LIFT study is discontinued

One-time general consent for research on biological samples Opt out system for patients is optimal and endorsed in many countriesEditor-Wendler's valuable overview of empirical studies of patients' preferences about the use of residual (leftover) tissue for research is not complete. 1 The discussion has already been settled by legislation in many countries.In 2004 the Danish act on patient rights was amended with an opt out system for using residual tissue for research.In 2004 the US Office for Human Research Protections (OHRP) issued guidance that research on residual tissue which is anonymous to the researcher is not human subject research and therefore the tissue can be used without consent. 2Earlier the Dutch Federation of Medical Research Societies' code of conduct on research with residual tissue drafted with patients' organisations had an opt out system for research on samples anonymous to the researcher. 3 In the recent UK Human Tissue Act no form of consent is needed for the use of fully anonymous or coded (or linked) residual tissue that is anonymous to the researcher, provided that an ethical review board has permitted the study.The more restrictive provisions in the original bill were amended also because of pressure from patient groups afraid that research to their benefit would be hampered by the proposed consent system.Wendler emphasises autonomy and argues that one-time consent protects the autonomy of individuals and protects them from serious risks.There are two major arguments against this.Firstly, autonomy should be balanced against other values such as the interests of patients who might benefit from this research. 4 Secondly, autonomy as such cannot protect individuals from risks but only from risks they do want to carry.Research on residual tissue, whether anonymous or anonymously used and being coded, does not carry any risks to individuals.Ethical review boards should oversee that sufficient measures have been taken to ensure that the samples used in research remain anonymously used.It should be possible to enrich data from tissue research with patient data.Fully anonymising samples, as suggested by Wendler, is a waste of valuable information.