Consent and Informed Consent: Their Ongoing Evolutions in Clinical Care and Research on Humans

The dual concepts of 'consent' and 'informed consent' continue to have three evolutions. The primary evolution of consent in the patient–physician relationship began in Great Britain in 1767 in the British case, Slater v. Baker and Stapleton , in the judge-made law of consent. The term 'informed consent' within the patient–physician relationship entered the judicial lexicon in the 1957 California appellate case, Salgo v. Leland Stanford Junior University . In its second evolution within research on humans following the Nuremberg trials that included experimental atrocities on humans, there is a key focus on clarifying the purpose of research and specifying the reasons for the need for an even more extensive risk disclosure to individuals considering volunteering for study participation. This second evolution continues with the further refinement of the Declaration of Helsinki and, within the USA, a focus on the Belmont Report . In its third evolution in research in the social science, there has been a recognition of problems with informed consent to questionnaire research. When questionnaires involve patients with moderate or severe posttraumatic stress disorder or abused individuals, there needs to be intense consideration focused on how to best protect the participants with these conditions during the questionnaire study.