Not present, but criteria are met (document in IRBNet) N/A Form is incomplete or missing information Criteria is not met to trial waiver Pending/missing Waiver of Documentation (signatures) of Present and criteria are Comments: Informed Consent. met to grant waiver Concerns: Required when waiving Not present, but criteria Requirements: documentation (e.g., signature) of informed are met (document in Recommendations: consent. NOTE: If PHI is involved, the IRB IRBNet) may accept the HIPAA waiver form to N/A document a request to waive informed Form is incomplete or consent. missing information Criteria is not met to grant waiver Pending/missing HIPAA Preparatory to Research Present Comments: Certification Form N/A Concerns: Pending/missing Requirements: Recommendations: Recruitment Materials (including, but not Present Comments: limited to flyers, brochures, ads, e-mails, N/A Concerns: telephone script, etc). Pending/missing Requirements: Recommendations: Subject Recruitment Authorization Form Present Comments: (Signed by patient). N/A Concerns: Pending/missing Requirements: Recommendations: Physician’s Documentation of Patient’s Present Comments: Verbal Authorization. N/A Concerns: Pending/missing Requirements: Recommendations: Questionnaires/Surveys. Present Comments: N/A Concerns: Pending/missing Requirements: Recommendations: Data Collection Tools (or list of data to be Present Comments: collected). N/A Concerns: Pending/missing Requirements: Recommendations: *Investigator Brochure for study involving Present Comments: an IND (investigational drug or biological N/A Concerns: agent). Pending/missing Requirements: Recommendations: *FDA Form 1572 for study involving an Present Comments: IND (investigational drug or biological N/A Concerns: agent). Pending/missing Requirements: Recommendations: *IND letter for involving an IND for an Present Comments: investigational drug or biological agent. N/A Concerns:
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
IRBChecklistFullorExpeditedReview01.30.2018-Pilot.docx