Forms & Templates

Welcome!

We strive to make it easy to do the right thing. This page contains everything you need to navigate your research project through the IRB and compliance approval processes.

1. Get Ready. Make sure you have completed any required training and FCOI disclosures. If you are not a CHR investigator, be sure to review first the Guidance for Research Collaborators and POLICY: Minimum Participation for Collaborative Research at KPNW.

Guidance for Research Collaborators

POLICY: Minimum Participation for Collaborative Research at KPNW

Training and Education

Financial Conflict of Interest (FCOI)

2. Get Set. Use the below guidance documents to register in IRBNet system and familiarize yourself with the submission process.

IRB Submission Guidance: Use the eIRB System - IRBNet

Compliance Submissions: Email to CHR_ComplianceApprovals@kpchr.org

3. Go! Use the forms, templates, and other resources on this page to assemble your study materials and submit them for review and approval. Check out the last section below for information about ongoing IRB requirements and Quality Improvement Monitoring.

Protocol and Supplemental IRB Forms

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) - see the Annotated Waiver Form for additional guidance on how to use this form
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)
Approval in Principle Form (use when grant funded activities will not involve human subjects until a later phase of the project)
IRB Process and Submissions Guidance
Protocol Deviation Log Template
Delegation and Training Log Template

Recruitment, Consent, and HIPAA Authorization

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

Consent Form Template
Information Sheet Template
HIPAA Privacy Rule Authorization Template
Telephone Consent Script Template (use with Information sheet)
Short Forms for participants with limited English proficiency (KFRI website - KP login required)
Consent Form for Treatment Use of Drug or Device (For use in FDA regulated, NON-research situations such as HUD's, Single Patient Expanded Access or Expanded Access)
Additional Guidance

IRB Reliance

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

sIRB Request Form
SMART IRB Protocol-Specific Form (and instructions)
SMART IRB KPNW Institutional Profile Form
SMART IRB Blank Institutional Profile Form
SMART Relying Site Survey
Local Context Supplement (use when KPNW is IRB of Record)
IRB Authorization Agreement (use when KPNW is IRB of Record)
Individual Investigator Agreement

Data Access and Sharing

Prep to Research Form
Decedents PHI 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)
Data Commitments Tracking System (CHR employees only)
Sharing Data Guidance (Help! I don't know which form I need.)

Post-Approval Reporting and Monitoring

Browse Guidance by Topic

Revised Common Rule

Effective January 21, 2019

More Information

CHR Employees

Visit the Research Compliance SharePoint site for additional resources, including the discussion board and example submission documents (coming soon).