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All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity.  Your relationship with the IRB does not end once you receive IRB approval for your study! You must maintain approval status by submitting post-approval applications and reports.

The WCM IRB utilizes Weill Research Gateway - Human Subjects for all study application submissions.  Once received, our IRB analysts review the application to ensure all required components of the application have been submitted.  It is then assigned to a member of the IRB for an independent review to ensure compliance with the criteria for approval. Click here for a brief explanation of a general IRB review process.

What is WRG?

Weill Research Gateway (WRG) is the central hub for research administration activity:

  1. Sponsored Programs (WRG-SP): Sponsored research; grants and contracts
  2. Human Subjects (WRG-HS): replacement for eIRB
  3. Research Safety (WRG-RS): Laboratory Safety, Institutional Biosafety Committee (IBC) and Radiation Safety Committee (RSC)
  4. Conflicts of Interest (WRG-COI): COI surveys/submissions
  5. Clinical Trials (WRG-CT): replacement for REDCap (CSEC submissions), Jira subject enrollment process, and CREST
  6. CITI Training: access to CITI website for training (Human Subjects, COI, Good Clinical Practice, Responsible Conduct of Research)

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

Read about recent new features and updates from the WRG-HS Sprint 5 release here and the WRG-HS Sprint 4 release here.

Initial Submissions

Your initial submission requires a protocol for the study.  Protocol Templates are available to assist you in developing a protocol with all of the necessary criteria included.

  • Downloadable templates for Consent Documents are available on our Forms, Templates, and Guidance page
  • All protocols require authorized signatures (required approvals) before submission. Please read the Investigator Manual for more information.

Amendments/Modifications

All modifications to research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects.

WCM ITS provides a helpful video on how to amend your protocol.

Report of New Information

Report of New Information: The WCM IRB requires investigators to report certain events or circumstances that occur during the conduct of a study.  There are specific reporting timelines.  Become familiar with the requirements to avoid non-compliance.

Continuing Review/Study Closure

At the time of approval, the WCM IRB will determine if and when the approval will expire.  The investigator must apply for a new approval period or study closure. Before IRB approval expires.

The IRB Review Process

The typical progression of a submission through the IRB application process begins when the Investigator submits an Initial Application in the WRG-HS system.  That then sets off a number of processes that must be complete before IRB analyst review.

A flowchart and complete description of the IRB Review Process is here.

Use WRG-HS to identify missing credentials

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.

Checking Your Submission Progress in WRG-HS

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.

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.