Informed Consent Basics

Informed consent is an ongoing process inherent in patient care. The underlying principle of informed consent is that patients have the right to be told what to expect and to determine what will be done with their bodies.

Through dialogue and discussion with you, your patients become more knowledgeable partners in medical decision-making and develop realistic expectations about the outcomes of medical intervention. Ideally, informed consent discussions build trust and reduce surprise and disappointment if complications or adverse events occur.

Informed consent covers general issues of managing an illness and specific procedures being proposed. Completion of a consent form is necessary for most invasive procedures. However, the form should be considered as just the documentation of the discussion(s), not the entire process.

Criteria for informed consent

Consent is given voluntarily, without coercion, and may be withdrawn. The patient is competent and able to understand the nature and consequences of the proposed treatment or procedure.

Information provided to the patient includes the rationale for the procedure or treatment, risks involved, expected benefits, and alternatives to treatment including the likely results of no treatment.

Physicians are responsible for obtaining their patient's informed consent, although others may assist in facilitating and documenting consent. Any other physicians (particularly house staff) involved in obtaining consent must be sufficiently knowledgeable about the procedure in order to adequately communicate the risks, benefits, and alternatives.

Consent should be obtained for all major therapeutic and diagnostic procedures (except emergencies) where disclosure of significant medical information, including major risks involved, would assist a patient in making an intelligent decision about the proposed procedure.

Your Harvard-affiliated institution has written informed consent policies that detail those procedures which require documented informed consent at that institution. Contact your department chairman or patient safety/risk manager for information and any applicable procedure-specific forms.

When to discuss consent

When practical, the informed consent discussion should be conducted when you and the patient have time to ask and answer questions, not on the way to the operating room. The process may occur over a period of several discussions, culminating in the signing of a consent form.

Consent during medical emergencies:

In the case of an emergency, a patient unable to give consent may be treated. Please consult your risk manager for advice regarding other special circumstances, such as handling consent for the minor patient or patient with mental incapacity.

What to disclose in the consent process

Determining which risks to discuss within the consent process should be based on the severity of the potential harm and the likelihood of its occurrence. Even a small chance of death or serious disability is significant. Alternative treatments, including the risk of no treatment, should be discussed. Explanations should be tailored to your patient's particular competency, comprehension, need, and desire for detail.

Procedure-specific consent forms

Procedure-specific consent forms should be developed and used wherever practical. When your patients have sufficient time to read and discuss the forms, they are the most comprehensive tools for communicating risks associated with specific treatment, and documenting your patient's consent. Personalizing the consent form through the addition of specific issues discussed with that particular patient is an excellent practice and demonstrates that the completion of the form was not just a perfunctory task.

During the informed consent discussion, address the most serious risks, the less serious risks with a high likelihood of occurring, and any other risks to which your patient attaches significance. Enter documentation of the discussion on either the form or in the patient's medical record. Documentation of patient-specific and procedure-specific risks is often crucial in the successful defense of malpractice claims and suits. Be certain to sign the form and initial any changes.

When a patient refuses to sign an informed consent form

Competent patients have the right to not consent, or to refuse treatment. If one of your patients refuses to sign a consent form, do not proceed without further attempting to obtain the consent. Treatment without the patient's consent may be construed, legally, as battery.

The first issue to be sorted out is whether your patient's refusal relates just to signing the form or to some aspect of care. Further explaining 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 treatment plan and the patient's preferences should take place. Documentation of the informed refusal is also crucial to support the clinical decision making.

If you, and other clinicians involved, believe a patient who is refusing life saving treatment may not be fully competent, you may need to proceed without a completed consent form. Fully document your decision and your reasons. You may also want to contact your risk manager or institutional legal department.

Advance directives

If you treat patients who are severely or terminally ill, you may need to discuss with them a plan in case they can no longer make medical decisions on their own behalf. Other, less ill patients may also want to discuss this subject and related topics (such as organ donation). Your risk manager can help you with your institution's policies related to living wills, health care proxies, and other advance directive issues.