AMA Journal of Ethics^®

Introduction

The Bander Center for Medical Business Ethics was established in 2007 at Saint Louis University with an endowment from the BF Charitable Foundation to promote “ethical business practices in medical care and research through the development of training and investigation responsibilities for medical students, residents and physicians in practice” [1]. The center defines medical business ethics (MBE) as “the ethical engagement of the financial dimension of medical practice and research” [1]. Many of physicians’ decisions related to clinical practice or medical research have a business component. In the market context of medicine in the United States, issues in MBE “such as conflicts of interest (COI), Medicare fraud and abuse, and the structure and functioning of reimbursement systems” affect the integrity of medical practice and research [2]. Preserving trust in the institution of medicine as it operates in an increasingly complex environment is challenging. To better prepare practitioners for this challenge, the Bander Center has published a freely available online case-based curriculum in medical business ethics. Exploring Integrity in Medicine: The Bander Center for Medical Business Ethics Casebook [3] serves as a comprehensive teaching instrument, highlighting pertinent variables in MBE decisions by exploring their effects on medical practice and research and reflecting on the values and motives that influence the behavior of health care professionals.

The Challenge

Major professional organizations such as the Institute of Medicine [4] and the Association of American Medical Colleges [5, 6], as well as government bodies such as the Office of the Inspector General [7], have produced reports and guidelines to encourage physician self-regulation and impose rules to limit physician relationships with for-profit entities. In addition, the Accreditation Council for Graduate Medical Education lists both professionalism (which includes ethics) and systems-based practice (which includes “awareness of the larger context and system of health care” and its resources) among their six core competencies [8]. Nevertheless, no published curricula exist in the area of MBE.

In 2013 the Bander Center surveyed medical students and residents at two academic medical centers in Missouri on “their awareness of major MBE guidance documents, knowledge of key MBE research, beliefs about the goals of an education in MBE, and the areas of MBE they were most interested in learning more about” [2]. The results revealed that “medical students and residents had little awareness of recent and major reports on MBE topics and had minimal knowledge of basic MBE facts” [2], such as what percentage of academic physicians have a financial relationship with industry. However, “both groups showed significant interest in learning more about MBE topics…such as ‘the business aspects of medicine’ and ‘health care delivery systems’” [2].

Topic Identification

Bander Center-affiliated faculty and staff conducted a Delphi consensus panel project “to establish priorities for curricula in business ethics in medical practice and research” [1]. The Delphi process, a structured communication technique in which a group of experts are polled and their responses used to generate further polls for them to respond to, is used to establish a consensus among experts on topics that involve subjective judgments rather than analytical problem solving, such as policy priorities or educational curricula [9]. A heterogeneous panel of 26 expert participants representing a diverse group of stakeholders in medical practice and research was selected using non-probability sampling and split into two groups, one focusing on medical practice (14 panelists) and one on research (12 panelists). Prospective panelists were identified via a web-based search by areas of expertise. Medical practice panelists had “expertise in medical practice, medical education, medical ethics, medical sociology, health care administration, health economics, health law, outcomes research, and government oversight” [1]. Medical research panelists had “expertise in medical research, research training, research ethics, social science, research administration, health economics, research regulations, and government oversight” [1]. Invitation to participate on the panels was done by e-mail, and all participants freely consented to be members of the panels.

The Delphi panels were surveyed in two phases. The first phase focused on data collection by giving participants open-ended prompts like “Please list up to 10 topics that you consider most important to address within educational programs for physicians-in-training in the domain of business ethics in medical practice” [1]. The medical practice panel produced 103 responses, which the researchers grouped into 14 distinct topics. The research-focused panel produced 97 responses, which the researchers reduced to ten distinct topics. The Bander Center team analyzed the responses to create a list for the second phase, in which the panelists ranked the importance of the list items to a curriculum on medical business ethics on a scale from1 (not at all important) to 5 (essential).

Eleven topics were rated as “very important” or “essential” by general agreement among the participants [1]. Five topics related to medical practice and included problems that can arise from conflicts of interest, general health care organization and systems, and fostering patient care quality and safety. The remaining six topics related to medical research and included the ideals of the medical research profession, strategies for managing conflicts of interest in research, and challenges of playing the roles of both physician and researcher.

Structure and Intended Uses of the Casebook

The casebook is designed for facilitating educational discussions among health care professionals about hypothetical case scenarios. The book includes fourteen case scenarios, each ending with a question about what the professional should do to remedy the situation. These vignettes are meant to help discussion participants understand their role as professionals in a given situation. The casebook includes a guide that outlines eight steps to facilitating a good group discussion and case notes to help structure it: in the facilitator’s version, each scenario includes information about pertinent stakeholders, medical facts, ethical norms, legal norms, options for addressing the situation, and reflection questions to spark further discussion. Indices are included to help the facilitators choose the appropriate case for highlighting particular issues in medical practice or medical research.

The educational experience of analyzing case scenarios is entirely dependent on a dynamic and productive discussion. Prior to presenting the case, the facilitator should become familiar with the relevant background information (described below). The key to a good discussion is asking questions, specifically open-ended questions to engage the audience in problem solving by examining decisions and mental processes used to arrive at them. The discourse is most effective when small discussion groups are provided with handouts of the case. The facilitator should allow time for a case introduction, debate, discussion, and conclusion—one or two cases can be covered in less than an hour.

SFNO Method of Case Analysis

The casebook utilizes the “so far no objections” (SFNO) approach [10]. The acronym SFNO also stands for stakeholders, facts, norms, and options—four components that medical decisions must take into account.

Stakeholders. Stakeholders are those significantly affected by the decision(s) being made. There is great variability in the impact experienced by the stakeholders; for example, a patient has a direct, significant stake in his or her health and the medical care received, while society has a lesser stake in patient protection and cost related to health care in that single case.

Medical facts. The casebook includes both quantitative and qualitative medical information relevant to the case discussion drawn from medicine, public health, economics, business management, and other fields. Including this medical information is important for both the facilitator and participants because of the improbability that any one person has all this information readily available.

Ethical and legal norms. Norms are the ethical principles or values relevant to the case at hand, including mid-level principles of bioethics, the American Medical Association’s (AMA) Principles of Medical Ethics [11], and legal norms focused on federal law and principles of state and tort laws. When presenting norms relevant to each case, the editors employed a standardized approach. First, the mid-level principles of biomedical ethics as described by Beauchamp and Childress [12] are examined in relation to the given case. The relevant sections of the AMA’s Principles of Medical Ethics are then identified and their application to each section of the case explained. The last group of norms considered is legal—federal and state legislation, regulation, and common law—presented not to offer legal advice or end the case discussion but rather to supplement the ethical norms described. Good ethical deliberation of a case scenario requires the facilitator and participants to discuss the interplay of all these norms to arrive at a decision in the patient’s best interest.

Options and reflection. The reflection questions and options included for each case are intended to aid discussion by eliciting the participants’ thoughts about the case presentation and the balancing of ethical and legal norms. The reflection questions draw out the differing opinions of the audience, which may lead the group to recognize a variety of options for remedying the situation. The response options included highlight those actions the editors consider plausible. The intention is for the case discussion to explore the nuances of the options with the goal of reaching the best possible conclusion among them. The options list also enables the facilitator to continue the discussion after the group has reached a decision, allowing for additional deliberation.

Conclusion

Exploring Integrity in Medicine: The Bander Center for Medical Business Ethics Casebook serves as an educational tool for facilitated discussion of important topics in medical business ethics related to clinical practice and medical research using a well-described model of case analysis, the SFNO approach. To date, the casebook has been used in teaching doctoral students in health care ethics, senior medical students in a medical business ethics capstone course, and first- and second-year medical students in business and ethics interest groups. It has also been presented to educators at the Academy for Professionalism in Health Care Annual Meeting [13], at the International Conference on Clinical Ethics [14], and at the annual Health Law Professors Conference [15]. By including an array of information pertinent to each case, the casebook educates health care professionals on the wide spectrum of information pertinent to decision making in medical business ethics. The materials included in the casebook make it possible for professionals not formally educated in the areas relevant to the case information to serve as discussion facilitators.