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Developed by Ofer Zur, Ph.D.
For actual samples of Office Policies and HIPAA consent (called HIPAA Notice of Privacy Practices, click here.
For additional samples of informed consents, click here.
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 due 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 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.
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 only be requested 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.
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 their right to decline it. Following are examples given by Answer.com for invalid informed consents:
The ethics aspects of informed consent have been addressed by almost all professional organizations (for a detailed list, click here).
The American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct 2010 (https://www.apa.org/ethics/code/principles.pdf) addresses three areas for the utilization of informed consents 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.)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 with psychotherapy clients. Samples of the questions for which a client deserves answers prior to providing informed consent, as articulated by the above authors, appear below:
Therapy:
- 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?
Alternatives
- 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?
Appointments
- 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?
Confidentiality
- 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?
Money
- 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?
Insurance/Managed Care
- 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?
General
- 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 which we can’t work out? (e.g., supervisor, state board of psychological examiners, American Psychological Association ethics committee)
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. This law brings new complexities to the issue of informed consent. For more information on this issue, click here.
The rest of articles for this course are:
#2. For professional association codes of ethics on informed consent, click here.
#3. For resources and references, click here.
#4. For actual samples of Office Policies and HIPAA consent, click here.
#5. For actual samples of many types of informed consents, click here.