Informed Consent: A Potential Dilemma for Complementary Medicine

Professor Ernst's recent commentary1 regarding the dilemma of informed consent was noteworthy and of significant value. Although he principally showed the potential problem of financial conflict of interest, it is important to note that the issue raises additional ethical concerns.

As with many other clinical procedures, manipulative therapy, particularly of the cervical spine, possesses defined risks.2 A crucial responsibility of the clinician is to effectively evaluate the ratio of therapeutic benefit versus (possible) risk(s) inherent to a particular procedure in the treatment of a defined pathology in a specific patient. This is a core ethical duty on which the fiduciary basis of the clinician-patient relationship is structured. Such risk assessment is obligatory to maintain the medical interest of the patient, to uphold nonmalficence and to respect patient autonomy.3 Fundamental to this is that the clinician must base their judgment on the highest standard of available knowledge. Thus, Professor Ernst's point about the extent of “necessary and relevant” information is directly applicable to both the clinician who is informing the patient and to the patient who is providing consent to treat.

Ethical responsibility demands that clinicians be versed in any/all scientific information that is relevant to the application of a given therapeutic procedure and that may be contributory to determining its risk: benefit value. This decision cannot be dogmatically driven, but should be derived from evidence-based studies of outcomes, effects, and/or mechanisms. To date, the majority of such studies of cervical manipulation to treat acute or chronic neck pain have failed to show a discriminable superiority compared with other conservative, nonsurgical treatments.4 Furthermore, attempts at a priori elucidation of at-risk patients have proven generally unsuccessful.2 Taken together, these factors should strongly weigh the disposition of clinicians toward their use of cervical manipulation.

The clinician's responsibility to obtain the most current information, and provide that information to the patient through effective communication, is based on 2 presumptions inherent to professional ethics. First is that the professional field is based on a foundation of veracity, and second is that the clinician's behavior is consistent with both truthseeking and truthtelling, and therefore scrupulously honest. In medicine, this professionalism is built on the ongoing acquisition of new scientific information that allows for paradigmatic self-revision. The paternalistic nature of medical practice has given way to one of shared responsibility in which the clinician-patient relationship dictates that the clinician: 1) is a reliable source of information for the patient, and 2) determines treatment(s) based on accurate knowledge that influences clinical decisions. This reinforces patient trust in the fiduciary nature of the relationship. Failure of the clinician to maintain this knowledge or failure to communicate this to patients, so that they may consent to treatment, is deceptive. As well, failure to acquire such knowledge to effectively make clinical decisions and weigh risk-to-benefit ratios, violates the fiduciary relationship and may threaten non-malficence.

Professor Ernst is correct in stating that this is an issue of practical and ethical importance, and that these emerging problems pose significant challenges to resolution. One possible solution is that further research should be conducted to more fully examine actions and effects of cervical manipulation. The first step is to define what conditions are specifically treatable using manipulative therapies. The second step is to recognize that the treatment itself is not completely understood, both in terms of outcomes and mechanisms. Therefore, additional studies need to address these variables by using methods that are resonant with and applicable to the broader scientific, and thereby, medical model.

The dogmatic use of a technique or procedure (eg, cervical manipulation) without direct supportive indication for its usefulness, benefit versus risk, and mechanisms is no longer a valid position for the clinician practicing in a pluralistic medical society. It is important to create an evidence-based foundation of knowledge from which clinicians may effectively support ethical clinical decision-making. Adherence to such ethically sound conduct will create improved standards of care and may decrease the potential for litigation. Although ethical professionalism is the duty of the individual, it is the academic institutions that must establish, maintain, and teach these ethical precepts to student clinicians.5 Furthermore, it is critical that institutions teach evidence-based practice, structured on scientific philosophical principles that afford students the knowledge and tools to carry the yoke of clinical responsibility and act as ethical agents to maintain the fiduciary clinician-patient relationship.