When setting up a clinical trial with vulnerable subjects and compiling the research dossier specific requirements for clinical trials with vulnerable subjects have to take into account.
The CTR has specific rules for the following groups of vulnerable subjects:
- Incapacitated subjects: see article 31 CTR and questions 9.1 and 9.4 Q&A CTR;
- Minors (in the Netherlands, ≤15 years): see article 32 CTR, questions 9.1 and 9.4 Q&A CTR, and Ethical considerations for clinical trials with minors;
- Pregnant and breastfeeding women: see article 33 CTR and question 9.1 Q&A CTR. In the Netherlands, rules following the Embryo Act may apply;
- Clinical trials in emergency situations, see article 35 CTR and CCMO memorandum with flow chart deferred consent.