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

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

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

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

Questions to consider:

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

Questions to consider:

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

Questions to consider:

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.

Questions to consider:

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

Questions to consider:

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!

Questions to consider:

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

Questions to consider:

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

Questions to consider:

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