All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. The purpose of the information below is to assist WCM faculty, staff, and students who are planning to conduct studies that involve human subjects. If you have a question that is not addressed here please reach out to us at irb@med.cornell.edu so we can help!
Submitting an Initial IRB Application
The purpose of this information is to assist WCM faculty, staff and students who are planning to conduct projects that involve human subjects. You are urged to read this information carefully in order to avoid unnecessary delay in obtaining Institutional Review Board (IRB) or PRMC approval.
For IRB questions/concerns, please reach out to the IRB Navigation team by submitting a consultation request here, and include the following information:
- WRG number (if available)
- Brief statement of issues
- Relevant deadlines
- Associated funding
What is WRG?
The WCM IRB utilizes an electronic submission system, Weill Research Gateway (WRG) - Human Subjects, for all study application submissions; WRG is the central hub for research administration activity:
- Sponsored Programs (WRG-SP): Sponsored research; grants and contracts
- Human Subjects (WRG-HS): replacement for eIRB
- Research Safety (WRG-RS): Laboratory Safety, Institutional Biosafety Committee (IBC) and Radiation Safety Committee (RSC)
- Conflicts of Interest (WRG-COI): COI surveys/submissions
- Clinical Trials (WRG-CT): replacement for REDCap (CSEC submissions), Jira subject enrollment process, and CREST
- 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 and the WRG-HS Sprint 4 release.
How do I get started? A step-by-step guide
1. Get access to the Weill Research Gateway-Human Subjects (WRG-HS) and Oncore:
- Modules to have access to: Clinical Trials/Human Subjects
- Your Department’s DA needs to submit a WRG access request form
- Make sure that you are selecting “add” for both “regulatorycoordinator” and “clinicalresearchassociate”, under ‘Clinical Trials Access’
2. Complete CITI training (Biomed, GCP; as well as Conflicts of Interest, if federally funded):
3. Complete a Conflicts of Interest survey:
4. Prepare your submission documents:
- IRB Review Application (IRA; Biomedical, Biorepository, or Social-Behavioral and Educational (SBER) and Records) and forms are available on our here
- Supplemental Forms are available here
- One of the following Joint Clinical Trials Office (JCTO) protocol templates:
- WCM Informed Consent Form(ICF) template available here
- Other documents, as applicable, to your research:
- Letters of Support
- Other IRB Approvals
- Data Transfer Agreements
- Certificates of Confidentiality
- Assent Document
- HIPAA Authorization
- Recruitment materials
- Surveys/questionnaires/data collection tools/interview scripts/questions
5. Submit an IRB intake (via WRG-HS) and Protocol Review and Monitoring Committee (PRMC) application (via Oncore) for review.
The first step is to submit an intake form which allows WRG to create and assign a record to your protocol.
After this, PRMC submission is recommended:
The PRMC is independent of the IRB. For questions about PRMC and PRMC reviews, please email the PRMC directly:
- For general PRMC-related questions: generalprmc@med.cornell.edu.
- For cancer PRMC-related questions: cancerprmc@med.cornell.edu
NOTE: There is a 90-day submission completion clock in WRG-HS that begins at initial intake. Please make sure you have all submission materials ready prior to submitting your intake form to avoid auto-closure of your submission due to inactivity!
6. Once PRMC has provided approval, and any potential modification requests have been addressed, then the PI should submit an Initial application to the IRB:
** It is advised that within the application at least one key personnel besides the PI is designated as “admin contact” so that they may correspond with the IRB on behalf of the PI as needed**.
7. Certify your application.
Once an Initial IRB Application is submitted, the first step is for ALL key personnel on that application to certify and approve their participation in the study. You will be notified of this required step a couple of different ways:
- You’ll receive an Action Item in WRG.
- You’ll receive anemail notificationin your regular email pointing you to that Action Item:
***Once certification has been completed by all study personnel, the application will then be routed to the IRB and an administrator will be assigned***.
What about SASP?
The Study Activation Status Page (SASP) is a dashboard where you can monitor a set of tasks and required activities which need to be completed for each of your study protocols. Depending on the specifics of the research, some requirements are not necessary, while others are always required:
Frequently Asked Questions & Resources
Q: What are the steps for local IRB submission?
- Please refer to the steps found here: Step-by-Step How to Submit to the IRB
Q: What if I am planning to use eConsent for the proposed research (WCM currently supports two eConsent tools: REDCap and DocuSign)?
Q: What if I am planning to compensate subjects for their participation in your project?
Q: What if my project involves live virtual sessions, such as interviews and focus groups, for which transcription would be needed?
Q: What if I will be using physician referrals as part of my recruitment methods?
Q: Do I need to register my study in CT.gov (ClinicalTrials.gov)?
Q: Is DSMB (Data Safety Monitoring Board) oversight appropriate for my proposed project?
Q: What if I will be collaborating/working with a researcher from another institution, or conducting research at another institution?
Q: What if I need translation services?
VITTORIO BUGATTI, Translation Coordinator
inlingua Metro New York
551 Fifth Avenue
New York, NY 10176
Telephone: 212.682.8585 email: translationsny@inlingua.com
Q: What if I need to obtain an Expanded Access IND (SPIND or eIND) for the treatment of an individual patient?
Q: What if I am using BRANYplus? What are the steps for submission?
- Please refer to the steps found here: Step-by-Step How to Submit to the IRB
Helpful Contacts
- Need consultation? Request IRB Consultation Hours
- BRANYplus-related questions: branyplus@med.cornell.edu
- General PRMC-related questions: generalprmc@med.cornell.edu
- Cancer PRMC-related questions: cancerprmc@med.cornell.edu
- Single IRB/reliance-related questions: singleirb@med.cornell.edu
- Oncore, WRG-CT-related questions: jctoctms@med.cornell.edu
- CTS-related questions: ctsc@med.cornell.edu
- WRG-related issues/questions: wrg-support@med.cornell.edu[RF1]
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.
Submitting an Amendment
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. For guidance on when to submit an amendment vs. when to submit a new study, see our guidance document, Amending an Existing Protocol vs. Submitting a New One.
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
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.
For an overview of the IRB review process at WCM, please review the Human Research Compliance Monthly Education and Training Series (METS) presentation, “IRB101: Introduction to the WCM IRB”
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:
- Log in to WRG: http://wrg.weill.cornell.edu.
- Click the Human Subjects tab.
- Locate your submission in the My Protocols widget on the WRG-HS page.
- Click the > to the left of the Record Number to expand that selection.
- Submission Type: Once expanded, you’ll see all submission types associated with this protocol (ex: Initial, Amendment, Continuing Review, etc)
- 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:
- 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.
