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FAQs About Informed Consent

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Q: How should I decide what to disclose in the consent process?

A:

Determining which risks to discuss within the consent process should be based on the severity of the potential harm, the likelihood of occurrence, and the relevance to the patient. Obviously, even a small chance of death or serious disability is significant. The type and the number of risks to be disclosed should also depend on the significance each patient would attach to such risks in deciding whether to consent to the procedure or treatment. For instance, a remote risk of hearing loss associated with an antibiotic treatment is of major significance to a musician. Alternative treatments, including the risk of no treatment, should always be discussed. Explanations should be tailored to the individual patient's competency, comprehension, need, and desire for detail.

Q: Which are better, general or procedure-specific consent forms?

A:

Risk-specific consent forms are most helpful in defending an allegation of failure to inform. However, obtaining a patient's signature is an important part of securing consent for treatment and the overall process of sharing risk and benefit information. Personalizing the consent form through the addition of specific issues discussed with the patient is an excellent practice and demonstrates that the form completion was not just a perfunctory task. The form serves as the objective evidence of the informed consent process.

The discussion should address the most serious risks, less serious risks with a high likelihood of occurring, and any other risks to which the patient attaches significance. The documentation of the discussion of risks can be entered on either the form or in the patient's medical record.

Documentation of patient-specific and/or procedure-specific risks has been helpful in the successful defense of numerous CRICO consent-related claims. For example, more than one claim arising from a pregnancy subsequent to a sterilization procedure has been successfully denied when the defense demonstrated that the procedure was correctly performed and the procedure-specific consent form listed "failure of the procedure to prevent pregnancy" as a risk.

Q: What special issues arise in the consent process when the patient is a minor?

A:

Laws and policies vary depending on your state and health care entity. Generally, a child cannot be given medical or surgical treatment without parental consent. The most common exception is an emergency situation in which the parents cannot be contacted and a delay in treatment would cause harm.

Minors

In some states, statutory provisions address circumstances such as pregnancy, venereal disease, and substance abuse, where minors may wish to seek treatment without parental knowledge. Other statutes enable minors to consent to treatment in order to prevent minors from delaying or foregoing crucial treatment in fear of parental involvement. In general, the law respects minors' wishes to keep certain sensitive information from their parents when the minors are mature enough to understand the nature of the procedure and when the procedure does not involve serious risks.

Mature or Emancipated Minors

The laws of most states permit a person below the age of majority to give valid consent if the patient has assumed adult responsibilities such as financial independence, marriage, or child rearing. With a mature minor, you should assess and record clearly that the minor is able to understand the risks and benefits of the treatment being considered.

In these situations, minors are responsible for payment of their own bills; issues regarding their parents' insurance policies can prevent hospital treatment of a minor without the parents' knowledge.

Additional Information

Contraceptives: Providing contraceptive services to competent minors is legal if they have given informed consent.

Pregnancy: Minors can consent to the diagnosis, prevention, and care of pregnancy. Parental notification is not required when pregnancy is diagnosed.

Abortion: The laws governing abortions for minors vary by state. In general, however, minors have a right to give their medical consent to an abortion without parental consent. A parent may not force an adolescent to have an abortion against her will if she is mature enough to give her consent.

Q: What should I do if a patient refuses to sign a consent form?

A:

The first issue to be sorted out is whether this refusal relates just to signing the form or to some aspect of care. Further explanations about the treatment plan and the meaning of the form (with the aid of translation services, if necessary) may alleviate the patient's concerns. If the refusal to sign the form is based on concerns about potential medical interventions, more dialogue about the patient's preferences vis-a-vis medical judgment is indicated. This discussion should be documented if proceeding without a signed consent form is necessary.

Q: What should be done if an obstetrical patient refuses to sign a consent form during delivery?

A:

If concerns about potential medical interventions are leading to the refusal to sign the form, more dialogue about the patient's preferences vis-a-vis medical judgment during labor and delivery is indicated. This discussion should be documented.

If the patient has issues of trust which cannot be resolved--and is in the early stages of pregnancy--referral to another practitioner may be indicated. Referral to another practitioner during the third trimester is not advised. This could give rise to allegations of abandonment. The obstetrical practitioner, labor and delivery nurses, administration, and the risk manager should develop a coordinated plan to manage the delivery of a patient with unresolved issues of trust.

In the latter situation, the absence of an institutionally required signed consent form still needs to be addressed. Document in office and hospital medical records the dialogue about the pregnancy and plans for labor and delivery that have occurred during the prenatal period. Note the proposed obstetrical procedures and activities, risks and benefits, including unexpected risks and complications. The patient's verbal consent for continuing obstetrical care and refusal to sign a consent form should also be documented. The institution's printed obstetrical consent form provides an excellent outline for the detailed note. The situation should be discussed with the institutional risk manager who may have additional advice to offer.


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