Informed consent is a voluntary agreement given by a person for undergoing a medical procedure (e.g. treatment, surgery) or for participating in an experiment, after receiving information about the risks and benefits. It is required from a person who is going to submit to either physical or psychological intervention, or both, particularly when the end-result of which can have unpredictable effects. Having given informed consent presupposes that the purpose, nature, potential risks and benefits of the intervention have been communicated to a person, ensuring that a decision is based on a reasonable understanding of the risks involved in either participating or not.

Informed consent became a standard concept for use in human experimentation following the Second World War; however, many eugenics programs had already contained provisions for informed consent, even in cases where consent had been secured under pressure. The original Alberta legislation, passed in 1928, included the need for informed consent from the patient and their next of kin, be that a husband, wife, mother, father or sibling. In 1937 the Alberta government amended its policy on sexual sterilization by removing the need to collect informed consent from individuals considered mentally defective. Obtaining consent, according to officials, seemed to slow down the process and officials worried that in some cases individuals were not sufficiently capable of appreciating the nature of the operation or its effects due to their intellectual disabilities and low intelligence quotients. The 1937 amendment addressed this concern by removing this requirement for people considered mentally defective, which was often judged using intelligence quotients. A score under 80 assumed that patients could not understand the consequences of the operation and that reproduction was both genetically and socially undesirable (see intelligence and IQ testing). This program stood alone in its decision to remove consent provisions from people undergoing sexual sterilization surgeries, and it maintained this position until the program’s end in 1972.

The idea of informed consent comes from clinical medicine. It assumes a shift in decision-making capacity from an all-knowing doctor/researcher to a patient/subject who is in control of their own care.

Over the nineteenth century, with the growth in immunology, bacteriology, and physiology, clinical medicine was practiced in hospitals wherein doctors actively continued to engage in medical procedures and experiments, without patients’ consent, in the name of scientific progress (see science, role of). The situation started to change at the end of the nineteenth century, when a physician-bacteriologist Albert Neisser (1855-1916) published the results of his experiments with syphilis vaccination of uninformed patients. This case became highly publicized at the turn of the 20th century. The outcome was a legal judgment stating that failure to get patient’s consent for medical procedures was criminally punishable, while the scientific ethos went unchallenged. This case set a precedent for future developments in the doctrine of consent in human experimentation. The prerequisites for human subject participation in experimentation – proper explanation, sufficient disclosure, voluntariness, responsibility of the researcher – were laid out in the German Circular of the Reich minister of the Interior in 1931. This document formulated the prototype of informed consent as well as defined which research was considered therapeutic and non-therapeutic. However, the guidelines were not legally binding. Interestingly, what preceded the document was an unsuccessful Bacillus Calmette-Guérin (BCG) vaccination of children at Lübeck in 1930. These developments set the standard for experimental medicine throughout the western world.

A few years later, in 1933, a flagrant misuse of scientific ideas, abuse of authority and disrespect for the individual were evident as the change of power was gradually occurring in Germany. Not only sophisticated medical, but also socio-biological human experimentation – the implementation of designs of the radical eugenics movement – took place at an unparalleled scale. The Nazi regime, tapping into racial ideology, set in motion a mechanism of “improving” the fitness of the general population – such as compulsory sterilization and institutionalization of the unfit, forced euthanasia – which led to a massive disposal of the experimental “human material” during World War II. German doctors and researchers had ignored the guidelines of 1931, not to mention the early model of informed consent (Nazi euthanasia and Nazi sterilization).

In the wake of World War II, numerous cases of documented unethical experimentation were exposed at the Nuremberg trials. As a result, the Nuremberg Code emerged in 1947, which is widely considered a landmark international document that outlines the criteria for voluntary consent. Significantly, the code refers to a person’s legal capacity to give consent, but it does not mention any safeguards for people considered mentally ill or disabled (psychiatry and mental health). This new international code created an important legal framework for considering consent within medical experimentation; it did not, however, provide any guidelines for how research should be monitored.

Since the establishment of the Nuremberg Code there have been several attempts to refine the use of informed consent in medical research. The phrase “informed consent” first appeared in the US court ruling in 1957 Salgo v. Leland Stanford, Jr. University Board of Trustees. In that case, a patient, Martin Salgo underwent an operation that left him paralyzed. He had not been informed of that risk and successfully sued Stanford University for failing to disclose the risks. The court ruled in his favour and introduced the concept of ‘informed consent’ as a provision that should be afforded to all patients or research subjects.

In 1964 the concept was further refined in the Declaration of Helsinki. Here the World Medical Association marked the advent of bioethics that put informed consent into a wider context of individual liberty and social justice. Considerably elaborated over the second half of the twentieth century, the concept acquired well-defined ethical and legal characteristics. Individuals’ autonomy, dignity, liability have a strong link with this concept that has become enforceable by major institutions in charge of human subject research. Still, there are challenges to informed consent. What qualifies as adequately informed consent? Which criteria of informed consent should constitute the morally best standard for the law-enforcement to deliver judgments on cases involving subjects’ exploitation on the basis of ignorance?

The case of informed consent in the Albertan program suggests that officials ignored this broader international context and the growing concern for consent among subjects. Officials in Alberta continued to justify ignoring the need for informed consent on the assumption that individuals with intellectual disabilities could not adequately understand the procedure, its consequences, or moreover could not become good parents. By the mid 1990s survivors of this program began challenging the state. In 1996 the first, and to date the only, successful legal challenge brought public attention to the issue.

-Erika Dyck

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