UNDP

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Company does not obtain free and informed consent from human subjects for research

 

All persons have a right not to be subjected 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.

 

Undertaking research on human subjects aids the development of new ideas, medicines and breakthroughs, all of which can benefit society as a whole. Irrespective of this, an individual’s rights cannot be disregarded or removed during this process, including the right to give or withhold consent freely, without undue pressure or consequences, and to be fully informed.

 

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 test subjects about the product, the testing procedure and the effect(s), terms and conditions – and the testing of products, including banned substances – can have serious impacts on the safety and well-being of individuals and violate their human rights to health and dignity.

 

Storage of research information should be carefully considered and businesses need to ensure an individual’s privacy is maintained. Domestic privacy laws often dictate acceptable storage procedures. Further, the individual should be permitted to withdraw their consent, as well as access their personal information at any time.

Relevant Human Rights Instruments


International Covenant on Civil and Political Rights, 1966, Article 7
International Covenant on Economic, Social and Cultural Rights, 1966, Articles 12 and 15
Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, 1984


SDG 3

GOOD HEALTH AND WELL-BEING

SDG 3

Ensuring human test subjects provide free and informed consent will assist in achieving SDG 3: Ensure healthy lives and promote well-being for all at all ages.