Consent and Governance
Cross-source consensus on Consent and Governance from 1 sources and 4 claims.
1 sources · 4 claims
Preparation
Risks & contraindications
Highlighted claims
- The trial uses staged consent because heart transplantation may happen urgently. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
- Participants may withdraw at any time without affecting their post-transplant clinical care. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
- Full trial consent later covers TR006 administration and the full follow-up schedule. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
- When full consent is not possible before urgent surgery, interim consent is sought for thymus tissue collection. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)