Research Ethics Committees

The paper attempts to provide an updated and holistic description of the research ethics system in Latvia and discuses the problems in its structure and functioning. It is based on the data gathered in an empirical study of RECs in Central and Eastern Europe in 2008 and it is structured according to the integrated framework proposed by Hyder et al. First a short outline of the historical development of the ethics review system in the 1990s is given, then the issues of general social, political and economic background and the resultant enabling conditions, as well as the national and regional strategy of ethical review are reviewed. Next, the discussion turns to institutional commitment, the factors influencing the quality of review, and ethically relevant aspects of investigators’ behavior. The main conclusion is that current developmental conditions are not too favorable for research ethics review; despite the overall progress, several crucial enabling conditions are not in place yet.

The institutional review board (IRB) is one part of the research enterprise designated to protect human subjects. At times the IRB can feel like an oppressive oversight body bound by regulations and designed to inhibit research. However, in reality the IRB was an attempt by the federal government to streamline a variety of processes to ensure the protection of human subjects. Growing out of a history of unethical scientific research, the principle goal of the IRB is to protect human subjects. At some institutions the IRB has an additional role, to take a second look at proposed scientific methods to ensure the highest quality research. The legal basis, purpose, composition, and function of an IRB, and potential challenges in human-subjects research are reviewed here.

The global proliferation of medical research has imposed a huge responsibility on research ethics committees (RECs). While South Africa has a climate conducive to serious growth in research, it is also home to a large number of vulnerable groups of poor populations. The potential for misuse of power in research cannot be ignored. Stipulations within the National Health Act now make the ethical practice of research a statutory requirement in South Africa. Commitment to REC support by institutions will be reflective of their commitment to ethical research. However currently RECs are overworked and understaffed. Regrettably, protecting participants in research has not kept pace with the rapid increase of research in the country.

The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised.

This open access book seeks to identify the ethical spirit of European Union (EU) law, a context in which we can observe a trend towards increasing references to the terms ‘ethics’ and ‘morality’. This aspect is all the more important because EU law is now affecting more and more areas of national law, including such sensitive ones as the patentability of human life. Especially when unethical behaviour produces legal consequences, the frequent lack of clearly defined concepts remains a challenge, particularly against the background of the principle of legal certainty. This raises the question to which extent the content of these references is determined and whether it is possible to identify an ethical spirit of EU law. Answering that question, in turn, entails addressing the following questions: In references to ethics concerning EU law, can we identify references to a particular theory of practical philosophy at all; and, if so, to one or more normative ethical theories (deontology, consequentialism, or virtue ethics)? Further, should these non-legal concepts be imported in an unaltered way (“absolute approach”), or be adapted to the legal context (“relative approach”)? This book explores the different layers of EU law (primary law, agreements, secondary law, and tertiary law), including the role of ethics in EU lawmaking and in EU case law, as well as the implementation of relevant EU directives in selected Member States. In addition to the above-mentioned normative philosophical lens, the book also analyzes the findings from the legal lens of EU integration, i.e., especially EU values, human rights and the cornerstone of human dignity.

Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process.

“Vulnerability” is a key concept for research ethics and public health ethics. This term can be discussed from either a conceptual or a practical perspective. I previously proposed the metaphor of layers to understand how this concept functions from the conceptual perspective in human research. In this paper I will clarify how my analysis includes other definitions of vulnerability. Then, I will take the practical-ethical perspective, rejecting the usefulness of taxonomies to analyze vulnerabilities. My proposal specifies two steps and provides a procedural guide to help rank layers. I introduce the notion of cascade vulnerability and outline the dispositional nature of layers of vulnerability to underscore the importance of identifying their stimulus condition. In addition, I identify three kinds of obligations and some strategies to implement them.
This strategy outlines the normative force of harmful layers of vulnerability. It offers concrete guidance. It contributes substantial content to the practical sphere but it does not simplify or idealize research subjects, research context or public health challenges.

La presente investigación tiene como objeto de observación a los comités ético- científicos de la región metropolitana. Estas organizaciones surgen en torno al problema del riesgo de la investigación científica, con la responsabilidad de hacer una revisión ética de los proyectos de investigación que se llevarán a cabo en instituciones académicas o clínicas, en las cuales participen seres humanos.
Tanto las pautas internaciones como la legislación nacional proponen una serie de principios éticos y normativos para llevar orientar la práctica científica, los cuales deben ser incorporados por los comités durante el procedimiento deliberativo como sus premisas de decisión, no obstante, al contrario de lo que se podría pensar teniendo en cuenta la denominación de estos comités, la discusión no se limita solo a la comunicación moral, sino que entran en juego otros argumentos provenientes de la ciencia y el derecho.
Por último, un comité ético-científico, toma un riesgo para el entorno y los procesa haciendo posible la investigación científica, aquello se realiza posicionándose como un posible afectado, evaluando el equilibrio en posibles prejuicios y posibles beneficios. En este punto podemos apuntar que el concepto de riesgo mínimo es insuficiente para describir como se lleva a cabo la función del comité, proponiendo que aquello sea observado como riesgo tolerable, es decir, esta organización establece un umbral de tolerancia que le permite justificar algunos riesgos con respecto a alcanzar ciertos conocimientos que beneficien a un grupo vulnerable, de aquí que se vuelva relevante el como se lleva a cabo el proceso deliberativo dentro del comité y el modo en que se establecen los riesgos tolerables.

Palabras clave: organización – comités ético-científicos – riesgo tolerable – prejuicios/beneficios – riesgo de la investigación científica.

The federal government has established guidelines and regulations for the protection of vulnerable research subjects, especially children, pregnant women, cognitively impaired persons, and prisoners. In addition, students, residents, and employees are recognized as special research populations. Clinical investigators need to be aware of and use these federal guidelines appropriately. This article provides practical guidance for respiratory therapists who conduct research with these patient populations and solutions to the barriers investigators commonly encounter when studying these patient populations.

OPPOSITION TO WITHDRAWAL OF COUNSEL

Do Attorneys and Judges have to disclose if they have investments in Mortgage Banked Securities ( MBS ) and might have a conflict of interest defending their client?

A Homeowner questions this situation where Bankruptcy Attorneys are caught in a conflict of interest, don't know what to do, and decide to stop representing their client instead of disclosing the truth and fighting against fraud and corruption within the administration of Justice.

In this article, I discuss the fact that doing “anthropology at home” involves the same core anthropological methodology as undertaking research abroad. This implies that while doing anthropology at home may have some advantages concerning field practicalities but is equally challenging. There are certain ethical and methodological essentials involved in every anthropological research undertaking. Through my personal experiences of conducting ethnography in Pakistan, I explain that doing anthropology at home does not make exceptions for the researcher in terms of these ethical and methodological aspects.

There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of k = 0.286 (95% confidence interval 20.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as ‘‘slight’’. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.