Are there any other concerns related to investigator No qualifications? Yes the following websites when applicable or Comments: concerned: Concerns: Requirements: Recommendations: PI Status: Does the PI have the required status? Yes No Comments: Concerns: Requirements: Recommendations: If multiple PIs are used in this project, are any No concerns with the roles, responsibilities or relationship to N/A the primary PI? Yes Comments: Concerns: Requirements: Recommendations: Adequacy of Research Site: Does the site adequate to conduct the research? Yes Evaluate the adequacy of the facility’s trial and No medical equipment Comments: Evaluate the adequacy of emergency or specialized Concerns: care, if the need arises Requirements: May require a statement from the research site Recommendations: indicating the site is adequate or require a description from the PI that includes a description of the facility the research will take place, including staffing and resources relevant to the research under review. General Criteria for IRB Approval of Non-Exempt Human Research/Clinical Investigations: Criteria Is Criteria Met? Yes In order to approve non-exempt human research all of the following requirements must be satisfied: No Comments: Risks to research participants are minimized: Concerns: by using procedures which are consistent with sound research design and which do Requirements: not unnecessarily expose research participants to risk, and Recommendations: whenever appropriate, by procedures already being performed for diagnostic or treatment purposes. Risks to research participants are reasonable in relation to anticipated benefits, if any, to research participants, and the importance of the knowledge that may reasonably be expected
Are there any other concerns related to investigator qualifications? the following websites when applicable or concerned: No Yes Comments: Concerns: Requirements: Recommendations: PI Status: Does the PI have the required status? Yes No Comments: Concerns: Requirements: Recommendations: If multiple PIs are used in this project, are any concerns with the roles, responsibilities or relationship to the primary PI? No N/A Yes Comments: Concerns: Requirements: Recommendations: Adequacy of Research Site: Does the site adequate to conduct the research? Evaluate the adequacy of the facility’s and medical equipment Evaluate the adequacy of emergency or specialized care, if the need arises May require a statement from the research site indicating the site is adequate or require a description from the PI that includes a description of the facility the research will take place, including staffing and resources relevant to the research under review. Yes No Comments: Concerns: Requirements: Recommendations: General Criteria for IRB Approval of Non-Exempt Human Research/Clinical Investigations: Criteria Is Criteria Met? In order to approve non-exempt human research all of the following requirements must be satisfied: Risks to research participants are minimized: by using procedures which are consistent with sound research design and which do not unnecessarily expose research participants to risk, and whenever appropriate, by procedures already being performed for diagnostic or treatment purposes. Risks to research participants are reasonable in relation to anticipated benefits, if any, to research participants, and the importance of the knowledge that may reasonably be expected Yes No Comments: Concerns: Requirements: Recommendations: trial
IRBChecklistFullorExpeditedReview01.30.2018-Pilot.docx