Background: Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods: The study used a rapid assessment incorporating multiple qualitative methods (...) including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results: MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions: It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. (shrink)

Background Despite the implementation of codes and declarations of medical research ethics, unethical behavior is still reported among researchers. Most of the medical faculties have included topics related to medical research ethics and developed ethical committees; yet, in some cases, unethical behaviors are still observed, and many obstacles are still conferring to applying these guidelines. Methods This cross-sectional questionnaire-based study was conducted by interviewing randomly selected 331 Lebanese physicians across Lebanon, to assess their awareness, knowledge and attitudes on practice regarding (...) international and national research ethics guidelines and scientific misconduct and misbehaviors. Results Our results revealed that although majority of participants declared familiar with ethical principles governing research that involves human subjects, the overall mean score achieved on their knowledge questions was 46%. Only 27.4% are aware of the presence of the Lebanese National Consultative Committee on Ethics, with only half of them aware of its functions and only 25.7% know about the charter of ethics and guiding principles of scientific research in Lebanon. Significant higher levels of research ethics knowledge were recorded among Ph.D. degree-holding subjects, higher university positions as in professors, research ethics trainings-attendees, and physicians with prior research experience. A significant correlation was observed between knowledge of research ethics principles and positive attitudes toward research ethics principles. Noteworthy, we found that more than one third of participants have reported witnessing scientific misconduct and misbehaviors at some period of their careers. Conclusions The presence of low mean awareness levels regarding research ethical principles among the study population of physicians and high levels of perception of scientific misconduct raises concern on the importance of implementing proper training for physicians on research ethics. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to determine the (...) social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with (...) the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form. (shrink)

This article examines issues relating to ethics decision‐making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of theICH‐GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existingICH‐GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles (...) outlined in theICH‐GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of theICH‐GCP Guideline in its present form. (shrink)