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.
For ethical principles and regulations pertinent to human subjects research, visit our reference page.
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.
Click here to learn how to use WRG-HS to proactively identify who on the study team has a missing/expired Conflicts Survey or requires CITI COI training so these items can be resolved before they have a chance to delay the IRB review and approval process. The article also provides recommended financial disclosure language for the Informed Consent Form, should disclosure be required.
There are several different paths your initial WRG Human Subjects (WRG-HS) submission can take after you create a new study protocol (ex: submitting an initial IRB application vs. an amendment or continuing review). Viewing the Submission Progress will map out the steps your submission will go through specific to the IRB and PRMC review processes, providing insight into what steps you need to take. You can check this progress by following the below steps:
1) Log in to WRG: http://wrg.weill.cornell.edu.
2) Click the Human Subjects tab.
3) Locate your submission in the My Protocols widget on the WRG-HS page.
4) Click the > to the left of the Record Number to expand that selection.
5) Submission Type: Once expanded, you’ll see all submission types associated with this protocol (ex: Initial, Amendment, Continuing Review, etc)
6) Click the View Submission Progress link associated with the specific submission type you want to view.
For more information about alternative ways to check the progress of your submission, as well as the difference between parallel vs sequential view, please refer to the Knowledge Base (KB) article found here.
Please note that the Submission Progress indicator is only available for submissions created on or after March 28, 2020.
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.
Who can serve as a Principal Investigator (PI) on a protocol?
WCM paid faculty can serve as PIs on all categories of protocols. Voluntary faculty cannot serve as PIs, but may serve as co-investigators.
In addition, employees of New York Presbyterian Hospital/Weill Cornell Medicine (only pharmacists, nurses, dieticians) can serve as PIs on protocols, except clinical trials that include an intervention with human subjects. However, medical residents cannot serve as PIs, but may serve as co-investigators.
Can students serve as investigators on protocols?
Students may not serve as Principal Investigators on protocols. However, students may serve as "co-investigators" or research personnel on protocols.
Where can I find the status of my submission?
All submissions in WRG submitted after March 27, 2020 include a "Submission Progress" tool that provides you with a visual of where your submission is in the PRMC and IRB review process.
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?
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.
My protocol came back from the IRB meeting with a status of "Deferred." Does this mean it is required to go to another meeting?
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.
What could delay the release of IRB approval?
The following may delay the release of an IRB approval letter and documents:
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.
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.
What if my protocol's IRB approval has expired?
Submit your Continuing Review or Post-Approval Monitoring Report-Annual Review (PAM-AR) as soon as possible, unless 90 days have past since the expiration, in which case the IRB's Guidance on Lapses in IRB Approval should be followed. This guidance is available for download in the Guidelines section above.
If it has been less than 90 days since expiration, all requests for Continuing Review/PAM-AR and approval 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 firstname.lastname@example.org.
If I am collaborating with a PI from NYP-Queens Hospital or NYP-Brooklyn Methodist, which IRB should I submit to?
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.
If I am collaborating with the Cornell University Ithaca campus, which IRB should I submit to?
The WCM IRB and Cornell-Ithaca IRB have a reliance agreement in place for cross-campus collaborations. Refer to the "Establishing a Single IRB (sIRB) Reliance and sIRB Submission Process" document under the Policies section as well as the "Human Subjects Research Inter-Campus Collaborations" document under the Guidelines section for more information.
When can I add a non-WCM/NYP co-investigator to my study?
The WRG-HS IRB Application includes a section for external non-affiliated personnel (non-WCM/NYP). Non-WCM/NYP investigators should only be added to this section when the WCM IRB will serve as the IRB of record and an IRB Authorization Agreement has been executed. This agreement can only be executed between IRB offices. The WCM IRB will not provide oversight for non-WCM/NYP investigators without an IRB Authorization Agreement.
The WRG-HS IRB Application will not allow the addition of external non-affiliated personnel if WCM is not serving as the IRB of record. If you wish to collaborate with non-WCM/NYP investigators, you must:
Does my study qualify for exemption?
To understand whether your study may be eligible for exemption, consult these decision charts from the U.S. Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP). Only the WCM IRB office can make a determination.
Click here to view exemption decision charts pertaining to studies approved by the IRB prior to January 21, 2019.
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 .
The IRB is pleased to offer help sessions via Zoom and by appointment every Thursday from 10am -12pm and from 2pm - 4pm. To schedule an appointment, email email@example.com with a brief description of your help request. We look forward to assisting you!
The U.S. Department of Health & Human Services Office for Human Research Protections has released decision charts to help investigators assess whether their research is exempt under the Revised Common Rule, effective January 21, 2019.
Access the decision charts here and then make the appropriate submission to the IRB for approval.
Click here to view exemption decision charts pertaining to studies approved by the IRB prior to January 21, 2019.
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.