Steps
I. Create a new WCG project type in myIRB to generate a UF Cover Letter
All submissions from UF and UF Health (aka Shands) researchers to WCG must include a copy of UF Cover Letter.
Effective 2/27/2026, UF researchers will need to generate the Cover Sheet in the myIRB system. Researchers will create a “New WCG Project.” (Note, this is only for “Industry Track” studies – not NIH or other non-industry funded protocols). The WCG protocol only consists of two sections:
1. List all of the UF personnel involved in the research (this is new, to comply with UF’s process for assessing conflict of interest); and
2. Collection of information used to generate the UF Cover Sheet (similar to the past web based form).
Researchers will “submit” the protocol, but it is not reviewed and approved by the UF IRB. Instead, the submitted myIRB will data will sync with eDisclose data overnight and the next day the UF Cover Sheet can be generated in myIRB, printed, and submitted to WCG along with the study materials just like it was in the past. The most notable difference is that all of the study staff must have completed their disclosure in eDisclose at least one business day prior to generating the Cover Sheet.
The Purpose of the UF Cover Sheet is to ensure:
A. that the paperwork approved by WCG complies with UF specific requirements. For example, UF requires certain language in the Informed Consent form that WCG does not necessarily require in consent forms for other institutions. Of considerable importance is that the Consent includes our relevant local language.
B. that UF and its research related offices are properly notified about the status of your research. For example, the new UF Cover Letter includes an institutional number that enables us to sync WCG data (eg approval date) with UF systems.
NOTE: DEVICE TRIALS: Since UF Health is responsible for acquiring, storing, and billing for devices, researchers must contact UF Health prior to submitting to WCG in order to facilitate the hospital’s acquisition and compliant billing of the devices. UF Health’s Research Billing Office (RBO) must authorize device trials before implementation. For more information visit:
Gainesville: https://research.med.ufl.edu/crh/intake-resources/uf-health-research-contacts/research-billing-office-rbo/ or email UF-ShandsResearchBillingTeam@shands.ufl.edu.
Jacksonville: UF Health/Jacksonville Supply Chain Services at (904) 244-4227 and/or the Value Analysis Facilitator at (904) 244-4524.
II. Informed consent templates
Informed consent forms must contain UF approved template language. Please review the requirements at https://irb.ufl.edu/irb-04-home-western-irb/icftemplate
NOTE 1: WCG or your sponsor may have their own version of the consent. You will use either template and edit the relevant portions consistent with your answers on the UF Cover Sheet.
NOTE 2: If WCG or your sponsor writes your informed consent for you, it is still your responsibility to ensure that the approved consent form has the relevant UF language.
NOTE 3: Please note that informed consent requirements regarding local language apply to all consents (including pregnant partners).
NOTE 4 IMPORTANT: effective June 2024, UF’s longstanding FLA process to determine the cost language for informed consents has been discontinued. Going forward, researchers pick one of four approved cost templates to put in the informed consent form. Please review the workflow diagram of the new process. In order to enroll subjects, researchers must get an IRB approved consent form AND CRH/ORA activation.
III. Submit your study to CRH or Jax ORA
Before you can enroll any subjects in a clinical trial, you must not only obtain IRB approval, but also have your study activated by either:
- Gainesville: College of Medicine Clinical Research Hub (CRH)
- Jacksonville: Office of Research Affairs
These offices work with researchers to ensure budgets, billing, and cost language is appropriate in informed consent forms. CRH/ORA review is independent of IRB review – you can initiate either first or simultaneously.
IV. Submit to HURRC (if applicable)
Research involving exposure of humans to ionizing radiation requires additional specific approval from the Human Radioisotope and Radiation Use Committee (HURRC). For HURRC process please see https://www.ehs.ufl.edu/departments/research-safety-services/radiation-safety/human-investigations-involving-radiation/
Contact: Jason Timm (392-7359) via e-mail at jtimm@ehs.ufl.edu.
VI. Submit to the Investigational Drug Service (IDS) / Pharmacy (if applicable)
If your protocol involves drugs, biologics, or other agents you must complete both of the following steps:
A. Submit a copy of the sponsor’s protocol and Investigator Brochure (if available) to the UF Health Investigational Drug Service Pharmacy prior to submitting the study to WCG. You may submit by email to the following address: IDS@shands.ufl.edu or by campus mail to: HSC Investigational Drug Service Pharmacy, Box 100316, Gainesville, FL 32610-0316. Please include current protocol, Investigator Brochure, and Pharmacy Manual (if available).
B. When submitting your new study to WCG, please add IDS@shands.ufl.edu as a contact within the initial submission form. This will ensure that IDS is automatically notified of all of the approvals for your project: Initial, Continuing Review, as well as other amendments. Failure to add IDS as a contact may result in your project/treatment being delayed while pharmacy verifies project or revision approvals. Further, if IDS is unaware of updated approvals or documentation, dispensing may occur on outdated information leading to protocol deviations and/or risks to patient safety.
VII. Obtain Institutional Biosafety Committee Review (if applicable)
If your study involves Human Gene Therapy, you MUST
A. Notify Michael Mahoney at (352) 294-2744 prior to submitting the study to WCG.
B. Submit a copy of your project to the Institutional Biosafety Committee (IBC) at UF. You may not use the IBC at WCG. A project that needs IBC review cannot begin until it has the approval of both the UF IBC and IRB. Click here IBC Cover Letter for additional information about submitting paperwork to the UF IBC. For more information, contact UF IBC, Box 112190, UF, Gainesville, FL 32611.
VII. Submit to WCG
Working with WCG Brown Bag Slides, presented by Jacob Johnson, July 22, 2020