This form is to be completed and returned to email@example.com to obtain protocol development approval
Program Development Approval – is an administrative approval granted by IRB staff so that the Principal Investigator can develop research design methods and materials. This type of approval can be useful if the actual human interaction portion of the research is expected to occur at a later date, but the researcher needs to provide proof that the project scope and intent has been approved by the local IRB.
Under this type of approval no human participants may be involved in any activities defined as research until the entire project, including data collection procedures and study instruments, recruitment materials and informed consent documents have been reviewed and approved by the IRB, or the project has been determined by IRB staff to qualify for exemption from IRB review.
Once the project and study instruments are developed and finalized, submit a completed Initial Approval Request along with the study instruments to the IRB for review and approval. Please contact the IRB Office with questions regarding whether a Program Development approval can be an option for your research project.