Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016: (Parte 2 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 2 of 3)

Como parte de la evaluación de la asignatura Bioética e Investigación de la Maestría en Bioética, se solicitó a los estudiantes de la VI Cohorte que realizarán un análisis comparativo de las Pautas CIOMS 2016 con documentos anteriores. En esta segunda parte, se presentan las pautas relacionadas con el consentimiento informado, la recolección, almacenamiento y uso de materiales biológicos y datos relacionados, así como la rendición pública de cuentas y la publicación de las investigaciones. Estas pautas son fundamentales para la realización de investigaciones científicas en seres humanos por eso el objetivo de estos trabajos es proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta CIOMS(AU)

As part of the evaluation of the Bioethics and Research subject of the Master in Bioethics, students of the VI Cohort were asked to make a comparative analysis of the CIOMS 2016 Guidelines with previous documents. In this second part, the guidelines related to informed consent, collection, storage and use of biological materials and related data, as well as public accountability and publication of research are presented. These guidelines are fundamental for carrying out scientific research on human beings, and for this reason the objective of this work is to provide researchers with a contribution in their training and a rapid adaptation to the new CIOMS proposal(AU)

Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks

RTI International, San Francisco, CA, USA

RTI International, Research Triangle Park, NC, USA

RTI International, Rockville, MD, USADepartment of Oncology, King Abdul Aziz Medical City for National Guard, Riyadh, Saudi Arabia

Ulm University –Faculty of Medicine, Ulm, Germany

University of ThePeople, Pasadena, CaliforniaDepartment of Anaesthesia, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, India

Department of Pharmacology, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, IndiaDiscipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia

Physiotherapy Department, College of Applied Medical Science, Taif University, Taif, Saudi Arabia

Charles Perkins Centre, Prevention Research Collaborati on, School of Public Health, The University of Sydney, Sydney, Australia

School of Public Health, The University of Sydney, Sydney, Australia

Practice and cogitation of ethical review of medical research involving human subjects / 中华医学科研管理杂志

Objective To enhance the recognition of the ethical principles and provide reference for the ethical review in medical research involving human subjects.Methods By summarizing the ethical review of the projects involving human subjects in past three years,analyzing common issues identified,and proposing the corresponding solutions.Results Conducting ethical review for research involving human subject according to ethical principles,is helpful for the protection of human subject,and also for the internationalization of medical research in China.Conclusions For the development of medical research in long term,the ethical review is necessary.All investigators need to improve their understandings and execute the ethical principles well in their research practice.

Discussion on Benefit-Sharing Rights of Human Subjects in Medical Research / 中国医学伦理学

Various forms of benefits may be obtained from biomedical research,including proven most effective prevention,diagnosis and treatment methods,progeny,derivative and compound produced by the human tissue of subjects,and the research data obtained with the forms of patents or trade secrets.Because the subjects participate in the research and thus take the risks,provide human tissues for the study and the genetic information or medical information attached to human tissue and so on,benefit-sharing rights of subjects can be defended from the two angles of retributivism and utilitarianism.Benefit-sharing rights of subjects can be realized through various ways such as autonomous negotiation,ethical review,statutory sharing,or judicial review.

The Function of Medical Ethics Professionals in Ethical Review of Clinical Trials Involving Human Subjects / 中国医学伦理学

The medical ethics professionals which have resourceful ethical knowledge ought to give full play to subjects superiority in the review of the clinical trials involving human subjects. Before ethical review, it is needed to learn the series of international and domestic laws, regulations, and documents, and communicate with peers timely. In the review, they should focus on the necessity and security of the research project, conduct a compre-hensive review combined with the principle of medical ethics, and master the review key point of informed consent, to fulfill their duty of protection of human rights of subjects.

Pesquisas envolvendo seres humanos: reflexões a partir da Antropologia Social / Research involving human beings: reflections from the Social Anthropology

Resumen Este artigo tem como objetivo discutir a complexificação do debate sobre ética na pesquisa no Brasil, principalmente a partir dos anos 1990. Para tanto, inicia fazendo uma breve contextualização sobre a bioética contemporânea e como seus códigos e princípios deram conteúdo e forma à metodologia do sistema CEP/CONEP. Na sequência, refletindo sobre a institucionalização nacional da regulamentação da ética em pesquisa, o artigo sugere que instrumentos, comitês e procedimentos de regulação não apenas avaliam eticamente pesquisas realizadas no Brasil, como configuram o sentido da "ética" a ser constituída e avaliada. Nesse sentido, o artigo recupera aspectos do debate desenvolvidos em publicações da área de antropologia social que colocam em evidência a necessidade de expandir os termos da configuração da "ética" e um trabalho para sua (re)politização.

AbstractThis article aims to discuss the complexity of the debate on ethics in research in Brazil, mainly from the 1990s. Therefore, it begins with a brief contextualization of contemporary bioethics and how its codes and principles gave shape and form to the CEP / CONEP system methodology. Then, reflecting on the national institutionalization of ethical regulation in research, the article suggests that instruments, committees and regulatory procedures not only ethically evaluate research conducted in Brazil, as they configure the meaning of "ethics" to be made and evaluated. In this sense, the article brings aspects of the debate developed in the Social Anthropology publications that stress the need to expand the terms of the setting of "ethics" and work for their (re)politicization.

The "mild-torture economy": exploring the world of professional research subjects and its ethical implications / "A tortura da economia moderada": explorando o mundo dos sujeitos de pesquisa profissionais e suas implicações éticas

AbstractThis paper documents the emergence of the subject of professional research in Phase I clinical trials that test the safety of drugs in development. Based on ethnographic research among subjects self-identified as "professional guinea pigs" in Philadelphia, USA, it examines their experiences and opinions on the conduct of trials and risks they take. The author argues that the risks posed by the continued participation, such as exposure to potentially dangerous drug interactions are minimized or ignored by research subjects because of the prospect of financial gain. Risks to the professional guinea pigs are also ignored by the pharmaceutical industry, which has become dependent on the usual participation of experienced research subjects. Arguing that financial incentives undermine the ethical imperative of informed consent to be given freely by volunteers, this research confirms the need to reform the policies governing the participation of paid subjects in Phase I clinical trials.

ResumoEste artigo documenta o surgimento do sujeito da pesquisa profissional na Fase I de ensaios clínicos que testam a segurança de medicamentos em desenvolvimento. Baseado em pesquisas etnográficas entre sujeitos autoidentificados "cobaias profissionais" na Filadélfia, EUA, o estudo examina suas experiências e opiniões sobre a condução dos ensaios e os riscos que assumem na participação. O autor argumenta que os riscos apresentados pela participação contínua, como a exposição às interações medicamentosas potencialmente perigosas, são minimizados ou ignorados pelos sujeitos de pesquisa devido à perspectiva de ganhos financeiros. Os riscos para as cobaias profissionais também são ignorados pela indústria farmacêutica, que se tornou dependente da participação habitual de sujeitos de pesquisa experientes. Argumentando que os incentivos financeiros comprometem o imperativo ético de consentimento informado a ser dado livremente pelos voluntários, esta pesquisa confirma a necessidade de reformar as políticas que regulam a participação de sujeitos pagos na Fase I de ensaios clínicos.

O código civil brasileiro na disciplinada pesquisa com seres humanos / Brazilian Civil Code in the area of research on human subjects

Este artigo tem por objetivo relacionar as normas éticas sobre pesquisas com seres humanos com o Código Civil brasileiro, lei que trata de diversos aspectos relacionados à proteção da pessoa humana. Em geral, os pesquisadores da área médica desconhecem a legislação civil, não se dando conta das consequências jurídicas dos erros causados pelas pesquisas realizadas. Apresenta-se, no início, um resumo da disciplina ética sobre pesquisas com seres humanos, com o Código de Nuremberg e a Declaração de Helsinque, além da disciplina infralegal no Brasil, realizada pelo Conselho Nacional de Saúde. Em seguida, com o intuito de demonstrar a inexistência de um vazio legislativo nessa matéria, analisaram-se os aspectos do Código Civil relativos às pesquisas com seres humanos, como a personalidade jurídica, a capacidade de agir, os direitos da personalidade e a responsabilidade civil.

This study seeks to relate the ethical norms for research on human subjects with Brazilian Civil Code, a law that considers many aspects of protection for individuals. In general, medical researchers are unaware of civil legislation and do not realize the legal consequences of any errors caused by their research. First, a summary of the ethical aspect of research on humansubjects is presented, along with the Nuremberg Code and the Declaration of Helsinki, as well as the non-statutory aspect of Brazilian law, which is performed by the Brazilian NationalHealth Council. Second, to demonstrate the inexistence of a lack of legislative consistency in this area, the study analyzes the aspects of Civil Code relative to research on human subjects,as well as legal status, the ability to act, rights to legal status, and civil liability.

Ethical standards of scientific research involving human subjects in Brazil: perspectives concerning psychology / Normas de regulamentação ética da pesquisa científica envolvendo seres humanos no Brasil: perspectivas da psicologia

Brazilian associations for research in human, social and applied social sciences have long sought ethical aspects regulation compatible with the epistemological, theoretical and methodological specificities of these sciences. Consequently, the Brazilian regulatory system (Research Ethics Committees/CEPs of the National Research Ethics Commission/CONEP) is currently undergoing an important review process. This article presents the positions taken by the National Association of Research and Postgraduate Studies in Psychology - ANPEPP. The article: (1) highlights the origins of the current ethics review model, based on biomedical research; (2) summarizes criticisms recurrent to this model; (3) identifies the directions required for the improvement of the system; and (4) lists the challenges to be overcome in the current process of creating specific regulations for the human and social sciences. The considerations presented highlight two crucial points that challenge the construction of a specific resolution for research ethics in the human and social sciences: (1) the clear characterization of what is meant by 'research in the human and social sciences' - and that would, therefore, have its ethical review regulated from the perspective of the specific resolution for the human and social sciences; and (2) the definition of parameters from which different risk levels in studies can be identified. (AU)

ResumoAssociações brasileiras de pesquisas em ciências humanas, sociais e sociais aplicadas há muito reivindicam uma regulamentação de aspectos éticos que atenda às especificidades epistemológicas, teóricas e metodológicas dessas ciências. Em consequência, o sistema brasileiro de regulamentação (Comitês de Ética em Pesquisa/CEP da Comissão Nacional de Ética em Pesquisa/CONEP) passa atualmente por importante processo de revisão. O presente artigo apresenta posições defendidas pela Associação Nacional de Pesquisa e Pós-Graduação em Psicologia - ANPEPP. Em síntese, o artigo: (1) situa origens do atual modelo de revisão ética, baseado na pesquisa biomédica; (2) sumaria críticas recorrentes a esse modelo, (3) aponta direções necessárias ao aprimoramento do sistema e (4) elenca desafios a serem superados no atual processo de criação de regulamentação específica para as ciências humanas e sociais. As considerações apresentadas ressaltam dois pontos cruciais que desafiam o trabalho de construção de resolução específica para ética em pesquisa nas ciências humanas e sociais: (1) a caracterização clara do que se entende por 'pesquisa em ciências humanas e sociais' - e que, portanto, passaria a ter sua revisão ética regulada pela ótica da resolução específica para ciências humanas e sociais; (2) a definição de parâmetros a partir dos quais se possa identificar diferentes níveis de risco em pesquisas. (AU)

Informed consent of human subjects: a review.

ABSTRACT: Informed consent is a vital part of the research process, and as such entails more than obtaining a signature on the consent form. Researchers or investigators must educate potential subjects to ensure that they can reach a truly informed decision about whether or not to participate in the research. Their consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Only then it can be regarded as ‘informed consent’. Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions.

Conflicts of interests and its effects on informed content, protection of human subjects in translational medicine / 中华医学科研管理杂志

Medicine,law and ethics are closely related to each other.Translational medicine is a research model to promote basic research into clinical application rapidly.Its ultimate goal is to promote development of new drug and method as quickly as possible,to improve the level of clinical diagnostics and treatment for health promotion.But some new challenges we have to face in line with accelerating medical research from lab to bedside.There are some potential risk and ethical issues.Among them,conflicts of interest and its affection on implementation of informed consent and protection of human subjects has not been given sufficient attention.The conflict of interest should be managed allows people to exercise their rights as autonomous agents to make their own informed decisions and deter investigators and institutions from having significant conflicts of interest.

Legal issues of human subjects protection and ethics review pertaining to vulnerable groups / 中华医院管理杂志

The ethics review for clinical trials pertaining to human body highly emphasizes human subjects protection.This study discussed how to balance the relationship between the rights,safety and health of the subjects and interests of the science and the community,how to review the damage compensation provisions and insurance provisions in the informed consent,how to scientifically define the human subject biomedical trials involving vulnerable groups,and how to conduct trials on vulnerable groups,as well as other sensitive issues in ethics review.

Justification of participation of human subjects in Phase 1 clinical trials: an ethical analysis.

Abstract: In the process of clinical trials, after ascertaining the safety of drugs or other therapeutic interventions in animals or in vivo, phase I clinical trials are conducted as initial step on healthy human volunteers (or patients with specific disease) to observe pharmacokinetics, safety and side effects associated with escalating doses of the drugs. Participation of human subjects having different biological system than animals is not without risks in these trials; this fact raises some important ethical issues. In the light of international research ethics guidelines, this paper analyses moral justification of use of humans as research subjects in phase I clinical trials, discusses what groups of participants should be involved, their economic status, questionable coercive effect of monetary remuneration on the subjects and soundness of informed consent obtained for the trials. These issues are also discussed in the perspective of four founding principles of bioethics i.e. autonomy, justice, beneficence and non-maleficence.

Suppressive effects on human flexion reflex induced by different pressure intensities and stimulation sites / 全日本鍼灸学会雑誌

Different intensities of pressure were applied to various tender or non-tender points and the suppressive effects on the flexion reflex were examined in 21 healthy humans (18-26 years), who gave informed consent. The sural nerve was stimulated transcutaneously with trains of 5 pulses at intervals of 13 sec (1.05-1.10x T, T : threshold) and evoked EMGs were recorded from the biceps femoralis muscle. Tender points in the contralateral forearm were detected by careful palpation, and conditioning pressure stimulation was applied at variousintensities by a push-pull gauge for 78 sec. Pressure applied to tender points induced slightly greater suppression of evoked EMGs than that to non-tender points (C statistics : time series analysis), although the difference was not significant (group comparison). Pressure intensities of ten and 50 % of pain tolerance pressure seemed to be adequate for suppression of EMGs in both tender and non-tender points. These results suggest that suppression of flexion reflex by pressure application in humans may be mediated by tactile and pain-related afferent fibers and the importance of adequate stimulus intensity for the induction of analgesic effects.

Effects of thermal stimulation on the flexion reflex in human subjects / 全日本鍼灸学会雑誌

Effect of thermal stimulation on the flexion reflex as a pain index was examined in healthy human subjects who gave informed consent (n=9, male, mean age 26 ± 8 years old). The evoked electromyogram (EMG) of biceps femoral muscle elicited by transcutaneous electrical stimulation of the sural nerve (5 trains of pulses at 100 Hz delivered at intervals of 13 sec) was successively recorded. The subjective pain sensation elicited by nerve stimulation was simultaneously recorded by the visual analogue scale (VAS) method. Significant correlation coefficients between the amplitudes of evoked EMGs and the stimulus intensity (r=0.791, P< 0.01), and the VAS value (r=0.724, P < 0.01) were observed. Conditioning hot water immersion of the hand (47 °C, 156s) tended to reduce the amplitudes of evoked EMGs, although change was not significant (P=0.678, Kruskal-Wallis test). However, C-statistics, a simple time series analysis method, demonstrated significant trends in several trials. These results suggest that the flexion reflex used in the present study is useful for pain research in human subjects and C-statistics are also useful for analyzing the effect on each individual.