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.

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.

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.

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.

Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project / Funcionamiento de los comités de ética en investigación en Colombia, Costa Rica, Guatemala y México: Proyecto Mesoamericano

Abstract: 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.

Resumen: Objetivo: Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos: Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados: Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones: Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación.

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.

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.

Allocating medical resources fairly: the CSG bioethics guide / Asignación justa de recursos médicos: guía bioética del CSG

Abstract 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 preference 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.

Resumen 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 preliminar, 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 criterio 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.

Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps.

BACKGROUND: In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. METHODS: We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans. FINDINGS: We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS's social value requirement. RECOMMENDATIONS: We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.

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.

Covid-19: A view from New York.

I live in New York City, identified as the epicenter of the Covid-19 pandemic. My view differs from that of many of the millions living in this large metropolitan area who are poor. I am not rich, but I am privileged: I have a retirement income for which I have saved all my working life and I have no debts. I am isolated in my apartment having food delivered. But what if I require hospitalization, from Covid-19 or another medical condition? New York State has guidelines for allocation of scarce ventilators in times of scarcity. The guidelines reject advanced age as a criterion for triage because it discriminates against the elderly. Other proposals contend that priority should be given to those who have not yet ;lived a full life. Allocation guidelines set a priority on saving the most lives, but hard choices remain within that broadly defined goal. Key words: Covid-19 pandemic, New York epicenter, resource allocation, age-based selection, shortage of ventilators, triage committee.

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.

The "Global gag rule": Curtailing women's reproductive rights.

The Global gag rule (GGR), originally known as the Mexico City Policy, is a United States policy that limits the reproductive rights of women in many resource-poor countries. In 2018, the US administration of President Donald Trump reinstated this policy, which was first issued by President Ronald Reagan in 1984, and later annulled by two US presidents in the intervening years. The policy prohibits any non-governmental organisation (NGO) outside the US from providing women or couples with family planning information that includes access to abortion, as a condition of receiving US funding. Although the policy is designed to reduce the rate of abortion in countries where NGOs have adopted it, studies have shown the opposite effect. The policy violates fundamental ethical principles, as well as United Nations human rights treaties and action programmes.

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.

La ética de la investigación en la actualidad: ¿qué problemas se presentan a los investigadores y a los comités de ética? / Current ethics in research: what problems do researchers and ethic boards face?

La respuesta a la pregunta "¿qué importancia tiene la ética en la investigación?" parecería obvia, pero merece la pena extenderse un poco. En primer lugar, los seres humanos que se someten a investigaciones sufren daños. La mayoría de las investigaciones con seres humanos la realizan profesionales médicos por lo que cabe recordar la antigua consigna que exige a los facultativos "abstenerse de hacer daño". Sin embargo, en la investigación no se puede anticipar todos los riesgos, ya que la actividad entraña aspectos novedosos. Y, debido precisamente a esta novedad, el daño que causa un estudio de investigación puede ser mayor que los beneficios que pudiera reportar. La adopción de una serie de protecciones y garantías para reducir al máximo la posibilidad de que los sujetos resulten perjudicados es, pues, imprescindible. No obstante, el daño no se presenta como la única categoría ética relacionada con la investigación; los sujetos humanos también pueden sufrir injusticias, incluso sin haber sido dañados. El uso de personas como «simples medios¼ o «instrumentos¼ para el beneficio de otros supone un trato injusto, puesto que viola un principio ético fundamental.1. Un ejemplo evidente en el campo de la investigación sería la experimentación con personas sin su conocimiento o consentimiento. Otras situaciones de agravios a personas que probablemente no causen daño serían, por ejemplo, ocultar la verdad, incumplir promesas hechas de buena fe y someterlas a engaño ­aunque las víctimas no lo sepan ni lo descubran­.

Challenges Working with Presidential Bioethics Commissions.

Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these commissions. ACHRE's charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners' approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners' views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners' positions without compromising my own integrity?