Vulnerable populations are groups of trial participants whose willingness to volunteer for a clinical trial could be unduly influenced by the expectation of a (real or perceived) benefit, or by the threat of disadvantage in the event of refusal. GCP guidelines and ethical principles require special protective measures for these individuals.
Vulnerable populations include, among others, children, pregnant women, breastfeeding women, people with severe intellectual or physical disabilities, prisoners, or individuals in a relationship of dependency (e.g. medical students in relation to their professor). Trials involving these populations require particularly careful ethical review by the Ethics Committee. It must be ensured that the research is relevant to the respective group and that additional protective mechanisms are implemented to prevent exploitation and to guarantee genuinely voluntary consent.