Parkview Health

Forms

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 Form
2. Consent Form Signature Line Template − Adult
3. Consent Form Signature Line Template − Child Assent
4. HIPAA Authorization Template
5. Research Conflicts of Interest Disclosure Form
6. Request for Waiver or Alteration of Consent and HIPAA
Authorization Form
7. 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 Form
2. SAE-UADE-UP Form

Continuing Review and Study Closure Forms:
1. Continuing Review Form
2. Study Closure Form

Consent and Protocol Templates and Forms:
1. Consent Form Signature Line Template-Adult
2. Consent Form Signature Line Template-Child Assent
3. Consent Form Required Basic Elements
4. Consent Form Template
5. HIPAA Required Elements
6. HIPAA Authorization Template
7. Protocol Writing Guidelines and Template
8. Sample Request for Waiver or Alteration of Consent and HIPAA
Authorization-Exempt
9. Sample Request for Waiver or Alteration of Consent and HIPAA
Authorization-non- exempt
10. De-Identifying Data

Research Conflicts of Interest Disclosure
1.Research Conflicts of Interest Disclosure Form

HUD and Emergency Use Forms:
1. Emergency Use Procedure: Pre-Use Form
2. Emergency Use Procedure: Post-Use Form
3. Emergency Use Consent Form and Patient Information
Template
4. HUD New Submission Form
5. HUD ICF Signature Line Template-Adult
6. HUD ADE Form
7. HUD Amendment Form
8. HUD Continuing Review Form
9. HUD Closure Form

IRB Member and Researcher Tools:
1. Acronym List
2. Curriculum Vitae Template
3. De-Identifying Data
4. IRB Reviewer Checklist