Ethical considerations in clinical investigation: exploring relevance in haemophilia research.
Painful controversy has so far been largely absent from the history of haemophilia-related clinical research. However, the investigative methods now needed to realize evidence-based clinical practice, therapeutic advance, and a progressive standard of care for patients worldwide will be accompanied by the potential for ethical dilemma and transgression. From the current vantage point, three primary ethical issues merit special consideration: (i) the therapeutic misconception inherent to all clinical research and the randomized trial in particular; (ii) high risk and potentially non-beneficial novel technology research in children; and (iii) a collaborative partnership approach to research in the developing world. This study will focus on a discussion of each of these, drawing from the research ethics literature to offer a potential template for future deliberations in clinical trial design.
Department of Pediatrics, Weill Cornell Medical College, New York, NY 10065, USA. dmdimich@med.cornell.edu
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DiMichele
D026688:Bioethical Issues; D035843:Biomedical Research / Q000941:ethics* / Q000639:trends; D002648:Child; D019317:Evidence-Based Medicine; D018014:Gene Transfer Techniques / Q000941:ethics* / Q000639:trends; D015316:Genetic Therapy / Q000941:ethics; D006467:Hemophilia A / Q000150:complications / Q000628:therapy*; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000592:standards