Informed Consent and Risk Management

Introduction

A chapter on the subject of informed consent must address a variety of complex historical, ethical, and medicolegal principles. The realistic risk in dermatology of incurring legal liability solely from failure to inform a patient about the risks of a given procedure or medication is relatively small. A study of medical liability claims against dermatologists from 1991 through 2015 found that only 18 out of a total of 1084 were based primarily on the physician’s failure to communicate adequately with the patient. Nonetheless, the topic of informed consent is important in dermatology. Besides legal considerations, this chapter emphasizes the ethical and medical principles from which informed consent (or, more properly, ‘informed choice,’ because it also entails the patient’s right to refuse medical interventions ) derives its meaning. The communication process that constitutes informed consent is emphasized, stressing that it is the communication, rather than merely obtaining a signature on a form, that is the basis of informed consent. In reality, most informed consent in medical practice occurs in the absence of any patient signature on a ‘consent’ form.

This chapter covers the historical evolution of informed consent in the United States and Europe, the underlying ethical perspectives and associated legal principles. In addition, the formal components of informed consent are addressed, and a brief overview of legal risk management in dermatology is presented.

Historical Perspective

Informed consent (as it is known today) was first recognized in 1767 in English Common Law, addressing the patient’s right to give or withhold permission for medical care. In the United States, Judge Cardozo in 1914 addressed the patient’s right to give or withhold permission for medical intervention, in the context of an assault and battery claim brought against a physician, holding that ‘every human being of adult years and of sound mind has the right to determine what shall be done with his body. The Nuremberg Code, which emerged from the 1947 War Crimes Trials, was the first major document to specify informed consent as a fundamental principle of medical research. The specific term ‘informed consent’ was first used in the treatment context by an American court in 1957.

The ‘professional’ or ‘reasonable physician’ standard for informing patients was first described in 1960 in a landmark Kansas malpractice case. The contrasting ‘material’ or ‘reasonable patient’ standard was first enunciated by a court in 1972. These two standards for information disclosure to patients are explained later.

The medicolegal concept of informed consent continues to evolve. The clinician should become familiar with the relevant statutes and judicial decisions in his or her practice jurisdiction. In addition, clinical practice guidelines (also called practice parameters ) developed by various professional organizations and other groups may influence the information to be shared with patients, as part of the informed consent process. The standards of private accrediting bodies, such as The Joint Commission (TJC), also affect the content of information disclosure.

Ethical Perspective

The legal doctrine of informed consent reflects the physician’s basic ethical responsibility to respect the personal autonomy of the patient. The goal is to have decisions to use a particular medication or to undergo a surgical procedure made in a shared manner, by the individuals who are most directly affected by the consequences of the decision, namely the patient and the physician. Ideally, this facilitates more intelligent and rational decision making.

Several important potential medical benefits may be achieved through a truly informed consent process. Q68.1 (1) There is a greater sense of partnership and active mutual participation within the patient-physician relationship. (2) Other benefits should include more overall openness and less authoritarianism in the relationship, increased patient adherence, and more assistance from the patient in ongoing surveillance for drug adverse effects (AE). (3) In addition, attention to obtaining informed consent encourages greater professional self-scrutiny, with respect to medical decisions.

As a rule, thorough provision of information to patients about their medical options is good, ethical, and legally sound medical practice. The ethical concept of autonomy, translated into the legal doctrine of informed consent, embraces the right to receive information and act on it, giving or withholding consent.

Basic Legal Principles

Several general legal principles need to be understood from the outset. As noted before, the physician should become familiar with the statutes, regulations, and judicial decisions that deal directly with informed consent in the physician’s own jurisdiction.

The physician has the ultimate legal responsibility for both the process and the outcome of medical therapy, even though many associated medical personnel might also be involved with the treatment. With this principle in mind, the ultimate duty to ensure the adequacy of a patient’s consent cannot be delegated by the physician to medical students, nurses, or others. Similarly, the physician may not completely replace the informed consent dialogue by relying solely on pamphlets or audiovisual aids. However, other members of the healthcare team and written and audiovisual materials can serve important complementary and reinforcing roles in the communications process.

Q68.2 ‘Express consent’ entails the explicit communication of consent by words, either spoken or put in writing. The greater the risk or invasiveness of the contemplated medical intervention, the more advisable it is to obtain express consent. ‘Implied consent’ is more commonly operant for routine medical interventions. In situations involving little risk or intrusiveness, the patient’s nonobjecting cooperation normally is taken to signify consent. Implied consent is not an exception to the informed requirement, but rather is one method of complying with that requirement.

Litigation based on total lack of consent—namely, unauthorized touching of the patient, or battery—is uncommon today. Instead, inadequate explanation of medication risks or other medical interventions is more likely to be framed as negligence, or deviation from the acceptable standard of care, under the circumstances. Liability may be imposed, at least theoretically, for such inadequate communication, even when the quality and outcome of care are otherwise fine.

The context of the patient-physician interaction may influence the extent of information exchange and documentation necessary. For instance, very specific requirements are imposed by federal regulations, when clinical drug research is being undertaken. Detailed written consent forms are central to investigative work in the pharmaceutical industry.

In the therapeutic context, the legal rules for prescribing US Food and Drug Administration (FDA)-approved medications with significant AE are less clear cut. Q68.3 As a general matter, the recommendation of an approved drug, for an off-label or unapproved indication, should be accompanied by especially vigilant attention to providing the patient with detailed information about anticipated risks and benefits.

A majority of the prescriptions for systemic drugs, used in dermatology, are for off-label indications. The FDA approves the manufacturer’s labeling and marketing of a specific drug for a specific purpose; the conditions of approval limit the types of claims a manufacturer may make in advertising and package inserts regarding that drug. FDA approval signifies that the pharmaceutical firm presented sufficient evidence to the FDA to satisfactorily establish the test drug’s efficacy and safety, for the indication specified in the firm’s application to the FDA. The FDA does not permit a drug to be marketed or prescribed if it is found to be too risky or ineffective. There are many rare diseases for which it is economically unrealistic for the pharmaceutical firm to bother gathering adequate data to apply for FDA approval for the specific, uncommon indication.

It is both medically acceptable and legal for a physician to prescribe drugs that have been approved by the FDA for one use to treat different, unapproved indications, when there are clinical data to support that unapproved use. The federal Food, Drug, and Cosmetics Act in 1937 clearly provides that the FDA has authority to regulate only drugs, not the physicians who might prescribe those drugs.

For both medical and legal purposes, the risks of any therapy should not be disproportionately greater than the risks of the disease being treated. For example, dermatologic conditions, such as toxic epidural necrolysis and pemphigus vulgaris are serious conditions that, in certain patients, can justify potentially risky treatments; this is a different risk-benefit calculus than would apply to less serious dermatologic conditions. Good medicine sometimes involves the taking of risks, with the patient’s consent, to attempt to achieve important medical results. The location of a physician’s practice (for example a private office vs. an academic setting) may dictate the justifiable level of risk regarding systemic drug therapy; specifically, medications carrying a high degree of risk are used more commonly in the academic setting, where more safeguards are present.

Separate signed consent forms are usually required legally only in the research protocol context. In clinical (in other words, diagnostic and therapeutic) practice, the TJC requires consent forms primarily for hospital-based surgical procedures. Among other things, TJC accreditation is a means (‘deemed status’) for hospitals to qualify for payment from third-party payers for medical services.

A signed consent form, even when not legally required, may be useful for legal risk management purposes, because it documents that at least some physician-patient communication took place. Except for TJC-required consent forms in surgical settings, the particular means by which documenting that consent occurred is secondary in importance to the communication process itself. Documentation of the patient’s consent to the administration of most systemic drugs used in dermatology requires only chart notations that discussion about medication risks, benefits, limitations, and alternatives took place. An important exception is the use of isotretinoin by women of childbearing potential, in which the iPledge program information packets and informed consent forms remain the standard of practice. When the dermatologist wishes to take and retain digital photographs of a patient, that patient’s informed consent should be obtained and clearly documented.