Forms & Templates

Note:  These forms and templates are also available within the eIRB system.

• Protocol Template
• Protocol Template - Data Only Studies
• Waiver or Alteration of Consent or HIPAA Authorization Form (use when you will alter or not provide consent or authorization)
• Local Context Supplement (use for multi-site studies when you cannot edit the protocol)
• IRB Inquiry Form (use when you don't know if you need IRB review or when you need formal documentation that IRB reveiw is not required)
• IRB Process and Submissions Guidance

Note:  These forms and templates are also available within the eIRB system.

• Consent Form Template
• HIPAA Privacy Rule Authorization Template
• Short Forms for participants with limited English proficiency (KFRI website - KP login required)
• Additional Guidance

Note:  IRB Reliance is complicated.  Make sure you have read through the IRB Reliance page in its entirety before completing any forms.

• Request sIRB Acknowledgement for Proposal (link to REDCap form)
• SMART IRB Protocol-Specific Form
• SMART IRB KPNW Institutional Profile Form
• IRB Authorization Agreement (use when KPNW is IRB of Record)
• Individual Investigator Agreement

• Prep to Research Form
• Decedents PHI Form
• Aggregate Data Approval Form
• KFRI Contract Templates (DUA, DTA, MDTA, etc; use with Agreement Cover Sheet, below)
• Agreement Cover Sheet (use with appropriate KFRI contract template or an agreement from another institution)
• Sharing Data Guidance (Help! I don't know which form I need.)

• Guidance on Modifications and Continuing Reviews
• Guidance on Reportable New Information
• Reportable New Information Form
• Quality Improvement and Monitoring (QI-M) Program Information
• QI-M Self-Assessment Tool
• QI-M Self-Assessment Tool - Data Only Studies
• Social-Behavioral GCP Tool - Protocol Deviation Log Template
• Social-Behavioral GCP Tool - Delegation and Training Log Template