Ethics in Mental Health Research with Haitian Migrants: Lessons from a Community-Based Study in Santiago, Chile.

Migration research poses several unique challenges and opportunities. Conducting ethical global health practice, especially when studying migrant mental health, is of particular concern. This article explores seven challenges and lessons learned in our mixed-methods study conducted to assess the impact of the migration experience on Haitian migrants' mental health in Santiago, Chile. The primary challenges were recruiting in a highly mobile population, building trust and community participation, overcoming language barriers, safety considerations during the Covid-19 pandemic, mitigating potential negative impacts of research on the community, providing psychological support, and finding meaningful ways to benefit the community. We propose moving toward a better and more ethical migrant research practice by ensuring language accessibility, hiring community members for the study team, working with local institutions and nongovernmental organizations, and maintaining sustainable connections.

Effects of intranasal oxytocin on pain perception among human subjects: A systematic literature review and meta-analysis.

INTRODUCTION: Oxytocin (OXT) is a peptide hormone produced in the hypothalamus that plays a neuromodulatory role in emotion, stress, and anxiety. Due to its multidimensional role, OXT is a promising target for therapeutic interventions to treat pain. OBJECTIVE: Perform a systematic literature review, followed by a meta-analysis to identify the effects of intranasal OXT on the self-perception of clinical and experimental pain among human subjects. METHOD: A systematic review was conducted in the PubMed, PsycINFO, Scielo, Lilacs, and Web of Science databases, using the keywords Oxytocin, Pain, Analgesia, and Nociception. RESULTS: Fifteen papers were included in the meta-analysis. None of the outcomes presented statistical significance in terms of the interventions' effect size: pain intensity (SMD = -0.02 (CI 95 %: -0.14 to 0.10; p = 0.76)) and pain unpleasantness (SMD = -0.15 (CI 95 %: -0.34 to 0.04; p = 0.12)). No meta-analysis was performed for pain threshold or tolerance because few papers address these outcomes. CONCLUSION: There was no statistically significant effect of intranasal OXT administration on pain perception, considering equivalence limits between (-0.2 and 0.2). However, it must be considered that the study designs may not have been sensitive enough to detect minor analgesic effects of OXT, which, being weak, may also not be perceived at a conscious level. Additionally, OXT effects possibly depend on specific characteristics of the painful condition, such as pain complexity, intensity, and duration, contextual variables like the presence of social and affective support, and individual characteristics.

Accreditation of research ethics committees in Paraguay: An ethical imperative.

In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.

Resumen: En la última década, el Paraguay ha presentado avances en el desarrollo de la investigación relacionada con la salud con seres humanos. Sin embargo, existe una obligación estatal de asegurar que las investigaciones sean realizadas éticamente: protegiendo la dignidad, los derechos y el bienestar de los participantes, la integridad científica y la adherencia a pautas éticas locales e internacionales. Los comités de ética de la investigación institucionales constituyen la instancia o recurso principal para garantizar la mencionada obligación. Ante lo expuesto y el contexto carente de adecuada regulación en el cual actualmente se desarrollan las investigaciones en el país, en el presente artículo defenderemos el imperativo ético de establecer un sistema de acreditación de los comités de ética de la investigación. Para ello, expondremos y justificaremos su necesidad y buscaremos responder algunas objeciones relativas al imperativo ético defendido, como, por ejemplo, el valor per se de la acreditación de los comités de ética en investigación en la protección de los participantes, la inversión de tiempo y burocracia que implican los procesos de acreditación y el marco regulatorio incipiente para las investigaciones en seres humanos en el Paraguay. Finalmente, propondremos el fortalecimiento de la gobernanza de la ética de la investigación en el país, como medio principal para establecer, implementar y supervisar un sistema de acreditación de los comités de ética de la investigación. Palabras clave: comité de ética en investigación; acreditación de los comités de ética de la investigación; investigación relacionada con la salud con seres humanos; protección de los sujetos de estudio en las investigaciones; pautas éticas internacionales; gobernanza de la ética de la investigación. Resum: A l'última dècada, el Paraguai ha presentat avenços en el desenvolupament de la recerca relacionada amb la salut amb éssers humans. Tot i això, hi ha una obligació estatal d'assegurar que les investigacions siguin realitzades èticament: protegint la dignitat, els drets i el benestar dels participants, la integritat científica i l'adherència a pautes ètiques locals i internacionals. Els comitès d'ètica de la investigació institucionals constitueixen la instància o el recurs principal per garantir l'obligació esmentada. Davant del que s'ha exposat i el context sense regulació adequada en el qual actualment es desenvolupen les investigacions al país, en aquest article defensarem l'imperatiu ètic d'establir un sistema d'acreditació dels comitès d'ètica de la investigació. Per això, exposarem i justificarem la seva necessitat i buscarem respondre algunes objeccions relatives a l'imperatiu ètic defensat, com, per exemple, el valor perseguit de l'acreditació dels comitès d'ètica en recerca en la protecció dels participants, la inversió de temps i burocràcia que impliquen els processos d'acreditació i el marc regulador incipient per a les investigacions en éssers humans al Paraguai. Finalment, proposarem l'enfortiment de la governança de l'ètica de la investigació al país com a mitjà principal per establir, implementar i supervisar un sistema d'acreditació dels comitès d'ètica de la investigació. Paraules clau: comitè d'ètica en investigació; acreditació dels comitès d'ètica de la investigació; investigació relacionada amb la salut amb éssers humans; protecció dels subjectes d'estudi a les investigacions; pautes ètiques internacionals; governança de l'ètica de la investigació.

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)

Compensation and reparations for victims and bystanders of the U.S. Public Health Service research studies in Tuskegee and Guatemala: Who do we owe what?

Using the infamous research studies in Tuskegee and Guatemala, the article examines the difference between victims and bystanders. The victims can include families, sexual partners, and children not just the participants. There are also the bystanders in the populations who are affected, even vaguely, decades after the initial studies took place. Differing reparations for victims and bystanders through lawsuits and historical acknowledgments has to be part of broader discussions of historical justice, and the weighing of the impact of racism and imperial research endeavors.

Reviving Human Research in Costa Rica.

Costa Rica is a small developing nation in Central America with a well-regarded universal health care system and a strong human rights tradition. In the latter part of the twentieth century, it became a popular site for clinical trials funded by multinational pharmaceutical companies. In light of concerns about ineffective oversight and alleged research abuses, the Constitutional Chamber of the Supreme Court passed a moratorium on all biomedical studies involving humans. This moratorium was in place between 2010 and 2014, when the Legislative Assembly passed a new national law to protect participants' rights and welfare. This case study reviews the history of human research protections in Costa Rica and provides recommendations for how Costa Rica can move forward responsibly as a leader in human research for the region.

Medical Research Participation as "Ethical Intercorporeality": Caring for Bio-Social Bodies in a Mexican Human Papillomavirus (HPV) Study.

While medical research ethics guidelines frame participants as individual and autonomous, anthropologists emphasize the relational nature of health research participation. I analyze interviews with Mexican male HPV study participants and their wives to examine how research participants themselves focus on relationships when imagining research-related benefits. I argue that couples incorporated the local trope of the Mexican citizenry as a biologically homogeneous national body, which individual members help or harm through their gendered health behavior to understand these benefits. I use the concept of "ethical intercorporeality" to discuss spouses' understandings of themselves as parts of bio-social wholes-the couple, family, and society-that they believed men's research participation could aid both physically and socially. This finding extends the insight that focusing on relationships rather than individuals is necessary for understanding the consequences of medical research by showing how participants themselves might apply this perspective in context-specific ways.

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.

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.

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)