CRITERIA FOR IRB APPROVAL

1. CRITERIA FOR IRB APPROVAL Dr. Ronald Washburn VAMC 3/19/12

2. Criterion # 1 • Risks to subjects are minimized through sound research design and acceptable procedures. • Study design and purpose are adequate to address the research question. • Examples: • Inclusion and exclusion criteria are appropriate. • Study endpoints are well defined. • Rationale for number of study subjects is justified.

3. Criterion # 1 (cont’d) • Study resources are appropriate. • Examples: • Personnel are qualified. • PI has sufficient time to conduct the research. • Research-related services are listed in Departmental Service Agreement. • Research procedures are clearly differentiated from standard of care.

4. Criterion # 2 • Risks to subjects are reasonable in relation to the anticipated benefits and importance of the knowledge that may be expected to result. • Examples: • Risks are clearly described. • Risks are minimized. • Potential benefits are described. • Some studies warrant continuing review more often than annually.

5. Criterion # 3 • Selection of subjects is appropriate for the purpose of the research. • Examples: • Vulnerable populations are identified and appropriately protected. • Recruitment methods are appropriate. • Coercion to participate is avoided or minimized.

6. Criterion # 4 • Informed consent will be sought from each prospective subject or their legally authorized representative. • Under certain conditions, informed consent may be waived. • Otherwise, PI or other qualified personnel will obtain consent from subjects. • Informed consent form (ICF) is consistent with the protocol, e.g. list of risks.

7. Criterion # 4 (cont’d) • Consent language is understandable to study subjects. • No exculpatory language. • Special considerations for vulnerable populations. • ICF must contain a statement that the subject will be informed if new findings may affect the subject’s willingness to participate.

8. Criterion # 5 • Informed consent will be appropriately documented. • Criteria for waiver of documentation. • The only record linking the subject and the research would be the consent document. • The research presents no more than minimal risk of harm to subjects.

9. Criterion # 5 (cont’d) • Documentation of consent • ICF contains a statement that the study has been explained to the subject or their authorized representative. • Understandable language. • Copy to subject or representative. • Adequate signature and date lines.

10. Criterion # 6 • The research plan adequately provides for monitoring the collected data to ensure safety of subjects. • There is an adequate plan for reporting unanticipated problems. • If the study is double blinded, the unblinding plan is adequately explained.

11. Criterion # 7 Adequate provisions are made to protect the privacy of subjects and to maintain confidentiality. - Pertains to recording and coding, storing and sharing data.

12. Criterion # 8 • Additional safeguards have been included in the study to protect the rights and welfare of vulnerable subjects. • Children • Pregnant women, fetuses and neonates • Prisoners • Cognitively impaired individuals

13. Criterion # 9 • Steps have been taken to manage, reduce or eliminate potential or real conflicts of interest

14. Criterion # 10 • PI and all other study personnel involved in the research have met all current educational requirements for the protection of human subjects

15. Additional VA Criteria • Separate protocol. • Unique forms, more forms. • No children or prisoners. • Reimbursement of study participants is more tightly regulated.

16. VA (cont’d) • Medical record must be flagged to indicate the subject’s participation in a research study. • Check with VA Office of Medical Research before submitting to IRB.

17. Reviewer Recommendations • Approve as submitted. • Disapprove. • Defer for substantive changes. • Defer for non-substantive changes.

18. Risk Categories • Minimal risk. • Greater than minimal risk. • Frequency of continuing review.