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

401 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 K E N J I M AT S U I , A L A A A B O U Z E I D , Z H A N G X I N Q I N G , B E N J A M I N K R O H M A L , VA S A N T H A M U T H U S WA M Y, Y O U N G M O K O O , D AV I D W E N D L E R , J E S S E C H A O , Y O S H I K U N I K I TA A N D R E I D A R L I E Introduction 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.1 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.2 Others have, however, argued that tissue donors cannot give valid consent for Asian Bioethics Review December 2009 Volume 1, Issue 4 401–416 F I N D I N G S I n f o r m e d C o n s e n t t o F u t u r e R e s e a r c h o n S t o r e d Ti s s u e S a m p l e s K e n j i M a t s u i e t a l . A s i a n B i o e t h i c s R e v i e w D e c e m b e r 2 0 0 9 Vo l u m e 1 , I s s u e 4 402 unspecified, future research. Consent requires specific information about what one consents to, and this would mean, at a minimum, some indication of the type of research that is envisaged. Clayton et al., summarising a discussion of a meeting called by the U.S. National Institutes of Health (NIH) and U.S. Centers for Disease Control and Prevention (CDC), advocated that prospective donors should be given specific choices, such as whether to limit research on their samples to certain types of research, or to allow their samples to be shared among other scientists.3 The Tri-Council of Canada endorses specific consent, requiring disclosure of “potential uses for the tissue, including any commercial uses”. For genetic studies, it specifically suggests either a comprehensive consent form, giving detailed options, or re-contact for new consent for future research.4 Similarly, the Council of Europe recommendation requires that consent be “as specific as possible with regard to any foreseen research uses and the choices available in that respect”.5 There are numerous studies of the attitudes of prospective research participants to issues of informed consent for future use of stored tissue samples.6 In contrast, there has not been a systematic study of the attitudes of researchers and others involved in the research with regard to this same issue. Also, most...