Informed Consent in Research

Article excerpt

The relationship between physician and patient, as generally delineated by the Hippocratic Oath and the American Medical Association's 1994 Principles of Medical Ethics, is one between a fiduciary and a principal. In such a relationship, the duties of loyalty and trust run from the fiduciary to the principal. The fiduciary (physician) is the person to whom the relevant interests of the principal (patient) are entrusted. It is the medical best interests of the patient, not the physician, that are in trust. The relationship, while usually gratifying and financially rewarding, is essentially one of professional altruism. Nevertheless, the satisfaction of this fiduciary obligation requires the performance of general duties at levels dictated by the nature and scope of medical intervention.

One such duty that medical fiduciaries owe medical principals is that of informed consent. The doctrine of informed consent, generally acknowledged as the means by which patient autonomy is protected, requires that the decision be voluntary and sufficiently informed. The patient, that is, must act voluntarily and in the light of adequate information. Interference with either of these required conditions by the health care provider results in a prima facie transgression of informed consent, and thus in a violation of patient autonomy.

The informational requirement has been delineated with considerable circumspection by the courts and legislatures within the law of torts. The various jurisdictions employ different standards, the purpose of which is to establish what constitutes the disclosure of information sufficient to ensure informed patient consent and hence respect for the patient's right of self-determination. There is some suspicion that even at best, some, if not all, of the standards fall more or less short of paying sufficient deference to the patient's right of self-government. Nevertheless, all of the standards regulating physician disclosure to the patient are designed to ensure that the patient receives information such that, in conjunction with the patient's voluntariness, respect for patient autonomy is at least approximated. Given that medical intervention takes place at both therapeutic and nontherapeutic levels, it is not at all clear that what constitutes proper informational disclosure at the former level will otherwise be satisfactory at the latter level.

After presenting both an outline of the various standards for achieving patient informed consent and a general distinction between therapeutic and nontherapeutic intervention, this note will briefly discuss the ethical and legal arguments on the adequacy of the standards within the respective interventional settings.

THERAPEUTIC DISCLOSURE STANDARDS

Three separate but related standards specify adequate informational disclosure by physicians to patients. In the majority of jurisdictions the so-called professional standard is employed (Natanson v. Kline). According to the professional disclosure standard or the "English Rule," a patient is adequately informed if the physician disseminates all the information that a reasonable and prudent physician practicing in the same field and in the same, similar, or national community would have disseminated. It is possible to argue that this standard is in accordance with traditional negligence tort law, according to which negligent behavior is generally determined in terms of what other reasonable and prudent individuals, in the defendant's position, might be expected to do to circumvent plaintiff harm. Whether or not a health care provider is negligent in performing a pulmonary arteriogram would be determined by referring to the professional standard in the medical community. This standard is evidenced by reference to what other health care providers in the community generally do. This standard applies also in the area of informed consent.

The second disclosure standard, the objective patient standard or the so-called "American Rule," switches the determination of adequate informational disclosure from the duty-bound party (the defendant) to the party who enjoys the right (the plaintiff) (Cobbs v. …