June 3, 2010
Supercedes: similarly named guideline (dated 8-2-01)
The Massachusetts Board of Registration of Chiropractors (Board) has today voted to adopt the following Policy Guideline. This policy guideline is intended as a recommended protocol for the profession to follow. The guideline set forth below does not have the force or effect of law, as would a Massachusetts General Law or a Board rule or regulation. However, the Board utilizes this and other guidelines as an internal management tool in formulating decisions that relate to issues of chiropractic practice.
The Massachusetts Board of Registration of Chiropractors, (the Board) is responsible for licensing Doctors of Chiropractic and ensuring that our licensees follow appropriate standards and protocols in all aspects of the delivery of chiropractic services to the citizens of the Commonwealth. Ensuring that patients receive appropriate information before undergoing chiropractic care is an important part of the Board's responsibility to protect the public.
Patients have the right to control their body and what happens to it. This autonomy relies on the patient being informed about care being proposed and the risks associated with receiving this care. The Board recognizes that nearly all medical treatment has some potential for causing injury to a patient. Performance of a particular treatment or procedure without the consent of a properly informed patient deprives that patient of what they may reasonably expect from such care. It also does not allow the patient to fully understand the inherent risks that may be associated with the treatment or procedure. Finally, it impairs a patient's fundamental right to make decisions about what kinds of care, if any, they wish to undertake. This is the doctrine of Informed Consent.
The Board recognizes that some chiropractors use the terminology "terms of acceptance" rather than "informed consent". It is the Board's view that the standards to be followed are the same even though the nomenclature is different.
II. When Should Consent be Obtained from a Patient?
A licensed chiropractor should obtain the informed consent of his or her patient before carrying out any diagnostic or therapeutic procedure on that patient.
It is impossible for a patient to give his or her consent to undergo a particular treatment or procedure if the treatment or procedure is performed without the patient's knowledge or before the patient fully understands his or her right to either accept or decline the care being proposed.
III. Who Can Give Informed Consent?
(A) Where the patient is an adult, the licensed chiropractor should obtain consent for care from the patient himself or herself.
The adult patient is presumed to be able to give legally effective consent for care unless there are other known factors that the patient is not adequately competent to understand what is being proposed along with the potential risks/benefits. If it is reasonably believed that the adult patient is somehow unable to understand the information being provided, the doctor should inquire whether the patient has a legal guardian or health care proxy with the legal authority to make decisions on their behalf. This concept extends to a language barrier, handicap or disability which may impede the communication and understanding of the patient.
( B) Where the patient is a minor, the licensed chiropractor should generally obtain the necessary informed consent from the parent or legal guardian of that minor patient.
The authority to give legally effective consent for care of a minor child typically belongs to the parents or legal guardian of that child. It should be noted that the consent of only one parent is generally necessary to permit treatment, but the doctor should be mindful that child custody disputes often complicate this issue. When consent must be obtained from a party other than the parent of a minor child, it is advisable to ensure that the individual giving the consent is the legally-appointed guardian and has the authority to give such consent. There are certain circumstances in which a minor child may be considered "emancipated" and can give legally effective consent himself or herself. This is generally the case only where the minor child is (1) married, widowed or divorced; (2) the parent of a child himself or herself; (3) a member of the armed forces; or (4) living apart from his or her parents and managing his or her own financial affairs. Practitioners are encouraged to seek the legal advice of private counsel if they have any questions about these issues.
IV. What Information Should Be Disclosed to the Patient?
( A) A licensed chiropractor should disclose to the patient all significant clinical information which the chiropractor possesses, or reasonably should possess, which would be material to an intelligent decision by that patient about whether or not to undergo the proposed diagnostic or therapeutic procedure.
For the consent of the patient to be legally effective, the patient must receive sufficient information, in layman's terms, about the proposed procedure, the potential benefits and risks of that procedure, and common alternatives to that procedure including not performing the procedure, to be able to make an intelligent decision about whether or not he or she should undergo the proposed procedure or treatment.
( B) In determining what information a licensed chiropractor is expected to possess about the potential benefits and risks of a particular diagnostic or therapeutic procedure, the benchmark is the quantum of information about that procedure typically possessed by the average Doctor of Chiropractor within the Commonwealth of Massachusetts (a state-wide standard).
However, a chiropractor who possesses specialized certification in a particular subject area (e.g., board certification in chiropractic orthopedics, neurology or pediatrics) could be expected to possess a higher amount of information about the potential benefits and risks of treatments or procedures in that specialty area.
(C) In determining what information to convey to a patient about a proposed diagnostic or therapeutic procedure, the licensed chiropractor should include information he or she knows, or has reason to know, that the patient would consider important in making his or her decision about whether to undergo the proposed procedure or not.
Where some jurisdictions apply a "reasonable doctor" standard and others use a "reasonable patient" standard, the comprehensive approach is to disclose risks which are inherent to the proposed procedure if either a reasonable doctor would disclose those risks as being material or a reasonable patient would think those risks are material and therefore important to the patient's decision-making process to accept or reject what is being proposed.
(D) In determining what information to convey to a patient about the risks involved in a particular proposed diagnostic or therapeutic procedure, the licensed chiropractor should take into consideration both the potential severity of the injury or adverse consequences which may result and the likelihood that the injury or consequence will occur.
The question of a particular risk and whether it may be material or not depends on both the severity of the adverse outcome which might occur and the probability that it will happen. A doctor is not required to disclose every single conceivable risk of a proposed procedure, regardless of how remote that risk of injury might be. However, for risks that involve the most serious adverse consequences, as for example paralysis or even death, the more material that risk becomes relative to informing the patient, in spite of the (presumably low) probability.
(E) If a chiropractor has reason to believe that a patient would consider information about a potential risk important in making his or her decision, the licensed chiropractor should not remain silent about that risk; he or she should disclose that information even if that information might prompt the patient to reject the proposed procedure.
The Chiropractic Oath, similar to the Hippocratic Oath, places the needs of the patient as paramount and in deference from any self- preference, curiosity or pecuniary interest of the doctor.
(F) What information a licensed chiropractor should disclose to his or her patient about the potential benefits and risks of a particular diagnostic or therapeutic procedure is not controlled by whether that information is customarily disclosed in similar circumstances.
It is not the customs of a particular health discipline which are decisive; rather it is whether the doctor has reason to know that his or her patient would consider the information important in making a decision about whether or not to accept care. Inherent risks are relative to a designated procedure and become more material relative to the patient's particular circumstance. The relative significance of any risk can not be viewed from any particular profession or society that as a profession or society arbitrarily chooses not to disclose those risks.
( G) A licensed chiropractor is not required to disclose information about the potential benefits or risks of a particular procedure or treatment if he or she has reason to believe that the patient already has that information.
A doctor should not be expected to disclose information about particular benefits or risks of a diagnostic or therapeutic procedure if those benefits or risks would be obvious to any reasonable person or if the doctor has a specific, factual basis for believing that the patient in question already knows about those benefits or risks.
(H) Where the option of not doing anything is a reasonable, clinically acceptable option, a licensed chiropractor should disclose information about the likely results of undergoing no care at all in order to fulfill his or her obligation to obtain informed consent.
It is important to explain to a patient that the "no care" option is a viable option.
V. Documentation of Patient Consent
(A) Board regulations 233 CMR 4.05(1)(f) require a licensed chiropractor to include written documentation of "informed consent" in every patient's treatment record.
Documenting the patient's informed consent for chiropractic care is a minimal standard, but aside from that it is the practitioner's best protection against malpractice litigation or patient claims that they have been provided a service which they did not want or ask for.
( B) A licensed chiropractor should document patient consent in a manner which acknowledges that:
- the patient has been part of an informed consent process;
- the patient received sufficient information about the diagnostic or therapeutic procedures which the chiropractor proposes to use;
- the material risks have been disclosed to the patient, including a description of those risks; and
- the patient, after assessment, has accepted (or rejected) the procedure or care understanding the material risks to that procedure.
Informed consent is more of a process than it is a procedure. The Board understands that the use of broad generalized consent forms in which a patient essentially authorizes the chiropractor to use any and all diagnostic or therapeutic procedures, but is not adequately informed about the procedures prior to their use, runs counter to the basic concept of "informed consent".
The process of informed consent should involve a meaningful discussion between the doctor and patient about the care that is being proposed. It should include a frank discussion about the material risks to any recommended procedure which are unique to that patient. It also necessitates that the patient adequately understand and accepts these risks, and agrees to receive the proposed diagnostic or therapeutic procedure.
This process of informed consent could also involve the patient participating in an educational presentation about chiropractic care that includes a description of the procedures that are commonly used in patient care. However, where these presentations are not individualized, they must also include information about the most serious adverse risks that are associated with these procedures. The chiropractor would still need to have a discussion with the patient about the presentation and the procedures the chiropractor is proposing to use. The chiropractor would then assess the patient's understanding of what is being proposed and lastly, elicit the patient's consent to receive the proposed diagnostic or therapeutic procedure.
Finally, whereas it is necessary that a chiropractor have notations in a patient's clinical record reflecting that the patient was advised of the material risks and consented to care, there is no substitute for having the patient's own signed confirmation of those facts.