PROTOCOL REVIEW Date: Reviewer: IRB #: Principal Investigator: Review Type: Initial Expedited Exempt Continuing Recommendation: Full Approval No changes needed; approved as is. Pending Approval Requires minimum clarifications, protocol modifications, or consent revisions. Deferred Requires substantive clarifications, protocol modifications, or consent revisions. Disapproved PROTOCOL CHECKLIST Evaluation Area Comments Yes Is a sound purpose statement provided? No Does the rationale for the include a brief Yes description of the relevant literature to No convey significance? Are research questions or hypotheses Yes researchable and consistent with the purpose No statement? Is selection of subjects equitable, given the Yes purpose of the research and the setting in No which the research will be conducted? Are recruitment procedures adequately Yes described and consistent with protection of No human subjects? Are procedures consistent with sound Yes research design and include a step-by-step No explanation of procedures that will be performed with human subjects? Is data analysis (whether quantitative or Yes qualitative) appropriate to answer the No research questions or test the hypotheses? Are research risks to subjects reasonable in Yes relation to anticipated benefits? No Are risks to subjects and procedures for Yes minimizing risks adequately described? No If there are vulnerable populations (minors, Yes pregnant women, economically or No educationally disadvantaged, intellectually N/A disabled, prisoners) involved, are additional safeguards included in the study to protect these subjects? Are potential benefits of the research to the Yes individual and society adequately described? No Are there adequate provisions to protect the Yes privacy of subjects and maintain No confidentiality of data?
PROTOCOL REVIEW Date: Reviewer: IRB #: Principal Investigator: Review Type: Initial Expedited Exempt Continuing Recommendation: Full Approval No changes needed; approved as is. Pending Approval Requires minimum clarifications, protocol modifications, or consent revisions. Deferred Requires substantive clarifications, protocol modifications, or consent revisions. Disapproved PROTOCOL CHECKLIST Evaluation Area Comments Is a sound purpose statement provided? Yes No Does the rationale for the include a brief description of the relevant literature to convey significance? Yes No Are research questions or hypotheses researchable and consistent with the purpose statement? Yes No Is selection of subjects equitable, given the purpose of the research and the setting in which the research will be conducted? Yes No Are recruitment procedures adequately described and consistent with protection of human subjects? Yes No Are procedures consistent with sound research design and include a step-by-step explanation of procedures that will be performed with human subjects? Yes No Is data analysis (whether quantitative or qualitative) appropriate to answer the research questions or test the hypotheses? Yes No Are research risks to subjects reasonable in relation to anticipated benefits? Yes No Are risks to subjects and procedures for minimizing risks adequately described? Yes No If there are vulnerable populations (minors, pregnant women, economically or educationally disadvantaged, intellectually disabled, prisoners) involved, are additional safeguards included in the study to protect these subjects? Yes No N/A Are potential benefits of the research to the individual and society adequately described? Yes No Are there adequate provisions to protect the privacy of subjects and maintain confidentiality of data? Yes No
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