NUEVOS DESAFÍOS ÉTICOS CAUSADOS POR LA INVESTIGACIÓN INNOVADORA EN BIOMEDICINA

La investigación innovadora en la biomedicina puede traer nuevos desafíos éticos, a menudo por diferentes razones. Esta presentación ofrece tres ejemplos: a) La investigación sobre la transferencia de genes, comúnmente llamada "terapia génica"; b) La investigación con células madres embrionarias y c) La investigación usando el trasplante de tejido fetal. Aunque las tres innovadoras áreas de investigación plantean problemas éticos, estos retos son diferentes y cada uno requiere una solución por separado. Debido a su novedad,  la investigación sobre transferencia de genes tiene peligros desconocidos y puede tener consecuencias impredecibles. El debate sobre la investigación con células madre embrionarias, se basa en convicciones religiosas en torno al estatuto moral de los embriones humanos. La controversia que rodea el trasplante de tejido fetal se puede remontar a la metodología utilizada en los ensayos clínicos, más que a la investigación de la maniobra en sí

In Conversation: Ruth Macklin, Alison Reiheld, Robyn Bluhm, Sidney Callahan, and Frances Kissling Discuss the Marlise Munoz Case, Advance Directives, and Pregnant Women

Feminist bioethicists of a variety of persuasions discuss the 2013 case of Marlise Munoz, a pregnant woman whose medical care was in dispute after she became brain dead

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

Modelling the effects of bacterial cell state and spatial location on tuberculosis treatment: Insights from a hybrid multiscale cellular automaton model

This work was supported by the Medical Research Council [grant number MR/P014704/1] and the PreDiCT-TB consortium (IMI Joint undertaking grant agreement number 115337, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.If improvements are to be made in tuberculosis (TB) treatment, an increased understanding of disease in the lung is needed. Studies have shown that bacteria in a less metabolically active state, associated with the presence of lipid bodies, are less susceptible to antibiotics, and recent results have highlighted the disparity in concentration of different compounds into lesions. Treatment success therefore depends critically on the responses of the individual bacteria that constitute the infection. We propose a hybrid, individual-based approach that analyses spatio-temporal dynamics at the cellular level, linking the behaviour of individual bacteria and host cells with the macroscopic behaviour of the microenvironment. The individual elements (bacteria, macrophages and T cells) are modelled using cellular automaton (CA) rules, and the evolution of oxygen, drugs and chemokine dynamics are incorporated in order to study the effects of the microenvironment in the pathological lesion. We allow bacteria to switch states depending on oxygen concentration, which affects how they respond to treatment. This is the first multiscale model of its type to consider both oxygen-driven phenotypic switching of the Mycobacterium tuberculosis and antibiotic treatment. Using this model, we investigate the role of bacterial cell state and of initial bacterial location on treatment outcome. We demonstrate that when bacteria are located further away from blood vessels, less favourable outcomes are more likely, i.e. longer time before infection is contained/cleared, treatment failure or later relapse. We also show that in cases where bacteria remain at the end of simulations, the organisms tend to be slower-growing and are often located within granulomas, surrounded by caseous material.Publisher PDFPeer reviewe