DR. RICHMAN is Assistant Professor, General Gynecology, and Directior, Section of Family Planning, Department of Obstetrics, Gynecology and Reproductive Science, Yale University School of Medicine, New Haven, Conn.

Susan Richman, MD

Informed consent is permission for a treatment or procedure-granted without coercion-by a competent, knowledgeable, and autonomous person.

  Signed documentation isn't always required, but if you perform a medical procedure without getting informed consent, you may technically, and in the eyes of the law, be committing battery, even if your only intent was to help the patient.

  For informed consent to be valid, you must provide a patient with all relevant information, her participation must be voluntary, and you must be assured of her competency.  

The guiding principle behind informed consent is respect for individuals and their autonomy. The American College of Obstetricians and Gynecologists emphasizes respect in ob/gyn practice, underscoring its importance to "bodily integrity, self-determination regarding sexuality and reproductive capabilities, and to the support of the patient's freedom within caring relationships."

  Because not all patients have the same ability to make autonomous decisions, clinicians may at times feel that they have to resort to paternalism-or making a decision 

 a patient-to prevent adverse consequences.  

This article will help clinicians sensitively address issues of informed consent in women with developmental disabilities and serious and persistent mental illness. In the past, these vulnerable individuals were often subjected to abuse, but strong ethical standards now in existence offer them protection beyond that afforded to the general public. 

Who makes the decision about a patient's competence is the subject of frequent debate. Assessing decision-making capacity in a woman with mental challenges is critical to determining whether she can consent to treatments and make reproductive decisions, and hence give informed consent. You can consider a patient capable of consent if she can demonstrate to you that she understands her health-care decisions and their potential consequences. 

When you are treating a woman who has a serious mental illness or diminished mental capacity, you must not allow bias to factor into your assessment of her competency.

  There is no single criterion you can use, and a patient may be functional in many aspects, yet be unable to engage in the complex decision-making that is required for medical consent.

  As a clinician, it's your responsibility to fully disclose all information that your patient needs to make sound decisions.

  To help increase a patient's understanding, you can and should use simple language and impart information in small segments. Tools such as the Hopkins Competency Assessment Test, the Competency Interview Schedule, and the MacArthur Competence Assessment Tool have been shown to be valuable in assessing comprehension in patients with limited verbal ability.

Keep in mind, too, that a patient's barriers to informed consent may be temporary. A usually competent person can be rendered unable to give informed consent by serious illness, fear, pain, or emotional distress.  

Culture and family values also can influence or impair a patient's ability to consent. The woman sitting across from you in the office today may have beliefs about autonomy and individual choice and rights that are far different from what might be considered "mainstream" in American culture.

  For example, she may shrug helplessly or look embarrassed when asked about her preferences for a birth control method, but that may imply that she feels that her husband has to make that decision, not that she cannot understand the different options. 

Articles

True consent requires an understanding of decisions-and their consequences. With sensitivity, it's possible to respect a patient's autonomy while acknowledging limitations in her mental state.

Susan Richman, MD

Articles

Informed consent and the mentally challenged patient