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Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity.

Abstract Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with their organoids, setting higher bars for informed consent and patient participation. Also, several organoid sub-types, e.g., brain organoids and human–animal chimeric organoids, have raised controversy. This systematic review provides an overview of ethical discussions as conducted in the scientific literature on organoids. The review covers both research and clinical applications of organoid technology and discusses the topics informed consent, commercialization, personalized medicine, transplantation, brain organoids, chimeras, and gastruloids. It shows that further ethical research is needed especially on organoid transplantation, to help ensure the responsible development and clinical implementation of this technology in this field.

Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with their organoids, setting higher bars for informed consent and patient participation. Also, several organoid sub-types, e.g., brain organoids and human–animal chimeric organoids, have raised controversy. This systematic review provides an overview of ethical discussions as conducted in the scientific literature on organoids. The review covers both research and clinical applications of organoid technology and discusses the topics informed consent, commercialization, personalized medicine, transplantation, brain organoids, chimeras, and gastruloids. It shows that further ethical research is needed especially on organoid transplantation, to help ensure the responsible development and clinical implementation of this technology in this field. [ABSTRACT FROM AUTHOR]

In 2015, President Obama announced plans for the Precision Medicine Initiative R (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of UsSM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program--to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare--might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participantswho become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies--developed under a protectionist paradigm in response to scandalous research practices with confined populations--dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities and increase levels of distrust in science. [ABSTRACT FROM AUTHOR]

Background: The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.Methods: We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability.Results: Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis.Conclusions: Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort. [ABSTRACT FROM AUTHOR]

The article argues for the need to revisit the concept of vulnerability in the context of psychiatric research as a reconsideration of the vulnerability of psychiatric participants is an important step to break down stereotypes in research ethics. Revisiting pivotal concept of vulnerability and supporting concrete changes in the governance of research ethics is said to be an essential component of a new approach with a potential to affect participation of psychiatric participants in research.

This article focuses on the ethics/research review practices of a university Research Ethics Board (REB) and a school board Research Review Committee (RRC). Applications to conduct school-based research submitted to the REB and RRC and in-depth, open-ended interviews with REB and RRC members serve as data for the study. In this paper, we highlight the institutional board decisions, especially requests for clarification documented in the applications, giving specific attention to applications proposing qualitative/teacher research. Empirical research focused on the inside workings of REBs and RRCs, which would provide particular kinds of knowledge related to research/ethics review, is recommended. URN: urn:nbn:de:0114-fqs0902326

This article focuses on the ethics/research review practices of a university Research Ethics Board (REB) and a school board Research Review Committee (RRC). Applications to conduct school-based research submitted to the REB and RRC and in-depth, open-ended interviews with REB and RRC members serve as data for the study. In this paper, we highlight the institutional board decisions, especially requests for clarification documented in the applications, giving specific attention to applications proposing qualitative/teacher research. Empirical research focused on the inside workings of REBs and RRCs, which would provide particular kinds of knowledge related to research/ethics review, is recommended. [ABSTRACT FROM AUTHOR]

This article examines whether and how a particular research practice is overseen and supervised, and by whom. This investigation fills notable gaps in the literature on science, including a lack of emphasis on larger sociopolitical structures, a neglect of regulation, and indifference toward ethics. The author focuses on the oversight of a particular research practice; data editing; which embodies qualities that are intriguing to sociologists of science: invisibility, uncertainty, heterogeneity, and reliance on tacit knowledge. These characteristics pose unique challenges to oversight efforts. An analysis of in-depth interviews with gatekeepers reveals that although the methodological and ethical implications of data editing strategies can be substantial, oversight of such practices falls outside the stages and domains of current gatekeeping activity. These findings serve as the basis for recommendations to ensure data integrity while maintaining the professional autonomy of researchers. [ABSTRACT FROM AUTHOR]