Informed consent



Informed Consent 1021
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Definition

Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, non-treatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to the treatment, non-treatment, or procedure. It is the method by which a fully informed, rational patient may be involved in the choices about his or her health. Informed consent applies to mental health practitioners (psychiatrists, psychologists, etc.) in their treatment with their clients in generally the same way as physicians with their patients.

Description

Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the mental health provider's ethical duty to ensure that the patient is involved in decisions about his or her own health care. The process of ensuring informed consent for treatment involves three phases, all of which involve information exchange between doctor and patient and are a part of patient education. First, in words the patient can understand, the therapist must convey the details of a treatment or procedure, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of treatment. Second the practitioner must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the treatment with full knowledge and forethought. Finally, the patient must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies. It is critical that the patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way.

According to the Ethical Principles of Psychologists and Code of Conduct designed by the American Psychological Association, informed consent also applies when conducting research involving human subjects prior to their participation. Participants in the study should be informed in understandable language to three main points. First, the participant should be informed about the nature of the research. Secondly, participants should be informed that their participation is completely voluntary and that they are free to withdraw from or not participate in the study at any time. Consent must be made without pressure being put on the participant to engage in the study. Finally, the potential consequences of participating or withdrawing should be presented to the participant. This includes risks, discomfort, and limitations of confidentiality.

With regard to either therapy treatment or research participation, another member of the health care/research team may obtain the signed informed consent with the assurance that the provider has satisfied the requirements of informed consent.

The actual informed consent form is to document the process and protect the provider and the hospital. Legally, it is proof that things have been covered and the patient agrees to the procedure, risks, benefits, options, etc. The informed consent process is in place for the protection of the patient. The process is in place to ensure that everything is discussed with the patient: all of the options, all of the common risks, the worst case scenario, and other similar situations.

Viewpoints

There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. Following the war crimes tribunal in 1949, as a result of the Kaarl Brandt case, 10 standards were put forth regarding physician's 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 within the realms of research. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology, and for studies performed that avoided physical and mental suffering to the fullest extent possible..

A crucial component of informed consent is that the person signing it is competent or able to make a rational decision and meaningfully give consent. This situation gets more complicated when working with people who are unable to understand what has been explained or are unable to make a reasonable decision about their health care. According to the Code of Conduct for Psychologists designed by the American Psychological Association, if this is the case, informed permission from a "legally authorized person" should then be sought, if that is a legal alternative. The ethical guidelines are more stringent than legal guidelines in many states, where the informed consent of the parent or guardian is all that is required, whether or not the professional has attempted to explain the procedure to the client.

Although it is necessary to present the procedure or treatment formally to the patient, there is concern that this process could hurt the therapeutic relationship between the client and therapist. For example, if an informed consent is too detailed, it could frighten a new client who may be hesitant about therapy to begin with. In addition, informing patients about the risks of treatment might scare them into refusing it when the risks of non-treatment are even greater. There are however, advantages to the informed consent process. First, it can be empowering to the patient to understand that he/she plays an important role in their own treatment. They are encouraged to be active participants in the treatment process and know their options well enough to make the best treatment decisions for themselves. This also shifts the responsibility to patients to work with the therapist towards their mental health goals, possibly increasing self-confidence and autonomy, and decreasing dependence on the therapist.

Professional implications

There are undoubtedly many issues regarding Informed Consent. As modern society continues to be litigious, the courts and/or government may take on a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled. Therefore, health care providers must become more educated as to what needs to be conveyed to patients, and to what extent.

Resources

BOOKS

Kazdin, Alan E. Research Design In Clinical Psychology. 2nd ed. Allyn and Bacon, 1992.

PERIODICALS

Beahrs, John O., Thomas G. Gutheil. "Informed Consent In Psychotherapy." American Journal of Psychiatry 158, no.1 (2001):4–10.

"Ethical Principles of Psychologists and Code of Conduct." American Psychologist 47, no. 12 (1992):1597–1611.

Lehman, C. M., G. M. Rodgers. "To IRB or Not to IRB?" American Journal of Clinical Pathology 115, no. 2 (2001): 187–191.

Lutz, S., S. J. Henkind. "Recruiting for Clinical Trials on the Web." Healthplan 41, no. 5 (2000): 36–43.

"Nuremberg Code (1947): Standards for medical experimentation." British Medical Journal 7070, no. 313 (1996).

Wirshing, D. A., W. C. Wirshing, S. R. Marder, R. P. Liberman, and J. Mintz. "Informed Consent: assessment of comprehension." American Journal of Psychiatry 155, no. 11 (1998): 1508–11.

OTHER

"Health Information for surgical procedures, family health, patient education." <http://www.docs4patients.com/informed-consent.asp> .

"Informed Consent." <http://www.nocirc.org/consent> .

"Informed Consent." The University of Washington. <http://eduserv.hscer.washington.edu/bioethics/topics/consntc1.html> .

"Informed Consent." Risk Management Handbook. Yale-New Haven Hospital & Yale University School of Medicine. <http://info.med.yale.edu/cim/risk/handbook/rmh_informed_consent.html> .

"Risk Management Issues: Improved Informed Consent." <http://www.rmf.harvard.edu/rmLibrary/rmissues/infconsent/body.html> .

Jenifer P. Marom, Ph.D.



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