- Pre-Submission Checklist (Considerations and activity needed prior to submitting a proposal for research at Children's Wisconsin)
- PREP: Calendar
- PREP: Pediatric Research Education Program at Children's Wisconsin
- PREP: CORe Series FAQs
Human Research Protection Program Investigator Resources
Resources
Forms
- Amendment form - for use with protocols in IRBNet
- Annual Status or Closure Report - IRBs other than MCW
- Appendix M Variance for State Radiation Approval
- Attestation for Local Principal Investigator at Children's Wisconsin for Multi-site Projects
- Consultation with Children's Wisconsin HRPP Request
- Conflict of Interest Disclosure - Supplement for Research at Children's Wisconsin
- Engagement Determination Request
- HIPAA Request for Waiver of Authorization
- HIPAA Authorization Template
- HUD Information and User Attestation - Children's Wisconsin
- Honest Broker Assurance
- Human Subjects Research Determinations + Honest Broker
- MRI Safety and Plan for MRI for Research Outside of Children's Wisconsin
- Permission to Contact
- PHI of Decedents Attestation Form
- Prep to Research Request for Access to PHI
- Pre-Submission Checklist
- Protocol Feasibility Checklist
- Protocol Feasibility Checklist 2
- Study Staff Transition
- Radiation Procedures Grid
- Reportable Events Forms - Full Version (for use in IRBNet)
- Reportable Events CW Supplement Form - For use in eBridge - CW studies
Guidance
Guidance Documents
- Analytics Overview - iNSIGHT and Epic Tools for Research
- Assent/Parental Permission/Consent of Research Participants with Limited English Proficiency
- Care Everywhere Data for Research & CW Engagement Determinations
- Consent of a Research Participant who Reached the Age of Majority
- Corrective and Preventative Action Plans (and Root Cause Analysis)
- Departmental Sign Off for Research at Children's Wisconsin
- Exemption Categories Reference Tool
- Expanded Access (Compassionate Use) IDE Applications (Treatment use of Investigational Devices for a Single Patient at Children's Wisconsin)
- Expanded Access (Compassionate Use) IND Applications (Treatment use of Investigational Drug for a Single Patient at Children's Wisconsin)
- Expedited Review of Research Categories
- Honest Broker Process
- Human Subject Research Determinations
- Human Subject Research Determinations - Operations v. Research
- Imaging for Research - Process at Children's Wisconsin
- Imaging in Research at Children's Wisconsin - Flow Chart
- Informed Consent Discussion Checklist
- Multi-Site Projects and Investigator Responsibilities
- Navigating Parental Permission and Recruitment
- Quality Program - Children's Wisconsin Human Research Protection Program
- Recruitment for Human Subject Research at Children's Wisconsin
- Reliance Agreements - Establishing a Reliance Between Children's Wisconsin and an External IRB
- Safety Committee Review - Research at Children's Wisconsin
- Signage Posted in Children's Wisconsin - Requirements for any signage being posted in Children's Wisconsin space, which includes recruitment flyers for research studies and other signage regarding human subjects research
- Training Requirements for Key Personnel Conduction Human Subject Research at Children's Wisconsin
Articles From Connect Intranet
- Assent in Human Subject Research at Children's Wisconsin
- Assent/Consent/Parental Permission of Subjects at Children's Wisconsin with Limited English Proficiency
- Engagement in Human Subject Research
- Expanded Access (Compassionate Use) Treatment Use of Investigational Products
- HUD - Humanitarian Use Devices at Children's Wisconsin
- Human Research Protection Program - What Is The Role?
- Human Subject Research Determination Requests
- Human Subject Research v. Other Activities
- Institutional Review Boards
- Multi-Site Human Subject Research
- Quality Monitoring of Human Subject Research at Children's Wisconsin
- Radiation and Imaging in Research at Children's Wisconsin
- Regulatory and Ethical Framework of Human Subjects Research
- Review Pathways for Human Subject Research
- Risk Levels in Pediatric Human Subject Research
CW Required Local Language for Consent/Assent/Parental Permission Documents
These are to be used when inserting local language into a model consent when CW relies on an IRB other than MCW. When MCW is the IRB of Record, the local language is already in the consent forms here.