Online research in philosophy

South Africa currently has a pluralistic health care system with separate public and private sectors. It is, however, moving towards a socialised model with the introduction of National Health Insurance. The South African legislative environment has changed recently with the promulgation of the Consumer Protection Act and proposed amendments to the National Health Act. Patients can now be viewed as consumers from a legal perspective. This has various implications for health care systems, health care providers and the doctor-patient relationship.

Background: The banking of biological samples raises a number of ethical issues in relation to the storage,export and re-use of samples. Whilst there is a growing body of literature exploringparticipant perspectives in North America and Europe, hardly any studies have been reportedin Africa. This is problematic in particular in light of the growing amount of research takingplace in Africa, and with the rise of biobanking practices also on the African continent. Inorder to investigate the perspectives of African research participants, we (...) conducted a studywith research participants in a TB study in the Western Cape, South Africa. Methods: Semi-structured interviews were conducted using an interview guide which drew on the mostprominent themes expressed in current literature on sample storage, re-use and exportation.Interviews were conducted in Afrikaans and subsequently translated into English by the sameinterviewer. Interviews were transcribed verbatim and analysed qualitatively. Results: The results of our study indicate that the majority of participants were supportive of givingone-time consent to the storage and re-use of their samples. The concept of research being fora "good cause" was a central prerequisite. Additionally, a significant minority requested thatthey be re-contacted if a future use was not stipulated on the original consent. There was alsoconsiderable variation in how participants understood the concept of a 'good cause', withparticipants describing three distinct categories of research, of which two were generallythought to constitute 'good cause' research. Research that was for-profit was considered tofall outside the spectrum of 'good cause' research. Participants displayed confidence in theabilities of the researchers to make future decisions regarding sample use, but seemedunaware of the role of ethics committees in either this process or more generally. Conclusions: Participants expressed a wide and complex range of views about issues of sample storage andre-use, and they showed a great deal of trust in researchers. Participants' willingness to havetheir samples stored and re-used is consistent with findings from existing studies. However,in contrast to existing literature, participants were generally not in favour of for-profitresearch. Further research needs to be done to explore these ideas in other communities, bothin South Africa and other countries. (shrink)

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. (shrink)

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. (shrink)

Trial participation in the proposed HIV Vaccine Trials in South Africa is discussed in the context of the ethical tension that exists between international ethical research standards and local standards of care and cultural norms in the Third World. The important concepts of informed consent, risk-benefit ratio and fair treatment of trial participants are interpreted differently in traditional, rural African communities, where a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. Research is an altruistic endeavor (...) that benefits communities and societies as a result of risks taken by individuals. Universal ethical guidelines that are highly individualistic and fail to emphasize communalism may represent serious problems for the sort of research needed in Africa today. (shrink)