Waiver of Informed Consent in Prehospital Emergency Health Research in Australia
Monash bioethics review 2010 Mar; 29(1): 07.1-16
Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research to proceed without patient consent. This article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients' perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment.
Alternatives; Culture; Consent; Decision Making; Emergency Care; Environment; Ethics; Guidelines; Health; Health Care; Informed Consent; Law; Medicine; Nature; Patients; Proxy; Proxy Consent; Research; Researchers; Values; Human Experimentation Policy Guidelines / Institutional Review Boards; Informed Consent or Human Experimentation; Health Care for Particular Diseases or Groups;
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Emergency Medicine and the Development of the Food and Drug Administration's Final Rule on Informed Consent and Waiver of Informed Consent in Emergency Research Circumstances Biros, Michelle H.; Runge, Jeffrey W.; Lewis, Roger J.; Doherty, Christopher (1998-04)This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that ...
Emergency Medicine and the Development of the Food and Drug Administration's Final Rule on Informed Consent and Waiver of Informed Consent in Emergency Research Circumstances Biros, Michelle H.; Runge, Jeffrey W.; Lewis, Roger J.; Doherty, Christopher (1998-04)