Volume 20, Issue 7, July 2020, Page 77-80.

Volume 20, Issue 9, September 2020, Page 18-20.

The Covid‐19 crisis has underscored the importance of the collection and analysis of clinical and research data and specimens for ongoing work. The federal government recently completed a related revision of the human subjects research regulations, founded in the traditional principles of research ethics, but in this commentary, we argue that the analysis underpinning this revision overemphasized the importance of informed consent, given the low risks of secondary research. Governing the interests of a community is different from governing the interests (...) of individuals, and here we suggest that, moving forward, the analyses of the risks of secondary research protocols be assessed from the perspective of the former. (shrink)

The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration’s expanded access pathway and the pathway created by the more recent Right to Try Act. In this issue of the Hastings Center Report, with a critical focus on patients, industry, and the research enterprise, Kelly Folkers and colleagues frame the inherent challenges that these pathways are meant to solve and (...) have also inadvertently created. But an additional key focus is how the relevant situations should be managed at the bedside and how the system risks both inefficient and inequitable access to options at the institutional level. Although either pathway could be helpful to patients, the challenges of having the pathways coexist are greater than the sum of their parts. Individual clinicians represent the front line of the regulatory and eligibility challenges of expanded access and right to try, making clinical education a critical component of a comprehensive approach to using them well. But it is medical institutions that must take the lead on supporting access to investigational options in the most equitable and effective manner possible. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether (...) they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling a standard‐of‐care sprawl where actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions.One of the best examples of the conflict between evidence‐based medicine and common clinical practice is the use of electronic fetal monitoring. Despite strong evidence and professional guidelines that argue against the use of EFM for healthy pregnancies, the practice persists. One of the main reasons for this is often assumed to be physicians’ concerns about liability. (shrink)

The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether (...) they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling a standard-of-care sprawl where actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions. One of the best examples of the conflict between evidence-based medicine and common clinical practice is the use of electronic fetal monitoring. Despite strong evidence and professional guidelines that argue against the use of EFM for healthy pregnancies, the practice persists. One of the main reasons for this is often assumed to be physicians’ concerns about liability. (shrink)

Generative artificial intelligence (GenAI) promises to revolutionize data-driven fields (Milmo 2023). Building on decades of large language modeling (LLM) (Toner 2023), GenAI can collect, harmonize...

The ethics of artificial intelligence and machine learning exemplify the conceptual struggle between applying familiar pathways of ethical analysis versus generating novel strategies. Mel...

A commentary on “‘Ever Vigilant’ in ‘Ethically Impossible’: Structural Injustice and Responsibility in PHS Research in Guatemala,” from the May‐June 2013 issue.

The STD experiments in Guatemala from 1946–1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so “ethically impossible,” how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process (...) into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpetrated on the subjects of the Guatemala STD experiments, it takes a comprehensive understanding of research ethics through professional education to achieve the longstanding ideal of the responsible investigator, and ensure ethical research under any regulatory scheme. (shrink)

Since their revelation to the public, the sexually transmitted disease experiments in Guatemala from 1946 to 1948 have earned a place of infamy in the history of medical ethics. During these experiments, Public Health Service researchers intentionally exposed over 1,300 non-consenting Guatemalan soldiers, prisoners, psychiatric patients, and commercial sex workers to gonorrhea, syphilis, and/or chancroid under conditions that have shocked the medical community and public alike. Expert analysis has found little scientific value to the experiments as measured by current or (...) contemporaneous research standards.Such an obvious case of research malfeasance, which violated research norms in place both in the past and now, has been uniformly repudiated. The Guatemala STD experiments were labeled “clearly unethical” by President Barack Obama and “reprehensible” by the Secretaries of State and Health and Human Services. (shrink)

Hundreds of articles have been written over the past several decades delineating the ethical tensions of health data commercialization, empirically querying the preferences of data contributors, an...