Informed consent in research and practice

¶ … Consent in CAM

Consent and Herbal Medicine: A Literature Review

The topic of informed consent is important for any portion of the legal profession. Informed consent assures that patients remain an integral part of the decision-making process. The field of complementary and alternative medicine has remained on the fringes of the medical community. This branch of medicine has avoided standardization until recently, when a hostile legal climate has forced it to adopt many of the components of formal medicine. Informed consent is an important part of this standardization process. The following literature review will examine the body of literature available regarding informed consent as it applies to complementary and alternative medicine (CAM).

An examination of standard medical texts and databases revealed that there is a considerable amount of information available on informed consent in standard medical practice, but there is little written about the legal aspects of CAM. This project is specifically about herbal medicine, but for the purposes of this literature review all forms of complementary and alternative medicine will have to be considered due to limited sources that specifically address herbal medicine.

The first choice in sources of information was peer-reviewed journals that address informed consent in CAM. However, only two-three sources were found that specifically address this issue. The second method used was to turn to the internet and search for journals and/or articles from credible sources. Credibility was a major concern for this literature review, as alternative medicine is still regarded as undocumented, according to medical standards set by governing committees. The literature found could be divided into several subcategories.

Legal Issues

US law mandates that patients be given informed consent for all medical treatments. (Drieman, 2006). This includes any form of complementary or alternative procedure. Three legal questions surround the issue of informed consent in any type of medicine, whether conventional or alternative. The first is whether the patient is competent to give consent. The second is whether consent is voluntarily given and the third is whether consent is based on sufficient information to make a reasonable decision. Many patients have the erroneous conception that alternative treatments are not risky (Ernst, 2004). Chiropractors have been found to withhold information, claiming that it is in the patient's best interest, often minimizing real risks for neck-related procedures (Ernst, 2004).

This issue has not been studied in the field of CAM, which until now, has been largely unregulated. It is not known if many practitioners use informed consent, or what standards are used to administer informed consent. However, under the law, CAM practitioners are under the same legal obligations as other medical professionals in the use of informed consent.

Some dentists claim that certain types of informed consent and risk should be "assumed" on the part of the patient (Jacobssen, 2006). One example of this is the use of local anesthetics by dental patients and rare cases where something goes wrong. This is similar to cases in alternative medicine where the patient should "assume" that certain risks are present in any treatment. There are several problems from this attitude, as it presumes a certain minimal level of knowledge on the part of the patient. The patient has little medical training and may simply trust the practitioner with little or no research on their own.

Lack of Standards

The field of complimentary and alternative medicine is still young, as compared to other forms to medicine (Ernst, 2003). Lack of consistency in informed consent is a key concern from a legal and safety standpoint. This issue has come to the forefront of the industry in recent years.

The topic of informed consent is difficult in the field of CAM largely due a lack of reliable information on the procedures themselves. The information that physicians provide is often opinion, rather than research-based information (Health Law Institute, 2003). Informed consent implies a certain level of reliability. However, credible evidence and a lack of standards make the provision of proper informed consent difficult in the field of CAM.

The scientific community continues to be skeptical about the use of CAM due to a lack of standardized, evidence-based studies (Hand-Boniakowski, 2007). Many patients have the perception that alternative procedures are safe, but this is not always the case and many alterative therapies can pose a potential risk to the patient. Promoters of alternative medicine often do not have the same formal training as standard medicine practitioners (Boniakowski, 2007). They have no formal oversight authority. Practices regarding informed consent are inconsistent. This poses a major concern for patient safety while using CAM.

Complimentary and alternative medicine (CAM) has been criticized for a lack of standards in the delivery of services. Holexa and Caspi (2005) found that this lack of standards extends into the practice of informed consent. Patients often do not have access to proper information during the decision-making process. This increases the potential for healthcare oversights and mistakes.

Conclusion

When one examines informed consent issues, it is found that they are similar to the issues addressed in conventional therapies. The Ayurveda Healing Arts Institute (2008) has developed a set of informed consent and ethics that it requires member practitioners to follow. An examination of this article reveals that standards require full disclosure of evidence-based research regarding the procedure. It requires confidentiality of the procedure, professional courtesy, peer review and many other elements that are found in conventional medicine informed consent policies.