Informed consent and research

In the debate opened by the BMJ on whether research is ethical if it meets the standards of the Declaration of Helsinki but is conducted without informed consent, Len Doyal provides some powerful arguments for why the request for informed consent should be inviolable.1

While vigorously defending the inviolability of informed consent, he concedes that it is not necessary in certain circumstances. An uncontroversial case is that of incompetent patients (although even here other rigorous requirements must be met). However, the other exceptional cases he mentions seem to have some unfortunate implications for his defence of informed consent. He thinks that for epidemiological research on patient records the informed consent requirement may be waived if certain conditions are met: (a) that access to the clinical record is essential to the research; (b) that consent is not practicable; (c) that the research is of sufficient merit; (d) that it may benefit the patient whose records are studied; (e) that, when possible, the researchers are unable to connect the records with the patient's identity, but that where this …