Oral Health Group
Feature

Innovation and Accountability in Dentistry Practice: Trying a Procedure for the First Time

May 1, 2010
by Randi Zlotnik Shaul JD, LLM, Ph.D, and Shelley Birenbaum BA, MSW, JD


Imagine that you are at a dentistry conference and you hear about the success a colleague has had with a procedure you have never tried before. The procedure has been validated elsewhere in Ontario, but does carry some risks. You would like to try it on your patients. Would any of the following be appropriate? (a) if it sounds reasonable, give it a try (b) observe the procedure being done before trying it yourself (c) have a colleague visit your office to teach you and your assistants the procedure and supportive care.

Introduction

At a time when both professional accountability and innovation are regularly being discussed in lay and professional circles, questions around when it is acceptable to try a new procedure on a patient are relevant to both patients and dentists alike.

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Dentistry is most typically practiced outside of an institutional setting – in private practice (although some dentists work within hospitals and teaching centres). Within hospitals, it is the norm to have institutional policies and formal structures outlining expected practices. However in private practice, dentists typically are responsible for ensuring that they satisfy relevant legal standards, professional guidelines and ethical values.

This paper outlines issues to consider in deciding when it is legally and ethically acceptable to try a procedure on a patient for the first time.

Defining Terms

When exploring issues related to innovation it is essential that all parties use consistently defined terms. The term “innovation” is sometimes used when referring to procedures that are so new as to never have been tried before in the context of patient care. We will refer to these as procedures that are “new to the world“. Such procedures generally differ significantly from standard practice and are viewed as experimental. These are procedures that need to be the subject of formal research protocols to assess their efficacy and safety in a manner that accords with research ethics requirements. This paper does not address procedures that are “new to the world”.

In contrast, there are procedures that have been the subject of research, are currently taught in dentistry schools but still remain untried by specific dentists. A procedure new to a practice or never before performed by a dentist may be introduced for the well being of individual patients or expected cost savings for the dentists or patients. Such expansions of practice would be change supported by scientific evidence. Rather than “new to the world”, this category of innovative practice would be “new to the particular practice or dentist“.

Context

Innovation is generally associated with new technology and procedures that are aimed at providing high quality care. Innovation is consistent with a professional life of continuing education. Innovation without legal and ethical accountability poses risks for patients and dentists.1

The challenge before us is determining what factors a dentist should consider when deciding whether to try a procedure on his or her patient for the first time. A decision to try a procedure which is new to the dentist, must be a defensible decision, grounded in the dentist’s competence, full compliance with the dentist’s regulatory obligations and performed only after a fully informed consent on behalf of the patient.

Legal Framework in Ontario

a) Health Professional Legislation and Regulations

Dentists in Ontario are self-regulating health professionals, subject to the Regulated Health Professions Act, 1991, the Dentistry Act, 1991 and regulations thereunder, including professional misconduct regulations. Dentists are also required to comply with the policies, guidelines, standards of practices, ethical code, by-laws and other standards of their regulatory body, as well as general clinical standards of practise in dentistry. The regulatory body in Ontario is the Royal College of Dental Surgeons of Ontario (“RCDSO”).

Many of these documents lay the framework for how dentists should approach procedures that are new to them.

The Professional Misconduct Regulation to the Dentistry Act, 19912 requires dentists to maintain the standards of practice of the profession, not provide treatments that are beyond their expertise or competence, ensure that consent is obtained and not make representations about treatments/procedures for which there is no generally accepted scientific basis.

The following are acts of professional misconduct …

1. Contravening a standard of practice or failing to maintain the standards of practice of the profession…

5. Treating or attempting to treat a disease, disorder or dysfunction of the oral-facial complex that the member knows or ought to know is beyond his or her expertise or competence….

7. Treating a patient for a therapeutic, preventative, palliative, diagnostic, cosmetic or other health-related purpose in a situation in which a consent is required by law, without such a consent…

13. Making a representation about a remedy, treatment, device or procedure for which there is no generally accepted scientific or empirical basis…

b) Code of Ethics3

The Code of Ethics adopted by the RCDSO for dentists in Ontario reflects the requirements to maintain competency, provide options to patients with full information, recognize limitations and make referrals as appropriate and only provide treatment with full disclosure and consent of patients. These matters are set out in The Principles in the Code of Ethics and are based on the core ethical values of integrity, fairness, beneficence, compassion and respect for patient autonomy.4

THE PRINCIPLES…

3. Commit to the highest level of professionalism by maintaining current competency…

6. Provide unbiased explanations of options with associated risk and costs, and obtain consent before proceeding with investigations or treatment.

Recognize limitations and refer patients to others more qualified when appropriate…

9. Never overstate or embellish qualifications including advertising or speech that could mislead a reasonable person…

12. Only provide compromised or unconventional treatment with full disclosure and consent of patients…

c) RCDSO Guidelines and Policies

The RCDSO has adopted Guidelines and Policies specific to various procedures, such as those relating to the use of sedation and general anaesthesia and educational requirements and professional responsibilities for implant dentisty. These guidelines prescribe criteria that must be fulfilled prior to engaging in “new to the dentist” treatments.5

The more difficult situation is when specific guidelines are not provided and dentists must make a self-assessment as to the appropriate circumstances in which he or she may try a procedure which is new to the dentist.

Position Statements of the Canadian Dental Association

The Canadian Dental Association (CDA) is the national professional association for dentists in Canada.6 The CDA provides up-to-date information on issues that affect oral health and the practise of dentistry. As part of this commitment, CDA develops position statements aimed at providing clarification on issues when there are varying points of view. Developed and updated by CDA committees, and approved by CDA’s Board of Directors, these position statements contain background information and evidence-based support of the CDA’s stated position on various issues.

A dentist should be aware of any position statements relating to a new procedure he o
r she is contemplating using in his or her practise.

Case Law

There are not many cases or articles that deal directly with the issue of liability in the context of dentists carrying out innovative procedures. The majority of case law relates to physicians. However, the principles articulated for physicians are instructive for dentists. The following principles can be distilled from the case law and are discussed below.

The need for fully informed patient consent in the context of a procedure which is innovative. This involves apprising the patient of the risks relevant to the patient’s decision as to whether or not to consent to the procedure.

A duty to refer when a professional is not able to handle a particular matter.

The standard of care required of the health professional increases according to whether the practioner holds himself/herself as a specialist and the riskiness of the procedure.

The need for appropriate training before undertaking a new procedure.

1. Informed Consent

It is clear both in statute and in case law that healthcare professionals have an obligation to disclose all information that is relevant to the decision making process. The patient must give an “informed consent” prior to treatment being rendered. In the case of Reibl v. Hughes,7 the Court confirmed that the test is a combined subjective-objective test: whether a reasonable person in the patient’s position would have agreed to the procedure if a proper disclosure had been made.

In our view, if a dentist is trying a procedure for the first time, this is relevant information to be communicated to the patient.

2. Duty to Refer8

A duty to refer has been found to exist to provide treatment to a patient the doctor is incompetent to give. A duty to refer has also been found to exist where the doctor is inexperienced.

3. Increased Standard of Care

The classic statement with respect to the standard of care can be found in Crits v. Sylvester:9

Every medical practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. He is bound to exercise that degree of care and skill which could reasonably be expected of a normal, prudent practitioner of the same experience and standing, and if he holds himself out as a specialist, a higher degree of skill is required of him than of one who does not profess to be so qualified by special training or ability.

The standard of care required increases when the degree of risk is high:

As the degree of risk involved in a certain treatment or procedure increases, so rises the standard of care expected of the doctor. The principle was expressed succinctly as follows:

The degree of care required by the law is care commensurate with the potential danger.“10

The highest standard is expected for new or experimental procedures.

The highest standard of care is expected of the doctor using a new or experimental procedure or treatment.11

Need for Appropriate Training

In the case of Poole v. Morgan,12 the Court reviewed the qualifications of Dr. Morgan to perform argon laser photocoagulation, focusing on his training and the extent of his training in comparison to other ophthalmologists. The Court found that Dr. Morgan was inadequately qualified to administer the procedure.

Case law provides insights into what level of precautions it would appropriate to take. In Lyne v. McClarty, it was necessary: “…to show that others in the same business considered it sufficient, that the surgeon could not have learnt how to avoid the accidents by example of another, that most probably no other practical precautions could have been taken…”13

Relevant Legal and Ethical Principles

In some instances, the law or documents of the regulator provide specific guidance in respect to appropriate training for new procedures.

When there is uncertainty about the appropriate way to proceed, one should look to insights from professional ethics. From the discipline of bioethics we can gain relevant insights on duties and rights, the significance of factoring consequences into our analyses, key principles that are commonly considered in the context of ethical practice as well as the role of relationships in health care.

Rights and duties relevant for the introduction of innovative practices can be found in the ethics literature,14 and highlight values related to patients’ health, pain-free oral functioning, patient autonomy, preferred patterns of practice, aesthetic considerations, efficiency, relationships with other professionals, and relations between dentists and the larger community.

Such values have to a large extent been embedded into professional guidelines, codes of ethics, case law and statutes dealing with accountability, consent, fiduciary duty and standard of care. These standards have been discussed earlier in this article.

Introducing Innovation in Practice

In the context of innovations that have already been supported by quality research and are now taught within jurisdictionally relevant dentistry curriculums and are the subject of continuing education courses for practicing dentists, a dentist should be able to justify the use of a procedure new to him or her, through demonstrating competency, ensuring informed consent and referring the patient, if the patient requires specialized care outside the scope of the dentist. While to be legally defensible, the results of a procedure do not always have to be good, the practitioner must always be able to defend the decision to attempt the procedure on particular patient at a particular time. The decision to go ahead with a procedure that is new to the dentist must always be a defensible one. Should the results of using an innovative procedure not be what the patient or dentist had hoped for – the dentist would need to be able to show that there was not anything else he or she could have reasonably done that would have prevented this result.

An Innovative Framework from The Hospital for Sick Children

At The Hospital for Sick Children, Toronto, Canada a process has been established for introducing innovative procedures new to the practitioner, in an ethically and legally informed manner.15 This policy was first established for the introduction of surgical innovations and then expanded to include innovations in many other departments and contexts. The policy grew out of insights from surgeons themselves re “best practices” for trying a procedure for the first time.

Some of the factors set out in this policy, while established for a hospital setting, also provide some relevant considerations for dentists in private or a group practise to consider. They include:

(1) evidence supporting the safety and efficacy of the innovative procedure

(2) the sort of experience needed to perform the procedure

(3) specific risks and benefits associated with the procedure

(4) any conflict of interest that would be appropriate to disclose to the patient

(5) what colleagues think about the procedure

(6) what education or training other members of the team would need to support the introduction of the procedure

(7) cost implications

(8) plans for reviewing outcomes of using the procedure in your patients.

Conclusion

Let us take our original example. Clearly the dentist needs to first ascertain that indeed the procedure has been validated and is considered standard care. The law requires that a dentist be competent, know her or his limitations and refer when appropriate. The dentist must ensure that he or she takes as much training as pos
sible to be confident in his or her ability to perform the procedure. Observing the procedure, being taught by a colleague who is experienced in the procedure, possibly being supervised the first time the dentist tries the procedure, having training for all staff in the office are all prudent. And, fundamental to legal and ethical requirements, the patient must be provided with all relevant information and have given a fully informed consent for the procedure.

Accountability of dentists is a concept grounded in ethics and law. Dentists must be clear about their ethical and legal responsibilities. They should think through how they will justify their approach to innovation. They should ensure that they are competent and have obtained informed consent prior to attempting a new treatment.

Special thanks to Jana Lambert for her excellent research assistance. OH

Randi Zlotnik Shaul is a bioethicist at The Hospital for Sick Children, an assistant professor in the Department of Paediatrics at the University of Toronto, is cross appointed to the Department of Surgery and is a member of the University of Toronto’s Joint Centre for Bioethics. randi.zlotnik-shaul@sickkids.ca

Shelley Birenbaum is a lawyer who specializes in health law and policy, and regularly advises health care organizations and individuals on regulatory matters.

Oral Health welcomes this original article.

References

1. Zlotnik Shaul Randi, McDonald Maria and Langer Jacob C., “Facilitating Innovation in the Clinical Setting: A Pathway for Operationalizing Accountability”, (2009) 12(3) Healthcare Quarterly 60-65 [Zlotnik Shaul].

2. Professional Misconduct Regulation, O. Reg. 853/93 under the Dentistry Act, S.O. 1991, ch. 24.

3. Royal College of Dental Surgeons of Ontario, “Code of Ethics”(Schedule 5 to By-Law 1, November 2004), online: http://www.rcdso.org/pdf/RCDSO_Ethics_v6_1706.pdf.

4. Ibid. at p. 1.

5. Royal College of Dental Surgeons of Ontario, Guidelines: “Use of Sedation and General Anaesthesia in Dental Practice” (May 14, 2009), online: http://www.rcdso.org/sedationAnaesthesia_pdf/Guidelines_sedation_06_09.pdf; and Guidelines: “Educational Requirements & Professional Responsibilities for Implant Dentistry” (August 2002), online: http://www.rcdso.org/pdf/guidelines/implant.pdf.

6. Canadian Dental Association, “About CDA”, online: http://www.cda-adc.ca/en/cda/about_cda/index.asp, last accessed on March 28, 2010.

7. Reibl v. Hughes [1980] 2 S.C.R. 880.

8. Poole v. Morgan, [1987] 3 W.W.R. 217, A.J.No. 1414 [Alta. QB] [Poole] at para. 135.

9. Crits v Sylvester (1956), 1 D.L.R. (2d) 502 (Ont. C.A.) at 508; affirmed [1956] S.C.R. 991.

10. Picard EI, Robertson GB, Legal liability of doctors and hospitals in Canada, 3rd ed. (Toronto: Carswell, 1996) at p. 162.

11. Ibid. at p. 163.

12. Poole , supra note viii.

13. Lyne v. McClarty, [2001] 8 W.W.R. 453 (Man. Q.B.) affirmed by [2003] 5 W.W.R. 598 (Man C.A.).

14. David T. Ozar, David J Sokol, Dental Ethics at Chairside: Professional Principles and Practical Applications, 2nd ed. (Washington D.C.: Georgetown University Press, 2002).

15. The Hospital for Sick Children “Clinical Innovation Policy” 2008 in Zlotnik Shaul, supra note 1.

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