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The study of low penetrance gene variants in a complex genetic disorder such as stroke does not pose the same risks and benefits as a study of highly penetrant mutations.1 Because of the nature of their disease, however, stroke patients may not understand the information given when they are asked for consent to participate in research and are potentially vulnerable subjects. In a systematic review of publications on ischaemic stroke genetics, we assessed the way in which informed consent and ethics committee approval are reported.
Methods
We searched the MEDLINE database for stroke genetics studies published in English between January 2000 and January 2002, using the medical subject heading term “cerebrovascular disorders, genetics of” plus the text words “ischaemic” and “stroke.”2 We included only original clinical trials and observational studies of human genetic risk factors for ischaemic stroke.
Both authors independently reviewed every article. We used standardised forms to record whether an explicit statement described informed consent and institutional review board (IRB) procedures. We also recorded whether …
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