Reviewer Checklist

What are some of the things the IRB reviewers are looking for in my application?

Generally, the IRB will be looking for the PI's articulation of risks and benefits, vulnerability, privacy and confidentiality, undue inducement, exploitation, equipoise.

Are the following addressed in the Application/Protocol?

1. Exemption category information and justification
2. Background, objectives, description of research, and role of subjects. (step by step)
3. Methodology description and how  the methodology benefits the study.
4. Number of subjects, records or specimens
5. Subjects are over age 18 and under age 89
6. Health information is not collected or health information is collected and a HIPAA De-Identification Certification form is attached
7. Expected duration of study and subject participation
8. Risks/benefits to the subject and to society
9. Explanation of how risks have been minimized
10. Procedures for protecting anonymity or confidentiality
11. Data security
12. Recruitment procedures
13. Gender/racial group involvement
14. Access to study population and authority to review records
15. Description of how subjects will be informed (cover letter, recruitment statement)
16. Consent/assent process and forms
17. Experience and role of investigators
18. Conflicts of Interest explained
19. Accompanying materials provided (sample survey questions, data collection sheet)
20. Do the benefits of the research outweigh the risks?

Are the following addressed in the RECRUITMENT STATEMENT/COVER LETTER/DEBRIEFING and/or CONSENT Documents?

1. Investigator's names and ranks
2. Explanation of purpose and justification of research
3. Description of subject's participation and duration (tasks and time)
4. Description of risks and minimization of risks
5. Explanation of how confidentiality/anonymity is protected
6. How will data be collected/recorded
7. Description of benefits to subject/society
8. Explanation of voluntary participation
9. Statement naming investigator who will answer questions and phone number, IRB contact information
10. Is the document clearly written and in lay language and formatted for easy reading? (Translated for subjects who are non-English speakers? )