Writing a Successful IRB ApplicationKaren 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

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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

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Subject population

• Explain the characteristics of the population to be studied

• List and define the inclusion/exclusion criteria• List the maximum number of subjects

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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.

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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

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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!

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Benefits

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

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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

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Market your IRB application

• Presentation is essential • Talk with the IRB

Administrators/Analysts• Be available• Curb frustrations • The power of “Thank

you”