Informed consent is a process by which a fully informed patient can participate in choices of health care. Collingridge, M. (1998) states “it originates from legal and ethical rights patients have to direct what happens to their body and from ethical duty of physician to involve them into their health care”.
An element of fully informed consent is that patients have an opportunity to be an informed participant in their health care and decisions.It is generally accepted that complete informed consent includes a discussion of the following: nature of decision or procedure, reasonable alternatives to proposed interventions, relevant risks, benefits, and uncertainties related to each alternative, and acceptance of interventions by patient. For a patients consent to be valid, the patient must be considered competent to make a decision at hand and consent must be voluntary. Informed consent is a legal doctrine that was developed by the courts over a number of years. Leaning, J. (1964) described this doctrine as having derived from the Nuremberg Code, (1947).
Mielke, F. , & Mitscherlich, A. , (1996) expressed that a doctrine of informed consent requires physicians to obtain voluntary informed consent from a subject prior to conducting medical experimentation.
An informed doctrine requires physicians to provide patients with all relevant information about a proposed procedure or treatment. Informed consent involves knowing about what a physician is proposing, whether it is a minor procedure or major surgery, nature and purpose of interventions, intended effects and unintended side effects, risks, harms, hoped-for benefits, and any reasonable alternatives.Voluntary informed consent deals with human subjects for experimentation. Closely associated with informed consent.
Voluntary consent is defined as a patient understands freedom from force, fraud, deceit, duress, overreaching, ulterior form of constraint, or coercion, knowing the right to refuse or withdraw, without prejudicing further health care, right to ask questions and negotiate aspects of treatment coerced perhaps by disease but not by other people.Judgments in the war crimes during the Tribunal Trials at Nuremberg (1947) put forth ten standards by Fritzgerald, K. , (1947, December 7). In which physicians must conform when carrying out experiments on human subjects. This is now a code that is accepted worldwide.
This judgment set forth a new standard of ethical medical behavior of post World War II human rights era. Amongst other requirements this doctrine enunciates the requirements of voluntary informed consent of the human subject.Nastqueki, J. (1946) explained a basic principle of voluntary informed consent is to protect rights of an individual to have control of their own body. How does a physician know when enough has been said about a certain decision? In literature and law this area suggest on one of three approaches:1. Reasonable physician standard – Allows physician to determine what information is appropriate to disclose, also this standard is inconsistent with goals of informed consent as the focus is on physician and not what the patient needs to know.
2. Reasonable patient standard – Focuses on considering what a patient will need to know in order to understand decisions at hand.3. Subjective standard – What a patient needs to know and understand to make an informed decision, this standard is most challenging to integrate into practice, requires tailoring of information to each patient.If a patient is determined to be incapacitated or incompetent to make informed health care decisions, a surrogate must speak for them. There is a hierarchy of appropriate decision makers defined by state laws.
If no surrogate is available, the physician is expected to act in the best interest of said patient, until a surrogate is found or appointed. Is there such a thing as “presumed” or “implied” consent? A patient’s consent should only be “presumed”, rather than obtained in emergency situations. For example, a patient’s presence in a hospital ward, ICU, or clinic does not represent implied consent to all treatments and procedures. Patient’s wishes and values may differ from that of the physician.
Furthermore, the principle of respects for persons obligated you to do your best to include patients in health care decisions affecting their life and body, principle of beneficence may require you to act on patients behalf when their life is at stake. In competent consent a patient must be competent and able to give voluntary and informed consent. Thus, competent consent involves a patient’s ability to make and stand by an informed, freely made decision. In a clinical setting competence is often equated with capacity.Decision-making capacity refers to a patient’s ability to make decisions about accepting health care recommendations.
To have an adequate decision-making capacity one must understand options, consequences by relating them to their personal values and priorities. Some factors that may make one incapable of providing competent consist either temporarily or permanently. For example; mental illness, mental retardation, alcohol or drug intoxication, altered mental status, brain injury, coma, or minor.