http://scholar.sun.ac.za:80/handle/10019.1/5079 2017-07-14T10:32:23Z 2017-07-14T10:32:23Z Moodley, Keymanthri http://scholar.sun.ac.za:80/handle/10019.1/5108 2016-06-09T09:04:10Z 2007-09-01T00:00:00Z

Microbicide research in developing countries : have we given the ethical concerns due consideration? Moodley, Keymanthri Background: HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Discussion: Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary: Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike. CITATION: Moodley, K. 2007, Microbicide research in developing countries : have we given the ethical concerns due consideration?. BMC Medical Ethics, 8(1): 10, doi: 10.1186/1472-6939-8-10.; The original publication is available at http://bmcmusculoskeletdisord.biomedcentral.com

2007-09-01T00:00:00Z Moodley, Keymanthri Myer, Landon http://scholar.sun.ac.za:80/handle/10019.1/5078 2016-06-09T13:11:49Z 2007-01-01T00:00:00Z

Health Research Ethics Committees in South Africa 12 years into democracy Moodley, Keymanthri; Myer, Landon Background: Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods: The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results: Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion: Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. CITATION: Moodley, K. & Myer, L. 2007. Health Research Ethics Committees in South Africa 12 years into democracy. BMC Medical Ethics, 8(1): 1, doi: 10.1186/1472-6939-8-1.; The original publication is available at http://bmcmusculoskeletdisord.biomedcentral.com

2007-01-01T00:00:00Z