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Human/animal relations are potentially controversial and biotechnologically produced animals and animal-like creatures – bio-objects such as transgenics, clones, cybrids and other hybrids – have often created lively political debate since they challenge established social and moral norms. Ethical issues regarding the human/animal relations in biotechnological developments have at times been widely debated in many European countries and beyond. However, the general trend is a move away from parliamentary and public debate towards institutionalized ethics and technified expert panels. We explore by using the conceptual lens of bio-objectification what effects such a move can be said to have.In the bio-objectification process, unstable bio-object becomes stabilized and receives a single "bio-identity" by closing the debate. However, we argue that there are other possible routes bio-objectification processes can take, routes that allow for more open-ended cases. By comparing our observations and analyses of deliberations in three different European countries we will explore how the bio-objectification process works in the context of animal ethics committees. From this comparison we found an interesting common feature: When animal biotechnology is discussed in the ethics committees, technical and pragmatic matters are often foregrounded. We noticed that there is a common silence around ethics and a striking consensus culture. The present paper, seeks to understand how the bio-objectification process works so as to silence complexity through consensus as well as to discuss how the ethical issues involved in animal biotechnology could become re-politicized, and thereby made more pluralistic, through an "ethos of controversies".

In this paper Iain raises important issues about how the process of applying for ethical permission should be viewed as more than a bureaucratic exercise. Hospital chaplains can take advantage of their personal experience and expertise to engage fully with the process and to help develop thinking around ethical issues. Whilst every author in this edition has probably had some kind of irritation around applying for and receiving NHS ethical approval for research, the reality is that doing research ethically and ethical research remains a challenge, one which healthcare chaplains are well placed to meet. The research ethics committee should be seen as a resource with which to engage and a help in refining the proposal.

Human/animal relations are potentially controversial and biotechnologically produced animals and animal-like creatures – bio-objects such as transgenics, clones, cybrids and other hybrids – have often created lively political debate since they challenge established social and moral norms. Ethical issues regarding the human/animal relations in biotechnological developments have at times been widely debated in many European countries and beyond. However, the general trend is a move away from parliamentary and public debate towards institutionalized ethics and technified expert panels. We explore by using the conceptual lens of bio-objectification what effects such a move can be said to have. In the bio-objectification process, unstable bio-object becomes stabilized and receives a single "bio-identity" by closing the debate. However, we argue that there are other possible routes bio-objectification processes can take, routes that allow for more open-ended cases. By comparing our observations and analyses of deliberations in three different European countries we will explore how the bio-objectification process works in the context of animal ethics committees. From this comparison we found an interesting common feature: When animal biotechnology is discussed in the ethics committees, technical and pragmatic matters are often foregrounded. We noticed that there is a common silence around ethics and a striking consensus culture. The present paper, seeks to understand how the bio-objectification process works so as to silence complexity through consensus as well as to discuss how the ethical issues involved in animal biotechnology could become re-politicized, and thereby made more pluralistic, through an "ethos of controversies".

Prevailing state and institutional ideologies regarding race/ethnicity, gender, and sexuality help to shape, and are influenced by, research priorities. Research ethics committees perform a gatekeeper role in this process. In this commentary, we describe efforts to obtain approval from the ethics committee of a large medical institution for research into the treatment of homosexual persons by health professionals in the South African military during the apartheid era. The committee questioned the "scientific validity" of the study, viewing it as having a "political" rather than a "scientific" purpose. They objected to the framing of the research topic within a human rights discourse and appeared to be concerned that the research might lead to action against health professionals who committed human rights abuses against lesbians and gay men during apartheid. The process illustrates the ways in which heterosexism, and concerns to protect the practice of health professionals from scrutiny, may influence the decisions of ethics committees. Ethics that exclude research on lesbian and gay health cannot be in the public interest. Ethics committees must be challenged to examine the ways in which institutionalized ideologies influence their decision making.

Background: In 2017, a North-South partnership was created, to strengthen Bioethics Committees in African Lusophone African countries (LAC), by joining the forces of National and Institutional Research Ethics Committees (REC) and Universities in Angola, Cape Verde, Mozambique and Portugal. This study is part of an EDCTP2-funded project and aims to describe key RECs operating in LAC, its establishment dates and further characteristics. Methods: Document analysis and interviews with REC representatives of five LAC were conducted in April 2018. Legal documents were obtained through official national sources. Results: We identified four National Ethics Committees, created between 2000 and 2008 by ministerial or governmental decree; only S. Tomé e Principe does not have an established REC. In Angola, the National REC was created in 2000, and since 2007, seven Institutional Committees were implemented at faculty level. National REC in Cape Verde and Guinee-Bissau (CNES) are unique and were founded in 2007 and 2009 respectively. In Mozambique, National REC (CNBS) dates to 2002, and since 2011, 8 Institutional Committees were formed; they functioned as a network under the umbrella of CNBS. Most National REC have representatives from health professional associations, lawyers, civil society and religious communities and have regular meetings (usually monthly). The number of members ranges between 6 (CNES) and 13 (CNBS). In 2007, around 200 protocols were reviewed by CNBS and 29 by CNES. Most of the National REC members attended training activities in bioethics but at different levels. Conclusion: Few publications described REC operating in LAC; this study fills this gap by reporting historical and functional characteristics of RECs in five Lusophone African countries. Additional tools based on quantitative and qualitative approaches are being developed to assess more in-depth REC operational characteristics and to identify their needs in order to target training and capacity building initiatives underlying our project. ; publishersversion ; published

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization–Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

The recent Ebola and Zika virus epidemics in some parts of Africa and Asia have showcased the porosity in disaster preparedness and response, not only in the affected countries, but on a global scale. For the Ebola epidemic, scientifically robust research was started late during the course of the epidemic, with waste of resources and lost research opportunities. Research Ethics Committees have a significant role to play with regards to epidemic response for the future. This paper presents key challenges and opportunities for ethics review during emergencies, specifically for low and middle income countries. There is no better moment to test the efficacy and safety of drugs or vaccines for infected, or at risk populations than during the disaster itself. The main mantras that form the back bone of research ethics review (Helsinki Declaration, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, WHO and the ICH guidelines for Good Clinical Practice) are increasingly showing their limitations. Most protocols are generally from developed countries where the funding originates. Not only is the direct transposition to Low and Middle Income Country (LMIC) settings inappropriate on its own, also, using such guidelines in times of public health disasters might be time consuming, and might also lead to wastage of research opportunities, especially when sociocultural peculiarities, and anthropological research arms are completely excluded or avoided within the care and research packages. Governments should include RECs as key members during the elaboration, and daily functioning of their national public emergency response packages. Developing simple research ethics review guidelines, involvement of health care staff in ethics training, community mobilization, and incorporation of anthropological research during the medical response, research and communication phases, are imperatives in epidemic response.

In response to increased research being performed in developing countries, many research ethics committees (RECs) have been established, but the quality of their ethics review systems remains unknown. Evaluating the performance of an REC remains a challenging task. Absent an accreditation process, a self-assessment mechanism would provide RECs a way to review their policies and processes against recognized international standards. We describe a self-assessment tool that was developed and reviewed by REC members and researchers from the Middle East. This tool reflects pragmatic aspects of human subjects protection, is based on international standards, is straightforward in its completion, and its items are relevant to the administrative processes that exist in many RECs in the developing world.

A survey of 750 university human Research Ethics Boards (HRECs) in the United States revealed that Internet research protocols involving online or Web surveys are the type most often reviewed (94% of respondents), indicating the growing prevalence of this methodology for academic research. Respondents indicated that the electronic and online nature of these survey data challenges traditional research ethics principles such as consent, risk, privacy, anonymity, confidentiality, and autonomy, and adds new methodological complexities surrounding data storage, security, sampling, and survey design. Interesting discrepancies surfaced among respondents regarding strengths and weaknesses within extant guidelines, which are highlighted throughout the paper. The paper concludes with considerations and suggestions towards consistent protocol review of online surveys to ensure appropriate human subjects protections in the face of emergent electronic tools and methodologies.