Informed consent in the context of "Unethical human experimentation"

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⭐ Core Definition: Informed consent

Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities.

Within the United States, definitions of informed consent vary, and the standard required is generally determined by the state. As of 2016, nearly half of the states adopted a reasonable patient standard, in which the informed consent process is viewed from the patient's perspective. These standards in medical contexts are formalized in the requirement for decision-making capacity and professional determinations in these contexts have legal authority. This requirement can be summarized in brief to presently include the following conditions, all of which must be met in order for one to qualify as possessing decision-making capacity:

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👉 Informed consent in the context of Unethical human experimentation

Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association, is widely regarded as the cornerstone document on human research ethics.

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Informed consent in the context of Consent

Consent occurs when one person voluntarily agrees to the proposal or desires of another. It is a term of common speech, with specific definitions used in such fields as the law, medicine, research, and sexual consent. Consent as understood in specific contexts may differ from its everyday meaning. For example, a person with a mental disorder, a low mental age, or under the legal age of sexual consent may willingly engage in a sexual act that still fails to meet the legal threshold for consent as defined by applicable law.

United Nations agencies and initiatives in sex education programs believe that teaching the topic of consent as part of a comprehensive sexuality education is beneficial. Types of consent include implied consent, express consent, informed consent and unanimous consent.

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Informed consent in the context of Research participant

A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as children, infants, and animals. Such individuals are preferentially referred to as subjects.

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Informed consent in the context of Family Justice System of England and Wales

The Family Justice System of England and Wales is a branch of the Courts of England and Wales that deals with disputes within families through family law. Disputes are resolved in the family magistrates court and in the Family Division of the High Court. The matters considered by the court include those arising from marriage, divorce, financial payments following divorce, protection from domestic abuse and the risk of domestic abuse, child custody matters, adoption cases, cases surrounding artificial insemination, and the medical treatment of children.

Legislation creates some obligations of the state to children, disputes involving such matters are dealt with by public family law.

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Informed consent in the context of Involuntary euthanasia

Involuntary euthanasia, typically regarded as a type of murder, occurs when euthanasia is performed on a person who would be able to provide informed consent, but does not, either because they do not want to die, or because they were not asked.

Involuntary euthanasia is contrasted with voluntary euthanasia (euthanasia performed with the patient's consent) and non-voluntary euthanasia (when the patient is unable to give informed consent, for example when a patient is comatose or a child). Involuntary euthanasia is widely opposed and is regarded as a crime in all legal jurisdictions. Involuntary euthanasia has been practiced in the past, notably in Nazi Germany, where many of the perpetrators were tried, convicted, and executed following World War II. Reference to it or fear of it is sometimes used as a reason for not changing laws relating to voluntary euthanasia.

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Informed consent in the context of Institutional review board

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed (or that harms are minimal and outweighed by research benefits). Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.

The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of people participating in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects, and seeks to maximize the safety of subjects. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted.

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Informed consent in the context of Ex vivo

Ex vivo (Latin for 'out of the living') refers to biological studies involving tissues, organs, or cells maintained outside their native organism under controlled laboratory conditions. By carefully managing factors such as temperature, oxygenation, nutrient delivery, and perfusing a nutrient solution through the tissue's vasculature, researchers sustain function long enough to conduct experiments that would be difficult or unethical in a living body. Ex vivo models occupy a middle ground between in vitro (lit.'in the glass') models, which typically use isolated cells, and in vivo (lit.'in the living') studies conducted inside living organisms.

Ex vivo platforms support pharmacologic screening, toxicology testing, transplant evaluation, developmental biology, and investigations of disease-mechanism research across medicine and biology, from cardiology and neuroscience to dermatology and orthopedics. Because they often use human tissues obtained from clinical procedures or biobanks, they can reduce reliance on live-animal experimentation; their utility, however, is limited by finite viability, incomplete systemic integration, and post-mortem biochemical changes that accumulate over time. The earliest perfusion studies were conducted in the mid-19th century, and subsequent advances in sterilization, imaging, and microfluidics have facilitated broader adoption into the 20th and 21st centuries. Regulatory oversight depends on specimen origin: human ex vivo research is subject to informed consent, whereas animal-derived models fall under institutional animal care guidelines.

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Informed consent in the context of Belmont Report

The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Belmont Report summarizes ethical principles and guidelines for human subject research. Three core principles are identified: respect for persons, Beneficence, and Justice. The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research.

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Informed consent in the context of Consensual crime

A consensual crime is a public-order crime that involves more than one participant, all of whom give their consent as willing participants in an activity that is unlawful. Legislative bodies and interest groups sometimes rationalize the criminalization of consensual activity because they feel it offends cultural norms, or because one of the parties to the activity is considered a "victim" despite their informed consent.

Consensual crimes can be described as crimes in which the victim is the state, the judicial system, or society at large and so affect the general (sometimes ideological or cultural) interests of the system, such as common sexual morality. Victimless crimes, while similar, typically involve acts that do not involve multiple persons. Drug use is typically considered a victimless crime whereas the sale of drugs between two or more persons would be a consensual crime. The fact that no persons come forward to claim injury has essentially made the two terms interchangeable in common use.

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