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By Birgit Wolz, Ph.D.
“Informed consent” is a legal and ethical term defined as the consent by a client to a proposed medical or psychotherapeutic procedure or for participation in a research project or clinical study. In order for the consent to be informed the client must first achieve a clear understanding of the relevant facts, risks, and benefits involved. Informed consent requires legal documentation in all 50 states. The concept of informed consent originated with the recognition that individuals have rights: to freedom, autonomy, and human dignity. Clients (whether in inpatient or outpatient treatment) possess these rights and cannot be denied their rights owing to mental health status or conditions. In this country, an individual has the right to decide what is done to him/her and what kind of treatment (medical, clinical, or experimental) s/he receives. It is the ethical duty of the psychotherapist or clinician to ensure that individuals make informed and sane decisions about their healthcare and any involvement with mental health research, clinical trials, or treatment.
Informed consent in the field of psychology is extremely important and is most relevant in psychotherapy, counseling, assessment (testing), and research settings. The standard of care in psychotherapy, psychological assessment, and mental health research requires that clients be informed so that they fully understand the nature of the proposed interventions or procedures (for instance, a client who speaks only Spanish must receive the instructions for consent in Spanish). Informed consent not only protects the client, but also protects the clinician. By obtaining informed consent in writing, the clinician possesses proof of the consent. Unless a client can provide proof that s/he was misinformed or was not competent to provide consent, the signed document can minimize risk for the clinician should the matter end up in court. In such proceedings, a written consent will usually legally override later denial of informed consent by a client.
The process of securing informed consent has three phases, all of which involve the exchange of information between therapist and client.
There are obvious exceptions to the process of securing informed consent, such as in emergent or unique settings. It is critical that a client receive enough information on which to base informed consent and that the consent is wholly voluntary and has not been forced in any way.
The law requires that reasonable standards for psychotherapy be applied when determining how much information is considered adequate when discussing a procedure or treatment with the client. There are three approaches to making this decision:
The ability to give informed consent obviously relates to the issue of competency. In most jurisdictions, adults are presumed to be competent to consent to treatment or intervention unless proven otherwise. This presumption can be rebutted, for instance, in circumstances of mental illness. Dependent persons, such as children, the aged, or the infirm, may be exposed to treatments to which their guardians have consented, but to which the patients themselves have not provided assent. In cases of adults who have been defined as incompetent, informed consent must be given by the legal representative. Minors (who may be defined differently by each state and jurisdiction) are generally presumed unable to provide their own consent (incompetent). In cases of minors who have been defined as incompetent, informed consent is usually required from the parent or from the legal guardian.
There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians’ requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could be requested only for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible. (From: Answer.com at https://www.answers.com/topic/informed-consent)
The question of the validity and applicability of informed consent has often been addressed and debated. “The reason for that is that informed consent can be complex to evaluate, because neither expressions of consent, nor expressions of understanding of implications, necessarily mean that full adult consent was in fact given, nor that full comprehension of relevant issues is internally digested. Many times consent is implied within the usual subtleties of human communication, rather than explicitly negotiated verbally or in writing. In some cases consent is legally prevented from ever being possible, even if the person protests they do indeed understand and wish” (Answer.com, 2006). Assumptions are always involved in inferring the level of validity of the consent. A client’s signature is not necessarily proof that the client understood the risks of the treatment or of his/her right to decline it. Following are examples given by Answer.com for invalid informed consents:
(Answer.com, 2006)
The ethics aspects of informed consent have been addressed by almost all professional organizations (for a detailed list, click here).
In their 2004 article, “Informed Consent Revisited: An Updated Written Question Format” (Professional Psychology: Research and Practice, 35/2, 201-205), Pomerantz and Handelsman provided an appendix, titled “Information You Have a Right to Know” which included a list of questions to be addressed in informed consent forms being utilized for psychotherapy clients. The areas that the informed consent should attend to are:
Following the events of September 11th, 2001, Congress passed the USA Patriot Act. The purpose of the legislation is to make it easier for law enforcement to act to prevent future acts of terrorism. As part of this new legislation, Section 215 of the Patriot Act authorizes certain FBI agents to request a subpoena from a special court. These FBI subpoenas can require access to any requested records, and the subject of the investigation (i.e., the client) may not be notified.