Institutional Review Board (IRB)

Introduction

The WCM IRB is an appropriately constituted group whose primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. In doing so, the IRB must ensure all human subject research activities are conducted ethically, and in compliance with Federal regulations, the requirements of applicable New York State and local law, and institutional policies and procedures. In accordance with the Common Rule and FDA regulations, the IRB has responsibility for approving, modifying, and/or disapproving human subject research. The IRB also has the authority to suspend or terminate research in order to protect research subjects and for noncompliance with applicable rules and regulations.

As part of the IRB’s partnership with the research community in the ethical conduct of human subjects research, this website acts as the entry point to IRB resources at Weill Cornell Medicine.

IRB Committee Structure

The WCM IRB spans across 5 committees that review different areas of research and submission types: The Expedited IRB, which reviews expedited submissions for General/Non-Cancer research; General IRBs #1 and #2 (G1 and G2), which review submissions requiring a convened full board review for General/Non-Cancer research; and Cancer IRBs #1 and #2 (CA1 and CA2), which review both expedited submissions and submissions requiring a convened full board review for all Cancer research.

FWA and IRB registration numbers for the WCM IRBs can be found here.

IRB Office Contacts

The research community is invited to contact the IRB staff for assistance.

Creating IRB Submissions

For information on the IRB's submission system, WRG-HS, refer to the FAQ and Knowledge Base. For technical support, email wrg-support@med.cornell.edu.

Related WCM Sites

For information about disclosing Conflicts of Interest, visit the Conflict of Interest Office website.

For WCM human subjects research in Qatar, visit the WCM-Qatar IRB website.

For human subjects research at Cornell University (Ithaca Campus), visit the Cornell University IRB website.

Policies and Forms

Guidelines

Human Subjects Research Inter-Campus Collaborations

Explains the steps necessary to initiate collaborative human subjects research between the WCM and Cornell Ithaca campuses.
Guidance for Conflicts of Interest in the Informed Consent Form and Disclosure in Publications and Presentations
IRB Statement of Compliance

Forms

English Short Forms & Translated Versions

For use in the event of unexpected enrollment of a non-English speaking subject.
Informed Consent and HIPAA Authorization for Research

Informed consent and HIPAA Authorization template document.
Assent Form for Minors for Clinical Investigation

Assent template document for enrolling children ages 7-11 or 12-17.
Informed Consent for Research Involving Genetic Testing

Informed consent template document for research involving genetic testing.
Protocol Exception Request Form

For submitting planned protocol deviations for IRB approval.
Immediate Report Form

For immediately reporting emergent risk information to the IRB, including adverse events and protocol deviations that impact the risk posed to human subjects.
AE & IND Safety Report Cumulative Table

A table for reporting adverse events to the IRB at the time of Continuing Review.

FAQs

Q: My protocol came back from the IRB meeting with a status of "Modifications Required." Does this mean it is required to go to another meeting?

A: No. Once you submit your response (also known as “RTQ” or “Response to Questions”), it will be reviewed via expedited review procedures. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

Be sure to include a cover memo with a detailed point-by-point response to all issues raised. This memo should indicate how the issue was addressed, changes to the text, and where the changes can be found (e.g., in the protocol document, IRB application, attachments, etc.) If you disagree with an issue that was raised by the IRB, please provide justification for why you are not making the requested changes. This memo should be uploaded in the "Attachments" section in WRG-HS.

Q: My protocol came back from the IRB meeting with a status of "Deferred." Does this mean it is required to go to another meeting?

A: Yes, once you submit your response (also known as “RTQ” or “Response to Questions”), it will be reviewed by the same committee at the next scheduled convened meeting. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

Be sure to include a cover memo with a detailed point-by-point response to all issues raised. This memo should indicate how the issue was addressed, changes to the text, and where the changes can be found (e.g., in the protocol document, IRB application, attachments, etc.). If you disagree with an issue that was raised by the IRB, please provide justification for why you are not making the requested changes. This memo should be uploaded in the "Attachments" section in WRG-HS.

Q: What could delay the release of IRB approval?

A: The following may delay the release of an IRB approval letter and documents:

Pending resolution of conflicts of interest information as instructed by the Conflict of Interest Office
Study team members who haven't completed the required CITI training (initial or refresher) courses.
Noncompliance with ClinicalTrials.gov requirements for any of the PI's protocols

Study team members should also check the Study Activation Status Page (SASP) for their study to ensure all applicable approvals are obtained PRIOR to starting human research activities. The SASP page is your "one-stop" location for all required approvals.

Q: What does "expedited review" mean and how long will it take for me to hear back from the IRB about an expedited submission?

Expedited review means the submission (e.g. new protocol, amendment and/or continuing review) will be reviewed by one member of the IRB. As such, expedited submissions do not have specific submission deadlines. Expedited reviews are reserved for minimal risk studies that fall into designated categories as prescribed by the federal regulations. It is also used for minor amendments (those that do not affect study design or risk to subjects) and some Continuing Reviews.

It is important to note that expedited review does not necessarily mean that the submission will be reviewed more quickly than a submission reviewed at a convened IRB meeting. Please allow a minimum of 10 business days for issues raised/approval to be communicated to the research team.

Q: What if my protocol's IRB approval has expired?

A: Submit your Continuing Review or Post-Approval Monitoring Report-Annual Review (PAM-AR) as soon as possible. All requests for Continuing Review/PAM-AR and approval submitted after current approval expiration must include an explanation of why the approval lapsed and the steps the investigator will take to ensure it does not happen in the future. No study related activities can continue beyond the WCM IRB expiration date, including subject recruitment, enrollment, intervention and data analysis.

However, OHRP guidance suggests that study intervention for subjects already enrolled can continue past the expiration date if the IRB determines that it is in the best interests of subjects already enrolled to continue participating in the research (e.g., when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects). While this determination may initially be made by the investigator, WCM requires that the investigator must seek confirmation that the IRB agrees with this determination as soon as possible.

If you submit your Continuing Review or PAM-AR such that the IRB will be unable to conduct continuing review prior to the expiration date, and you believe it is in the best interest of the subjects to continue study intervention, please send your request to irb@med.cornell.edu.

If the IRB agrees that it is in the best interests of the subjects to continue with the study intervention, then the request for an extension will be granted.
If the IRB concludes that it is not in the best interest of the subjects to continue the study intervention, or that there will not be an increased risk to the subjects, then the request will not be approved.

Q: If I am collaborating with a PI from NYP-Queens Hospital or NYP-Brooklyn Methodist, which IRB should I submit to?

A: Oncology Network Trials: The WCM IRB serves as the IRB of Record for oncology trials conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

COVID-19 Studies Led by WCM: The WCM IRB serves as the IRB of Record for COVID-19 studies led by WCM and conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

All Other Studies: These studies must be submitted separately to each IRB office for separate IRB approval.

For questions related to NYP-Queens, please contact Nancy Garcia, IRB Manager, NYP-Queens.

For questions related to NYP-Brooklyn Methodist, please contact Pearlia Fullard, IRB Coordinator or Dr. Ted Gaeta, IRB Chair, NYP-Brooklyn Methodist.

Announcements

COVID-19 and Reopening Clinical Research at WCM

View the latest information on reopening clinical research at WCM, provided by the Senior Associate Dean of Research, Dr. Hugh Hemmings, and the Senior Associate Dean for Clinical Research, Dr. Rainu Kaushal.

Click here for a prior COVID-19 human subjects research-related memo from Senior Associate Dean for Clinical Research, Dr. Rainu Kaushal, outlining requirements for reopening clinical research at WCM .

IRB Office Hours

The IRB is pleased to offer help sessions via Zoom and by appointment on Thursdays between 10am and 12pm. Email irb@med.cornell.edu to schedule an appointment for one of the following days:

May 14, 2020
May 21, 2020
May 28, 2020

We look forward to assisting you!

Common Rule Changes

Effective January 21, 2019, the human research regulations (officially known as 45 CFR 46, but widely known as the “common rule”) have changed. This new/revised regulation was initiated by the U.S. Department of Health and Human Services and is also adopted by fifteen other federal department and agencies (for a complete list click here). Regulations affected by these changes include the categories for “exempt,” new definition of “human subject”, and specific requirements for single IRB review (also known as “sIRB”), among others. More information is available here.

Index