Comment on revisions to paragraph 30 of Declaration of Helsinki
Comment on revisions to paragraph 30 of Declaration of Helsinki
Comment on revisions to paragraph 30 of Declaration of Helsinki
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n<strong>on</strong>etheless must be justified <strong>to</strong> relevant ethics committees and<br />
participants should be informed about the treatment opti<strong>on</strong>s after<br />
the study before they give their c<strong>on</strong>sent’.<br />
As is well known, there have been a number <strong>of</strong> c<strong>on</strong>troversies which arose<br />
from ambiguous provisi<strong>on</strong>s <strong>of</strong> guidance in the past, most notably with regard<br />
<strong>to</strong> the standard <strong>of</strong> care provided in HIV transmissi<strong>on</strong> trials. 7<br />
Some <strong>of</strong> the<br />
ensuing discussi<strong>on</strong> has helped both sides in the c<strong>on</strong>troversy <strong>to</strong> better<br />
understand the reas<strong>on</strong>s for differing interpretati<strong>on</strong>s. Subsequently, many<br />
agreed that neither side could be described adequately as acting<br />
‘unethically’. While this is a desirable outcome, the Council takes the view<br />
that it is important that c<strong>on</strong>flict be pre-empted. Avoiding unnecessary<br />
ambiguity <strong>of</strong> guidelines plays an important role. It can prevent damage in<br />
relati<strong>on</strong> <strong>to</strong> the trust and understanding am<strong>on</strong>g and between investiga<strong>to</strong>rs,<br />
regula<strong>to</strong>rs and sp<strong>on</strong>sors. Equally, it will help <strong>to</strong> ensure that healthcarerelated<br />
research in developing countries is not slowed down, delayed or<br />
inhibited al<strong>to</strong>gether. We therefore str<strong>on</strong>gly recommend that the WMA’s<br />
Medical Ethics Committee disregard the c<strong>on</strong>clusi<strong>on</strong> <strong>of</strong> the current draft<br />
Report <strong>of</strong> its workgroup not <strong>to</strong> revise or amend <strong>paragraph</strong> <strong>30</strong> <strong>of</strong> the DoH. 8<br />
The matter <strong>of</strong> providing post trial treatment is <strong>to</strong>o important not <strong>to</strong> be<br />
addressed explicitly in the Declarati<strong>on</strong> <strong>of</strong> <strong>Helsinki</strong>.<br />
7<br />
Lurie P, Wolfe SM (1997) Unethical trials <strong>of</strong> interventi<strong>on</strong>s <strong>to</strong> reduce perinatal transmissi<strong>on</strong><br />
<strong>of</strong> the human immunodeficiency virus in developing countries, New England Journal <strong>of</strong><br />
Medicine, 337(12): 853–856; Angell M (1997) The ethics <strong>of</strong> clinical research in the third<br />
world, New England Journal <strong>of</strong> Medicine, 337(12): 847–49.<br />
8<br />
WG/DoH/Jan2004, Workgroup report <strong>on</strong> the revisi<strong>on</strong> <strong>of</strong> <strong>paragraph</strong> <strong>30</strong> <strong>of</strong> the declarati<strong>on</strong> <strong>of</strong><br />
<strong>Helsinki</strong>, http://www.wma.net/e/ethicsunit/pdf/wg_doh_jan2004.pdf<br />
6