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IRB Submission Guidance
WVU Flex Model
In an effort to streamline human subject research submissions and reduce the burden on investigators and staff at WVU, the WVU Human Research Protection Program (HRPP) is implementing a new submission/review process for non-federally funded, minimal risk IRB submissions . This new review type called the “WVU Flex Model” or “ Flex” is specifically designed to be a shorter, faster submission in WVU+kc.
Full Board Protocols
General Submission Guidance
- Advertisement Requirements (PDF)
- FDA Regulations for Drugs, Devices, and Test Articles (PDF)
- Guidance on Forms and Attachments (PDF)
- Informed Consent and Assent Guidance (PDF)
- Lay Summary Guidance (PDF)
- Requirements for IRB Approval (PDF)
Post Approval Guidance
Protocol Amendments and Renewals
- Events and Notifying the IRB (PDF)
- Guidance on Deviations, Adverse Events, Closure Requests, and Other (PDF)
Protected Health Information (PHI) in Research
Protected Populations in Research
- ICH Good Clinical Practices (GCP), Applicability to Human Subjects Research (PDF)
- Guidance on Requirements of the Sponsor and the Investigator as a Sponsor (PDF)
The Office of Research Integrity and Compliance is pleased to offer a new resource to investigators for the development of their research protocols. Protocol Builder can be used to assist researchers with developing quality and consistent research protocols that make internal and IRB review processes more efficient. Protocol Builder provides standardized templates that promote consistency and help prevent common mistakes, allows researchers to collaborate and communicate, tracks changes and gathers feedback, and provides a step-by-step approach with contextualized tips to streamline the process of developing a research protocol. Protocol Builder offers a wide range of protocol templates that can be utilized by Biomedical Researchers as well as Social and Behavioral Researchers.
Please contact Sarah Stutler in the Office of Research Integrity and Compliance about gaining access to the Protocol Builder site. Once you have gained access to this resource and completed your protocol in Protocol Builder, you can generate a pdf file of the document and upload into WVU+kc as an attachment for review. If you have technical questions about how to use Protocol Builder, please contact their customer support at 844-563-1042.