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What are some of the things the IRB reviewers are looking for in my application?
Exemption category information and justification
Background, objectives, description of research, and role of subjects
Number of subjects, records or specimens
Subjects are over age 18 and under age 80
Expected duration of study and subject participation
Risks/benefits to the subject and to society
Explanation of how risks have been minimized
Procedures for protection anonymity or confidentiality
Data security
Recruitment procedures
Gender/racial group involvement
Access to study population and authority to review records
Description of how subjects will be informed
Consent process and forms
Experience and role of investigators
Conflicts of Interest explained
Accompanying materials provided (sample survey questions, data collection sheet)
Do the benefits of the research outweigh the risks?
Are the following addressed in the RECRUITMENT STATEMENT/DEBRIEFING and/or CONSENT documents?
Investigator's names and ranks
Explanation of purpose and justification of research
Description of subject's participation and duration (tasks and time)
Description of risks and minimization of risks
Explanation of how confidentiality/anonymity is protected
How data will be collected/recorded and how will have access to this
Description of benefits to subject/society
Explanation of voluntary participation
Statement naming investigator who will answer questions and phone number, IRB contact information
Is the document clearly written and in lay language and formatted for easy reading?
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