Coronavirus (COVID-19) Human Subjects Research Oversight Committee Process

    April 28, 2020

    Dear Research Community,

    Yale University is committed to conducting research on COVID-19 to combat the ongoing Pandemic. To streamline and fast track study activation and implementation, Yale established a COVID-19 Human Subjects Research Oversight Committee process. Note that this process is designed to help accelerate approvals and at the same time respect the need for patients, families, and health care workers to participate in research through mechanisms that minimize multiple contacts with multiple research teams as best as possible and to recognize the need to take into account any limited resources. With representation from Faculty level experts representing all the relevant Schools of the University (YSM, FAS, YSN, Public Health, etc.) and operational level experts, the Committee will have oversight from study concept through study initiation. There are two levels of review and approval: Preliminary (Concept) Review and Institutional (Feasibility) Review. A workflow is published on the University website.

    What It Means For Your Research

    New studies and modifications to existing studies that include research related to COVID-19 must be reviewed by a designated COVID-19 Human Subjects Research Oversight Committee prior to submission of the project to the HRPP in IRES IRB for IRB review including:

    • New biomedical and social-behavioral research projects and clinical trials (international, domestic, interventional, and observational);
    • Expanded Access (“Compassionate Use”) Protocols, i.e. protocols allowing an investigational drug/biologic/device to be delivered to a limited number of patients for treatment. (For an emergency use of a test article in a single patient, see the exception section below);
    • Modifications to existing projects to add COVID-19 populations, collection of samples from participants diagnosed with COVID-19, or study aims related to COVID-19;
    • Research consisting of only Medical Record Reviews related to COVID-19;
    • Repositories with biospecimen or data collected from or about COVID-19 participants; and
    • Other human research-related projects focusing on COVID-19.

    This applies to all new studies that will be reviewed by the Yale IRB or an external IRB and modifications to existing studies under the purview of the Yale IRB or an external IRB.

    Exception

    • The Emergency Use of a Test Article does not follow the COVID-19 Human Subjects Research Oversight Committee review process. Investigators should however contact the HRPP to obtain concurrence from an IRB chair regarding the proposed emergency use by sending an email to hrpp@yale.edu. Investigators should also contact clinicalresearchresources@yale.edu for the requirements when contemplating an emergency use of a test article as there are differences between the use of drugs/biologics and devices (e.g., contacting the sponsor/manufacturer, FDA, pharmacy, etc.).
    • The Emergency Use of a Test Article is defined as the use of a test article in a single patient (unapproved drug, biologic, or device) in a life-threatening situation where no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval (21 CFR 56.102(d)).

    Process

    STEP 1: Preliminary (Concept) Review

    • Complete the online COVID Research Intake Form. The purpose of the review is to ensure that the study can be conducted at Yale and to identify resources necessary to successfully conduct the research.
    • In some cases of potentially competing studies, it may be possible to combine protocols. The investigator may be contacted by the Committee representatives with questions or suggestions.
    • Once the research obtains preliminary concept review approval, you will be notified via an email correspondence.
    • An appeal of a Committee disapproval will be considered.

    Timelines for Preliminary (Concept) Review

    Reviews are generally completed in 2 business days or less depending on the risk and complexity of the study.

    STEP 2: Submission to the HRPP For IRB and Institutional (Feasibility) Review 

    • Upload the approval email from the concept review in IRES IRB as a supporting document. o Submit the protocol and the associated documents to the HRPP in IRES IRB for IRB and institutional review.
    • Yale HRPP will reject your submission if the concept review has not been completed.

    STEP 3: IRB and Institutional (Feasibility) Review

    • Once the study is submitted to the HRPP in IRES IRB, the HRPP will route the study for IRB and Institutional (feasibility) review. The reviews will be conducted concurrently by the committees.

    Institutional (Feasibility) Review

    • The Committee designees will conduct an in-depth Institutional (Feasibility) Review and prioritize the availability of resources such as JDAT and other services. (The investigator may be contacted by the Committee representatives with questions.)
    • The final Committee decision will be communicated to the HRPP using IRES IRB.
    • An appeal of a Committee disapproval will be considered.

    Timelines for Institutional (Feasibility) Review

    • Minimal risk studies with minimal resource utilization (e.g., observational study) are reviewed within 24 hours.
    • Minimal risk studies that require resource utilization (e.g., biorepository or medical record review requiring data analytics support) are reviewed within 48 hours.
    • High Risk studies that require resource utilization (e.g., interventional drug study) are reviewed within 3 business days.

    IRB Review

    Once Institutional (feasibility) review approval is confirmed, the IRB will release the final IRB approval documents.

    Timelines for IRB Review

    The Yale IRB will convene a special meeting for COVID-19 studies. The IRB is able to meet every day (including weekends if necessary). For studies sent to an external IRB, the review will occur based on that IRB’s timelines.

    If you have any questions, please contact Yale Clinical Research Resources team at clinicalresearchresources@yale.edu