Community-Engaged Research With Latino Dementia Caregivers: Overcoming Challenges in Community Advisory Board Development.

BACKGROUND AND OBJECTIVES: Latinos caring for a person with Alzheimer's disease and related dementias (ADRD) have the highest prevalence of caregiving. Yet, they are less likely to benefit from evidence-based interventions given their continued underrepresentation in ADRD-related research. Community advisory boards (CABs) have the potential to address barriers to research for underrepresented communities; however, there are complexities to establishing and sustaining CABs. This article describes how our work addressed challenges in CABs related to unbalanced power relations, language barriers, the value of time, and low research knowledge and health literacy. RESEARCH DESIGN AND METHODS: Nine Latino CAB members, including older Latino caregivers, were trained in a comprehensive program designed to increase knowledge about health research methods and ethics, cognitive health, and cultural adaptation methods. Members completed pre- and post-training measures of Alzheimer's disease knowledge, attitudes, and beliefs toward research, and a satisfaction survey. RESULTS: Results from the satisfaction questionnaire indicated that the program was well received. CAB members increased their knowledge regarding the management of behavioral and psychological symptoms of dementia and dementia-associated risk factors and treatment. Positive changes in members' attitudes toward research included increased willingness to participate in trials and subject protection measures. DISCUSSION AND IMPLICATIONS: Formalized training in research conduct and ethics and health literacy is a promising strategy to reduce challenges in establishing and maintaining CABs and can also optimize CAB impact to address gaps in older Latino ADRD caregiving research.

Ethical Imperatives for Working With Diverse Populations in Digital Research.

Digital research methodologies are driving a revolution in health technology but do not yet fully engage diverse and historically underrepresented populations. In this paper, we explore the ethical imperative for such engagement alongside accompanying challenges related to recruitment, appreciation of risk, and confidentiality, among others. We critically analyze existing research ethics frameworks and find that their reliance on individualistic and autonomy-focused models of research ethics does not offer adequate protection in the context of the diversity imperative. To meet the requirements of justice and inclusivity in digital research, methods will benefit from a reorientation toward more participatory practices.

Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group.

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

For health or for profit? Understanding how private financing and for-profit delivery operate within Canadian healthcare (4H|4P): protocol for a multimethod knowledge mobilisation research project.

INTRODUCTION: Privatisation through the expansion of private payment and investor-owned corporate healthcare delivery in Canada raises potential conflicts with equity principles on which Medicare (Canadian public health insurance) is founded. Some cases of privatisation are widely recognised, while others are evolving and more hidden, and their extent differs across provinces and territories likely due in part to variability in policies governing private payment (out-of-pocket payments and private insurance) and delivery. METHODS AND ANALYSIS: This pan-Canadian knowledge mobilisation project will collect, classify, analyse and interpret data about investor-owned privatisation of healthcare financing and delivery systems in Canada. Learnings from the project will be used to develop, test and refine a new conceptual framework that will describe public-private interfaces operating within Canada's healthcare system. In Phase I, we will conduct an environmental scan to: (1) document core policies that underpin public-private interfaces; and (2) describe new or emerging forms of investor-owned privatisation ('cases'). We will analyse data from the scan and use inductive content analysis with a pragmatic approach. In Phase II, we will convene a virtual policy workshop with subject matter experts to refine the findings from the environmental scan and, using an adapted James Lind Alliance Delphi process, prioritise health system sectors and/or services in need of in-depth research on the impacts of private financing and investor-owned delivery. ETHICS AND DISSEMINATION: We have obtained approval from the research ethics boards at Simon Fraser University, University of British Columbia and University of Victoria through Research Ethics British Columbia (H23-00612). Participants will provide written informed consent. In addition to traditional academic publications, study results will be summarised in a policy report and a series of targeted policy briefs distributed to workshop participants and decision/policymaking organisations across Canada. The prioritised list of cases will form the basis for future research projects that will investigate the impacts of investor-owned privatisation.

Making research ethics work for global health: towards a more agile and collaborative approach.

In this reflective essay, we seek to engage in a constructive dialogue with scholars across medicine, public health and anthropology on research ethics practices. Drawing on anthropological research and ethical dilemmas that our colleagues and we encountered as medical anthropologists, we reflect on presumed and institutionalised 'best' practices such as mandatory written informed consent, and problematise how they are implemented in interdisciplinary global health research projects. We demonstrate that mandatory, individualised, written, informed consent may be unsuitable in many contexts and also identify reasons why tensions between professionals in interdisciplinary teams may arise when decisions about ethics procedures are taken. We propose alternatives to written informed consent that acknowledge research governance requirements and contextual realities and leave more room for ethnographic approaches. Beyond informed consent, we also explore the situatedness of ethical practices when working in contexts where decision-making around health is clearly a shared concern. We use vignettes based on our own and colleagues' experiences to illustrate our arguments, using the collective 'we' instead of 'I' in our vignettes to protect our research participants, partners and interlocutors. We propose a decolonial, plural and vernacular approach to informed consent specifically, and research ethics more broadly. We contend that ethics procedures and frameworks need to become more agile, decolonial, pluralised and vernacularised to enable achieving congruence between communities' ideas of social justice and institutional ethics. We argue that global health research can benefit from anthropology's engagement with situated ethics and consent that is relational, negotiated and processual; and accountability that is not only bureaucratic but also constructive. In doing so, we hope to broaden ethical praxis so that the best outcomes that are also just, fair and equitable can be achieved for all stakeholders.

Eastern Mediterranean Health Journal [2023; Vol.29, Issue 7]

Eastern Mediterranean Health Journal is the official health journal published by the Eastern Mediterranean Regional Office of the World Health Organization. It is a forum for the presentation and promotion of new policies and initiatives in health services; and for the exchange of ideas concepts epidemiological data research findings and other information with special reference to the Eastern Mediterranean Region. It addresses all members of the health profession medical and other health educational institutes interested NGOs WHO Collaborating Centres and individuals within and outside the Region

المجلة الصحية لشرق المتوسط هى المجلة الرسمية التى تصدرعن المكتب الاقليمى لشرق المتوسط بمنظمة الصحة العالمية. وهى منبر لتقديم السياسات والمبادرات الجديدة فى الصحة العامة والخدمات الصحية والترويج لها، و لتبادل الاراء و المفاهيم والمعطيات الوبائية ونتائج الابحاث وغير ذلك من المعلومات، و خاصة ما يتعلق منها باقليم شرق المتوسط. وهى موجهة الى كل اعضاء المهن الصحية، والكليات الطبية وسائر المعاهد التعليمية، و كذا المنظمات غير الحكومية المعنية، والمراكز المتعاونة مع منظمة الصحة العالمية والافراد المهتمين بالصحة فى الاقليم و خارجه

La Revue de Santé de la Méditerranée Orientale est une revue de santé officielle publiée par le Bureau régional de l’Organisation mondiale de la Santé pour la Méditerranée orientale. Elle offre une tribune pour la présentation et la promotion de nouvelles politiques et initiatives dans le domaine de la santé publique et des services de santé ainsi qu’à l’échange d’idées de concepts de données épidémiologiques de résultats de recherches et d’autres informations se rapportant plus particulièrement à la Région de la Méditerranée orientale. Elle s’adresse à tous les professionnels de la santé aux membres des instituts médicaux et autres instituts de formation médico-sanitaire aux ONG Centres collaborateurs de l’OMS et personnes concernés au sein et hors de la Région

Documentary Assessment of the Abilities of Kyrgyzstan's Research Ethics Committees During Public Health Emergency and Non-Emergency Situations.

Institutional Research Ethics Committees (RECs) play crucial roles in the impartial and competent review of scientific research, particularly during public health emergencies. In this report, we examined their ability and capacity to provide this basic service during public health emergencies and non-emergency situations. Our qualitative documentary analysis revealed that there are currently no legal regulations guiding the activities of Kyrgyz RECs during public health emergencies. In addition, major policy gaps exist in how RECs should operate in non-emergency circumstances. This lack of guidance highlights the urgent need to develop and implement ethical guidelines to meet the evolving needs of such emergencies. Our findings underscore the growing urgency of supporting capacity building of RECs to respond effectively to future pandemics and other public health crises.

Murru Minya-informing the development of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research: a protocol for a national mixed-methods study.

INTRODUCTION: Conducting ethical and high-quality health research is crucial for informing public health policy and service delivery to reduce the high and inequitable burden of disease experienced by Aboriginal and Torres Strait Islander people. Ethical guidelines and principles specifically for health research with Aboriginal and Torres Strait Islander people have been developed for use since 1987. However, there has been limited examination of how these are being applied to the conduct of research. METHODS AND ANALYSIS: Murru Minya will be a large-scale national study to examine the implementation of ethical processes in Aboriginal and Torres Strait Islander health research. A mixed-methods design will be used in four baarra (steps). The first three baarra will collect knowledge, experiences and wisdom from three key groups: Aboriginal and Torres Strait Islander communities, research academics, and Human Research Ethics Committees using online surveys, yarning, and semistructured interviews. This knowledge will inform the final baarra of developing a set of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research into the future. ETHICS AND DISSEMINATION: Ethical approval for this research project has been granted by National, State and Territory Human Research Ethics Committees. This research has been developed in collaboration with Aboriginal and Torres Strait Islander researchers, Aboriginal Community Controlled Health Organisation representatives, Aboriginal community members, the National Health Leadership Forum, and Aboriginal and Torres Strait Islander research team. The knowledge translation plan will be integrated and revised throughout the project as partnerships and engagement with Aboriginal and Torres Strait Islander communities continue. All findings will be shared with peak Aboriginal research bodies and Aboriginal and Torres Strait Islander communities in ways that are meaningful to them.

["This is Not at All Foreseeable from the Outset" - Research Ethics in Qualitative Health Services Research: A Survey of Researchers]. / "Das ist vorher gar nicht absehbar"? ­ Forschungsethische Fragen in der qualitativen Versorgungsforschung. Eine Befragungsstudie mit Forschenden.

BACKGROUND: Health services research is multidisciplinary and involves the use of a plurality of research methods. Medicine as a discipline serves as an important reference, also in terms of addressing ethics issues in research. At the same time, however, the highly formalized ethical reviews common in medicine, are controversial within the social sciences, especially among qualitative researchers. So far, little is known about which research ethics issues arise in qualitative health services research. METHODS: In summer 2019, an online survey was conducted among health services researchers on two main topics: a) research ethics issues in qualitative health services research and b) experiences with the ethics review procedures. The questionnaire contained ten open questions; the responses were analyzed for content. The first topic (ethical issues) is addressed within this article. RESULTS: A total of 73 researchers with heterogeneous professional background and an average of more than seven years of work experience in health services research participated in the survey. The following were reported as central research ethics issues: a) legitimacy and anticipation of ethical challenges in the planning of research, b) field access, consent and burdens during data collection, c) anonymization and data protection in data processing, d) data analysis, e) publication of results and data and f) general topics such as central principles and goals of research as well as the role of researchers. The main formats for dealing with these issues were exchange and consultation as well as referring to texts and regulations. CONCLUSIONS: On the one hand, the data documents typical central research ethics questions that researchers are confronted with in the context of qualitative health services research; on the other hand, they also point to gaps and less considered topics. A systematizing ethical reflection could take up these findings in order to develop health services research-specific principles and strategies for handling research ethics issues.

Health data privacy through homomorphic encryption and distributed ledger computing: an ethical-legal qualitative expert assessment study.

BACKGROUND: Increasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland's geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations. METHODS: To conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform. RESULTS: For our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation. CONCLUSION: Our findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies.

The Development of a Literacy-Based Research Integrity Assessment Framework for Graduate Students in Taiwan.

Graduate education is a critical period in shaping and fostering graduate students' awareness about the importance of responsible conduct of research and knowledge and skills in doing good science. However, there is a lack of a standard curriculum and assessment framework for graduate students in Taiwan. The aim of this study was to develop a literacy-based research integrity (RI) assessment framework, including five core RI areas: (1) basic concepts in RI, (2) RI considerations in the research procedure, (3) research ethics and research subject protection, (4) publication and authorship, and (5) conflict of interest. The five areas were derived through a comprehensive review of major topics and areas covered in existing research integrity education and training programs and were rated by RI experts with adequate content validity. Test items on the five core areas were developed across three literacy levels: remembering and understanding, applying and analyzing, and evaluating and creating. Seven thousand and eighty-seven graduate-level trainees took an 18-unit RI course covering the five RI areas. Upon finishing the course, trainees completed a computer-based RI assessment randomly selected from 26 RI testing booklets. The design of test items followed the mastery-oriented assessment principles to promote trainees' learning of RI with adaptive assessment feedback. Results showed that the items in the RI assessment had adequate discrimination and low difficulty level. Thus, the RI assessment can be used to assess a range of trainees' RI literacy and can provide the most information in identifying trainees in need of more instruction or alternative training. The low guessing parameters also indicated the online RI assessment had an appropriate control of test exposure and cheating prevention. Higher education authorities can use this framework to assess graduate students' RI literacy based on a standard curriculum and prepare them for conversations about the responsible conduct of research for RI culture-building.

"We're already doing this work": ethical research with community-based organizations.

BACKGROUND: Public health research frequently relies on collaborations with community-based organizations, and these partnerships can be essential to the success of a project. However, while public health ethics and oversight policies have historically focused on ensuring that individual subjects are protected from unethical or unfair practices, there are few guidelines to protect the organizations which facilitate relationships with - and are frequently composed of - these same vulnerable populations. As universities, governments, and donors place a renewed emphasis on the need for community engaged research to address systematic drivers of health inequity, it is vital that the ways in which research is conducted does not uphold the same intersecting systems of gender, race, and class oppression which led to the very same health inequities of interest. METHODS: To understand how traditional notions of public health research ethics might be expanded to encompass partnerships with organizations as well as individuals, we conducted qualitative interviews with 39 staff members (executive directors and frontline) at community-based organizations that primarily serve people who use drugs, Black men who have sex with men, and sex workers across the United States from January 2016 - August 2017. We also conducted 11 in-depth interviews with professional academic researchers with experience partnering with CBOs that serve similar populations. Transcripts were analyzed thematically using emergent codes and a priori codes derived from the Belmont Report. RESULTS: The concepts of respect, beneficence, and justice are a starting point for collaboration with CBOs, but participants deepened them beyond traditional regulatory concepts to consider the ethics of relationships, care, and solidarity. These concepts could and should apply to the treatment of organizations that participate in research just as they apply to individual human subjects, although their implementation will differ when applied to CBOs vs individual human subjects. CONCLUSIONS: Academic-CBO partnerships are likely to be more successful for both academics and CBOs if academic researchers work to center individual-level relationship building that is mutually respectful and grounded in cultural humility. More support from academic institutions and ethical oversight entities can enable more ethically grounded relationships between academic researchers, academic institutions, and community based organizations.

Philosophical Foundations of Human Research Ethics.

In his book For the Common Good: Philosophical Foundations of Research Ethics (2022), Alex John London argues that the current framework for human research ethics and oversight is an assortment of rules, procedures, and guidelines built upon mistaken assumptions, policies, and practices that create spurious dilemmas and serious moral failings. He claims that his theory can fix these problems by placing human participant research on a solid philosophical foundation. London argues that human participant research is a social activity guided by principles of justice, in which free and equal individuals work together to promote the common good. This review essay analyzes London's approach to the foundations of human research ethics. Although London's theory of human research ethics is excessively idealistic, his book succeeds in showing why it is necessary to expand the scope of human research ethics beyond its current confines to adequately deal with questions of intranational and international justice.

Training needs of health researchers in research ethics in Cameroon: a cross-sectional study.

BACKGROUND: Researchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon. METHODS: It was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants' exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants. RESULTS: Of 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants' protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31-7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant's protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles. CONCLUSION: The coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Acesso a medicamentos para doenças raras no pós-estudo: revisão integrativa / Post-trial access to drugs for rare diseases: an integrative review / Acceso a medicamentos para enfermedades raras en el posestudio: una revisión integradora

Resumo A fim de analisar a produção científica acerca do acesso a medicamentos no pós-estudo por participantes de ensaios clínicos com doenças raras, realizou-se revisão integrativa da literatura nas bases Biblioteca Virtual em Saúde, Embase, PubMed, SciELO, Scopus e Web of Science, abrangendo 21 estudos. No processo analítico, surgiram duas categorias: pesquisa clínica com drogas órfãs e regulação do mercado; e acesso a drogas órfãs: história, globalização e direito à saúde. A primeira analisa questões relativas à quantidade de pacientes com doenças raras, à eficácia e à segurança dessas pesquisas e aos custos e preços dos medicamentos. A segunda trata do panorama histórico do acesso pós-estudo, da globalização dos ensaios clínicos e das dificuldades para efetivar o direito ao acesso a drogas órfãs no pós-estudo. Poucos artigos abordaram o acesso ao medicamento no pós-estudo por participantes com doenças raras como questão central, o que aponta a importância de mais estudos sobre esse tema.

Abstract This study is an integrative literature review to analyze the scientific production about post-trial drug access by participants of clinical trials for rare diseases. The search was carried out in the Virtual Health Library, Embase, PubMed, SciELO, Scopus and Web of Science databases, covering 21 studies. Two categories emerged from the analysis: clinical research with orphan drugs and market regulation; and access to orphan drugs: background, globalization and the right to health. The first analyzes issues related to the number of patients with rare diseases, the efficacy and safety of these studies and the cost and price of medications. The second addresses the historical background of post-trial access, the globalization of clinical trials and the difficulties to ensure the right to post-trial access to orphan drugs. Few articles addressed post-trial drug access by participants with rare diseases as a central issue, which points to the importance of further studies on this subject.

Resumen Se pretende analizar la producción científica sobre el acceso a medicamentos para enfermedades raras en el posestudio a partir de una revisión integradora en las bases de datos Biblioteca Virtual en Salud, Embase, PubMed, SciELO, Scopus y Web of Science, que encontraron 21 estudios. Surgieron dos categorías en el análisis: investigación clínica con medicamentos huérfanos y regulación del mercado; y acceso a medicamentos huérfanos: historia, globalización y derecho a la salud. La primera examina el número de pacientes con enfermedades raras, la eficacia y seguridad de los estudios, así como los costes y precios de los medicamentos. La segunda aborda el panorama histórico del acceso posestudio, la globalización de los ensayos clínicos y las dificultades para materializar el derecho al acceso a medicamentos huérfanos en el posestudio. Pocos estudios plantean el acceso a estos medicamentos en el posestudio, y son necesarios más estudios sobre el tema.

Research bystanders, justice, and the state: Reframing the debate on third-party protections in health research.

Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these "research bystanders." The standard rationale for extending protections to research bystanders contends that they are sufficiently like research participants that the ethical principles governing health research ought to extend to them. In this article we argue that this analogical reasoning is mistaken. Salient moral differences mean that research ethics frameworks are not fit for purpose. We defend the research bystander category by articulating a novel foundation for this new class of stakeholder. Focusing on bystanders directly impacted by publicly funded health research, we argue that bystanders are sometimes owed protections-but neither because of their similarity to research participants nor because research ethics principles should extend to them. Instead, we reframe the issue as a question of justice. Building on the work of Douglas MacKay, we argue that bystanders to publicly funded health research are owed protections as citizens of liberal states to whom the state owes duties of justice. The state has duties to protect the interests of citizens and to conduct health research. When the means by which the state fulfils the latter duty comes into conflict with the means by which it fulfils the former, the state must ensure that those impacted, including research bystanders, are afforded protections.

Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators.

To strengthen research ethics systemically, the Pan American Health Organization (PAHO) devised a strategy that includes objectives and indicators to address core components of research ethics systems. We assessed 22 countries in Latin America and the Caribbean using these indicators. Most countries have adopted legal instruments to govern research with human participants and have implemented national bodies tasked with the oversight of research ethics committees. However, performance with regard to ethics training policies and clinical trial registration was less advanced, and efforts to adopt policies on responsible conduct of research and accelerated ethics review of emergency research did not meet the PAHO objectives in most countries. We discuss the pending challenges and provide recommendations aimed at helping countries from Latin America and the Caribbean to achieve the indicators, and, more generally, to strengthen research ethics with a systemic approach.

Regulamentação ética da pesquisa no Brasil: papel do controle social / Ethical regulation of research in Brazil: the role of social control / Regulación ética de la investigación en Brasil: el rol de control social

Resumo Este trabalho apresenta fatos históricos que resultaram na primeira normalização de pesquisa em saúde no Brasil e busca salientar a importância da participação social no seu controle. Ao percorrer os marcos regulamentadores do país, é evidente que as movimentações sociais foram responsáveis por mudanças no sistema formado pelos comitês de ética em pesquisa e pela Comissão Nacional de Ética em Pesquisa. Entretanto, existem entraves no que concerne aos padrões de análise nos diversos comitês, às dificuldades de acompanhamento dos projetos em andamento e ao cadastro na Plataforma Brasil. Porém, o sistema brasileiro é referencial para outros países quanto a respeito e proteção de participantes de pesquisa e à inserção da sociedade no âmbito dos comitês.

Abstract This work presents historical facts that resulted in the first health research normalization in Brazil and seeks to highlight the importance of social participation in its control. Going through the Regulatory marks of the countries, the social movements were evidently responsible for changes in the system formed by the research ethics committees and by the National Committee of Research Ethics. However, there are hindrances regarding the standards of analysis in the diverse committees, the difficulties of following the projects in course, and the register on the Plataforma Brasil. The Brazilian system is, nonetheless, a referential for other countries regarding respect and protection of research participants and the insertion of society in the committees.

Resumen Este trabajo presenta los hechos históricos que resultaron en la primera regulación de la investigación en salud en Brasil y busca señalar la importancia de la participación social en su control. Los marcos de regulación en el país ponen en evidencia que los movimientos sociales fueron los responsables de los cambios en el sistema conformado por los comités de ética en investigación y la Comisión Nacional de Ética en Investigación. Sin embargo, existen obstáculos con respecto a los estándares de análisis en los diversos comités, a las dificultades de seguimiento de los proyectos en curso y al registro en la Plataforma Brasil. A pesar de esto, el sistema brasileño es una referencia para otros países con relación al respeto y protección de los participantes en investigación y la inclusión de la sociedad en el ámbito de los comités.