INTRODUCTION
With legal precedent established in 1905, informed consent conversations before initiating treatment are universally considered a standard part of the patient-care process.1 Leading national and international organizations recommend informed consent as a necessary legal and ethical requirement for health care.2–4 The American Chiropractic Association and International Chiropractic Association both endorse that all health care interventions come with risks and that every patient is entitled to be informed of those risks.5
The Council on Chiropractic Education (CCE) is the programmatic accrediting agency for Doctor of Chiropractic Degree Programs and Chiropractic Residency Programs in the United States (US).6 The July 2021 CCE Accreditation Standards, Meta-Competency 2 – MANAGEMENT PLAN, CURRICULAR OBJECTIVE: (G) specifically states that program curricula must prepare students to “Obtain informed consent” and, under OUTCOMES,3: includes that students will be able to “Present a management plan that includes obtaining informed consent”.7 No additional details or guidance are provided in the published CCE standards. The PARQ acronym8,9 (explain Procedures, explain treatment Alternatives, explain material Risks, and answer patient Questions) framework is an accepted method for carrying out informed consent conversations, but is not specifically endorsed by CCE or any chiropractic institutions.
Chiropractic health professional licensure is governed by state, district, and territory licensing boards without national oversight.10 The lack of central governance results in more than 50 separate and distinct jurisdictions and boards across US states and territories. These boards are tasked with the shared responsibility of protecting the health, welfare, and safety of the public through licensure, education, and enforcement of the chiropractic profession.11 To this end, boards uphold regulations and statutes that are dependent on their independent roles and responsibilities.
The large number of independent governing bodies sets the stage for parity of regulations and discrepancies in guidance for informed consent delivery. The objective of this study was to summarize the laws, statutes, and regulations regarding informed consent on the websites of each of the US jurisdictional boards governing chiropractic practices.
METHODS
The Northwestern Health Sciences University Institutional Review Board reviewed this project and determined that it did not meet the definition of research requiring ethical approval. The study design was modeled on prior studies that reviewed US jurisdictional boards.11,12 We used he Federation of Chiropractic Licensing Board (FCLB) website to identify state, district, and territory board websites.13 Between June 2023 and July 2023, data was collected from the board websites of all 50 US states, one federal district, and two US territories (Table 1). Google searches were performed to identify the websites of regulatory boards for the US territories that were not listed on the FCLB website, which included American Samoa, Guam, and the Northern Mariana Islands. American Samoa does not have a dedicated regulatory body for the chiropractic profession and thus was not included in the analysis.
Data extracted from the websites included: 1) regulatory language relevant to informed consent, 2) web location where the content was identified, 3) whether there were oral and/or written requirements, 4) if components of a PARQ (explain Procedures, explain treatment Alternatives, explain material Risks, and answer patient Questions) informed consent were outlined, and any other relevant general comments.
The jurisdictions were divided up among the authorship team. For each jurisdiction, one author served as the primary extractor, while a second author verified the extracted data for accuracy. Data were extracted into a Google Sheets spreadsheet (Alphabet, Inc., Menlo Park, CA). Any disagreements were discussed between the reviewers until consensus was reached. All electronic documents were searched manually and using the “find” function with the term “informed consent.” Descriptive statistics were used to report findings with categorical variables described in proportions and continuous variables with means and median.
Results
All 50 US states, 1 federal district, and 4 territory licensing boards were reviewed. The majority (n=45, 82%) of the jurisdictions do not have minimum requirements on the specific format of informed consent expected from the chiropractor (Table 2). Ten (18%) jurisdictions required documentation with written consent, and 5 (9%) required both written consent and oral informed consent conversation.
Eleven jurisdiction websites provided direction regarding the content to be included as part of informed consent (Table 3). Eight websites (15%) required an explanation of procedures, 8 (15%) required an explanation of treatment benefits and alternatives, 10 (18%) required an explanation of material risks, and 3 (5%) required answering of patient questions. Only North Carolina and Oregon websites indicated that all components of a PARQ informed consent were required.
Thirteen jurisdictions did not provide any specific requirements or guidance on informed consent specific to chiropractors, but they did have requirements for circumstances that were potentially relevant to chiropractic practice (Table 4). Four states required informed consent when an extern, intern, or student was participating in care. Three states required informed consent prior to performing dry needling. Kentucky and Texas required informed consent for telehealth, and informed consent was required for each of the following by at least 1 state: sharing of confidential information (Colorado), application of experimental treatments (Florida), prior to prepaid treatment plans (New Mexico), when using testimonials for advertising (Arkansas), and for the treatment of minors (Delaware).
Discussion
We did not locate any chiropractic-specific regulations regarding formatting, PARQ components, or special circumstance on the websites of more than half of US jurisdictions (53%), and there was a lot of variation when we did find guidance. Informed consent articles published related to the chiropractic profession around the world similarly reflect variation of implementation. Similar to our US study, a review of provincial regulatory bodies in Canada reported a de-centralized structure to regulations for approaching informed consen69 and diversity of requirements. Three of the 10 Canadian provinces require written informed consent, and in Saskatchewan chiropractors are mandated to use the Canadian Chiropractic Protective Association form.70 And in Australia, despite informed consent being a fundamental common law right of the patient, written consent is not required, and a case study from the 1990s suggested that verbal consent was seldom occurring.71–73 Boucher et al. stated that the heterogeneity of statutes could lead to large variations in the routine implementation of informed consent procedures.69
While 10 US jurisdiction websites listed a requirement of written informed consent, it is unclear if this is a more appropriate approach to informing the patient of potential risks of their care.74 Findings from qualitative interviews by Winterbottom et al. suggested that patients tend not to read informed consent documents and generally perceive informed consent as a process rather than a single static event.75 Winterbottom et al. further suggested that written forms may have some value as a legal waiver, but conversations may be better suited to educating patients about risk, developing trust with the treating chiropractor, allowing a patient-practitioner feedback loop to withdraw consent, and satisfying legal requirements for informed consent.75
The specific content of an informed consent conversation is not well established, and very few US jurisdiction websites have provided direction on specific aspects that must be included. Oregon and North Carolina were the most comprehensive in their recommendations, each requiring all components of the PARQ consent framework. Guidelines from The College of Physicians and Surgeons of Ontario “Consent to treatment” recommend that surgeons document the date, who was involved, material risks, unique risks, special circumstances of the patient, risks of not undergoing intervention, whether consent was given or refused, and if there were findings of incapacity and identify a substitute decision maker.76 Chiropractic profession clinical practice guidelines and preliminary competencies recommend that informed consent conversations include explaining examination and treatment procedures in terms the patient understands, describing potential benefits and alternative treatment options, explaining any material risks, and answering patient questions.77–79 Material risks are defined as risks with materiality (importance) that may be determined by a physician and which a reasonable person would determine should be disclosed and would be important to the patient for their decision-making.80,81 Surveys of chiropractors from the United Kingdom suggest there is a lack of convincing evidence to support the presence of serious adverse events, and thus, they are selectively included among material risks.82,83 A Declaratory Ruling from the State of Connecticut, Connecticut Board of Chiropractic Examiners judged that, while obtaining informed consent is standard of care, there was sufficient evidence that stroke or a cervical arterial dissection is not a risk or side effect of joint mobilization or manipulation and, therefore, chiropractors are not required to address stroke as a risk with each patient prior to treatment.84
The largest chiropractic malpractice insurance company in the US, NCMIC, does not offer an official position on informed consent and does not endorse any specific form for use in chiropractic practice.85 However, in a letter to practitioners, they do recommend practitioners be familiar and compliant with state requirements and consult a local attorney about any forms to be used, and indicate that “For the patient to truly consent it is generally held that they should know and completely understand the following: 1) Nature of the treatment rendered; 2) All material risks attendant to the treatment; 3) The possibility of an occurrence of the aforementioned risks; 4) Alternative treatment available and the risks attended to those treatments; The consequences of allowing the condition to remain untreated.”86 In this letter, they provided an example informed consent form.
Future studies of informed consent could build on the work of Winterbottom et al. investigating patient experiences regarding consent conversations and how they impact their decision-making to pursue or abstain from chiropractic care. Surveys could appraise chiropractors’ practices in delivering informed consent regarding the method, content, impact on clinical encounters, and regional differences. State regulators may wish to study whether requiring written informed consent correlates with a protective effect for the number of complaints filed, and malpractice insurance carriers may be interested in looking at how it correlates with liability damages rendered.
Limitations
While we made every attempt to comprehensively review each regulatory website, it is possible that states we identified as not providing guidance may have shared informed consent information on their websites in a way that was missed and not captured by our team. For several jurisdictions, we had to search through multiple web pages before identifying relevant content or being satisfied that no such content was publicly available. Several jurisdiction websites did not have chiropractic-specific informed consent language but did provide generalized guidance for health professions, and we did include this information whenever encountered. Further, some jurisdictions reported as not providing guidance may have required informed consent but not formalized it into their regulations or communicated the regulation to their members through other means than their website (e.g., direct mailings). Our search only included regulatory websites and did not review case law. We caution against the interpretation of a lack of regulatory language on the jurisdiction websites to mean that chiropractors in those regions should not carry out informed consent with their patients. Information made available on regulatory websites after July 2023 was not captured or reported. Lastly, we could only locate literature discussing informed consent related to chiropractic from English-speaking countries. The World Federation of Chiropractic has member associations from over 90 countries in 7 world regions.87 Cultural and legal differences with non-English-speaking countries warrant study, and information in this report may be of value to those national associations and stakeholders working to develop guidance.
Conclusion
We reviewed the regulatory websites for all US states, territories, and the District of Columbia. The majority of websites do not provide guidance for informed consent. Written consent from the patient is listed as a requirement by approximately half of the state websites that do offer formalized requirements. In the US, regulatory guidance reflects a general lack of consistency in terms of content required in consent conversations. A few state websites provided guidance on informed consent that only applies in specific situations.
Abbreviations
CCE – The Council on Chiropractic Education
PARQ – Procedures, Alternatives, Risks, Questions
US – United States
Acknowledgements
The authors would like to thank Logan University librarian Sheryl Walters for her assistance in acquiring a challenging to access article.
Authors’ Contributions
C.D. and D.P. designed the study. All authors performed website searches and data extraction. C.D. and D.P. drafted the manuscript. All authors reviewed and approved the final manuscript.