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George Harston, Mark Sheehan and James Kennedy discuss the cultural practices of informed consent for medical research and argue that the status quo does not meet the needs of emergency research. They suggest that extensive written consent is required on neither legal nor ethical grounds and a witnessed verbal consent process may be more appropriate during the early stages of emergency research.
Driven in part as a response to the systematic abuses of autonomy during the World War II, the importance of an individual giving informed consent is enshrined in clinical care and academic research. Documents such as the Nuremberg code,1 Declaration of Helsinki2 and the Belmont Report3 set out the tenets of informed consent—for instance, the Belmont Report defines three elements to informed consent: information, comprehension and voluntariness.3 Not one of these requires extensive documentation. Yet, the processes of ‘informed consent’ have ballooned well beyond the original need to safeguard the individual to include protections for others, such as physicians, hospitals and pharmaceutical companies. In the setting of research, prospective study participants are presented with a compendium of information to process. This is not straightforward to digest even where time and an individual's capacity are not an issue. The supposition that an acutely unwell individual or their representative can …
Contributors All authors contributed to the intellectual content, drafting, revision and approval of this manuscript.
Competing interests None.
Provenance and peer review Not commissioned; internally peer reviewed.