scholarly journals Research ethics committees: Need for harmonization at the national level, the global and Indian perspective

2014 ◽  
Vol 5 (2) ◽  
pp. 66 ◽  
Author(s):  
AparnaSanjiv Walanj
2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A4.2-A4
Author(s):  
Virginie Pirard ◽  
Louis Penali ◽  
Armande Gangbo ◽  
Oumou Younoussa Sow ◽  
Samira Ouchhi

BackgroundThe establishment of research ethics committees (RECs) in charge of reviewing research protocols answers the need to regulate with an ethical framework the development of clinical trials, biomedical research and technologies affecting human health. The first RECs were instituted at the national level in the 60 s, and were gradually put in place in Africa as a result of research projects development in the area of epidemics such as HIV infection, and to meet one of the major requirements of the Helsinki Declaration and the international ethical Guidelines CIOMS: ‘each research protocol involving humans has to be reviewed by an independent ethics committee’. However, RECs in Africa are still facing various challenges in the accomplishment of their missions. Among them, RECs located in the West-African French speaking area are reporting an urgent need for networking and coordinating their effort.Supported by EDCTP, AFREENET (AFRica Ethics Excellence NETwork) is a 3 year collaborative project between three RECs, respectively in Côte d’Ivoire, Guinea and Benin, and coordinated by the Ethics Unit of Institut Pasteur (France), which aims to reinforce RECs capacities.The project will lead to reinforcement of training capacities through a long-term strategy to establish mechanisms to ensure and update members’ training, and to develop a pool of ethics trainers. Based on RECs experiences, network activities will permit to share and identify valuable practices on global ethics oversight, such as monitoring, SOPs, regulatory issues and sensitisation. The preparation of Ethics Committees for the potential occurrence of outbreaks will be specifically addressed through an Outbreak preparation plan built upon lessons learnt from the Ebola crisis.Creating synergies and mutual empowerment between „African RECs will increase their visibility, their capacity for advocacy and their recognition as key actors of a responsible ethics research framework at the national, regional and international level.


Author(s):  
Charlotte Gauckler

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.


2020 ◽  
pp. 174701612092506
Author(s):  
Kate Chatfield ◽  
Doris Schroeder ◽  
Anastasia Guantai ◽  
Kirana Bhatt ◽  
Elizabeth Bukusi ◽  
...  

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping.


BMJ ◽  
1990 ◽  
Vol 300 (6724) ◽  
pp. 608-608
Author(s):  
M. Drury

Author(s):  
Sarah J. L. Edwards ◽  
Tracey Stone ◽  
Teresa Swift

Objectives:To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).Methods:We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.Results:There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.Conclusions:The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”


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