Aspectos éticos de las periciales en la valoración de la praxis médica / Ethical aspects of the experts in the evaluation of medical praxis

Los médicos que realizan actividades médico-periciales deben o debemos detenernos a reflexionar sobre nuestra propia tarea, sobre los valores que desarrollamos, sobre el servicio que aportamos a la sociedad, sobre los fines que perseguimos, las consecuencias que podemos llegar a soportar, etc., y cómo orientar nuestra práctica hacia la calidad y la excelencia. En el entorno de la medicina pericial se hace necesaria esta reflexión, para tratar de evitar que determinados criterios o cuestiones sustituyan en buena medida al compromiso responsable con nuestra actitud médica, y que podamos llegar a dejar de lado los elementos que legitiman nuestra acción, en pro de un beneficio o de una labor de intercambio de servicios que es al menos digna de ser analizada en nuestro ámbito

Physicians who carry out medical-expert activities must pause to reflect on our work, on the values we develop, on the service we provide to society, on the goals we pursue, the consequences we can endure, etc., and how to guide our practice towards quality and excellence. In the area of expert medicine, this reflection is necessary, to prevent certain criteria or questions largely replacing responsible commitment with our medical attitude, and get rid of the elements that legitimize our action, in favour of a benefit or exchange of services that is at least worthy of being analysed in our field

Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles.

Since its advent in 2012, CRISPR has spawned a cottage industry of bioethics literature. One principal criticism of the technology is its virtually instant widespread adoption prior to deliberative bodies conducting a meaningful ethical review of its harms and benefits-a violation, to some, of bioethics' "precautionary principle." This view poorly considers, however, the role that the law can play-and does, in fact, play-in policing the introduction of ethically problematic uses of the technology. This Perspective recounts these legal regimes, including regulatory agencies and premarket approval, tort law and deterrence, patents and ethical licenses, funding agencies and review boards, as well as local politics. Identifying these legal regimes and connecting them to the precautionary principle should be instructive for bioethicists and policy makers who wish to conduct ethical reviews of new applications of CRISPR prior to their introduction.

Public Health Data Collection and Implementation of the Revised Common Rule.

For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices.

From protectionism to inclusion: A New Zealand perspective on health-related research involving adults incapable of giving informed consent.

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health-related research (2016) heralds a paradigm shift from the 'protectionist' policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the potential for exploitation and research-related harms. This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a 'minimal risk' threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a 'best interests' standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand's legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research.

Las responsabilidades éticas / Ethical responsibilities

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[Ethical review of research in the grey area. The Ethical Review Act should be widened and case management more efficient]. / Forskningsetisk prövning i gråzonen--Etikprövningslagen bör vidgas och ärendehanteringen effektiviseras.

The present legal definition of the term research creates problems with what can be considered for ethical vetting by the Research Ethical Review Board. The Ethical Review Act should be revised in order for student projects involving patients or quality assurance in healthcare to be accepted for ethical vetting by the Board.

An unfortunate experiment? The future of ethical review in New Zealand.

This report describes the system of ethical review that was adopted in New Zealand based on the findings and recommendations from the Cartwright Inquiry in 1988. It discusses the changes made to this system under recent governmental initiatives enacted by the National Party, and some of the implications of those changes.

From global bioethics to ethical governance of biomedical research collaborations.

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved.

Beyond bioethics: reckoning with the public health paradigm.

In the wake of scandal over troubling research abuses, the 1970s witnessed the birth of a new system of ethical oversight. The bioethics framework, with its emphasis on autonomy, assumed a commanding role in debates regarding how to weigh the needs of society against the rights of individuals. Yet the history of resistance to oversight underscores that some domains of science hewed to a different paradigm of accountability--one that elevated the common good over individual rights. Federal officials have now proposed to dramatically limit the reach of ethical oversight. The Institute of Medicine has called for a rollback of the federal privacy rule. The changing emphasis makes it imperative to grapple with the history of the public interest paradigm.

Bioethics governance in Israel: an expert regime.

This paper provides an overview of bioethics governance in Israel through an analytical description of the legal framework for the interface between individuals and biomedical practices. There is no national agency with general oversight of bioethics policy and decision making, and the rules that apply to individual usage of biomedical technologies are laid down in a multitude of different statutes, regulations and administrative directives. Expert committees play a central role in this regulatory system in two capacities: as governmental advisory bodies that recommend policy; and as decision-making bodies that resolve conflicts around patients' rights or grant individual access to biomedical technologies. This decentralised system of governance through expert committees allows for adaptation to dynamic technological developments and flexibility in accommodating creative societal usage. At the same time the experts are the agents of the state's bio-power at the expense of personal autonomy and open public deliberation. The paper is part of a larger study investigating Israel's bioethics governance and its regime of experts, which includes an examination of the normative level of regulation, and an analysis of the composition of the expert committees. Our findings suggest that Israel has a decentralised system of governance with piecemeal regulation that has established a bioethics technocracy, governed by the ministry of health and dominated by the medical profession. The present paper is confined to a description and discussion of the legal framework of Israel's expert bioethics regime. Here, our major conclusion is that Israel has established a technocracy of official expert ethics committees, which controls life and death decisions.

Revisar un artículo para R adiología: quién y cómo / Reviewing an article for R adiología: who and how

La labor de un revisor es fundamental en el proceso editorial de una revista científica. La calidad de sus revisiones determina la calidad de la revista. Por lo tanto, es muy importante que el revisor interiorice esta misión y contribuya al desarrollo de la ciencia y el de la propia revista. Por otro lado, el enfoque de una revisión dependerá mucho del tipo de revista para la que se revisa. En este artículo se expone qué espera R adiología , revista científica de la Sociedad Española de Radiología Médica, de sus revisores y sus revisiones de los artículos originales. Con ello se pretende establecer unas normas básicas que sirvan de punto de partida para el desarrollo posterior de unas normas de revisión más elaboradas para Radiología (AU)

The reviewer's job is fundamental to the editorial process in a scientific journal. The quality of the review will determine the quality of the journal. Therefore, it is very important for the reviewers to make this mission their own and to contribute to the development of science and of the journal. On the other hand, the focus of a review will depend largely on the type of journal for which one is reviewing. In this article, we explain what the journal R adiología , the scientific journal of the Spanish Society of Medical Radiology, expects of its reviewers and their reviews of original articles. We aim to establish some basic rules to lay the groundwork for the development of more detailed guidelines for reviewing articles for the journal Radiología (AU)