Ethics-Governance: Article: eMJA: In reply: RARE SALAMI trial revisited

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eMJA: In reply: RARE SALAMI trial revisited Michael C Kennedy MJA 2002 177 (8): 462-463 In reply: Rasmussen, Hansen and Nelson have missed the entire thrust of my article.1 When an individual calls a health professional for help, we can assume he or she agrees to standard treatment, but not to be placed into an experiment. Failure to inform patients that they are being placed into an experiment is a denial of basic human rights. I outlined a mechanism by which it would be possible to conduct an experiment such as RARE SALAMI that would comply with the appropriate guidelines and avoid denial of informed consent. It is worth noting that failure to inform patients that they have been placed in a clinical experiment could also worsen our present medical indemnity crisis and lower the standing of medical research. It has been shown how institutional ethics committees can be subjected to local pressures.2 As a result, it is possible some may adopt pseudolegalistic interpretations of accepted guidelines and approve studies that would be rejected elsewhere. This is another reason why informed consent is so important. Without it some studies simply can't be done. → Read the letter by Rasmussen et al Kennedy MC. Clinical trials without consent: some experiments simply cannot be done. Med J Aust 2002; 177: 40-42. McNeil PM. The ethics and politics of human experiment-ation. Cambridge: Cambridge University Press, 1993. 239-240. (Received 13 Aug 2002, accepted 15 Aug 2002) Manly Non-Invasive Cardiac Laboratory, Manly, NSW. Michael C Kennedy, MD, FRACP, Physician; and Research Associate, Department of Clinical Pharmacology, St Vincent's Hospital, Darlinghurst. Full Article: http://www.mja.com.au/public/issues/177_08_211002/kennedy_211002.html


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