Writing a Successful IRB Application

1. Writing a Successful IRB Application Karen Adams Regulatory Specialist, ITHS May 17, 2013

4. Goals for today • General tips • Background/purpose • Study procedures • Subject population • Recruitment • Consent process • Risks • Benefits • Confidentiality

5. Quick tips • Ascertain level of IRB review • Know the rules that apply to the study • Follow institutional instructions • Use current forms and template from the IRB site • Write with clear, simple lay language • Use active voice • Write from scratch • Be complete. Don’t leave anything out. • Include attachments. • Leverage your resources • Proofread carefully

6. The purpose of this study is… • Include sufficient background information • State the objectives of the research • Include the rationale for the study

7. Questions to consider: 1. 2. 3.

8. Study procedures (1) Accurately describe the study design (2) List complete description of research activities • Include primary and secondary data collection • Research procedures and not standard of care • Use a visual outline of the procedures • Format! (bullet points, numbering) • Include brief data analysis procedure • Attach data collection tools • Attach the study protocol

9. Questions to consider: 1. 2. 3. 4.

10. Subject population • Explain the characteristics of the population to be studied • List and define the inclusion/exclusion criteria • List the maximum number of subjects

11. Questions to consider: 1. 2. 3.

12. Recruitment: who, how, when, what? • Describe every recruitment method • Check for institutional policies • Avoid “cold calls” • Give details! • Explain the privacy of the setting • Attach direct ads, scripts, dear doctor letters, etc.

13. Questions to consider: 1. 2. 3. 4. 5.

14. Consent as a process • Explain how consent will be obtained • Written informed consent is standard • Give details! • Explain the privacy of the setting • Attach consent documents

15. Questions to consider: 1. 2. 3. 4. 5.

16. Discussion of risks • Show awareness of the risks involved • Only include risks related to the research • Explain the likelihood of these risks occurring (e.g., likely, less likely, rare) • Point to published literature • Use bullet points, or outline the risks in a table or grid • Explain how each risk will be minimized • Minimal risk? • Risks still exist!

17. Questions to consider: 1. 2. 3. 4.

18. Benefits • Explain individual benefits vs. benefits to society • Assess benefits accurately • Only include benefits related to the research • Remuneration is not a study benefit

19. Questions to consider: 1. 2. 3.

20. Confidentiality procedures • Convey how you will maintain the confidentiality of research data • Confidentiality protections are relative • Use the gold standard and code! • State how long you will keep data linked to identifiers (DD/MM/YYYY) • Follow institutional policies on storage and security

21. Questions to consider: 1. 2. 3. 4. 5.

22. Market your IRB application • Presentation is essential • Talk with the IRB Administrators/Analysts • Be available • Curb frustrations • The power of “Thank you”