IRB - Investigator Tools
All items can also be found under the Library tab in the ICON online system.
Research Match Protocol Preparation Instructions
IRB Reliance Tools
Prior to accessing the appendices listed below, please take a moment to review the IRB Reliance guidelines.
- Reliance on UT-TMC Member IRB
- ICON Instructions: Rely on External IRB
- UT-TMC Member Institution Rely on UH
- ICON Instructions: External IRB rely on UH
- Sterling IRB
- Jaeb IRB
- UH Reliance on Other Institutions (not named above)
- Other Institutions (not named above) Relying on UH
- Addition of a Site Form (UT-TMC)
- Local Context Form (Out of State)
Protocol Templates
Informed Consent and HIPAA Templates
- HRP- 502a - TEMPLATE CONSENT DOCUMENT - NON- CLINICAL
- HRP- 502b - TEMPLATE PARENTAL PERMISSION DOCUMENT - NON- CLINICAL
- HRP- 502c - TEMPLATE CONSENT DOCUMENT - CLINICAL
- HRP- 502d - TEMPLATE PARENTAL PERMISSION DOCUMENT - CLINICAL
- HRP- 502e - TEMPLATE COVER LETTER (waiver of documented consent)
- TEMPLATE - CHILD ASSENT
- TEMPLATE - HIPAA AUTHORIZATION
- Translation Assurance
External Study Team Member Template
Informed Consent SOPs
- HRP- 090 - SOP - Informed Consent Process for Research
- HRP- 091 - SOP - Written Documentation of Consent
Select Regulatory Worksheets and Checklists
These are tools used by the IRB and are not required to be used/submitted by investigators. Research teams may find them helpful when writing protocols to more clearly understand what the IRB must determine for certain types of research.
- HRP- 410 - CHECKLIST - Waiver or Alteration of Consent Process
- HRP- 411 - CHECKLIST - Waiver of Written Documentation of Consent
- HRP- 412 - CHECKLIST - Pregnant Women
- HRP- 415 - CHECKLIST - Prisoners
- HRP- 416 - CHECKLIST - Children
- HRP- 417 - CHECKLIST - Cognitively Impaired Adults
- HRP- 418 - CHECKLIST - Devices
- HRP- 430 - CHECKLIST - Investigator Quality Improvement Assessment (a helpful tool for investigators to evaluate ongoing research projects)
- HRP- 441 - CHECKLIST - HIPAA Waiver of Authorization
- HRP- 306 - WORKSHEET - Drugs
- HRP- 310 - WORKSHEET - Human Research Determination
- HRP- 314 - WORKSHEET - Criteria for Approval
- HRP- 315 - WORKSHEET - Advertisements
- HRP- 316 - WORKSHEET - Payments
- HRP- 318 - WORKSHEET - Additional Federal Agency Criteria
- HRP- 331 - WORKSHEET - FERPA Compliance
Active IRB Policies not yet incorporated into ICON