Ethics in occupational health: deliberations of an international workgroup addressing challenges in an African context.

BACKGROUND: International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and cogency of an ethical code in occupational health for an African context through an iterative consultative process. DISCUSSION: Firstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace. SUMMARY: A stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region.

Engaging diverse communities participating in clinical trials: case examples from across Africa.

BACKGROUND: In the advent of increasing international collaborative research involving participants drawn from populations with diverse cultural backgrounds, community engagement becomes very critical for the smooth conduction of the research. The African Malaria Network Trust (AMANET) is a pan-African non-governmental organization that sponsors and technically supports malaria vaccine trials in various African countries. CASE DESCRIPTION: AMANET sponsored phase Ib or IIb clinical trials of several malaria vaccine candidates in various Africa countries. In Burkina Faso, Mali and Tanzania trials of the merozoite surface protein 3 -- in its Long Synthetic Peptide configuration (MSP3 LSP) -- were conducted. In Mali, the apical membrane antigen 1 (AMA1) was tested, while a hybrid of glutamate rich protein (GLURP) and MSP3 (GMZ2) was tested in Gabon. AMANET recognizes the importance of engaging with the communities from which trial participants are drawn, hence community engagement was given priority in all project activities conducted in the various countries. DISCUSSION AND EVALUATION: Existing local social systems were used to engage the communities from which clinical trial participants were drawn. This article focuses on community engagement activities employed at various AMANET-supported clinical trial sites in different countries, highlighting subtle differences in the approaches used. The paper also gives some general pros and cons of community engagement. CONCLUSIONS: Community engagement enables two-way sharing of accurate information and ideas between researchers and researched communities, which helps to create an environment conducive to smooth research activities with enhanced sense of research ownership by the communities.

Capacity building of ethics review committees across Africa based on the results of a comprehensive needs assessment survey.

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.

Validation of a Career Guidance Brochure for Student Nurses Using the Nominal Group Technique.

BACKGROUND: Nursing is a career which, especially for male students, requires one making an informed choice prior to pursuing it. A mixed-method, qualitative study, investigating the professional socialization process of male student nurses in Malawi found that most students did not make an informed choice regarding their selected career. This resulted in some of them facing many challenges which compromised their academic performance, and in some cases, contributed to high attrition rates. An "unmet need" for career guidance was identified by the study participants. Further, the study participants made recommendations on the need to address the unmet need for career guidance. A brochure entitled "A career in nursing and midwifery in Malawi" was designed. This article reports on the validation of the brochure. OBJECTIVE: The goal of the study was to validate the brochure utilising the Nominal Group Technique. METHODS: The validation exercise was part of the mixed method study. Five steps of the Nominal Group Technique (NGT) were utilised, as expounded by Vigra-Atkins, aimed at evaluating the content contained in the brochure. Study participants in four nursing colleges (n = 37) participated by studying the draft brochure and identifying strong and weak areas for improvements. Responses were ranked based on group consensus. FINDINGS: A total of five groups were involved in NGT discussions. Four of the five groups found the brochure relevant and motivating to prospective students. However, two groups suggested that pictures needed to be more gender sensitive. CONCLUSION: Through the NGT, the brochure was commended by the majority of the participants as being clear and relevant in terms of giving information necessary for a nursing career choice. Finally, the authors recommend the use of the NGT compared to other group-based research techniques, considering the benefits the NGT offers.

Ethical and regulatory issues surrounding African traditional medicine in the context of HIV/AIDS.

It has been estimated that more than 80% of people in Africa use traditional medicine (TM). With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code, African TM seems to be exempt from such scrutiny. Although recently there have been calls for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues. In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: (i) the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; (ii) the importance of research on TM in order to improve and demystify its therapeutic qualities; (iii) the need to tailor-make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers' associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients' welfare.

Professional ethics: an overview from health research ethics point of view.

The advancement of the medical field has been to a large extent made possible by the hard work contributed by researchers all over the world. The pool of knowledge generated through research is the basis for diagnostic methods, therapeutic interventions and policies that continue to improve the quality of life for mankind. Health researchers are the ones who interact directly with research participants as they implement research protocols. Although other players involved in health research such as Ethics Review Committees, Regulatory Authorities, Data Safety and Monitoring Boards, and sponsors help to ensure that the health research meets internationally acceptable scientific and ethical standards, researchers could be considered to be the major determining factor as to whether the research is actually done properly. Although professional associations of health researchers help to uphold the integrity of their members, there is need to complement the efforts of such associations and sensitize researchers on the ethical implications of some acts of commission or omission, done inadvertently or knowingly, that may not be adequately addressed by requirements of the associations. This paper gives an overview of professional ethics from the point of view of health research ethics, and concludes that alerting health researchers about these issues is not only good for the protection of the welfare of research participants, but is also critical for the carrier development of the researchers, be they junior or senior.

Ethical and practical challenges surrounding genetic and genomic research in developing countries.

The nature of some potential benefits and risks associated with genetic research is different from the types of potential benefits and risks associated with other types of health research such as clinical trials and biomedical research involving humans. Whereas most potential risks associated with biomedical research or clinical trials are mainly biological in nature, potential risks associated with genetic research are mainly of socioeconomic nature. Although the peculiarity of some of the aspects of genetic research and the complexity of the science involved are acknowledged, the extent to which these characteristics hinder firstly disclosure of information to participants and their communities and secondly comprehension of the disclosed information is a practical challenge that tends to be exaggerated in some cases. In this article, a brief overview of the various types of genetic research will be given in order to set the scene for some ethical and practical issues surrounding the research in developing countries that will be discussed subsequently. Case studies that illustrate some of the ethical and practical issues flagged will be given, followed by suggestions on possible ways of tackling some of the challenges in developing country settings. Nevertheless, genetic and genomic research could go a long way in providing knowledge that could be useful in the development of drugs and vaccines for many diseases affecting the developing countries.

Animal research ethics in Africa: an overview.

With research projects that use animals on the increase worldwide and in Africa in particular, animal research ethics should continue to be reviewed to improve the welfare of animals used in research. The welfare of animals used in research has gained attention globally that has led to the development of guidelines and in some instances national laws governing animal experimentation. Although there may not be empirical data on the existence or adequacy of national and/or institutional policies and guidelines on the use of animals in research in Africa, most African countries are not yet at the same level as developed countries. Consequently, some researchers based at institutions in developed countries may be tempted to 'export' their research activities to collaborating African institutions where ethical and legal frameworks on use of animals may be less stringent than in the developed countries. An appreciation of the intrinsic value of animals should be enough driving force for human beings to strive to promote humane treatment of animals. This paper gives an overview of uses and potential abuses of animals in research for the benefit of stakeholders such as researchers, research institutions, Ethics Review Committees (ERCs) and policy makers and ends with suggestions on possible ways of ensuring humane treatment of animals used in research in Africa in particular and globally in general.

The ethics of improving African traditional medical practice: scientific or African traditional research methods?

The disease burden in Africa, which is relatively very large compared with developed countries, has been attributed to various factors that include poverty, food shortages, inadequate access to health care and unaffordability of Western medicines to the majority of African populations. Although for 'old diseases' knowledge about the right African traditional medicines to treat or cure the diseases has been passed from generation to generation, knowledge about traditional medicines to treat newly emerging diseases has to be generated in one way or another. In addition, the existing traditional medicines have to be continuously improved, which is also the case with Western scientific medicines. Whereas one school of thought supports the idea of improving medicines, be they traditional or Western, through scientific research, an opposing school of thought argues that subjecting African traditional medicines to scientific research would be tantamount to some form of colonization and imperialism. This paper argues that continuing to use African traditional medicines for old and new diseases without making concerted efforts to improve their efficacy and safety is unethical since the disease burden affecting Africa may continue to rise in spite of the availability and accessibility of the traditional medicines. Most importantly, the paper commends efforts being made in some African countries to improve African traditional medicine through a combination of different mechanisms that include the controversial approach of scientific research on traditional medicines.

DNA vaccination with map1 gene followed by protein boost augments protection against challenge with Cowdria ruminantium, the agent of heartwater.

A DNA vaccine encoding the immunodominant MAP1 protein of Cowdria ruminantium (Crystal Springs (CS) strain) was shown to partially protect DBA/2 mice against homologous lethal challenge. To enhance the protective capacity of this DNA vaccine, the effects of length of interval between vaccinations and of prime-boost regimes were investigated. Increasing the interval between vaccinations from 2 to 12 weeks did not result in better protection (P=0.900). However, boosting DNA vaccine-primed mice with recombinant MAP1 protein significantly augmented protection on homologous challenge in various trials from 13-27 to 53-67% (P<0.050). The augmented protection by the prime-boost regimen correlated with augmented T(H1) type immune responses that were induced by the DNA vaccine. These responses were characterized by production of IFN-gamma, IL-2 and anti-MAP1 antibodies of predominantly IgG2a isotype, and were critical for protection against C. ruminantium infection. Cytokine analyses were done at 48h after in vitro stimulation of splenocytes with C. ruminantium or control antigens. In contrast, splenocytes of DNA vector control mice produced no cytokines and these mice were fully susceptible to challenge. In addition, DBA/2 mice immunized with the recombinant MAP1 protein without DNA vaccine priming produced non-protective T(H2) type immune responses which were characterized by production of IL-4, IL-5, IL-10 and IgG1 anti-MAP1 antibodies. A second DNA vaccine containing map1 gene from the Mbizi strain of C. ruminantium also delivered by a prime-boost regime, conferred less protection against heterologous challenge. Hence, in developing DNA vaccines against heartwater that contain map1 gene, a prime-boost regimen should be adopted and gene sequence heterogeneity of field isolates should also be considered.