Kind, Firm, and Fair Medical Regulation: A Systems Approach and Six Ethical Principles

Health profession regulators have a primary responsibility to safeguard the public interest. They use a complex system of monitoring of health professionals and institutions, complaint processes, and accreditation. However, there is evidence that regulatory processes induce stress, shame, and anxiety in health professionals.¹  The complainants too could be dissatisfied with the process, and the regulators are known to be stressed by the prolonged and often antagonistic attitudes taken by the health professional under scrutiny.²  These issues have led regulators to incorporate kindness and compassionate communication into their practices. A recent article recognized the complexity of these situations when attempting to be humane while focusing on patient and public safety.³  When addressing a complaint, the regulators and other agents have mental models to explain the situation. This is based on the observation that mental models are used to provide a framework for reasoning and arriving at decisions, in instances when new information is required to be weighed in.⁴  There are no specific studies on such mental models, though the frameworks are dominated by individualized approaches and methods of personal conflict resolution.^{5, 6}  For example, a systematic review which was used to develop a coding taxonomy to analyze patient complaints, found three domains: clinical, management, and relationship for analyzing patient complaints.⁵  Almost two-thirds of complaints were related to more individually determined interactions such as domains in the clinical arena (eg: poor quality of care and issues related to incidents on safety) and relevant to relationships (eg: acts of miscommunication between staff and patients, and apparent inhumaneness of staff).⁵  We term these as reductionist mental models, meaning that the situation is often adversarial and viewed as a conflict between a complainant, the health professional concerned, and the individual regulator dedicated to the case. In contrast, we propose a systems approach to unpack these issues using an illustrative case study.

A systems approach views a situation as having several elements or components that interact to function as a whole.⁷  There are proximal factors and several other agents or elements that we could include. The proximal factors are best described as a reductionist mental model that deals with the core set of issues, while the latter includes the wider environment, such as the healthcare institution, the healthcare profession, the public, and the regulatory authorities. A systems approach lends to a mental model in which there are dynamic interactions across these elements accompanied by positive and negative feedback loops that maintain some overall stability of the whole system. A hypothetical case study is used to illustrate these concepts further.

The case relates to Dr. Ali, a 30-year-old doctor new to a hospital in Australia. He was an overseas medical officer from Iraq and the only non-Australian member on the medical and nursing team led by Dr. Adam. The first two months were without any overt incidents, though Dr. Ali seemed quiet and occasionally faltered, despite carrying out his work efficiently. Dr. Adam felt that this was due to the poor process of induction in the hospital. However, he noticed that Dr. Ali was allocated to on-call status on most occasions when the shifts were expected to be heavy, and he rarely attended social activities. Dr. Ali's absence was often attributed to cultural and religious differences by the team. When probing deeper, Dr. Adam realized that Dr. Ali was not getting invited to these events and he was being rostered to work during heavy shifts. Dr. Adam raised the issue informally with his manager, who suggested giving more time to Dr. Ali to adjust to the new working environment. However, Dr. Adam became very upset when observing an event in the emergency department when he saw Dr. Ali leaving the procedure room after failing to complete a difficult chest drain insertion. Dr. Evelyn, another doctor on the team, followed Dr. Ali out of the procedure room and commented in a loud voice, “Ali, your skills are very poor. Didn't you learn these in your country? It is so hard for us to work with you. We must do your work.” Dr. Adam felt what he witnessed was above the threshold of decency. He lodged an official complaint with the regulator. He felt guilty because in retrospect he believed that this event was probably one of many incidents of microaggression that Dr. Ali had faced. Following the complaint, Dr. Adam faced a few adverse comments in passing from Dr. Evelyn and her friends. He also heard that Dr. Evelyn was aggressive toward Ms. Melba, the contact person from the medical council, when she contacted her.

A systems approach to describe this situation will include identifying the components, their interactions, and feedback loops (Figure 1). In this instance the key interactions are between Dr. Ali (the distressed person), Dr. Evelyn (the originator of questionable behavior), Dr. Adam (the informant; note that in some instances the patient concerned would be the complainant), and the regulatory authority. The other relevant actors are members of the team. In this instance they are those who ignored previous questionable behavior within the institution, and the institution, which was at fault by not providing adequate orientation for Dr. Ali. Systems thinking encourages us to view how these elements are influenced by two other sub-systems: the health profession and regulatory authority and embedded in the wider system of society or the public.

Systems thinking widens the scope beyond a mere individual interaction at the micro-level (eg: involving a distressed person, a person exhibiting questionable behavior, the informant to a regulatory body, and the regulatory authority) to involve other relevant actors: members of the healthcare team, the institution, the health profession, the regulatory authority, and the public. We analyze the issues faced by these actors by borrowing a framework used in medical ethics, “Four Principles of Ethics” described by Beauchamp and Childress, and two other principles identified by the authors.⁸  The former appeals to ethicists as encompassing most of the key issues in ethics concerning clinical care: non-maleficence (ie: do no harm); beneficence (ie: benefit and best interest of the patient); autonomy (ie: respect the dignity of the individual); and justice (ie: be fair by all).⁹  The additional two principles, truthfulness and building of trust, were selected because these are considered key features in ethics related to healthcare institutions.^{10, 11, 12}  Trust between patients and health workers influences outcomes. Truthfulness reflects respect for the patient as a person. It is considered a duty of the health worker to do so and cements trustworthiness.

The Six Principles can be summarized as:

1. Did the event cause harm? (ie: The opposite of non-maleficence)

2. Did it affect beneficence? (ie: Was it not in the best interest of the individual?)

3. Did it affect the autonomy of the individual? (ie: Respect the dignity of the individual)

4. Was it unjust? (ie: Not fair by all)

5. Was there evidence of truthfulness? (ie: Was the action or statement a true reflection of a situation?)

6. Did it lead to distrust or mistrust about an individual or the wider system? (ie: Did the actions or statements build trust or adversely affect trust about individuals, institutions or the system?)

We now apply the Six Principles to each of the agents or actors of the system to develop a set of ethical, legal, and administrative issues that are relevant to the case study; specifically, the incident involving Dr. Ali and Dr. Evelyn, Dr. Evelyn's reactions to the regulator, the microaggression suffered by Dr. Ali and the potential for a repetition of the events (Table 1).

A fundamental goal of regulators is to prevent harm to patients and the public. Though other principles are important, it is reasonable to believe that the main goal of a regulatory process is to prevent harm to patients and the public. This ‘first among equals,’ approach is used in medical ethics when autonomy is awarded an indispensable role as a fundamental component interwoven within the other three principles of no-maleficence, beneficence, and justice.⁴ 

To apply a systems approach to be fair and firm would require the identification of all the relevant actors and address a wider and comprehensive set of issues as depicted in the Figure and outlined in the Table. These may go well beyond the current more reductionist practices of dealing with specific problems as individualized issues.

Concerning the Case Study, the approach of Ms. Melba and the regulatory body should be to identify and address the ethical issues outlined in Table 1 and intervene appropriately. Some of these steps may be perceived as beyond the responsibilities of a regulatory process, and how this could be addressed will depend on the context. Ms. Melba and her team need debriefing to ensure their judgement is not adversely affected in the future. Their communications with Dr. Adam, Dr. Evelyn, and Dr. Ali should continue to remain courteous and friendly yet firm. The regulatory bodies could recommend interventions such as counseling for Dr. Ali, to help him to build links to other social networks and ensure that Dr. Adam is also not further victimized. The institution should establish a fair and transparent rostering of shifts. Dr. Evelyn should undergo mandatory training in diversity and inclusivity, anger management, and counseling on effective communication skills for handling institutional matters. Dr. Adam's actions exemplify those of a good clinical lead and should be reinforced and normalized. The institution and other health workers should take steps to discuss and learn from these experiences. This may include posters, social media posts, and internal administrative circulars expressing the institution's stance against discrimination. These interventions could extend to the broader community, helping to rebuild trust in the institution.

This process can be further refined and kinder to those concerned by acting on other recommendations at an institutional level:⁷ 

1. Developing a sensitive approach to improving the assessment of risks from different complaints (eg: distinguishing between persons with serial offenses and those who have done a minor offense).

2. Using feedback and other ways to identify issues in the regulatory process that are sensitive and reduce stress (eg: adapting transparent procedures, and not causing undue delays to the process).

3. Embedding regulatory activities as part of a broader patient safety system minimizes individual blame and appears to be non-threatening.

Health profession regulators are mainly responsible to safeguard the public interest. However, the process is often stressful for institutions like hospitals, the health professionals involved, and the regulators. The paper proposes a systems approach to identify the agents and issues in such a situation which will make the process fair and comprehensive. This is complemented by recommendations to ensure that the regulatory process is kinder.

The author would like to thank Anna van der Gaag, University of Surrey, England, and Susan Biggar of the Australian Health Practitioner Regulation Agency for their comments on the initial draft.