda.hhs.gov 4. Notify/consult the IRB of record and the HMH IRB 5. If emergency, notify the IRB within 5 days of use (the definition of emergency can be stretched in a pandemic) *Know what else is in the pipeline.*
Use of Legally Authorized Representatives (LARs) in the Context of COVID-19 Enrollment Institutional waiver of documentation of informed consent for LAR to consent via phone • Email consent to LAR in advance • Document your communication and the LAR’s consent • This should be documented on the same form that the individual obtaining informed consent is signing. Then, the consent should be photographed and the original discarded.
Considerations for COVID- 19’s E ffects on Other Ongoing Trials
Information and Resources for Handling Existing Trials FDA Guidance on Conduct of Clinical Trials of Medical Products • during COVID-19 Pandemic (Released 3/18): Guidance for Industry, Investigators, and Institutional Review Boards • Institutional policy: Suspension of all studies that do not pose the possibility of direct benefit to subjects. Restrictions Regarding COVID-19 • Don’t abandon those potentially benefitting from trials, but any new studies should have the potential for rapid clinical use • New risk/benefit ratio: Risk of coming to the hospital needs to be considered
What needs IRB approval? • Regulations prefer prospective review and approval [21 CFR 56.108(a)(4)] “except where necessary to eliminate apparent immediate hazards to human subjects.” • If possible, submit amendments to the IRB overseeing the research prior to making the changes (elimination/reductions of study visits, switching to telemedicine, collection of labs offsite, etc.) • Indicate if the changes are temporary (until pandemic is managed) or permanent protocol changes. If temporary, correspondence with the IRB of record is required when protocol will revert back to original version. • If changes are made without prior IRB approval, submit to the IRB overseeing the research as soon as possible (within 5 days).
What needs IRB approval? Onsite monitoring being transitioned to offsite/remote monitoring: Does NOT need IRB review or approval. This the Sponsor’s responsibility and not under the purview of the IRB.
Communication to Subjects “Re - consent” -The regulations state that significant new findings/information that relates to subjects’ willingness to continue to participate must be communicated to subjects. Below are some ways in which this can be accomplished, given the current circumstances: • Revise current consent and have the subjects re-consent • Create addendum to the consent • Release a memo/letter • Orally relay information via phone Be sure to document this communication!
Protocol Deviations to IRBs (HMH and External) Deviations are expected and do not need to be reported to IRBs UNLESS: The deviation impacts the risks to participants or has a negative effect on study integrity Ex. NO submission: Scheduled visit out of window because patient is in self quarantine (unless safety or study integrity is impacted) Ex. YES submission: One or more patients are immediately withdrawn from the study without tapering (or safety labs not done because facility is closed) If anticipated, prospectively reach out to the IRB and document everything.
Submitting Protocol Changes to the HMH IRB When HMH IRB is the IRB for the research, submission goes through eResearch: • For prospective change(s) in non-emergency situations, submit an ‘Amendment’ If change(s) cannot wait for IRB review/approval, submit • ‘Protocol Deviation’ within 5 days (by submitting a ‘Reportable Event’ with “Protocol Deviation” selected as the ‘event type’)
Resources/Contacts For updates/information/slides, go to the Office of Research Administration website: https://www.hackensackmeridianhealth.org/research/office-research- administration/researcher-resources/ For COVID-19 related questions: 551-996-2994 Other Contacts: Avery Freed, CIP, Director, Human Research Protection Program: 201-880-3651 Daniel Alderson, MS, CIP, Manager, Office of Research Integrity: 201-880-3652 Linda Regensburg, CIC, Institutional Review Board Specialist: 201-880-3669 Tamara Friedman, PhD, Clinical Research Education Specialist: 551-996-2193
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