Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results Of the 600 participants interviewed, two thirds were female. Overall mean age of study participants was 37.6 years. Amongst all participants, less than a tenth reported that they were not given enough information before making a decision to participate. A similar proportion reported that they had not signed a consent form prior to making a decision to participate in the study. A third of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; ] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. (...) In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the fields imposition of broad fiduciary responsibilities on health care professionals and researchers.In addition to debating how to properly describe laws historical relationship to bioethics, commentators have argued over whether laws influence in bioethics is now good or bad. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. (...) I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)