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Medical sociologists have studied informed consent as well bioethics more generally. Oonagh Corrigan, looking at informed consent for research in patients, argues that much of the conceptualization of informed consent comes from research ethics and bioethics with a focus on patient autonomy, and notes that this aligns with a neoliberal worldview.
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine, and technologies.
The social effects of the field of bioethics have been studied by medical sociologists. [14]: 2 Informed consent, having its roots in bioethics, is the process by which a doctor and a patient agree to a particular intervention. Medical sociology studies the social processes that influence and at times limit consent. [15]
The issue of consent is pivotal to the Convention because of the relationship it has to individual autonomy. Medical intervention carried out without consent is a general prohibition within Article 5. [20] Furthermore, consent must be free and fully informed. Free and informed consent is based on objective information. Protection is afforded to ...
There can be issues with how to handle informed consent in a doctor–patient relationship; [14] for instance, with patients who do not want to know the truth about their condition. Furthermore, there are ethical concerns regarding the use of placebo .
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established and was tasked with establishing the boundary between research and routine practice, the role of risk-benefit analysis, guidelines for participation, and the definition of informed consent.
Morality and ethical theory allows for judging relative costs, so in the case when a harm to be inflicted in violating #1 is negligible and the harm prevented or benefit gained in #2–4 is substantial, then it may be acceptable to cause one harm to gain another benefit. Academic literature discusses different variations of such scenarios.
Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'.