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Board Member Review Checklists
Amendment Checklist
Children Checklist - Assent Checklist
Children Checklist - Children Involved as Subjects in Research - Category 1
Children Checklist - Children Involved as Subjects in Research - Category 2
Children Checklist - Children Involved as Subjects in Research - Category 3
Children Checklist - Children Involved as Subjects in Research - Category 4
Children Checklist - Criteria for IRB Approval of Children Involved in Research
Children Checklist - Wards of State
Cognitively Impaired - Mentally Disabled Persons with Cognitive or Decisional Impairment
Conflict of Interest Disclosure
Criteria for Approval - Additional Considerations
Criteria for Approval - Criteria for IRB Approval of Research
Criteria for Approval - Vulnerable Populations
Determining if Human Research is Exempt from IRB Review
Device Checklist - Risk Determination for Devices
Emergency Use - Exception from Informed Consent Requirement
Emergency Use - Exemption from IRB Review Requirements for Emergency Use of a Test Article
Expedited Checklists - Amendment Application - Expedited Review
Expedited Checklists - Continuing Review (Renewal) Application - Expedited Review
Expedited Checklists - New Study Application - Expedited Review
Final Decision - Disapproval Criteria
Final Decision
IND Determination Checklist - IND Determination for Investigational Drugs - Category 1 Approved Drugs
IND Determination Checklist - IND Determination for Investigational Drugs - Category 2 In-Vitro Diagnostic Biological Products
IND Determination Checklist - IND Determination for Investigational Drugs - Category 3 In-Vitro or Animal Use
IND Determination Checklist - IND Determination for Investigational Drugs - Category 4 FDA Determination of Exemption
IND Determination Checklist - IND Determination for Investigational Drugs
Informed Consent Requirements
Informed Consent - Waiver of Documentation of Informed Consent
Informed Consent - Waiver or Alteration of HIPAA Authorization Requirements
Informed Consent- Waiver or Alteration of Informed Consent (HIPAA - when applicable)
Informed Consent - Written Documentation of Informed Consent
Pregnant Women - Neonates - Pregnant Women and Fetuses
Pregnant Women - Neonates - Research Involving Neonates of Uncertain Viability
Pregnant Women - Neonates - Research Involving Neonates
Pregnant Women - Neonates - Research Involving Nonviable Neonates
Prisoner Checklist - Research Involving Prisoners
Renewal Checklist - Continuing Review
Reviewer Description