Initial Review Guidance for WIRB Submission
Guidance for Initial Applications to WIRB
- Required Initial Review Documents
- Naming Conventions
- Submission Tips
- CV's and Licenses
- Training Verification
- WIRB Application
- Submission Process
- Phase I Submissions
- Conflict of Interest (COI) Form -- Assessment form for potential conflicts of interest for research involving human subjects
- HIPAA Authorization--UW-Madison
retains purview of the HIPAA authorization. All HIPAA language must be
removed from the consent form, and placed into a separate, stand-alone
- Institutional Compliance Review Form - This form replaces both the pre- and post-initial review cover sheets. Please complete this form and upload in WIRB Connexus as part of your initial review submission.
- Shared Checklist--A checklist that is utilized by the research team and the UW WIRB Gateway Team for guidance on institutional policies required by the UW for inclusion with all protocols. This document does NOT go to WIRB and is removed from Connexus by the UW WIRB Gateway Team during institutional review.
- UW Clinical Trials Agreement (CTA) Form--The research team is required to review and certify that the consent form compensation for injury language is in line with the signed CTA. This form documents the PI's acceptance of this UW requirement.
- WIRB Billing Verification Form - WIRB requires this form to be completed in order to bill industry sponsors. Please complete this form and upload in WIRB Connexus as part of your initial review submission. .
- Billing Verification
- Please indicate "to be assigned" in the WIRB Study # and Work Order # fields.
- WIRB Consent Form Checklist--A checklist that provides verification to WIRB regarding language specific to protocol activities that should be used within study consent document(s). This document is included in the submission to WIRB in Connexus.
- Site Delegation Log - UW must sign-off on human subjects training for all key personnel. Please complete the site delegation log and attach in WIRB Connexus as part of the initial review submission.
- If you have more than one consent and HIPAA authorization document for the study, please designate the difference between them.
- example: 2015-5000ICFPrimary.doc/2015-5000HIPAAPrimary.doc
- The UW Tracking Number (e.g., 2015-5000) can be used as the "New Research" Submission Name.
- Please upload the most recent version of your protocol with your WIRB Connexus submission.
- Check WIRB Connexus for finalization of application submission.
CV's and Licenses
Physicians: All physicians listed on the application key personnel role sheet need to have their CV submitted with the initial application regardless of their duties.
RN’s & LPN’s: All nurses listed on the applications key personnel role sheet need to have their CV submitted with the initial application regardless of their duties.
Research study staff who may conduct a medical procedure (e.g. blood
pressures, taking temperatures, performing injections) need to send a current CV.
WIRB only requires the submission of the PI's license. However, if the study sponsor requires the submission of all licenses, please include them in the submission to WIRB.
Who does not need to send their CV or License?: Study staff not involved in medical procedures do not need to submit their CV and can simply be listed on the application key personnel role sheet.
Anyone listed as a study team member on the WIRB application who is engaged in human subjects research must complete human subjects protection and HIPAA Privacy Rule training for researchers. Prior to submitting the Initial WIRB submission, study teams must verify all study team members have completed required training (see below on how to complete and verify). If a study team member's HIPAA Privacy Rule training cannot be verified in the database for which there is a link below, please contact the WIRB Gateway Team.
UW-Madison Online Training for Researchers
The UW-Madison requires CITI training for UW personnel engaged in human subjects research and HIPAA Privacy Rule training for those who are within the Health Care Component of the university or part of the Affiliated Covered Entity (UW-Madison and UW Health). Below is information about how to access the required training:
- CITI Human Subjects Training
- Search Research Certification Course Completion Database (requires UW-Madison NetID) to review and print training certificates
- Did you complete UW-Madison CITI training without a NetID? How to request a merger of your new NetID account with your completed training account.
- Did you previously take CITI human subjects training at another institution? How to get credit against the UW-Madison CITI human subjects training for training you previously took at another institution.
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Training
Overview of the Process
See Eligibility for how to determine when a study is eligible for review by WIRB.
- The UW research team contacts WIRB Client Services at 1-800-562-4789 to determine type of initial application to submit. There are two types of applications:
- A) Submit New Investigator Site(protocol was previously reviewed by WIRB; WIRB will give research team the WIRB study number)
- B) Submit New Study (protocol has never been reviewed by WIRB)
- WIRB Initial Review Application
- Billing Verification Form
- Institutional Compliance Review Sheet,
- UW COI Form
- UW CTA Form
- Consent Form(s)
- Shared Checklist
- WIRB Consent Checklist
- HIPAA Authorization form(s)
- Protocol and supporting documentation
- NOTE: The UW WIRB Gateway Team will remove the HIPAA Authorization form(s), UW CTA, UW COI, UW-Madison Institutional Compliance Review Sheet, and Shared Checklist from Connexus before submitting to WIRB because they are for internal review only.
- In Connexus 3.0, go to "My Investigators" Page.
- Enter the the Investigator's name provided at the time you created the submission and click "Get Studies."
- Select the Investigator's name displayed under the "Get Investigator" button.
- In section 2, "Select Study," select the study you are looking to provide access for.
- Click "Search" and scroll down.
- The "Submissions" tab will list the Connexus submission.
- If you select the "Submission ID" you will be directed to the submission profile where you can edit the unsubmitted submission.
- Select the "Manage Access" tab.
- Select your Investigator's name and then select the Manage Access Link.
- Please put "email@example.com" in the email field, and select "Institution" for the Represents Field and "Manager" in the Access Level Field.
- This will prompt WIRB Connexus to notify the submitwirb email box of the submission (and provides access to the WIRB Gateway Team to review the pre-submission). Please note that after this invitation has been made, no modifications should be made to any documents within the site workspace, except by the UW WIRB Gateway Team.