Informed Consent and Rights
The Nuremberg Code states:
1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
The Alliance for Human Research Protection recommends 5 Essential Safeguards for ALL human subjects in clinical trials.
- Informed consent should never be abrogated for any research involving human subjects, under any circumstances, in any country, regardless of local standards and regardless of the type of research. For this safeguard to be meaningful, researchers must fully disclose the known and foreseeable risks, and the person who is being asked to be a subject, must be capable of understanding potential risks and benefits, before being asked to consent.
- Patients who volunteer to be human subjects must be fully informed about all the foreseeable risks—including the risks associated with randomization, which requires patients to be on a fixed dose, level or combination of a tested treatment compared to usual treatment in current care.
- Strict treatment protocols may result in suboptimal patient outcomes, whether the research is classified as “comparative effectiveness research” or any other classification, in which a new treatment or a fixed dose of a treatment must be tested against another fixed dose. There must always be an option to diverge from the protocol when a patient’s life or health is endangered by strict adherence to it.
- All clinical trials must include a true standard of care comparator arm, to protect human beings from exploitation in poorly designed clinical trials; and to ensure that treatment practices that fail to improve on current standard of care are not adopted as practice guidelines based on flawed comparative trial designs.
- There are currently no mandatory licensure requirements for researchers conducting research on human subjects. AHRP recommends that those who conduct medical research involving human beings should be required to undergo rigorous training on how to minimize risks and demonstrate proficiency in ethical and clinical standards, BEFORE they can be licensed to conduct medical experiments in human beings.
The informed consent ethic is enshrined in numerous international treaties to which Canada is signatory. The Universal Declaration on Bioethics and Human Rights is one such treaty:
Article 6 – Consent in the treaty reads as follows:
“Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be expressed and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.” [Vaccine Choice Canada website]
“Informed consent is the ethical cornerstone of the practice of medicine. Every medical professional, including nurses, is taught the theory and application of medical ethics. As such, nurses understand that informed consent is the foundational medical ethic on which ethical medical practice rests. Nurses also understand that obtaining informed consent from the patient prior to any medical procedure, including vaccination, is an essential requirement both legally and ethically.
Every human being, prior to submitting to a medical treatment that carries known risks, has the right to know the risks and side effects that can result from such a medical treatment, has the right to consider the risks and benefits prior to making a voluntary, informed decision and has the right to accept or reject the treatment. Informed consent to medical risk taking is accepted as a basic human right.”
“For consent to serve as a defense to allegations of either negligence or assault and battery, it must meet certain requirements. The consent must have been voluntary, the patient must have had the capacity to consent and the patient must have been properly informed.”
“The document goes on to emphasize that as the law on consent to medical treatment has evolved, it has become a “basic accepted principle” that,
“every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body.” Clearly physicians may do nothing to or for a patient without valid consent. This principle is applicable not only to surgical operations but also to all forms of medical treatment and to diagnostic procedures that involve intentional interference with the person.”
“Patients must always be free to consent to or refuse treatment, and be free of any suggestion of duress or coercion. Consent obtained under any suggestion of compulsion either by the actions or words of the physician or others may be no consent at all and therefore may be successfully repudiated.”
CMPA Good Practices Guide – Negligence in Common Law [physicians/medical practitioners]Rescuing Informed Consent: How the new “Key information” & “reasonable person” provisions in the revised US common Rule open the door to long overdue informed consent improvementsCma code of ethics and professionalism