All persons have a right not to be subject to medical or scientific experimentation without free and informed consent. Testing on humans is a high-risk activity that can cause sudden death, disease, permanent disabilities and ailments and reproductive health risks. A person’s mental or physical ability to give consent must be considered before commencing testing or research, and testing should (except in rare circumstances where it is necessary for the person’s health or on some other basis) only be performed where it can be ascertained that the person has given informed consent, taking into account the individual’s particular mental or physical condition. In certain circumstances, it may be possible to obtain consent from a caregiver.
Mechanisms should be put in place to protect the individual as well as the business enterprise conducting the test or research. Documenting the decision-making process in detail will assist in demonstrating that consent was obtained from the individual or their caregiver. Illegal, unethical or discriminatory practices, such as the provision of misleading information to individuals or their caregiver regarding the product, the testing procedure and the effect(s), terms and conditions, and the testing of products, including banned substances, can have a serious impact on the safety and well-being of the individuals, and will violate their human rights to health and dignity.