Another Defense of Common Morality.

Robert Baker and Rosamond Rhodes each argue against the universality "common morality," the approach to ethics that comprises four fundamental principles and their application in various settings. Baker contends that common morality cannot account for cultural diversity in the world and claims that a human rights approach is superior in the context of global health. Rhodes maintains that bioethics is not reducible to common morality because medical professionals have special privileges and responsibilities that people lack in everyday life. Baker fails to demonstrate how the human rights approach to global ethics is more sensitive to culture than the use of bioethics principles that comprise common morality. Rhodes has a narrow interpretation of "common morality," which when understood more broadly, accounts for the special privileges and obligation of medical professionals.

Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project.

OBJECTIVE: To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. MATERIALS AND METHODS: The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). RESULTS: Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. CONCLUSIONS: Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research.

Misrepresenting "Usual Care" in Research: An Ethical and Scientific Error.

Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

Allocating medical resources fairly:the CSG bioethics guide.

On April 12, 2020, a bioethics guide for allocating scarce hospital resources during the current Covid-19 pandemic was posted on the website of the Consejo de Salubridad General(CSG) of the Government of Mexico. The guide, entitled Guía bioética para asignación de recursos limitados de medicina crítica en situación de emergencia, was intended as a preliminary document, but the website posting did not describe it as a first step in the process. The publicity resulted in a wide array of comments and criticisms. That first version posted on the CSG website contained an age-based criterion for breaking a tie between two or more medically eligible patients who needed of a ventilator: younger patients would have prefer-ence over older ones. The final version of the guide eliminated that criterion and instead, relied on the leading public health principle, "save the most lives", without regard to personal characteristics other than the possibility of benefitting from the scarce medical resources.

El 12 de abril de 2020, se publicó en el sitio web del Consejo de Salubridad General (CSG) del Gobierno de México una guía de bioética para asignar recursos hospitalarios escasos durante la actual pandemia de Covid-19. La guía titulada Guía bioética para asignación de recursos limitados de medicina crítica en situación de emergencia pretendía ser un documento pre-liminar, pero la publicación en el sitio web no lo describió como un primer paso en el proceso. La publicación resultó en una amplia gama de comentarios y críticas. La primera versión publicada en el sitio web del CSG contenía un cri-terio basado en la edad para romper el empate entre dos o más pacientes médicamente elegibles que necesitaran un ventilador: los pacientes más jóvenes tendrían preferencia sobre los de mayor edad. La versión final de la guía eliminó ese criterio y, en cambio, se basó en el principio principal de salud pública, "salvar la mayoría de las vidas", sin tener en cuenta las características personales que no sean la posibilidad de beneficiarse de los escasos recursos médicos.

Erosion of informed consent in U.S. research.

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to 'comparative effectiveness research' and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research.

Can one do good medical ethics without principles?

The criteria for determining what it is to do good medical ethics are the quality of ethical analysis and ethical justifications for decisions and actions. Justifications for decisions and actions rely on ethical principles, be they the 'famous four' or subsidiary ethical principles relevant to specific contexts. Examples from clinical ethics, research ethics and public health ethics reveal that even when not stated explicitly, principles are involved in ethical justifications. Principles may come into conflict, however, and the resolution of an ethical dilemma requires providing good reasons for preferring one principle over another.

Informed consent and standard of care: what must be disclosed.

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of "standard of care" in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of "standard of care" may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

Abortion laws in the United States: Turning the calendar back 50 years?

Just as nations around the world have begun to revise their laws that restrict women's access to safe, legal abortions, the United States is moving rapidly in the opposite direction. The past few years have seen several countries in Latin America enact new legislation; these include Argentina, Mexico, and Colombia as well as Chile [1], which formerly had an absolute ban that prohibited abortion even to save the life of the pregnant woman. In Africa, Tunisia, Zambia, South Africa, and other countries have loosened their restrictions on abortion [2]. In the US, despite nearly 50 years of having a constitutionally protected right to abortion, women now face an array of current and pending restrictions in about half of the fifty states. A case before the Supreme Court promises to upend that constitutional right. Recent developments leading up to the Court's decision promise to reverse a half century of women's right to abortion in the United States. When hard-won rights such as this are overturned, it not only requires an explanation; it also calls for a look at what other well-established structures are at risk in a liberal democracy.

A new definition for global bioethics: COVID-19, a case study.

A truly global bioethics involves cooperation and collaboration among countries. Most of the articles published in bioethics journals address a problem that exists in one or more countries, but the articles typically do not discuss solutions that require collaboration or cooperation. COVAX is one example of proposed international cooperation related to the current COVID-19. pandemic. Yet it is evident that nations have been proceeding on their own with little, if any collaboration. Despite international research ethics guidance from the World Health Organization (WHO), an article published under WHO auspices violates an ethical principle rejecting "double standards" in the conduct of global research. The COVID pandemic provides an opportunity for countries to learn from the recent lack of international cooperation and employ a multi-national strategy in future global health crises.

Defying the will of the people: The US Supreme Court overturns right to abortion.

On June 24, 2022, the US Supreme Court issued its ruling in the landmark case Dobbs v Jackson Women's Health Organization that overturned the constitutional right to abortion with a decision that opposes the will of the majority of Americans. Two earlier Supreme Court decisions had established and upheld that constitutional right for almost 50 years. Now, however, a "super majority" of the Court (6 of its 9 members) has voted to leave laws regarding abortion to the individual states. As soon as the Court's final decision was announced, demonstrations began in front of the Supreme Court in Washington, DC and throughout many states and cities. At the same time, anti-abortion crowds celebrated their victory in the streets, an indication of how polarised the United States has become.

Double standards redux.

It is fair to say that nothing is more pressing in today's world than bringing an end to the Covid-19 pandemic. Or to be more precise, if not an end, then the quickest and most effective reduction of mortality and morbidity from the disease in every country where infections exist. The forthcoming theme issue of IJME explores a long-standing ethical concern in research with human beings, focused mainly on a question posed about vaccine research for prevention of Covid-19. Contributors from six continents address the question: In what circumstances - if any ‒ is it ethically acceptable to use a research design in which the control group in a randomised, controlled trial (RCT) receives a placebo instead of a vaccine already approved for emergency use by regulatory bodies? That ethical question is not new.

The death of bioethics (as we once knew it).

Fast forward 50 years into the future. A look back at what occurred in the field of bioethics since 2010 reveals that a conference in 2050 commemorated the death of bioethics. In a steady progression over the years, the field became increasingly fragmented and bureaucratized. Disagreement and dissension were rife, and this once flourishing, multidisciplinary field began to splinter in multiple ways. Prominent journals folded, one by one, and were replaced with specialized publications dealing with genethics, reproethics, nanoethics, and necroethics. Mainstream bioethics organizations also collapsed, giving way to new associations along disciplinary and sub-disciplinary lines. Physicians established their own journals, and specialty groups broke away from more general associations of medical ethics. Lawyers also split into three separate factions, and philosophers rejected all but the most rigorous, analytic articles into their newly established journal. Matters finally came to a head with global warming, the world-wide spread of malaria and dengue, and the cost of medical treatments out of reach for almost everyone. The result was the need to develop plans for strict rationing of medical care. At the same time, recognition emerged of the importance of the right to health and the need for global justice in health. By 2060, a spark of hope was ignited, opening the door to the resuscitation of bioethics and involvement of the global community.