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umbrella projects

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umbrella projects

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  1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

  2. umbrella projects Developed by: U-MIC University of Michigan IRB Collaborative

  3. OHRP Umbrella projects IRB review not required for projects lacking immediate plans for involvement of human subjects Developed by: U-MIC

  4. Umbrella projects • Certain types of applications and proposals lack definite plansfor the involvement of human subjects either because the specific human subject activities have not yet been fully developed or because human subject research was not anticipated at the time of the application. In such cases, the application or proposal need not be reviewed by the IRB prior to an award (see 45 CFR 46.118 and46.119). • OHRP memo, 2000 • “IRB Review of Applications for HHS Support” Developed by: U-MIC

  5. Umbrella projects Certain types of applications and proposals lack definite plans for the involvement of human subjects either because the specific human subject activities have not yet been fully developed or because human subject research was not anticipated at the time of the application. In such cases, the application or proposal need not be reviewed by the IRB prior to an award (see 45 CFR 46.118 and46.119). OHRP memo, 2000 “IRB Review of Applications for HHS Support” Developed by: U-MIC

  6. Umbrella projects • Certain types of applications and proposals lack definite plans for the involvement of human subjects either because the specific human subject activities have not yet been fully developed or because human subject research was not anticipated at the time of the application. In such cases, the application or proposal need not be reviewed by the IRB prior to an award (see 45 CFR 46.118 and46.119). • OHRP memo, 2000 • “IRB Review of Applications for HHS Support” Developed by: U-MIC

  7. Umbrella projects • Certain types of applications and proposals lack definite plans for the involvement of human subjects either because the specific human subject activities have not yet been fully developed or because human subject research was not anticipated at the time of the application. In such cases, the application or proposal need not be reviewed by the IRB prior to an award (see 45 CFR 46.118 and46.119). • OHRP memo, 2000 • “IRB Review of Applications for HHS Support” Developed by: U-MIC

  8. Umbrella projects • Certain types of applications and proposals lack definite plans for the involvement of human subjects either because the specific human subject activities have not yet been fully developed or because human subject research was not anticipated at the time of the application. In such cases, the application or proposal need not be reviewed by the IRB prior to an award (see 45 CFR 46.118 and46.119). • OHRP memo, 2000 • “IRB Review of Applications for HHS Support” Developed by: U-MIC

  9. granting agencies • request documentation of IRB approval before releasing funds • may request approval documentation even for research that will not directly or immediately involve human subjects • training grant • program project • center grant • project that will eventually involve human subjects • http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.118 Umbrella projects Developed by: U-MIC

  10. Umbrella projects umbrella projects or dry applications Developed by: U-MIC

  11. Umbrella projects Developed by: U-MIC

  12. Umbrella projects expedited review Developed by: U-MIC

  13. umbrella applications Umbrella projects • that do anticipate a human subjects research component • must receive IRB approval before starting research • amend umbrella application to become a standard application • or • create a separate standard application that do not anticipate a human subjects research component may be able to terminate after grant is finalized Developed by: U-MIC

  14. Umbrella projects Contact the IRB for more information about umbrella projects. Developed by: U-MIC

  15. Lark Speyer IRBMED thank you. Developed by: U-MIC

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