The basic premise of informed consent dates back to the early part of this century, and centers on the principle of battery. Courts have clearly ruled that "every human being of adult years and sound mind has a right to determine what shall be done with his own body."
Most states now have specific informed consent statutes, yet even in the absence of such laws physicians have a common law duty to ensure that diagnostic, medical, and surgical procedures are authorized by the knowledgeable consent of the patient or his/her legal representative. A physician who fails to obtain his/her patient’s consent to treatment commits Thirda battery.
It is very important to realize that courts have increasingly held that informed consent is a process, and is not evidence by a signature on a piece of paper. A written and signed consent form will not necessarily withstand a legal challenge if it can be shown that the patient was not adequately informed about the treatment, risks, and alternative procedures available.
Informed Consent Standards
Courts generally use one of two informed consent standards. The older “professional disclosure” standard is followed in about half the states. This standard requires the physician to disclose to the patient everything that is customary in the profession to disclose under the same or similar circumstances. In court, plaintiffs in these states must produce an expert witness to testify that the defendant’s actions fell below the standard of customary disclosure.
The newer "reasonable patient standard" has been adopted in the remaining states. Under this standard, physicians are required to tell their patients everything that would reasonably bear on a decision to submit to treatment. Because expert testimony is not needed, it is generally easier to sue on informed consent grounds in states using this standard. In the case of federal court malpractice suits, the standard of the state in which the facility is located is used.
Courts also require proximate cause. This means that plaintiffs must also prove that a reasonable person would not have gone through with the procedure if they had been fully informed of the risks and alternatives. In the case of elective surgery, it is easier for a patient to prove that he/she would not want the procedure if additional information had been provided; for more urgent or lifesaving procedures, the plaintiff’s argument must be much more convincing. As a general rule, the more elective the procedure (and hence the greater the number of therapeutic alternatives), the more detailed the disclosure should be.
Required Elements: No matter what standard is applicable, there are five basic elements that must be disclosed to patients in language that a lay individual reasonably can be expected to understand:
- The diagnosis, including the disclosure of any reservations the provider has concerning the diagnosis;
- The nature and purpose of the proposed procedure or treatment;
- The risks and consequences of the proposed procedure or treatment. This includes only those risks and consequences of which the physician has, or reasonably should have, knowledge. It is not necessary to disclose every potential minor risk or side effect.
- Reasonable treatment alternatives. This includes other treatment modalities that are considered to be appropriate for the situation, even though they may not be the personal preference of the disclosing physician.
- Prognosis without treatment. The patient must be informed of the potential consequences, if he/she elects not to have the recommended procedure.
Therapeutic Privilege: Under limited circumstances, courts have recognized that a physician may be justified in withholding information if it can be shown to be in the patient’s best interest. This privilege applies only when a patient is unusually sensitive, anxious, or emotional.
Patient hypersensitivity should never be presumed. There must be ample justification for withholding information and the physician should carefully document his/her reasoning in the medical record. If the physician’s use of the therapeutic privilege is challenged, it must be determined whether the physician acted appropriately. The use of this therapeutic privilege should be relied upon only in rare circumstances.
Implied Consent: Consent is either expressed (verbally or written) or implied. Consent may be implied under a variety of circumstances. For example, when a patient visits a physician for a particular ailment, it is implied that he consents to be examined. If a patient has a fractured arm, it is implied that he consents to casting. In general, physicians can assume that most patients would readily consent to care or treatments that are customary, noninvasive, and non-experimental.
Implied consent also relates to the performance of additional procedures when medically justified. When a physician is performing a hysterectomy, for example, an incidental appendectomy cannot be performed without the patient’s expressed consent to do so. However, if the appendix is diseased, it is reasonable to assume that the patient would allow the procedure, unless the patient had expressly prohibited the appendix from being removed.
The use of general or blanket consent forms is not sound practice. These types of consent forms do not represent true informed consent as they are often solicited by an admission clerk, adequate information is not given, and they are not specific to any particular treatment or procedure. Blanket consent forms only serve as evidence of the patient’s voluntary submission to treatment in general, which is usually self-evident (implied), but these types of forms do not demonstrate that the patient understood specific indications and risks of any proposed invasive procedures. Again, it is recommended that blanket consent forms not be used but that evidence of properly obtained informed consent be documented in the medical record.
Who May Give Consent: If the patient is a competent adult, the authority to give consent to treatment rests exclusively with the patient, unless the patient formally delegates that authority to someone else. Through the use of a document called a "power of attorney," executed in writing, a competent adult can delegate the responsibility for health care decisions to another competent adult.
A power of attorney in most states becomes ineffective when the person granting it becomes incompetent. For this reason, many states now recognize a “durable power of attorney,” which generally remains effective even after the person granting the power becomes incompetent.
In the health care setting, a durable power of attorney is the preferred document. Health care providers should always be careful to ensure that the proposed treatment lies within the scope of the expressed authorization.
Individuals who have not attained the legal age of majority (in most states, age 18) cannot legally give consent except in the following situations:
- The patient is an emancipated minor (e.g., the minor is married, lives away from the parental home, or is financially independent);
- The state has fixed a lower limit of age for certain health care decisions (such as in the case of pregnancy and treatment of venereal disease);
- The state recognizes a “mature minor” exception, which allows minors to give consent to health care when there is a pressing need and the parent or guardian is unavailable. It is recommended that the reader be familiar with the laws in the state in which you practice.
The law holds that the closest available relative or legal guardian can authorize necessary and reasonable care when the patient is incapable of giving consent because of age, incompetency, or incapacity. A health care provider acting on the reasonable belief that a person is the patient’s next of kin is legally protected if the authorizing person turns out not to be a close relative.
Emergency Situations: When the need for care is urgent, the patient is unable to give consent, and it is not feasible to contact the patient’s next of kin, then the law does allow the physician to proceed with lifesaving diagnostic and therapeutic procedures without informed consent. The emergency consent exception is based on the following concepts:
- The health care provider is entitled to presume that the patient would have chosen the care others would have chosen under similar circumstances, unless the provider has information to the contrary;
- The exception only applies to situations where immediate action is necessary to preserve life (or in some states “to prevent serious physical harm”);
- The circumstances justifying the emergency consent exception are well documented, including all attempts to notify the next of kin before treatment is begun.
Informed Refusal: The issue of documenting informed refusal is a relatively recent development. It is clear, as noted above, that a patient has both the right to determine what is or is not done to her body. However, a patient should be very well informed if he/she is going to refuse a well-established, common procedure such as a cancer screening test. On more than one occasion when patients have sued over a delayed diagnosis of cancer, courts have held that the physician was liable because he/she failed to adequately inform a patient about the consequences of the patient’s prior refusal to accept standard cancer screening procedures.
For this reason, it is becoming more common for physicians to send letters to patients who decline certain types of care, informing them of the consequences in detail. Alternatively there may be circumstances where it would be wise to have the patient sign a written "informed refusal" document. Is this necessary every time a patient declines a test? No, but it would seem prudent to assess each situation carefully.
Document, Document, Document: All physicians should accept the doctrine of informed consent. It has strong ethical and moral backing, and it emanates from the right of self- determination.
In most states, verbal consent to treatment is legally sound, but it is very difficult for the provider to prove what the patient was told in the event that an adverse outcome leads to a malpractice claim. There is no question that written documentation enhances a physician’s credibility. It therefore makes for good defensive medicine to carefully document the informed consent process, which includes, but is not limited to, a form that details the information disclosed to the patient, signed by both the patient and provider, and witnessed by a third party. It is helpful to have a third person (preferably a health care provider) present at the counseling session to witness the exchange of information, help solicit and answer questions, verify that the patient understands the information, and attest that the session took place. By signing the consent form, the third party is serving as a witness, and he/ she is not liable for the quality and sufficiency of the information given.
The patient-counseling session must be documented. There should be ample written evidence that informed consent was given to the patient, and the process by which it was given. In addition to a signed consent form, a progress note should include the fact that a counseling session took place, the mode of information delivery, and any additional clinically important details not specified on the consent form.
The American College of Surgeons recommends that the following principles be adhered to when documenting informed consent:
- There should be a clear explanation of each medical term in lay language;
- There should be a listing of commonly occurring risks of the procedure;
- Never describe a procedure as “simple,” “uncomplicated,” or “minor.” The consent form should include a statement that no result has been guaranteed;
- Avoid the use of national statistics, as the operating surgeon’s own experience may vary from the national norm;
- Indicate on the consent form if the patient has been given an informational brochure or shown a video;
- The signature of both the patient and operating provider should be on the consent form, timed and dated;
- The form should include a statement indicating that "unexpected risks or complications not discussed may occur," and that "unforeseen conditions may be revealed requiring the performance of additional procedures, and I authorize such procedures to be performed."
The patient should acknowledge on the consent form that the information disclosed has been understood, that an opportunity to ask questions has been provided, and that all questions have been answered to the patient’s satisfaction;