Authorisation or broad consent for research?

摘要

I read Edozien's editorial and the rapid responses with interest, in particular Ilangaratne's quote "the basic principles—and the resulting duty of care-defined in Montgomery are likely to be applied to all aspects of the provision of advice given to patients by medical and nursing staff." This concern extends beyond direct patient care. At the recent European Society of Human Genetics conference, Genomics England's 100000 Genomes Project's chief scientist gave two presentations, in both he gave reassurance that full informed consentwould be obtained from participants, even though the website refers to broad consent only. Genomics England's ethics advisory committee finds that "broad consent is possible and acceptable" despite acknowledging that "the detail of future research will be unknown at the time of consent." This is the problem—can the concept of informed consent be applied to such a project in the absence of information regarding future use of the donated material.