La acreditación de los comités de ética de la investigación / Accreditation of Independent Ethics Committees

Objetivo: Según la Ley 14/2007 y el Real Decreto 1090/2015, la investigación biomédica debe ser evaluada por un comité de ética de la investigación (CEI), que deberá estar acreditado como comité de ética de la investigación con medicamentos (CEIm) si el dictamen recae sobre un estudio clínico con medicamentos o una investigación clínica con productos sanitarios. El objetivo de este estudio es comprobar cómo se regula la acreditación de los CEI y de los CEIm. Métodos: Se ha analizado la legislación estatal y autonómica sobre investigación biomédica. Resultados: Ni los CEI ni los CEIm tienen un procedimiento de acreditación definido con claridad en la legislación estatal o autonómica. Discusión: Los CEI son fundamentales en el desarrollo de la investigación biomédica básica o clínica, y deben estar acreditados por un órgano externo para evitar que la independencia, la composición multidisciplinaria y la revisión se vean afectadas (AU)

Objective: According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. Methods: National and regional legislation governing biomedical research was analysed. Results: No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Discussion: Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures (AU)

[Accreditation of Independent Ethics Committees]. / La acreditación de los comités de ética de la investigación.

OBJECTIVE: According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. METHODS: National and regional legislation governing biomedical research was analysed. RESULTS: No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. DISCUSSION: Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures.

Paving the road to negligence: the compensation for research-related injuries in Spain.

The planned reform of the regulation of clinical trials in Spain has reopened the debate over how to regulate research-related injuries. Act 29/2006 and Royal Decree 223/2004 regulate the insurance of research-related injuries, and they include a general clause requiring mandatory insurance and imposing a no-fault compensation system; they also contain an exception clause enabling clinical trials to be carried out without insurance under some conditions, and an exclusion clause excluding compensation when there is no causal connection between injuries and a clinical trial. National legislation is under review, affecting the requirement of mandatory insurance and paving the road to a liability system based on negligence, which will affect the level of protection of the persons enrolled in clinical trials because it would not ensure compensation. Regulatory texts on individuals' participation as research subjects should include not only mandatory insurance, but also a no-fault compensation system for cases when voluntary research subjects are injured, irrespective of negligence.

La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010

Objetivos: En España, en tiempos recientes, algunas voces han puesto en cuestión ciertas polìticas de salud pública por posibles invasiones de la libertad personal. El objetivo del capítulo es responder a dichas voces con argumentos éticos y económicos que justifican tales políticas.

La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010 / Grounding public health policies in ethics and economic efficiency. SESPAS report 2010

Objetivos: En España, en tiempos recientes, algunas voces han puesto en cuestión ciertas políticas de salud pública por posibles invasiones de la libertad personal. El objetivo del capítulo es responder a dichas voces con argumentos éticos y económicos que justifican tales políticas. Métodos: El presente trabajo plantea la corriente de opinión y sus características. Después, partiendo de Stuart Mill, expone los principios éticos de no maleficencia, beneficencia, autonomía personal y justicia, y algunos conceptos correlativos pertenecientes al plano de la eficiencia económica: efectos externos, monopolio, información incompleta y asimétrica, relación de agencia, bienes públicos y selección adversa. También se hace somera mención a la justicia o la equidad en economía, y al Estado del bienestar y los sistemas sanitarios públicos. Se discute también la justificación y los límites de las actuaciones «paternalistas» por parte del Estado. Conclusión: El respeto a la libertad individual no sólo no se opone, sino que exige, la adopción de medidas de salud pública. Si esas actuaciones cumplen ciertos requisitos, no sólo no limitan sino que protegen y amplían la libertad individual (AU)

Objectives: In recent times, various voices in Spain have questioned public health policies as an assault to personal freedom. The present article aims to respond to these voices with ethical and economic arguments. Methods: The scope and characteristics of this current of opinion are described. Then, starting with John Stuart Mill, the ethical principles of non-maleficence, beneficence, personal autonomy and justice, as well as related concepts taken from economic efficiency, such as externalities, monopoly, incomplete and asymmetric information, agency relationship, public goods and adverse selection, are discussed. A short mention is made of equity in economics, the welfare state and public health systems. The justification for paternalist actions by the state, as well as limits to these actions, are briefly discussed. Conclusion: Respect for individual freedom does not exclude the implementation of public health actions but rather demands the adoption of such policies. If these actions comply with certain conditions, they do not limit individual freedom but rather serve to protect it (AU)

[Grounding public health policies in ethics and economic efficiency. SESPAS report 2010]. / La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010.

OBJECTIVES: In recent times, various voices in Spain have questioned public health policies as an assault to personal freedom. The present article aims to respond to these voices with ethical and economic arguments. METHODS: The scope and characteristics of this current of opinion are described. Then, starting with John Stuart Mill, the ethical principles of non-maleficence, beneficence, personal autonomy and justice, as well as related concepts taken from economic efficiency, such as externalities, monopoly, incomplete and asymmetric information, agency relationship, public goods and adverse selection, are discussed. A short mention is made of equity in economics, the welfare state and public health systems. The justification for paternalist actions by the state, as well as limits to these actions, are briefly discussed. CONCLUSION: Respect for individual freedom does not exclude the implementation of public health actions but rather demands the adoption of such policies. If these actions comply with certain conditions, they do not limit individual freedom but rather serve to protect it.