Suchergebnisse

This article reports a study carried out in the cities of La Paz, Cochabamba and Santa Cruz in Bolivia. The interestwas to know the situation of bioethics in Bolivia and how research subjects are being protected.After revising some bioethical concepts, Bolivian legislation and study methods, results revealed great lack of knowledge on howto protect research subjects, due to the almost absence or inadequate functioning of scientific ethical review committees. ; Este artículo reporta un estudio realizado en las ciudades de La Paz, Cochabamba y Santa Cruz en Bolivia. Interesabasaber cuál era la situación de la bioética en Bolivia y cómo se estaba protegiendo a los sujetos de investigación.Luego de revisar algunos conceptos bioéticos, la legislación boliviana y los métodos del estudio se dan a conocer los resultadosdel mismo, los cuales revelan gran desconocimiento respecto de cómo proteger los derechos de los sujetos, por la casi ausenciao el inadecuado funcionamiento de los comités de ética de la investigación. ; Este artigo reporta a um estudo realizado nas cidades de La Paz, Cochabamba, e Santa Cruz, na Bolivia. Interessava-sesaber qual era a situação da bioética na Bolivia e como se estava protegendo os sujeitos de pesquisa. Ao revisar alguns conceitosbioéticos, a legislação boliviana e os métodos de estudo foi possível identificar os resultados pesquisados; esses revelaramgrande desconhecimento a respeito de como garantir os direitos dos sujeitos de pesquisa, por conta da quase ausência e/oudo inadequado funcionamento dos comitês de ética de pesquisa.

AbstractThe Nuremberg code, a response to the 1946 Nuremberg Medical Trials, was the first attempt to formally state ethical requirements for medical research. The Code was generally ignored as a response to the peculiarly barbaric Nazi atrocities and an unnecessary fetter on normal research. A series of research scandals, however, led to more successful attempts at regulating medical research and to the introduction of various ethical committees during the 1970s. Since then, ethical committees have expanded their remit to regulate social as well as medical research and operate according to precautionary standards that far exceed what is necessary to protect public safety. Ethical committees block investigations of medical practice even when the intent is to benefit patients directly and they prevent social research entailing even far‐fetched possibilities of 'stress'. Although purportedly designed to protect patients and civil liberties, modern ethical regulation damages the doctor–patient relationship, undermines professional responsibility, and encourages negative scientific practice.

Current regulatory guidelines require the ethical review committee to consider one question when evaluating payment: Is the payment to the participant undue or coercive? Although this is a seemingly simple question, determining appropriate payment involves a series of complex issues. There is limited empirical knowledge to assist with this determination and little consensus on which elements of a study should be considered in making these decisions. For example, should the culture of the study population or the potential risks and benefits of the research be considered in the selection of appropriate payment? Following a review of national and international guidelines, the concerns and benefits of paying research participants are presented, and prior ethical debate is outlined. The current research literature on the practice of paying participants and the impact of payment on participants and study integrity are reviewed. Finally, given continued debate with limited data to help determine best practices, a research agenda is proposed to assist in the development of an empirical basis to aid investigators and ethical review committees in making appropriate decisions about payment to research participants.

This casebook collects 64 case studies, each of which raises an important and difficult ethical issue connected with planning, reviewing, or conducting health-related research. The book's purpose is to contribute to thoughtful analysis of these issues by researchers and members of research ethics committees (RECs, known in some places as ethical review committees or institutional review boards), particularly those involved with studies that are conducted or sponsored internationally. This collection is envisioned principally as a tool to aid educational programs, from short workshops on research ethics to in-service learning for scientists and REC members, to formal degree or certificate courses. In such settings, instructors will typically select a number of case studies that will be distributed to the participants to provoke and focus discussion. To assist those using these case studies in their classrooms and workshops, a teaching guide has been included.--Publisher's description

Acquired Immune Deficiency Syndrome ("AIDS") has emerged as a health issue of global significance, and clinical research on Human Immunodeficiency Virus ("HIV") and AIDS has become increasingly international in scope. A clinical trial of a vaccine designed to prevent the spread of the HIV raises important legal and ethical questions because injection drug users who were believed to be unsuitable subjects for study in the United States were singled out for research in Thailand. The protections for human subjects must not be compromised when U.S. pharmaceutical companies conduct research abroad, particularly where clinical trials are conducted in vulnerable populations. U.S. regulations, as well as international declarations and guidelines, require two primary protections for research subjects: individual voluntary informed consent, and prior review of proposed research by an independent ethical review committee. Ethical review committees should gauge the adequacy of informed consent by the substance of the information communicated between researcher and participant, and should not be satisfied with a mere signature on a consent form. The recent clinical trial of HIV vaccines in the United States and Thailand highlights the gaps and weaknesses in the current system of protections for human subjects. Members of the committees that reviewed the protocols for the AIDSVAX vaccine failed to properly consider the vulnerability of the subject population and the implications for informed consent. Countries that host research sponsors, as well as countries that host research volunteers, must share the responsibility of protecting human subjects. To strengthen the protections for human subjects, Thailand should enact comprehensive national legislation, and existing legislative protections in the United States should be expanded to reflect the increasingly international scope of biomedical research. As a case study, the AIDSVAX clinical trials can provide useful information for planning more equitable HIV vaccine trials in ...

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

Ethical evaluation of projects involving animal testing is mandatory within the EU and other countries. However, the evaluation process has been subject to criticism, e.g., that the committees are not balanced or democratic enough and that the utilitarian weighting of harm and benefit that is normally prescribed is difficult to carry out in practice. In this study, members of Swedish Animal Ethics Committees (AECs) completed a survey aiming to further investigate the decision-making process. We found that researchers and animal laypersons make significantly different ethical judgments, and hold disparate views on which ethical aspects are the most relevant. Researchers were significantly more content than laypersons with the functioning of the committees, indicating that the ethical model used suited their preferences better. We argue that in order to secure a democratic and proper ethical evaluation, the expectations of a scientific discourse must be acknowledged, while giving room for different viewpoints. Further, to fulfil the purpose of the project evaluations and meet public concern, the functions of the different AEC member categories need to be clarified. We suggest that one way of achieving a more thorough, balanced and inclusive ethical evaluation is to allow for more than one model of ethical reasoning.