We have received questions from several research sponsors about the appropriate process for making changes to clinical studies in response to the current COVID-19 epidemic. These changes may include things like:
We want to provide information on the requirement for IRB review of changes in research made in response to this situation.
The FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, many not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the WCG IRB within 5 days, as per WCG policy. Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposures. WCG encourages sponsors and investigators to take such steps as necessary to eliminate apparent immediate additional risks to participants.
We have created a special streamlined form for the submission of these changes related to COVID-19, or you can use the standard form. The notification to the IRB may be a full protocol amendment, but it does not have to be. The notification of the Change In Research (CIR) plans may also be a memo, letter, or other document that explains the changes being made, and provides enough information for the IRB to assess the relative risks resulting from the changes. The amendment or CIR document will proceed through IRB review as per the usual process.
Informed consent documents should be updated when the new information may relate to the decision of the participant to remain in the study. Generally, information about procedural changes would not fall into this category. Participants should certainly be informed of these changes, Sponsors should choose the most expedient pathway based on their internal processes. It may be more practical to communicate this type of information via a Dear Subject Letter/Memo or other document.
First, reach out to the study sponsor(s) for recommendations. Sponsors likely have prepared contingency plans for when normal operations are interrupted. The course one pursues may depend on the drug type (oral, IV, controlled substance), and whether a pharmacist or blinded investigator is involved. If the IP is an orally administered dosage, for example, shipment of remaining pills/containers could be arranged by courier to a location approved by the Sponsor and compliant with local restrictions.
ICFs ought to state who will have access to study records; typically, however, they do not spell out every scenario of how the sponsor/designee will have access. Research is only approved when research plans make adequate provision for monitoring data collected to ensure subject safety, privacy, and data confidentiality. Studies ought to already have in place plans to provide these subject protections. If sponsors have specific concerns, WCG will be happy to discuss; please feel free to connect them with us.
The site can submit the COVID-19 Change in Research form. The form has a check box under “submission type” for site suspension/closure of a research study due to COVID-19. Please note that the IRB needs to have documentation that affected Sponsors/CROs have been notified and have acknowledged the site’s actions. Subject safety considerations are also critical, so the IRB would need to know what steps were taken to either transfer subjects or withdraw them from the study safely.
If the site is completely withdrawing from the study and does not intend to continue in the study even after the pandemic, then they must also submit a Closure Report (found on the IRB’s website).
WCG has Business Continuity Plans in place for all business units to ensure that there is no interruption of services. These measures include, but are not limited to:
All staff are currently working remotely. The WCG IRBs have the infrastructure in place to support remote operations, including IRB meetings. All WCG timelines are being met and business operations are operating at full capacity.
Please note: protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.
Disclaimer: All information available on this site is intended for your general knowledge and is not for the purpose of providing regulatory advice, medical advice, or a substitute for institutional review board review. You should not use this information to determine compliance with any applicable laws or regulations governing institutional review boards and human subjects research.