Patient involvement in the development, regulation and safe use of medicines

Patient involvement in the development, regulation and safe use of medicines
Council for International Organizations of Medical Sciences (CIOMS)
Working Group XI on Patient involvement, 2022; 236 pages
…Informed consent and informed assent
Informed consent is a fundamental patient’s right and an ethical imperative in medicine, whether for research, treatment, or sharing personal data. The patient needs to be given all relevant information and invited to ask questions about the procedure, treatment or data-sharing arrangement. To give informed consent, the patient should have the capacity to understand the implications of the consent. Also, the patient should be able to make the decision to give consent freely and without undue pressure.

When a child is too young to give informed consent, informed assent must be sought. The child should be meaningfully engaged in discussions about the research or medical procedure, according to the child’s capacity. Consent should also be obtained from the child’s parents or legal guardian. Moreover, the child’s written agreement can be obtained if the child’s literacy level allows this, taking into account emotional and psychological maturity as well as relevant individual circumstances. Informed assent is also appropriate for adults who do not have the legal capability to give consent…

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