Ethical Issues in Academic Medicine

Issues of Concern

Clinical Ethics

Ethics likely originated in multiple societies, while Aristotle may have been the first to develop a system of rational ethics. Thomas Percival first described medical ethics in 1803, with the first code of medical ethics in 1847. Today, physicians recite the Hippocratic Oath or the Declaration of Geneva. Some add solidarity, confidentiality, and acceptance of ambiguity to the 4 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 from different backgrounds may not observe all aspects of Western Medicine (eg, 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. 

Academic medicine professionals must adhere to all of the standard medical ethics principles. Academic medical centers can have unique challenges in their clinical care.[1] Examples include withdrawing and withholding treatment, goals of care, and patient capacity and autonomy. Overcrowding continues to disrupt hospital flow processes, particularly in academic medical centers.[2] Please see StatPearls' companion resource,"Medical Ethics", for further expansion on these concepts.

Educational Ethics

Educators prioritize ethics just as in medicine. In a Code of Ethics for Educators, the National Education Association (NEA) 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, guaranteeing equal educational opportunity for all. The NEA abides by the following:

1. A commitment to the student 
2. 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, “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.”[3] 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.[4]

Medical education now provides more instruction on maintaining health and wellness for clinicians. 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 reporting 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 conflict directly with the formal curriculum and even in “tension with ideals of the medical profession.”[5][6]

Students must be prepared for instances in which their 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. However, drawbacks to this model certainly exist (eg, lack of face-to-face interaction, difficult transition to clinical care, and the potential deficit in group education) on ethics and professionalism.[7] 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.[8]

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.[9] As research protocols and data become more complex, ethical standards and operational oversight will only increase in importance. Although individuals 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. Please see StatPearls' companion resource, "Research Ethics," for a more in-depth analysis.

In 2024, the World Medical Association revised the Declaration of Helsinki. One revision changed the word "subject" to "participant" to emphasize the voluntary nature of research. The update also added language that demands “meaningful engagement with potential and enrolled participants and their communities.”[10] The strict research ethics should be applied to all research personnel, not only physicians. The paper discussed the contextual nature of vulnerability, allowing for more inclusion of members of vulnerable populations historically excluded by default. Other revisions to the declaration involve procedures related to biobanking, machine learning, and secondary research.[10]

Institutional Review Boards

Successful research endeavors begin with planning and clearance with the proper oversight committees. Generally, an institutional review board (IRB) 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 the following 3 principles of equal importance that must be adhered to in human subject research: 

• Respect for persons
• Beneficence
• Justice [11] 

IRBs have evolved significantly over subsequent decades, requiring more personnel and more precise descriptions of research procedures. IRB approval generally requires meeting the following 7 criteria for informed consent:

1. Sought when appropriate
2. Documented
3. Measures in place to protect the privacy and confidentiality of subjects
4. Risks minimized
5. Risks reasonable relative to benefits
6. Data monitored for safety
7. Selection of subjects is equitable [11]

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.”

Informed Consent

If the IRB decides that research is being performed on human subjects, researchers must ensure that subjects have received properly informed consent. Some exceptions exist, eg, 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 be able to understand the diagnosis, risks and benefits, and treatment options, including no treatment (or intervention) at all. Research subjects must be free 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 to informed consent, and matters of therapeutic privilege. Research involving protected populations must also be cleared with the IRB, eg, studies involving minors, pregnant patients, and prisoners.

Trial Design

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. Clinical trials should involve blinding, randomization, and controlling for other variables when possible.

Because safety is paramount, clinical trials have the following 4 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, to establish that the treatment under investigation is superior or at least noninferior to the standard care
• 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 the 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 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.[12]

All research study personnel, especially PI(s), must disclose and reflect on potential conflicts of interest. For instance, if a pharmaceutical company funds a trial, do the researchers have complete 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.

Bias

The number of cognitive biases affecting biomedical research is vast. While bias cannot be eliminated entirely in some studies, it can be addressed openly and constructively in discussions of limitations. Failing to eliminate (or discuss) sources of bias, even as errors of omission, could be considered an ethical violation.

A few of the most common and crucial biases to eliminate when possible include:

• Selection bias: This bias involves the nonrandom choice of subjects or choice of intervention in subjects that will introduce bias in outcomes.
• Procedure bias: This can describe an inequitable protocol or procedural treatment for different groups in a trial.
• Measurement bias: Studies may display measurement bias when data is collected or coded inconsistently, thus affecting the integrity of results.
• Observer-expectancy bias: This can occur when research personnel believe in the efficacy of treatment and affect results by treating subjects differently based on this bias.
• Confounding bias: This bias occurs when factors other than the studied exposure affect outcomes.

Publishing Ethics

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. Please see StatPearls' companion resource, "How to Write a Scientific Manuscript," for further instructions on writing a paper. When seeking to publish your own research, beware of so-called "predatory journals" that charge fees to publish or even submit and have questionable practices.[13] Most libraries keep databases delineating "safe" versus predatory journals. Predatory journals, publishers, and conferences target early-career researchers, as well as residents and even medical students.[14] 

Results should be conveyed concisely in plain language, clearly delineating objective results versus 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.[15][16] A different paper described scientific misconduct in 29% of respondents unaware of it.[17]

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 quickly become standard of care but fail to have reproducible findings in subsequent studies can harm patients. This "medical reversal" should be avoided by clearly interpreting published research findings in a big-picture context. Concerns related to replication, validation, and reliability are covered in many publications.[18] 

Academic Discourse, Integrity, and Information

Partially driven by concerns raised during and after the COVID-19 pandemic, the American College of Physicians released a position paper on Ethics and Academic Discourse, Scientific Integrity, Uncertainty, and Disinformation in Medicine.[19] The committee presents 4 "positions." COVID-19 brought issues of scientific integrity, information, and dissemination to the forefront of the conversation, which is particularly important to ethical concerns in academia.[20]

• Position 1: Humility in the face of the uncertainty inherent in the scientific process, collegial respect for competing views, and openness to thoughtful and rigorous debate are critical to the evolution of science. Today’s contrarian view can become tomorrow’s clinical guidance.
• Position 2: Scientific values, including objectivity, honesty, and openness, must be cultivated, taught to clinicians and scientists in training, and modeled by physicians and scientific spokespersons.[21]
• Position 3: Healthcare institutions and organizations should create and sustain a culture that advances knowledge and supports norms of openness, independence, objectivity, and healthy scientific skepticism.[22]
• Position 4: Public education, health, and healthcare literacy should be promoted so that patients and the public have a better understanding of the scientific process and the uncertainty associated with and evolving nature of medical advancements. Disinformation and misinformation should be countered, but the terms “misinformation” and “disinformation” should be used with care.[23]

Clinical Significance

One cannot practice medicine, learn about medicine, or conduct medical research without attention to high ethical standards. The 4 core principles of autonomy, beneficence, nonmaleficence 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 (ED), every decision to prioritize a 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 clinicians 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 clinicians.

Enhancing Healthcare Team Outcomes

Effective interprofessional collaboration is essential in addressing ethical challenges in academic medicine, ensuring patient-centered care, safety, and improved outcomes. Physicians, advanced practitioners, nurses, pharmacists, and other health professionals must collaborate to navigate complex ethical dilemmas in clinical care, education, and research. This requires developing skills in ethical reasoning, shared decision-making, and effective communication to balance patient autonomy, beneficence, and justice. Strategies, eg, case discussions, ethics consultations, and interdisciplinary training sessions, can help teams proactively identify and address ethical concerns, particularly in areas like informed consent, privacy, and equitable treatment. By fostering a culture of open dialogue, healthcare teams can better align patient care with ethical and professional standards.

Interprofessional communication and care coordination are vital in ensuring that ethical principles are upheld across all domains of academic medicine. Healthcare professionals must engage in transparent discussions about conflicts of interest, research integrity, and the responsible use of big data in clinical decision-making. Ethical challenges such as data privacy, confidentiality, and fair access to emerging treatments require collaboration between medical, legal, and administrative professionals. Advanced practitioners and nurses play a key role in advocating for patients, while pharmacists contribute by ensuring ethical medication use and education. By integrating ethical decision-making into everyday practice and fostering accountability within the team, healthcare professionals can enhance patient trust, safety, and overall team performance in academic medicine.