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Published Article / In this article the focus is on the role of ethics in the research cycle. The author argues that current thinking with regard to ethics in research is very often scattered and limited to certain disciplines and certain activities only. It is also pointed out that research ethics is not only applicable to the actual doing of research but also processes associated with research such as supervision, the commercialization of research and the presentation of research within the public domain.

Thesis (MPH)--University of Limpopo, 2010. / Background The National Health Research Ethics Council (NHREC) of South Africa (SA) is mandated to oversee health research ethics activities within the country. The oversight role is achieved through registration and auditing of Health Research Ethics committees (RECs). This study indicates that 22 RECs are registered with the NHREC. Purpose This study examines compliance levels of registered RECs with the SA DOH national health research ethics guidelines regarding composition and operational procedures as well as highlight commonalities and differences. Methods Secondary data of 22 RECs registered with NHREC were used to examine the level of compliance related to composition and operational procedures disaggregated by REC. Data were processed using Statistical Package for Social Scientists (SPSS). Categories of systematic compliance, non-systematic compliance and non-compliance were used to determine RECs compliance levels with the standards specified in the DOH national ethics guidelines in research. Results Registered RECs in South Africa have an average membership of 16 ranging from 6 to 35. The RECs membership on gender has a 6% marginal difference and is dominated (68%) by scientists or clinicians. Majority (82%) of RECs have lay persons and 77% legal representatives. Eighty six percent of RECs xvi complied with operational procedures as stipulated by DOH national health research ethics guidelines. Conclusions Most RECs in SA registered with NHREC have a functional structure and are well organized. However, RECs demonstrated a non-systematic compliance with composition and procedures of DOH national guidelines. Most RECs based at public hospitals, government department and private organizations experienced high variations. Disparities related to gender, professional identity, legal and lay representations are noticeable and could be easily addressed.

No / This is a re-publication of an earlier journal article that was selected by the editor for inclusion in the 2015 volume. The original article was: Richardson S and McMullan M (2007) Research ethics in the UK: What can Sociology learn from health? Sociology. 41(6): 1115–1132.

Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity. IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced. Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised. Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process. Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered. The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

The purpose of this study is to discover the relationship between the specifications of medical institutes, FERCAP (Forum for Ethical Review Committees in Asia and the Western Pacific), TJCHA IRB Accreditation (Taiwan Joint Commission on Hospital Accreditation, TJCHA) and the practice of IRBs. By using questionnaires, and comparing the differences between all these medical institutes, we would have the information Research Ethics and the differentials in all the medical institutes. In this study, 268 completed questionnaires to the most southern region (64.7%), Medical Center (66.4%), physicians (36.9%), research assistants (21.3%), nurses (14.6%) and so on. About 60¢H can answer correctly of the knowledge of Human Research Ethics. We found that different medical institutions (Medical Centers and non-medical centers) and distinction (north, south and other regions) score differences in terms of cognition, in "human trials testing program information must be saved after three years", "IRB memberlist should be submitted to DOH", "study of individual or group characteristics or behavior (such as feeling, cognition, motivation, identity, language, communication, cultural beliefs or habits and social behavior, etc.) is expetided review " and "IRB membership and minutes should be open" have significantly difference (p <0.05). Also, we need to pay attention that only 30¢H of IRB members and staff have correct answer of "IRB memberlist should be submitted to DOH". Medical Centers and non-medical centers score differences in terms of attitude, in ¡uunit IRB that the information provided sufficient for you to understand the operation of the IRB¡v,¡uIRB promote education in human trials of great help to the project execution¡v,¡uIRB review process can focus on the implementation of the risk-benefit plans to provide specific advice¡v and ¡uyou are familiar with the regulations of the Department of Health ¡isuch as GCP, Medical Law and Research collected by the human body provides¡j¡vhave significantly difference (p <0.05). And expect the future to have further information for health policy evaluation and questionnaire data will be cross-comparison analysis of human trials to confirm the operation of the Board to provide further quality assurance and the IRB timely help.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

Evidence available shows that the ethics review process in Malaysia suffers from a range of problems (Kaur, 2011). These problems may be the result of a lack of training given for REC members and relatedly, it may stem from a lack of understanding of the role of RECs. Since Malaysia is striving to promote the country as a research hub for international collaboration, it is important that the ethics review system that is in place is well set up to ensure only ethical research are being approved. The aim of this thesis is to develop three important key elements of a framework that can be used to provide practical guidance for RECs and their governance in Malaysia. These three important elements of the ethics review process are: - the role of RECs, the criteria of REC membership and the acceptability of variation in decisions made between different RECs. These analysis is then applied to the Malaysian context. My initial recommendation is for RECs to adopt the Daniels and Sabin (1997) accountability for reasonableness model to assist with the decision-making process. The adoption of the model helps to clarify the role of RECs and can be used as a basis to develop the criteria for REC membership as well as to provide a better understanding of the acceptability of variation in decisions between different RECs.