All requests for review of research involving human subjects by PH IRB must be submitted on the appropriate PH IRB form and accompanied by the appropriate supporting documentation. A review of PH IRB policies and procedures will ensure that forms are completed accurately and thoroughly.
Initial Submission Forms: 1. New Protocol Submission Form2. Consent Form Signature Line Template − Adult3. Consent Form Signature Line Template − Child Assent 4. HIPAA Authorization Template5. Research Conflicts of Interest Disclosure Form6. Request for Waiver or Alteration of Consent and HIPAA Authorization Form7. Parkview Health Clinical Research Proposal Form (PHCRPF)
Amendments (Revisions or Additions to Approved Research):1. Amendment Form
Reportable Events, Deviations, Noncompliance Forms:1. Deviation and Noncompliance Report Form2. SAE-UADE-UP Form
Continuing Review and Study Closure Forms:1. Continuing Review Form2. Study Closure Form
Consent and Protocol Templates and Forms:1. Consent Form Signature Line Template-Adult2. Consent Form Signature Line Template-Child Assent3. Consent Form Required Basic Elements4. Consent Form Template5. HIPAA Required Elements6. HIPAA Authorization Template7. Protocol Writing Guidelines and Template 8. Sample Request for Waiver or Alteration of Consent and HIPAA Authorization-Exempt9. Sample Request for Waiver or Alteration of Consent and HIPAA Authorization-non- exempt10. De-Identifying Data
Research Conflicts of Interest Disclosure1.Research Conflicts of Interest Disclosure Form HUD and Emergency Use Forms:1. Emergency Use Procedure: Pre-Use Form2. Emergency Use Procedure: Post-Use Form 3. Emergency Use Consent Form and Patient Information Template4. HUD New Submission Form5. HUD ICF Signature Line Template-Adult6. HUD ADE Form7. HUD Amendment Form8. HUD Continuing Review Form9. HUD Closure Form
IRB Member and Researcher Tools:1. Acronym List2. Curriculum Vitae Template 3. De-Identifying Data4. IRB Reviewer Checklist