If a trial has no or only minor effects on important patient interests, do we need it?
Informed consent is a bioethical precept of paramount importance in medicine. Ever since the publication of the Belmont Report in 1978, researchers have by and large applied this principle to their daily work.
However, the very authors of that 1978 report are now questioning their conclusions. In an article in the February 20th edition of the New England Journal of Medicine, Dr Tom Beauchamp et al outline a new set of principles providing for the waiving of informed consent in situations that fall below “a threshold of negative effect”. The authors argue that in cases where research has “no or only minor effects on important patient interests” it is permissible to proceed without explicit consent.
The paper, entitled ‘Informed Consent, Comparative Effectiveness, and Learning Health Care’, contains a new seven principle framework – the ‘Common Purpose Framework’ – that emphasises the importance of improving health care quality through research and the development of a “learning health care system”. The principles are such that the need for patient consent may be overridden where it is impracticable to obtain it and the effects on patients are negligible.
The authors put forward the example of “pragmatic, randomized clinical trial that compares two widely used hypertension medications, perhaps two diuretics”. In the hypothetical case, there are no clinical characteristics that would favour one drug over the other for patients participating. They argue that “It may even be acceptable for an ethics-oversight panel to permit the study to proceed with broad notification to the community of the system, without requiring that individual patients be told about the randomization.”
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