Not present, but criteria are met (document in IRBNet) N/A Form is incomplete or missing information Criteria is not met to waiver Pending/missing Waiver of Documentation (signatures) of Informed Consent. Required when waiving documentation (e.g., signature) of informed consent. NOTE: If PHI is involved, the IRB may accept the HIPAA waiver form to document a request to waive informed consent. Present and criteria are met to grant waiver Not present, but criteria are met (document in IRBNet) N/A Form is incomplete or missing information Criteria is not met to grant waiver Pending/missing Comments: Concerns: Requirements: Recommendations: HIPAA Preparatory to Research Certification Form Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Recruitment Materials (including, but not limited to flyers, brochures, ads, e-mails, telephone script, etc). Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Subject Recruitment Authorization Form (Signed by patient). Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Physician’s Documentation of Patient’s Verbal Authorization. Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Questionnaires/Surveys. Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Data Collection Tools (or list of data to be collected). Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: *Investigator Brochure for study involving an IND (investigational drug or biological agent). Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: *FDA Form 1572 for study involving an IND (investigational drug or biological agent). Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: *IND letter for involving an IND for an investigational drug or biological agent. Present N/A Comments: Concerns: trial
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