Writing an IRB Application

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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:
1.
2.
3.
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:
1.
2.
3.
4.
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:
1.
2.
3.
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:
1.
2.
3.
4.
5.
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:
1.
2.
3.
4.
5.
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:
1.
2.
3.
4.
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:
1.
2.
3.
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:
1.
2.
3.
4.
5.
Market your IRB application
• Presentation is essential
• Talk with the IRB
Administrators/Analysts
• Be available
• Curb frustrations
• The power of “Thank
you”
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