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DIER-and-SRERS-Administration_SickKids_2022JAN11-1.pdf
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🔗 Source: ctontario.ca
📊 Size: 179 KB
👤 Author: Erin Bell
⬇️ Downloads: 77

Summary

The Hospital for Sick Children (SickKids) has specific requirements for non-Phase 1, multi-centred, pediatric clinical trials. The Ontario Cancer Research Ethics Board (OCREB) is the only ethics board that can act as the Board of Record (BOR) for these studies. SickKids has requirements for informed consent forms, including a paragraph about pregnancy testing and a bullet point about access to medical records. Capacity assessments must be based on individual capacity, not age, and conducted by a registered healthcare professional. Separate consent forms are required for participants who can consent for themselves and those who need a substitute decision maker. The researcher is responsible for ensuring these requirements are followed. The CTO Streamlined System provides a streamlined approach to research ethics review, and each site must ensure necessary institutional authorizations and contracts are in place before beginning research. Specific collaborators must be given roles on application forms, and the Primary Institution Representative must be indicated as David Kenney.

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Description

The Hospital for Sick Children (SickKids) has specific requirements for non-Phase 1, multi-centred, pediatric clinical trials.

Technical Information

  • File Format: PDF
  • File Size: 179 KB
  • Pages: 2
  • Language: EN
  • Author: Erin Bell
  • Total Downloads: 77
  • Last Updated: 2 months ago

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