Appendix 8: Reviewer's Checklist

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

Are the following addressed in the Application/Protocol?

1.                   Exemption category information and justification

2.                   Background, objectives, description of research, and role of subjects

3.                   Number of subjects, records or specimens

4.                   Subjects are over age 18

5.                   Health information is not collected or health information is collected and a HIPAA De-Identification Certification form is attached

6.                   Expected duration of study and subject participation

7.                   Risks/benefits to the subject and to society

8.                  Explanation of how risks have been minimized

9.                   Procedures for protecting anonymity or confidentiality

10.               Data security

11.                Recruitment procedures

12.                Access to study population and authority to review records

13.                Description of how subjects will be informed (cover letter, recruitment statement)

14.                Consent/assent process and forms

15.                Experience and role of investigators

16.                Conflicts of Interest explained

17.                Accompanying materials provided (sample survey questions, data collection sheet)

18.               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.                   Investigators’ names and positions

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 maintained

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 not English speakers?)