Is Gaining Consent a Legal Requirement
The concept of consent derives from the ethical principle of patient autonomy[1] and fundamental human rights. [2] The patient has the freedom to decide what should and should not happen to their body and to gather information before undergoing a test/procedure/surgery. No one else has the right to force the patient to act in a certain way. Even a doctor can only act as an intermediary in the patient`s decision-making. There is also a legal aspect to this concept. No one has the right to touch, let alone treat, another person. Any such act committed without authorization is qualified as “bodily harm”[3] – physical assault – and is punishable. Therefore, obtaining consent is essential for anything but a routine physical examination. All patients have the right to participate in decisions about their treatment and care and to be supported to make informed decisions when they are able to do so. Competent adult patients have the right to refuse treatment, even if it would clearly benefit their health. The only exception to this rule is if the treatment is for a mental disorder and the patient is imprisoned under the Mental Health Act. Patients can change their mind and withdraw consent at any time as long as they are able to do so.
[Note: The previous version of the response to this FAQ contained the following sentences. “Remuneration should in no way be seen as a means of compensating for risks; That is, it should not be considered as an advantage that must be weighed against the risks of the study. The level of compensation should not be so high that a potential subject takes risks that he or she would not take without the compensation. The first sentence was deleted because this FAQ focuses on possible undue interference with the consent process (45 CFR 46.116) and not on the IRB`s considerations under 45 CFR 46.111. However, OHRP continues to assert that IRBs should not consider compensation as a means of offsetting risk. The second sentence has been deleted to clarify that subjects` remuneration may include compensation for risks associated with their participation in research and that remuneration may be an acceptable reason for consenting to participate in research. In addition, the previous version included the following sentence, which was deleted because it focused on IRB considerations under 45 CFR 46. 111 and was misplaced in this FAQ: “IRBs may need to ask the investigator for a plan to monitor the recruitment of subjects to ensure that such incentives do not lead to unfair recruitment of subjects (e.g., recruitment of economically disadvantaged individuals only).”] Several exceptions to the informed consent requirement are (1) the patient is unable to work, (2) life-threatening emergencies with a lack of time to obtain consent, and (3) voluntary waiver of consent. If the patient`s decision-making capacity is questioned or unclear, an assessment by a psychiatrist may be requested to determine competence. There may be times when a patient cannot make independent decisions, but has not appointed a decision-maker. In this case, the hierarchy of decision-makers, determined by the laws of each State, must be sought in order to determine the next substitute decision-maker.If this is not successful, a legal guardian may need to be appointed by the court. The informed consent process is the essential communication link between the potential human subject and a researcher, beginning with a researcher`s first approach to the potential subject (e.g., through a pamphlet, brochure, or advertisement for the research study) and ending with the end of the research study. For purposes of HHS regulations in 45 CFR Part 46, “investigators” are individuals who conduct research involving humans, including individuals directly involved in obtaining voluntary consent from potential subjects. Investigators may include doctors, scientists, nurses, administrative staff, teachers, and students, among others. Yes, in certain circumstances, legally effective informed consent can be obtained in the event of an emergency or emergency care. For a particular research study, the response of (1) depends on the expected health status of the potential subject population; (2) the nature of the research; (3) whether potential participants or their legally authorised representatives have sufficient time to consider participation; and (4) whether the circumstances in which informed consent was obtained reasonably reduce the possibility of undue coercion or influence.