Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

Guinea pigbots.

Doing research with human subjects is costly and cumbersome. Can AI chatbots replace them?

China sets new ethics rules for human studies.

Revised regulations follow controversy over work that created genetically edited babies.

Renegar del agujero en el caldero: defensas inconsistentes sobre el experimento de gemelos de Neubauer / To deny the hole in the cauldron Inconsistent defenses over Neubauer's twin experiment

El documental Three Identical Strangers, de Tim Waldle (2018) revela una investigación secreta sobre el desarrollo de hermanos genéticamente idénticos separados de manera deliberada para ser criados en circunstancias diferentes. Desde su estreno el experimento expuesto ha provocado una serie de rechazos en la opinión pública y entre los profesionales de la salud mental. El presente trabajo analiza los argumentos de los psiquiatras y psicoanalistas Leon Hoffman y Lois Oppenheim, que han cuestionado el documental y defendido el experimento, para analizar sus argumentos y evaluar si los mismos son consistentes o, por el contrario, pretenden legitimar una investigación éticamente inaceptable

Tim Waldle documentary film Three Identical Strangers (2018), reveals a secret investigation on the development of genetically identical siblings who were separated on purpose so as to be raised in different social contexts. Since it´s premiere, the exposed experiment has caused a series of rejections among public opinion and mental health professionals. This paper focuses in the arguments of psychiatrists Leon Hoffman and Lois Oppenheim in defense of the experiment and against the film, so as to analyzse if their arguments are consistent, or on the contrary, they pretend to legitimate an ethically unacceptable investigation.

Prison research: a bioethics or an ethics issue? / Investigación en prisión: ¿una cuestión de bioética o de ética? / Investigação em contexto prisional: Um questão de bioética ou de ética?

Abstract: The hypothesis of reducing aggressiveness through transcranial direct current stimulation was recently tested on a cohort of inmates in Spain. The experiment, including 1.5 mA electric shocks, was an external research initiative that received the initial acquiescence of the carceral system. An alarm was raised at the time the research was published, encouraging the directorate of prisons to stop the ongoing replication of the experiment. Nevertheless, no (bio)ethics committee, in the universities or among bioethics experts, has questioned the research. In this think piece, we aim to again discuss some ethical approaches to these clinical interventions on crime. After its positivistic period, the field of criminology has been questioning the simple psychobiological approach to crime because of the reductionistic view of this phenomenon and its harmful consequences. Thus, we address academic experimentation under prison governance and the "re" roles of prisons. We argue that the minor disadvantages of such research, if performed with consent, could be positive if the research can minimize the harmfulness of prison itself; thus, penitentiary treatment and science should go together. Prison administrations, in addition to their duty to protect the individuals under their control from ethically biased research, must promote reintegration. We conclude that human rights are over criminal policy and science and that ethics are over narrower bioethics.

Resumen: La hipótesis de la reducción de la agresividad por medio de estimulaciones transcraneales ha sido recientemente testada sobre encarcelados en España. El experimento, que incluyó descargas eléctricas de 1.5mA, fue una iniciativa de investigadores externos que encontró la aquiescencia inicial del sistema carcelario. La alarma surgió en el momento en que se publicó la investigación, alentando a la dirección de las prisiones a detener la replicación del experimento. Sin embargo, hasta entonces, ningún comité encontró ningún inconveniente, ni en las universidades ni entre expertos en bioética. En este artículo de reflexión pretendemos argumentar algunos enfoques éticos de estas intervenciones clínicas sobre la delincuencia. De nuevo, ya que la criminología, después de su periodo positivista, ha venido cuestionado el mero enfoque psicobiológico de la delincuencia. Así, abordamos el experimento académico dentro de la gobernanza penitenciaria y los roles "re" de las prisiones. Argumentamos que no es tanto que no se pueda investigar con internos, sino que posibles inconvenientes de tales investigaciones puedan servir, bajo consentimiento, para minimizar los inconvenientes de la misma pena de prisión. La administración, además del deber de proteger a sus individuos de investigaciones éticamente sesgadas ha de fomentar la reintegración. Concluimos que los derechos humanos han de estar por encima de la política criminal y de la ciencia, y la ética por encima de una más limitada bioética.

Resumo: A hipótese de diminuir a agressividade através da estimulação elétrica transcraniana foi recentemente testada num grupo de reclusos em Espanha. A experiência, que incluiu choques elétricos de 1,5mA, partiu de uma iniciativa de investigadores externos que encontraram a aquiescência no sistema prisional. O alarme surgiu no momento em que a investigação foi publicada, o que levou a direção administrativa das prisões a interromper a replicação do estudo. No entanto, até ao momento, nenhuma comissão de (bio)ética encontrou qualquer inconveniente, nem nas universidades, nem entre os especialistas em bioética. Com este artigo, pretendemos discutir algumas abordagens éticas dessas intervenções clínicas no crime. A criminologia tem vindo a questionar, após o seu período de investigação positivista, a abordagem psicobiológica do crime, devido à visão redutora desse fenómeno e das suas consequências nefastas. Assim, neste artigo, abordamos a experiência académica dentro da governança prisional e os fins da prisão. Concluímos que as pequenas desvantagens da investigação seriam positivas se pudessem, sob consentimento, minimizar os malefícios da própria prisão, o que significa que o tratamento penitenciário e a ciência deveriam andar 'de mãos dadas'. A administração das prisões, para além do dever de proteger os indivíduos de estudos que acarretem problemas éticos, deve promover a reintegração. Concluímos, assim, que os direitos humanos estão acima da política e da ciência criminais, e a ética acima da bioética mais restrita.

Ética y jurisprudencia administrativa de los derechos de los sujetos de investigación en pandemia (COVID-19): función de los comités éticos científicos: Chile / Ethics and administrative jurisprudence of the rights of subjects of research in pandemic (COVID-19): role of the scientific ethics committees: Chile

RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.

SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.

Human Infection Challenge Experiments: Then and Now.

In the midst of the Covid-19 pandemic, ethicists, researchers, and journalists have recommended studies that deliberately infect healthy volunteers with the coronavirus as a scientific means of expediting vaccine development. In this essay, we trace the history of infection challenge experiments and reflect on the Nuremberg Code of 1947, issued in response to brutal human experiments conducted by Nazi investigators in concentration camps. We argue that the Code continues to offer valuable guidance for assessing the ethics of this controversial form of research, with respect particularly to the acceptable limits to research risks and the social value of research necessary to justify exposing human participants to these risks.

Incorporating ethics and welfare into randomized experiments.

Randomized controlled trials (RCTs) enroll hundreds of millions of subjects and involve many human lives. To improve subjects' welfare, I propose a design of RCTs that I call Experiment-as-Market (EXAM). EXAM produces a welfare-maximizing allocation of treatment-assignment probabilities, is almost incentive-compatible for preference elicitation, and unbiasedly estimates any causal effect estimable with standard RCTs. I quantify these properties by applying EXAM to a water-cleaning experiment in Kenya. In this empirical setting, compared to standard RCTs, EXAM improves subjects' predicted well-being while reaching similar treatment-effect estimates with similar precision.

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.