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Effective stakeholder engagement is essential if PRO-Ethics is to have lasting, sustainable impact. PRO-Ethics needs to draw on the expertise of organisations outside the consortium in order to develop a robust ethics framework and practical, usable guidelines for assessing the ethics of participation processes in innovation processes. Its wider impact also depends on results being taken up and used by organisations beyond the consortium. Work Package 4 is designed to ensure that key stakeholders are meaningfully involved in PRO-Ethics from an early stage and throughout the project. Task 4.3, dialogue with ethics committees and research integrity (RI) bodies, is designed to facilitate this process. This document describes the results of PRO-Ethics' initial steps to engage this key set of stakeholders. It presents findings from a set of interviews and a workshop conducted between July and September 2020. These activities engaged important stakeholder organisations for PRO-Ethics at both the national and regional levels, including the European Network of Research Integrity Offices (ENRIO), the European Federation of Academies of Sciences and Humanities (ALLEA), and the European Network of Research Ethics Committees (EUREC, a PRO-Ethics partner), as well as academic institutions. DISCLAIMER: The present Deliverable has been submitted to the European Commission for review. The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein.

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".

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

Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a complex procedure, and the participant concerned "must receive comprehensible oral and written information" (Swiss legislation: Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be established considering the complex relationship between these stakeholders. This contribution presents findings from two perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined. Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical researchers. Thus, the project shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures.

Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a complex procedure, and the participant concerned "must receive comprehensible oral and written information" (Swiss legislation: Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be established considering the complex relationship between these stakeholders. This contribution presents findings from two perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined. Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical researchers. Thus, the project shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures.

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.

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19(th) March 2019 by Government of India. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA). This document is divided into different sections like definitions and applicable chapter & schedules for EC; changes related to registration of clinical studies and biomedical and health research; changes related to constitution, functions, proceedings, responsibility of EC for clinical trial; maintenance of records by EC; suspension and cancellation of registration of EC, post-trial access of drugs, changes and clarity related to academic clinical trials and role of ECs in compensation and medical management process.

The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this article provides a brief review of the history of ethic committees in Italy. We then discuss certain considerations about the current situation and formulate some proposals in terms of the regulatory choices that must be made. There is a vital need for rules that promote efficiency, to guarantee that Italy's position remains competitive and attractive within the European Union.

OBJECTIVE: To determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom. STUDY DESIGN: Audit of records. SETTING: Clinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016. MAIN OUTCOME MEASURES: Correlation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion). RESULTS: Over the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%. CONCLUSIONS: Despite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies. (www.actabiomedica.it)