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

Most studies require modifications to keep the investigative team current, to incorporate changes to the protocol, study instruments, or consent form(s).  Amendments to approved studies represent the single largest volume of IRB submissions.  No changes may be made to the approved resrach plan without first submitting a request to the IRB and obtaining the iRB's approval, unless there is need to eiminate an immediate hazard facing the subject as outlined in 45 CFR 46.103(b)(4)

Common Issues with Study Amendments

Amendments can be more complicated and harder for the IRB to review than initial submissions. It takes attention to detail, on the investigator's part, to fully explain the changes that are proposed, the reasons for those changes and to ensure that all of the applicable study documents consistently incorporate the proposed changes throughout.

Frequent Reasons for Amendments to Fail to Obtain Approval During Initial Review

Amendment fail to obtain IRB approval during their initial review due to the following:

  • failure to explain the rationale for the proposed change;
  • failure to consistently implement the proposed change throughout the protocol, eIRB application, consent form, etc.;
  • failure to update the analysis plan and sample size to account for the changes in objectives, endpoints, measurements or sample size;
  • submitting the wrong documents or incorrect versions of documents to the IRB; and
  • inclusion of changes in study documents that are not discussed or listed in the cover letter or list of changes document.

Careful review of each revised document prior to submission can prevent unnecessary delays.

Amending the Protocol vs. Creating a New Study

When the amendment involves a new study population, new inclusion/exclusion criteria, and new analysis plans, an amendment is no longer appropriate. The investigator should develop a new protocol rather than try to amend an existing one. The IRB strongly prefers that investigators complete their approved study and open a new one rather than trying to amend a previously approved study. If uncertain, consult one of the IRB chairs and discuss the proposed changes.

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.

adopted from the CHOP site

Report of New Information

The WCM IRB requires investigators to report certain events or circumstances that occur during the conduct of a study, including situations where participants experience unanticipated or anticipated problems during the course of the research study.  There are specific reporting timelines; familiarizing yourself with the requirements will help in avoiding non-compliance.

Continuing Review/Study Closure

At the time of approval, the WCM IRB will determine if and when the approval will expire. it is the investigator's responsibility to either apply for a new approval period (i.e. submit a continuing review application) or submit a study closure before the IRB approval expiration date.

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.