Is Informed Consent Necessary for Research on Stored Human Samples?

Abstract

Informed consent is always required before patients can be treated in health centers as well as participating in any kind of research. This requirement often poses a serious challenge to researchers in situations where existing guidelines are not clear about the ownership of donated or discarded human biological samples in hospital archives. The current regulations demand that when doing research, the major bioethical principles of autonomy, beneficence, nonmaleficence and justice should always be respected and adhered to. There is increased value of stored biomaterials due to advancement in biotechnology which has also contributed to increased debate on whether researchers should seek informed consent from the individual donors before such materials can be used for research. In enforcing these bioethical principles, most guidelines focus on research involving direct contact with human beings, and no much attention is given to stored or discarded body parts and biomaterials that end up being used for research in later years. There are some hypotheses that can be tested by doing research on the stored biological samples, especially by students or scientists attached to various University hospitals, researchcenters and laboratories. We attempt to provide some scenarios and reviewed guidelines that can help provide a consensus as to whether it is strictly necessary to have informed consent for research on stored or discarded human body parts and who should claim ownership of collected human biomaterials for research or potential commercial purposes.