Issues of Concern
Ethics likely originated in multiple different societies, while Aristotle may have been the first to develop a system of rational ethics. Medical ethics was first described by Thomas Percival in 1803, with the first code of medical ethics in 1847. Today we recite the Hippocratic Oath or the Declaration of Geneva. Some add solidarity, confidentiality, and acceptance of ambiguity to the four core principles of autonomy, beneficence, non-maleficence, and respect for human rights.
Conflicts can arise between these values; for instance, patient autonomy can inhibit a physician from exercising beneficence. More recent debates within medical ethics focus on healthcare disparities and social determinants of health. Physicians should seek justice for all patients, providing individualized, culturally competent care. Patients coming from different backgrounds may not observe all aspects of Western Medicine (e.g., they may practice Chinese, Buddhist, Islamic, or Ayurvedic medicine). Other new concepts of investigation include medical technology, reproductive health, mental health, organ donation, suicide and assisted death, futility, and surrogate decision-making.
Professionals in the field of academic medicine must adhere to all of the standard medical ethics principles. Please see the StatPearls Medical Ethics for further expansion on these concepts.
Educators prioritize ethics just as we do in medicine. In a Code of Ethics for Educators, the National Education Association highlights “the worth and dignity of each human being, the supreme importance of the pursuit of truth, devotion to excellence, and nurture of the democratic principles. Essential to these goals is the protection of freedom to learn and teach and guarantee an equal educational opportunity for all. The NEA abides by I. a commitment to the student and II. a commitment to the profession. Professionals in academic medicine have dual roles of educating learners and caring for patients (and conducting research).
Ethical standards in medical education begin before students even reach professional school. Faculty have a duty to the community to facilitate access to a proper early education that makes a path to medicine possible. Admissions committees should consider student backgrounds in a just and fair approach to considering applicants. Well-rounded students must have more than prior academic success – they should have compassion and a humble willingness to care for patients without judgment. Harvey Cushing stated that “A physician is obligated to consider more than a diseased organ, more even than the whole man—he must view the man in his world.” As the business of medicine continues to encroach on the art and duty of the physician, we must affirm that the “acknowledgment of nonfinancial values is fundamental to achieve quality in health care and education.”
Medical education continues to add content on the concepts of cultural competency and healthcare disparities. Race, gender, socioeconomic class, and other differences should not limit access to medical education or optimal health. Social determinants of health are now introduced early during medical education, and instruction in cultural competency extends beyond training years.
Medical education now provides more instruction on the maintenance of health and wellness for the providers. This includes financial and mental health in addition to nutritive and physical pillars. Healthcare professionals who are not healthy cannot ensure the health of patients. Students also receive instruction on responsible use of social media, along with more traditional professionalism standards. Students receive instruction on how to report incompetent or unethical behaviors by colleagues or supervisors. The so-called “hidden curriculum,” which can mean different things to different people, often refers to negative customs or rituals that often occur in direct conflict with the formal curriculum and even in “tension with ideals of the medical profession.”
Students must be prepared for instances in which their own personal values diverge from professional values, such as granting full autonomy to patients. With changes in technology, especially those brought on by pandemics, educators must reconsider the structure of medical education. More and more instruction may transition to virtual learning, although drawbacks to this model certainly exist (lack of face-to-face interaction, difficult transition to clinical care, and the potential deficit in group education on ethics and professionalism. One final issue relates to the care of patients directly by trainees, sometimes without knowledge or true consent, and for which a framework may be adopted from research ethics.
Professionals who gravitate to a career or niche in research must practice meticulous methods and maintain high ethical standards. Due to the increasing complexity of scientific and medical research, some academic medical centers offer formal research ethics consultation services to assist clinical investigators with various tasks: assisting with research design and implementation, providing a forum for the deliberative exploration of ethical issues, and supplementing regulatory oversight. As research protocols and data become more complex, ethical standards and operational oversight will only increase in importance. Although one may encounter many pitfalls in scientific and medical research (see StatPearls EBM Research Pitfalls), concerns related to ethical violations are easily avoided with background knowledge, planning, and good intentions. See the StatPearls Research Ethics chapter for a more in-depth analysis.
Institutional Review Boards
Successful research endeavors begin with planning and clearance with the proper oversight committees. Generally, an institutional review board decides whether a project constitutes human subject research and then reviews and makes recommendations before giving their authorization to proceed. The 1974 Belmont Report declared three principles of equal importance that must be adhered to in human subject research: Respect for persons, beneficence, and justice. IRBs have evolved significantly over subsequent decades, requiring more personnel and more precise descriptions of research procedures.
IRB approval generally requires meeting seven criteria: Informed consent 1) sought when appropriate and 2) documented, 3) measures in place to protect privacy and confidentiality of subjects, 4) risks minimized, 5) risks reasonable relative to benefits, 6) data monitored for safety, and 7) selection of subjects is equitable.
The IRB protocol outlines the background, objectives, procedure, subject selection, data collection forms, statistical methods, and expected outcomes. Study personnel must have the requisite training and documentation to participate in research. The standards for clinical trials will generally be much higher than a prospective cohort study, and chart reviews are often declared “not human subjects research.”
If the IRB decides you are performing human subjects research, you will have to ensure subjects have properly informed consent. There will be some exceptions, such as incapacitated patients in emergency research (Langlois), but in general, informed consent is crucial for ethical research. Truly informed consent requires disclosure, understanding, capacity, and voluntariness. Patients must have the capacity to understand the diagnosis, risks and benefits, and treatment options, including no treatment (or intervention) at all. Research subjects must have the freedom to revoke their consent at any time after enrollment. Other than emergency research, other exceptions to informed consent include legally incompetent patients, patients who waive their right of informed consent, and matters of therapeutic privilege. Research involving protected populations must also be cleared with the IRB, such as studies involving minors, pregnant patients, and prisoners.
Clinical trials typically compare a new treatment to either a placebo or a treatment already established as the standard of care. The placebo must be appropriate and can only be used if the subjects will experience no harm by not receiving an already established treatment. When possible, clinical trials should involve blinding, randomization, and controlling for other variables.
Because safety is paramount, clinical trials have four different phases. Phase I occurs in a low number of healthy volunteers to establish safety. Phase II has a larger subject set to determine the efficacy of the treatment (along with dosing and adverse effects). Phase III tests the intervention on a larger number of subjects, ideally with randomization, attempting to establish that the treatment under investigation is superior or at least non-inferior to the standard care. Finally, Phase IV includes continued surveillance after the treatment has been approved to detect long-term or more rare adverse effects.
Those conducting research must protect all data collected in the course of the project. Patient confidentiality covers privacy but also respects the autonomy of subjects. Subjects should understand the level of privacy regarding the data collected, with deidentification being a common method of ensuring these standards. All researchers must have certification in Health Insurance Portability and Accountability Act (HIPAA). Database managers should ensure data protection and the integrity of data, with frequent cleaning, detecting missing data, and ensuring consistency in data entry.
After designing, receiving approval for, and initiating a clinical trial, the amount of work and oversight only increases. Principle investigators (PIs) and research teams must continuously monitor protocols and data collection. Generally, trials will perform intervention analyses at preset intervals to determine if the intervention or control group shows a clearly superior outcome. Research personnel must also conduct regular safety monitoring and log all adverse events.
Conflicts of Interest
Conflicts of interest can impact medical research, practice, and even education. A 2020 follow-up report on the 2009 Institute of Medicine findings declared that COIs are still very prevalent and can negatively impact individual patient care and aggregate care by influencing FDA approval and clinical practice guidelines. COI can alter judgment in publishing, drug review, social media, and patient advocacy.
All research study personnel, but especially the PI(s), must disclose and reflect on any potential conflicts of interest. If a pharmaceutical company funds a trial, do the researchers have full freedom to design it and report honest results? If the funding is federal, do any of the researchers have financial ties to private industry that could bias their reporting and interpretation of data? All of these factors must be determined before, during, and after research is conducted.
The number of cognitive biases that can affect biomedical research could encompass multiple StatPearls chapters. A few of the most common and crucial biases to eliminate (when possible) appear below. A bias cannot be completely eliminated in some studies but can be addressed in limitations discussion openly and constructively. Failing to eliminate (or discuss) sources of bias, even as errors of omission, could be considered an ethical violation.
Selection bias involves the nonrandom choice of subjects or choice of intervention in subjects will introduce bias in outcomes. Procedure bias can describe a non-equitable protocol or procedural treatment for different groups in a trial. Measurement bias occurs when data is collected or coded in an inconsistent manner, thus affecting the integrity of results. The observer-expectancy bias can occur when research personnel believe in the efficacy of treatment and affects results by treating subjects differently based on this bias. Confounding bias occurs when factors other than the exposure being studied affect outcomes.
Whether retrospective chart review or randomized control clinical trial, studies that reach the point of data analysis should be summarized in manuscript form for dissemination to the larger scientific community, see StatPearls How to Write a Scientific Manuscript for instruction on writing the paper itself. When seeking to publish your own research, beware of predatory journals that charge fees to publish or even submit, and have questionable practices. Most libraries keep databases delineating ‘safe’ vs. predatory journals.
Results should be conveyed concisely in plain language, with a clear delineation of objective results vs. subjective interpretation. The ethics of publishing also involves addressing financial incentives for journals (and authors), adhering to authorship criteria, and avoiding intentional and unintentional scientific misconduct. A systematic review and meta-analysis found that 1.97% of scientists admitted to having fabricated, falsified, or modified data or results at least once; 33.7% admitted questionable research practices, and 72% admitted following questionable research practices. A different paper described scientific misconduct in 29% of respondents who had no awareness of it.
Another concern related to research ethics involves the significant delay in applying new knowledge; the adoption of new evidence into practice can take many years. Conversely, treatments that become standard of care quickly, but fail to have reproducible findings in subsequent studies, can harm patients. This medical reversal should be avoided by a clear interpretation of published research findings in a big-picture context. Concerns related to replication, validation, and reliability are covered in many publications.
One cannot practice medicine, learn about medicine, or conduct medical research without attention to high ethical standards. The four core principles of autonomy, beneficence, non-maleficence and respect for human rights are cornerstones of medical practice. The practice of medicine does not deal ion black and white, binary decisions. Every decision we make comes with potentially unintended consequences. For example, in the Emergency Department, every decision to prioritize one patient implies a deprioritization of the other patients in the ED. In academic medicine, especially, the education of clinicians inherently puts some degree of risk onto the patient. This risk must be acknowledged and then minimized as much as possible.
Medical educators must teach students and residents to consider the whole patient, not just a collection of parts or disease processes. This applies to all caregivers in the health profession. Additionally, race, gender, socioeconomic class, and other differences should not limit access to medical education or optimal health.
The rigorous demands of clinical medicine also involve a tradeoff with the health of the providers themselves. Physicians who do not take care of their own mental and physical health cannot act as models for their patients. This self-care to ensure clinical competency represents an ethical obligation of all of us in clinical medicine.
Any research in clinical medicine inherently involves the clinical care of real patients. Research goals can never supersede the ethical care of patients. IRBs provide oversight, but each member of research teams must prioritize the ethical treatment of patients in the clinical setting. Of course, informed consent and shared decision-making extend far beyond the realm of research studies. Each patient interaction depends on trust, honesty, and consideration of the patient's welfare and his or her autonomy.
Like any other clinician, clinicians in academic medicine must always act in the patient's best interests while attending to their own health and well-being. Academic physicians have the added responsibility of teaching the importance of these principles and behaviors to the next generation of clinical providers.