Revista de Bioética y Derecho

Twentieth Anniversary of the Bioethics and Law Observatory of the University of Barcelona

Assaig transhegelià

The debate about harms in social science research

En el contexto de la ética de la investigación en ciencias sociales el debate sobre los daños a las/os participantes ha recibido menor atención respecto de otras áreas de la investigación con seres humanos, y suele prevalecer la idea según la cual la posibilidad de daño es poco probable en estas investigaciones. El propósito principal de este artículo es ampliar el debate sobre los daños en investigación social. Con este fin se hará un análisis pormenorizado de los conceptos y tipos de riesgos y daños y se mostrará que es posible defender un concepto amplio de daño que contemple diversos aspectos de la vida de las personas que pudieran verse afectados como consecuencia de su participación en una investigación.

In the field of social science research ethics the controversy about harming participants has received less attention than among other areas of research with humans, and tend to dominate the idea that the possibility of harm is unlikely in this kind of researches. The main purpose of this article is to broaden the debate on harms in social sciences research. To this end, it will be done a detailed analysis of the concepts and types of risks and harms and it will be shown that it is possible to defend a broad concept of harm that considers different aspects of the lives of people who could be affected as a result of their participation in a research.

Legal nature of International Bioethical Regulations

Para los juristas resulta imprescindible establecer la naturaleza jurídica de las instituciones que investigan, toda vez que de ellas se derivan una serie de efectos jurídicos inequívocos que le son propios. En esta línea, las declaraciones bioéticas, al no poseer estatuto jurídico de Tratados Internacionales, resulta válido indagar acerca de su verdadera eficacia. Para lo cual es necesario determinar previamente su naturaleza jurídica. En este trabajo se intenta dilucidar si es posible considerar a las declaraciones bioéticas como principios generales del derecho y qué efectos supondría adscribir esta tesis en los ordenamientos jurídicos internos.

For lawyers it is essential to establish the legal nature of the institutions that they investigate, since there are many legal effects that derive from it. In this line, most bioethical declarations do not have the status of international treaties, and it is valid to inquire about their true effectiveness. In order to do this it is necessary determine their legal nature. This paper attempts to establish whether it is possible to consider bioethical declarations as general principles of law and what is the effectiveness of supporting this thesis within domestic legal system.

Ethical implications of flu investigations: the Principle of Global Colaboration

Dos equipos de investigadores encabezados por Fouchier, en Holanda, y Kawaoka, en Estados Unidos, han efectuado modificaciones en el virus de la gripe aviar para demostrar que puede transmitirse con facilidad entre seres humanos. Al tratar de publicar sus trabajos se abrió un intenso debate en la comunidad científica sobre si los resultados de las investigaciones debían difundirse o no. Finalmente, los trabajos se publicaron al amparo de un nuevo principio en bioética, el Principio de Colaboración Global, dado que los resultados de las investigaciones podían tener alcance planetario. Analizaremos en el presente artículo el sentido y alcance de dicho principio, y cómo la polémica generada por estas investigaciones han tambaleado los cimientos de la ética científica.

Two equipments of investigators headed by Fouchier, in Holland, and Kawaoka, in The United States, has effected modifications in the virus of the avian flu to demonstrate that it can be transmitted by facility between human beings. On having tried to publish his works an intense debate was opened in the scientific community on if the results of the investigations had to spread or not. Finally, the works were published under the protection of a new principle in bioethics, the Principle of Global Collaboration, provided that the results of the investigations could have planetary scope. We will analyze in the present article the sense and scope of the above mentioned principle, and how the polemic generated by these investigations there have staggered the foundations of the scientific ethics.

Ressarcimento das despesas de sujeitos de pesquisa: experiência de pesquisadores

Objetivo: Conhecer a experiência e opinião de pesquisadores da área de ginecologia e Obstetrícia (GO) sobre o ressarcimento de despesas a sujeitos de pesquisa. Sujeitos e métodos: Estudo qualitativo em que se realizaram entrevistas semiestruturadas, por telefone, com sete pesquisadores-docentes de cinco programas de pós-graduação em GO de universidades paulistas. Realizou-se análise temática de conteúdo das entrevistas transcritas. Resultados: Cinco pesquisadores tinham experiência com estudos em que se fez o ressarcimento aos sujeitos, geralmente pago em dinheiro. Nenhum pesquisador referiu ter encontrado dificuldades para calcular o valor do ressarcimento porque isso era determinado pelo Comitê de Ética em Pesquisa (CEP) ou pelas agências de fomento. O projeto da pesquisa havia sido aprovado por um CEP que não questionou o valor do ressarcimento proposto. Os participantes concordaram que, além de transporte e alimentação, também se deveria considerar o tempo, dia de trabalho, em que consistiria a participação da pessoa e a complexidade da pesquisa para calcular o valor do ressarcimento. Este não pode ser alto porque pode "comprar a consciência" ou produzir uma "mercantilização", mas, se for baixo, "não vale a pena" participar. Conclusão: Os pesquisadores não dispõem de parâmetros oficiais, regulamentados, para estabelecerem o valor do ressarcimento em cada pesquisa. Reconhecem que é difícil estabelecer esse valor para não constrangerem as pessoas, mas, ao mesmo tempo, entendem que o ressarcimento pode motivá-las a participarem das pesquisas. Evidencia-se a necessidade ampliar a discussão a esse respeito para prover diretrizes mais claras aos pesquisadores.

Objective: To assess the experience and opinion of the researchers in the area of Gynecology and Obstetrics about the reimbursement of expenses to the research subjects. Subjects and Methods: A qualitative study was conducted in which semi-structured interviews were done by telephone, with seven researchers-professors from five post-graduate programs in Obstetrics and Gynecology in São Paulo universities. Thematic content analysis from the transcribed interviews was conducted. Results: Five researchers had experience with studies in which the compensation was made to the subjects, usually paid in cash. No researcher reported having any difficult to calculate the amount of compensation because it was determined by the Research Ethics Committee (REC) or by any agency which is given the funds for the research. The research project was approved by an REC which did not make any question about the amount proposed. Participants agreed that in addition to transportation and food, it is convenient to also take into account the time, day job, what exactly would be the subject participation and the complexity of the survey to calculate the amount of compensation. This may not be high because it can "buy the conscience" or produce a "way of commerce"; even in cases it is low; however, if the compensation is so low the participants reported that "it does not worth" to take part of the study. Discussion: The researchers have no official rules regulated, to establish the amount of compensation for each survey. They recognize that it is difficult to establish this value not to constrain people, but at the same time, understand that the compensation can motivate them to participate in the research. They highlights the need to broaden the discussion about it to provide clearer guidelines to researchers.

Panorama bioético e jurídico da reprodução humana assistida no Brasil

A normatização, ética e jurídica, da reprodução humana assistida no Brasil faz-se por meio de poucos instrumentos, sobretudo pela Resolução do Conselho Federal de Medicina n. 2013, de 16 de abril de 2013, que veio revogar a regulação de 2010 e reconhecer a possibilidade de casais homoafetivos se utilizarem das técnicas. Muitas são as discussões levantadas por essa regulação, inclusive quanto às consequências jurídicas da reprodução assistida realizada após a morte de um dos pais. Sobre essa situação específica cita-se um julgado, em que o pai falecido não havia permitido expressamente o uso de seu sêmen para depois da morte.

The regulatory, ethical and legal, of assisted human reproduction occurs in Brazil for a few instruments, especially the Resolution of the Federal Council of Medicine n. 2013, April 16, 2013, which revoked the Resolution 1957/2010 and recognized the possibility of homosexual couples when using the techniques. The discussions raised by this regulation are many, including as to the legal consequences of assisted reproduction made after the death of a parent. Concerning this specific situation, there was a trial in which the deceased father had not expressly permitted the use of their semen after his death.

Access to medicines: patents and generic drugs: the consequences of considering drugs as a market commodity and not as a social value

El objetivo de este trabajo es reflexionar sobre las dificultades en el acceso a los medicamentos, uno de los principales problemas de salud pública en los países en vías de desarrollo. Se analizarán sus posibles causas, tomando como punto de partida el concepto del uso del medicamento como un bien de mercado y no como un bien social. Esta reflexión tendrá su eje en la relación existente entre los precios de estos productos y la protección de la propiedad intelectual a través de las patentes de los medicamentos, entendida como centro de los conflictos ocurridos en la última década entre la Industria Farmacéutica y los países en desarrollo. Se considerarán las principales propuestas implementadas para permitir el acceso a los medicamentos, destacando la política de medicamentos genéricos en su conjunto como modelo regional para confrontar los oligopolios actuales de investigación, producción y comercialización.

The aim of this paper is to reflect on the difficulties in the access to medicines, one of the main problems in public health of developing countries. Possible causes will be analyzed, using as a starting point the concept of drug as a market commodity rather as a social value. This reflection mainly focus on the relationship between the prices of these products and the protection of intellectual property through patents of drugs, defined as the center of the conflicts in the last decade between the Pharmaceutical Industry and the developing countries. The main proposals implemented to allow access to medicines are considered, emphasizing the generic drug policy as a whole regional model to confront the current research, production and marketing oligopoly.