Informed Consent to Future Research on Stored Tissue Samples: the Views of Researchers, Ethics Review Committee Members and Policy Makers in Five Non-Western Countries

Collections of large repositories of human tissue have become increasingly important for biomedical research. Amongst the most controversial is the question about the type of consent needed for the collection, storage, and future research use of tissue samples for yet to be specified research. Such biobanks raise a host of unique ethical and policy questions, many of which are quite controversial. Typically, when investigators collect samples, either for a specific research project, or with the aim of establishing a biobank, they have only a vague idea of what future research might be conducted. Some have advocated that a one-time, general consent for any future research is ethically appropriate. In this model, tissue donors would be asked whether they agree to have their tissue samples stored for any future research. If they agree, the investigators are free to use the samples as they wish, subject to appropriate ethics review procedures. If they decline, the tissue samples would have to be destroyed after the specific purpose for the initial collection has been satisfied, or the tissue donors would have to be re-contacted for a new consent procedure for a future, specific project. Others have, however, argued that tissue donors cannot give valid consent for