Number-8-wire ethics: a New Zealand ethics committee's response to lengthy international clinical trial information sheets.
USA dominance of international clinical trials mandates complex and lengthy participant information sheets and limits the amount of scrutiny New Zealand ethics committees can have over information sheets form or content. This paper provides an alternative exemplar: a summary of a lengthy participant information sheet written in less than one page, inviting potential participants to read the lengthy document. The succinct invitation provides participants with sufficient information to decline to read the lengthy document or better informs the reading of the longer document. Equally, the one-page letter permits New Zealand ethics committees, researchers, study coordinators, and Maori consultation groups to comment and alter the informed consent process without compromising rigid FDA prescriptions for clinical trial research.
Tolich
Martin
M
Department of Anthropology, Gender and Sociology, University of Otago, PO Box 56, Dunedin, New Zealand. martin.tolich@otago.ac.nz
Hapuku
Jonas
J
D035843:Biomedical Research / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D003219:Confidentiality / Q000941:ethics; D032962:Consent Forms / Q000941:ethics / Q000592:standards*; D017041:Ethics Committees; D005260:Female; D033161:Government Regulation; D006801:Humans; D007391:International Cooperation; D008297:Male; D009520:New Zealand; D010358:Patient Participation; D018579:Patient Selection / Q000941:ethics*; D014481:United States