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, and available alternatives 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 due to mental health status or condition.
In their widely cited article, Two models of implementing informed consent, Lidz, Appelbaum and Meisel (Lidz, C. W., Appelbaum, P. S., and Meisel, A. (1988). Archives of Internal Medicine, 148 1385-1389.) state:
The doctrine of informed consent has been controversial since its inception. In spite of the professed ideal of improving physician-patient communication, many commentators have argued that it interferes with the relationship. However, the problem may not be the doctrine itself but rather the manner in which it is usually implemented. This article describes two different ways in which informed consent can be implemented. The event model treats informed consent as a procedure to be performed once in each treatment course, which must cover all legal elements at that time. The process model, in contrast, tries to integrate informing the patient into the continuing dialogue between physician and patient that is a routine part of diagnosis and treatment. We suggest that the process model has many benefits.
Like Lidz, et al., many other scholars have emphasized the importance of the process of communication between caregivers and patients in obtaining informed consent. Rather that viewing informed consent as a single event where a clients sign on the dotted line at the end of a long detailed document, it is viewed as dialogue between therapists and clients and as a decision-making process where clients get to make decisions based on discussion and information.
In general, 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. As Thomas Szasz has clarified for the last 40 years, these rights have been violated regularly, probably daily, by psychiatrists and institutions in locking people up and medicating them without consent. 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.
According to some scholars, the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. These scholars assert that at the war crimes tribunal in 1949, ten standards were put forth regarding physicians' requirements for experimentation on human subjects. The trials established a new standard of ethical medical behavior for the modern era, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the benefit of society, for the potential acquisition of understanding of the pathology of disease, and for studies performed that avoided physical and mental suffering.
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 is also relevant in situations where therapists and clients communicate via email, and when a client authorizes a therapist to release confidential information or to record a session. There are many other situations where informed consent is applied.
Informed consent not only protects the client but also protects the clinician. By obtaining informed consent, the clinician possesses proof of the consent. By obtaining informed consent in writing, the clinician possesses even clearer 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. However, written consent is neither always possible nor always clinically advised. Consent is most often used prior to beginning of therapy, counseling or psychological assessment. It is also used to authorize psychotherapists to release or reveal confidential information about the patients whom they are treating or have treated. As discussed later in this paper, written informed consent is only one form of consent, and there are situations where informed consent is either not required or impossible to obtain. Other situations may avail verbal or other consents but not written ones.
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The Process of Informed Consent
The process of securing informed consent has three phases, all of which involve the exchange of information between therapist and client. Many scholars emphasize that informed consent is not just signed documents. It often involves a process, dialogue or discussion between a therapist and a client.
Generally, the process of informed consent involves three parts: Providing the client with information, evaluating the client's capacity to understand the information and, finally, obtaining consent from the client. Following are short discussions of these three parts:
- The therapist must communicate the nature, risks and benefits of the procedure, treatment, research or any other eventuality that the client is consenting to. This also includes authorizing the therapist to release information, communicate by email, record a session, etc. At this phase the client gets to ask questions and be engaged in a dialogue or discussion with the therapist. The therapist should also outline feasible alternatives to the treatment (if there are any) and emphasize the element of choice (if there is any), so the client is clear on all options. The client should also be presented with information about the most likely outcomes of the treatment, release of information, etc. It is very important that information be presented so that the client can comprehend it clearly and rationally.
- The therapist must evaluate whether or not the person has the capacity to understand the information and is competent to make an informed decision regarding his/her healthcare and treatment or other occurrences. Once this has been determined, and the therapist has provided the necessary information, the therapist must determine whether or not the information provided was understood. The therapist must be able to ensure that the client clearly understands and accepts the risks inherent in the procedure, release, or treatment. When appropriate and possible, the therapist may verify that the individual is proceeding with the identified option with clear knowledge and forethought about its risks and benefits.
- Finally, the client must acknowledge the s/he has been informed and expresses their consent in some way. As will be discussed later on in this paper, there are several ways that a client may acknowledge that s/he has been informed and that consent is given.
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Exceptions to Informed Consent
There are, obviously, many exceptions to the process of securing informed consent in psychotherapy and counseling. Emergencies are obvious examples. Many state laws and professional association codes of ethics have provisions that permit or even mandate to release information and provide treatment and assessment under certain circumstances, without an informed consent. These situations may include when a client is in danger to self or others, child or elder abuse or neglect, and Tarasoff. For a summary article, "Ethics Codes On Record Keeping and Informed Consent In Psychotherapy and Counseling," click here.
As was noted above, Thomas Szasz has written extensively about the prevalence and abusive practices of these exceptions. Additional critique of involuntary incarcerations and hospitalizations has been provided by HHCR. In contrast to emergency situations and other exceptions, 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. HIPAA regulations have introduced numerous exceptions and allow information to be shared among team members and other health care providers. However, these regulations, as is often the case with mental health laws, are pre-empted by stricter state laws.
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Validity of Consent
How much information is given and the person's capacity to comprehend the information are the two main issues that determine the validity of informed consent. The law requires that reasonable standards for psychotherapy be applied when determining how much information is considered adequate in discussing a procedure or treatment with the client.
There are three elements to making this decision:
- What would a typical (reasonable) therapist say about the mental health intervention, procedure, release of information, or research project? In other words, this first element takes into consideration what an average or reasonable therapist would convey, giving the context of the consent. What a reasonable therapist would say would vary according to the client, therapeutic orientation employed, and setting of therapy. For a more detailed view of what constitutes context of therapy, click here.
- What would an average mental health client (in similar physical or mental condition) need to know to be an informed participant in the decision? This element focuses on the client factors within the context of therapy.
- What would a client need to know and understand to make a decision that is truly informed? This element is as important as it is vague and is more open to interpretations, debate and disagreements than the above two items.
The ability to give informed consent obviously also 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 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 (which 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.
The question of the validity and applicability of informed consent has often been addressed and debated. The reason for this is that informed consent can be complex and hard to evaluate because neither expressions of consent, nor expressions of understanding of implications, necessarily mean that full adult consent was not, in fact, given nor that full comprehension of relevant issues had been understood. Many times consent is implied within the usual complex subtleties of human communication rather than explicitly negotiated verbally or in writing. 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 their right to decline it.
Examples of invalid informed consent:
- A person may verbally agree to something from fear, perceived social pressure, or psychological difficulty in asserting their true feelings, and the person requesting the action may honestly be unaware of this and believe it is genuine and rely upon it. Consent is expressed but not internally given.
- A person may state they understand the implications of some action, as part of their consent, but in fact not have appreciated the possible consequences fully and later deny the validity of their consent for this reason. Understanding needed for informed consent is stated to be present but is in fact (through ignorance) not present.
- A person may move from friendship to sexual contact on the basis of body language and apparent receptivity. However, very few people on dates that result in sexual contact have explicitly asked the other if their consent is informed, if they do in fact fully understand what is implied and all potential conditions or results. Informed consent is implied (or assumed unless disproved) but not stated explicitly.
- A person below the age of consent may agree to sex and know all the consequences, but their consent is deemed invalid as they are deemed (regardless of the reality) to be a child unaware of the issues and thus incapable of providing informed consent. Individual is barred from legally giving informed consent, despite what they may feel.
- In some countries (notably United Kingdom), individuals may not consent to injuries inflicted upon them, and so a person practicing sadism and masochism with a consenting partner may be deemed to have caused actual bodily harm without consent, actual consent notwithstanding. Individual is barred from legally giving informed consent, despite what they may feel.
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Different Forms of Consent & The Issue of Explicit vs. Implicit Consent
Many experts, professional and lay people alike, mistakenly believe that the only valid way for a client to give consent is by signing on the dotted line of a printed (written) document. As was stated above, in reality there are many ways consent can be given.
Types of consent:
- Expressed or Presumed
- Explicit or Implicit
- Verifiable or Conjectural
- Written, Verbal or Non-Verbal
- Legal or Illegal
- Ethical or Unethical
Before this paper proceeds to discuss the different forms of consent, following are some basic definitions of some of the above-mentioned terms as identified by Apple Inc. Dictionary, 2007:
Expressed Convey (a thought or feeling) in words or by gestures and conduct: he expressed complete satisfaction.
Presumed [With clause] suppose that something is the case on the basis of probability: I presumed that the man had been escorted from the building | [trans.] the two men were presumed dead when the wreck of their boat was found.Or take for granted that something exists or is the case.
Explicit Stated clearly and in detail, leaving no room for confusion or doubt: the speaker's intentions were not made explicit.
Implicit/Implied implied though not plainly expressed: comments seen as implicit criticism of the policies. [predic.] (implicit in) essentially or very closely connected with; always to be found in: the values implicit in the school ethos. [OZ Implicit consent includes non-verbal and other forms of consents. Implied consent is given when clients engage in behaviors that reasonable people would interpret as informed choice.]
Verifiable Make sure or demonstrate that (something) is true, accurate, or justified: his conclusions have been verified by later experiments | [with clause] "Can you verify that the guns are licensed?"
Conjecture Noun an opinion or conclusion formed on the basis of incomplete information: conjectures about the newcomer were many and varied | the purpose of the opening in the wall is open to conjecture. Verb [trans.] form an opinion or supposition about (something) on the basis of incomplete information: he conjectured the existence of an otherwise unknown feature | many conjectured that she had a second husband in mind.
Written Mark (letters, words, or other symbols) on a surface, typically paper, with a pen, pencil, or similar implement: he wrote his name on the paper | Alice wrote down the address | [intrans.] he wrote very neatly in blue ink.
Verbal Relating to or in the form of words: the root of the problem is visual rather than verbal | verbal abuse.Spoken rather than written; oral. [OZ Verbal consent can be implicit or explicit, depending on the extend and type of words and language used to give the consent.]
Non-Verbal: Not involving or using words or speech. [OZ May involved gestures or other non-verbal cues.]
Implicit vs. Explicit Consent
- While explicit and/or written consent seems to be the ideal way to obtain informed consent, there are many situations where implicit or implied consent is reasonable, sufficient or the only available option.
- It is important to remember that neither explicit nor written consent necessarily guarantees that the concern is informed or valid.
- The notion of implicit consent is rarely discussed in the psychotherapy literature, even though it is probably the most common form of consent given. As a result, the poorly or rarely defined is often misunderstood. Consistently, there is little practical guidance as to the extent and depth of explanation that is needed.
- Implicit or implied consent is often referred to as a consent that is inferred from a patient's actions. Implied consent is given when clients engage in behaviors that reasonable people would interpret as informed choice. Needless to say, what is reasonable is highly debatable, and as a result, the degree of implicit consent is not clear and is set by the courts and professional bodies on a case-by-case approach. (For more details, see Vacc, N.A. & Loesch, L. C., 2000. Professional Orientation to Counseling).
- Examples of implicit, presumed, and non-verbal consent are
- When a client puts his or her hand forward to shake the therapist's hand, this is considered implied consent to physical touch.
- If the therapist asks the client whether he or she can touch the client's shoulder, and the client affirmatively nods, one can reasonably assume that this is non-verbal consent to touch. In these situations one may make the argument that what seems like an affirmative nod was a head bob stemmed from an involuntary muscle spasm or a Tourette twitch. It seems unrealistic and, some may say, ludicrous or counter clinical to have a client sign an informed consent for touch prior to a simple supportive touch on the shoulder. Requiring such consent is likely to be detrimental to the therapeutic alliance, as the client will, most probably, view the therapist as rigid and scared rather than supportive and caring.
- Another example of a consent that is neither explicit, in writing nor verbal is when a client shows up to a session with his or her spouse and tells the therapist that he or she would like the spouse to join them for that session. Implied in this situation is that the client authorizes the therapist to reveal, at the very least, confidential information that the therapist uses in treating the client. In this situation it is not clear how much information the therapist is authorized to reveal. The most cited concern is, what if the therapist reveals to the spouse that the client has or had a sexual extramarital affair that the spouse was not aware of. While in an ideal world the therapist would have discussed what information he or she is authorized to reveal and whether the affair or other issues should be brought up. In some situations it is advisable to have a written consent that summarizes the communication regarding the joint session. However this options is not always possible or realistic.
- Unlike the commonly help beliefs, some professional organizations codes of ethics, such as American Psychological Association (APA), do not always mandate that the informed consent is written and signed.
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Ethics of Informed Consent
The ethics aspects of informed consent have been addressed by almost all professional organizations. For a summary article, "Ethics Codes On Record Keeping and Informed Consent in Psychotherapy and Counseling," click here.
Following is an example of one code of ethics in regard to informed consent. The American Psychological Association's Ethical Principles of Psychologists and Code of Conduct 2010 (http://www.apa.org/ethics/code/principles.pdf) addresses three areas for the utilization of informed consent in psychotherapy, assessment and research:
- 10.01 Informed Consent to Therapy
(a) When obtaining informed consent to therapy as required in Standard 3.10, Informed Consent, psychologists inform clients/clients as early as is feasible in the therapeutic relationship about the nature and anticipated course of therapy, fees, involvement of third parties, and limits of confidentiality and provide sufficient opportunity for the client/client to ask questions and receive answers. (See also Standards 4.02, Discussing the Limits of Confidentiality, and 6.04, Fees and Financial Arrangements.)
(b) When obtaining informed consent for treatment for which generally recognized techniques and procedures have not been established, psychologists inform their clients/clients of the developing nature of the treatment, the potential risks involved, alternative treatments that may be available, and the voluntary nature of their participation. (See also Standards 2.01e, Boundaries of Competence, and 3.10, Informed Consent.)
(c) When the therapist is a trainee and the legal responsibility for the treatment provided resides with the supervisor, the client/client, as part of the informed consent procedure, is informed that the therapist is in training and is being supervised and is given the name of the supervisor.
- 9.03 Informed Consent in Assessments
(a) Psychologists obtain informed consent for assessments, evaluations, or diagnostic services, as described in Standard 3.10, Informed Consent, except when (1) testing is mandated by law or governmental regulations; (2) informed consent is implied because testing is conducted as a routine educational, institutional, or organizational activity (e.g., when participants voluntarily agree to assessment when applying for a job); or (3) one purpose of the testing is to evaluate decisional capacity. Informed consent includes an explanation of the nature and purpose of the assessment, fees, involvement of third parties, and limits of confidentiality and sufficient opportunity for the client/client to ask questions and receive answers.
(b) Psychologists inform persons with questionable capacity to consent or for whom testing is mandated by law or governmental regulations about the nature and purpose of the proposed assessment services, using language that is reasonably understandable to the person being assessed,
(c) Psychologists using the services of an interpreter obtain informed consent from the client/client to use that interpreter, ensure that confidentiality of test results and test security are maintained, and include in their recommendations, reports, and diagnostic or evaluative statements, including forensic testimony, discussion of any limitations on the data obtained. (See also Standards 2.05, Delegation of Work to Others; 4.01, Maintaining Confidentiality; 9.01, Bases for Assessments; 9.06, Interpreting Assessment Results; and 9.07, Assessment by Unqualified Persons.)
- 3.10 Informed Consent
(a) When psychologists conduct research or provide assessment, therapy, counseling, or consulting services in person or via electronic transmission or other forms of communication, they obtain the informed consent of the individual or individuals using language that is reasonably understandable to that person or persons except when conducting such activities without consent is mandated by law or governmental regulation or as otherwise provided in this Ethics Code. (See also Standards 8.02, Informed Consent to Research; 9.03, Informed Consent in Assessments; and 10.01, Informed Consent to Therapy.)
(b) For persons who are legally incapable of giving informed consent, psychologists nevertheless (1) provide an appropriate explanation, (2) seek the individual's assent, (3) consider such persons' preferences and best interests, and (4) obtain appropriate permission from a legally authorized person, if such substitute consent is permitted or required by law. When consent by a legally authorized person is not permitted or required by law, psychologists take reasonable steps to protect the individual's rights and welfare.
(c) When psychological services are court ordered or otherwise mandated, psychologists inform the individual of the nature of the anticipated services, including whether the services are court ordered or mandated and any limits of confidentiality, before proceeding.
(d) Psychologists appropriately document written or oral consent, permission, and assent. (See also Standards 8.02, Informed Consent to Research; 9.03, Informed Consent in Assessments; and 10.01, Informed Consent to Therapy.)
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Content of Consents
The content of the informed consent varies from situation to situation. Generally, a description of the intervention, treatment, procedure, and release of information must be articulated and, when appropriate and relevant, the risks and benefits, alternatives options, etc. are articulated. Risks and benefits and the exact nature of the procedures are sometimes clear and other times need to be explained. Yet in other situations, they are vague and not easily explainable. The extent and depth of information given vary from one situation to another. Child custody evaluation often entails an elaborate consent about risks, such as having less time with one's child or needing to pay more in child support. Similarly, Electric Shock Therapy, Forensic Evaluations, Fitness to Serve, and prescription of medication may require elaborate consent. On the other side of the spectrum, physical touch, such as a ritualistic handshake, is considered implicit consent, and it is presumed that the client is aware of risks, such as transmission of germs. Consent to release information often includes information, such as who the entity is that the information is being released to, what kind of information is to be released, purpose of the release and time limit or period when such release is authorized.
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 customarily given prior to the onset of psychotherapy or counseling. Samples of the questions for which a client deserves answers prior to providing informed consent, as articulated by the above authors, appear below:
- What is the name of your kind of therapy?
- How did you learn how to do this therapy?
- How does your kind of therapy work?
- What are the possible risks involved? (like divorce, depression)
- What percentage of clients improve? In what ways? How do you know? (e.g., published research? your own practice experience? discussions with your colleagues?)
- What percentage of clients improve or get worse without this therapy? How do you know?
- About how long will it take?
- What should I do if I feel therapy isn't working?
- Do you do therapy over the phone? Over the Internet?
- What other types of therapy or help are there? (like support groups)
- What are the risks and benefits of these other approaches? What are the risks and benefits of NO therapy?
- How is your type of therapy different from these others?
- How are appointments scheduled?
- How long are sessions? Do I have to pay more for longer ones?
- How can I reach you in an emergency?
- What happens if the weather is bad, or I'm sick?
- What kind of records do you keep? Who has access to them? (insurance companies, supervisors, etc.)
- Under what conditions are you allowed to tell others about the things we discuss? (suicidal or homicidal threats, child abuse, court cases, insurance companies, supervisors, etc.)
- How do governmental regulations influence how you handle the confidentiality of my records?
- What is your fee?
- Do I need to pay for missed sessions?
- What are your policies about raising fees? (for example, how many times have you raised them in the past two years?)
- If I lose my source of income, can my fee be lowered?
- How much and what kind of information will you be required to tell the insurance company about our sessions? (diagnosis, symptoms, etc.).
- What if I switch insurance companies or lose my insurance? Or what if you stop accepting my insurance?
- How would therapy be different if I chose to pay without using insurance?
- What is your training and experience? Are you licensed by the state? Supervised? Board certified?
- Who do I talk to if I have a complaint about therapy that we can't work out? (e.g., supervisor, state board of psychological examiners, American Psychological Association ethics committee)
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Patriot Act Beware
Following the events of September 11, 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. This law brings new complexities to the issue of informed consent. For more information on this issue, click here.
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Informed consent is a legal and ethical term defined as the consent by a client to a proposed mental health 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 and available alternatives. The concept of informed consent originated with the recognition that individuals have rights: to freedom, autonomy and human dignity, and acknowledges that clients possess these rights and cannot be denied their rights due to mental health status or condition. Of course, involuntary hospitalization is an example where such consent has not been considered or honored. Informed consent in the field of mental health 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 understand, as fully as possible, the nature of the proposed interventions or procedures.
As this short paper discusses it, the term, informed consent, is quite broad. It is often unclear what constitutes "informed" and what constitutes "consent." Consent can be implicit or explicit, can be written, verbal or non-verbal, it can be expressed or presumed. Unlike the commonly held belief, not all consents are required to be in a form of signed-written documents. In many situations written consents are neither possible, mandated nor advised. It is important that psychotherapists, and all mental health care providers, are cognizant and informed of the clinical, ethical and legal complexities involved in providing and obtaining informed consent.
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