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UWA IRB New Protocol Application Form

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The document outlines the UWA IRB New Protocol Application Form for research projects involving human participants. It provides detailed instructions on the submission process, required materials, and guidelines for ensuring research integrity and compliance with ethical standards. The form includes sections for general information about the project, funding details, financial conflict of interest disclosures, data collection methods, privacy and confidentiality procedures, and a documentation checklist. It emphasizes the importance of responsible conduct training and outlines the roles of principal investigators and faculty supervisors in overseeing research activities.

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What is the purpose of IRB approval?

Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

How to fill IRB form?

Before completing the IRB application form, you must know: The identity of all of the investigators who will be working on the project; Who will be recruited to participate and how they will be recruited; Where the research will be conducted; What data will be collected and what will happen to that data; How

How do I get an IRB approval?

When is approval required? MDH researchers engaged in human subjects research must get IRB approval before gathering or analyzing data for the study. Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

What happens if you dont get IRB approval?

IRB Approval Process Investigator Submits Study via iStar: Investigators must indicate if the application requires exempt, expedited, or full board review. Faculty Advisor/Department Sign-off: Once the application is submitted, the faculty advisor or department chair signs-off on the application.

What is IRB approval form?

This form is used by institutions or organizations operating IRBs that review: Research involving human subjects conducted or supported by the Department of Health and Human Services, or other federal departments or agencies that apply the Federal Policy for the Protection of Human Subjects to such research; and/or.