Legal and Ethical Regulation of Biomedical Research in Developing Countries

Nwabueze, Remigius N.

doi:10.4324/9781315591971

Cited by 10 publications

(5 citation statements)

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“…The findings show that countries differ in their arrangements for health research ethics and IRB oversight at the national level, whether as a statutory body for health research ethics (Zambia), under the STI regulatory institution (Uganda and Kenya), or within the ministry of health (Botswana). Likewise, other sub-Saharan African countries including South Africa and Nigeria have established national ethics committees to guide the establishment of IRBs [34]. The main challenge is that IRBs are under-resourced, and the institutional capacity for coordination of these regulatory bodies and research institutions is a persisting challenge across the countries.…”

Section: Discussionmentioning

confidence: 99%

Governance of health research in four eastern and southern African countries

Juma¹,

Jones

Mijumbi-Deve

et al. 2021

Health Res Policy Sys

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Background Health research governance is an essential function of national health research systems. Yet many African countries have not developed strong health research governance structures and processes. This paper presents a comparative analysis of national health research governance in Botswana, Kenya, Uganda and Zambia, where health sciences research production is well established relative to some others in the region and continues to grow. The paper aims to examine progress made and challenges faced in strengthening health research governance in these countries. Methods We collected data through document review and key informant interviews with a total of 80 participants including decision-makers, researchers and funders across stakeholder institutions in the four countries. Data on health research governance were thematically coded for policies, legislation, regulation and institutions and analysed comparatively across the four national health research systems. Results All countries were found to be moving from using a research governance framework set by national science, technology and innovation policies to one that is more anchored in health research structures and policies within the health sectors. Kenya and Zambia have adopted health research legislation and policies, while Botswana and Uganda are in the process of developing the same. National-level health research coordination and regulation is hampered by inadequate financial and human resource capacities, which present challenges for building strong health research governance institutions. Conclusion Building health research governance as a key pillar of national health research systems involves developing stronger governance institutions, strengthening health research legislation, increasing financing for governance processes and improving human resource capacity in health research governance and management.

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Section: Discussionmentioning

confidence: 99%

Governance of health research in four eastern and southern African countries

Juma¹,

Jones

Mijumbi-Deve

et al. 2021

Health Res Policy Sys

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“…Even where ethical rules are in place, they require legal backing and underpinnings [17,18] for the following reasons: human beings everywhere suffer from important limitations with regard even to what they themselves freely accept as right and reasonable to do; there is the problem of akrasia/weakness of will or backsliding in moral matters; there are the problems of self-interest and egoism, abuse and misuse of power/expertise and the enticement of economic advantage; social regulation and particularly legislation is a powerful aid to morally correct behavior; the law is one of the ‘road companions’ of morality, the others being religion and social customs.…”

Section: Discussionmentioning

confidence: 99%

“…Whereas the research arena has relatively well-accepted ethical rules now regarded as standard (for example, informed voluntary consent is essential for participation in medical research; the ability and capacity to exercise voluntary free choice must be ensured; research must have benefits or prospect of benefits for the participants and their wider community; research protocols must be approved by an independent ethics review committee; the burden for demonstrating ethical research rests squarely with the researcher), there is less attention to the ethical implications of practice, and particularly so in the occupational health field. Even where ethical rules are in place, they require legal backing and underpinnings [ 17 , 18 ] for the following reasons: human beings everywhere suffer from important limitations with regard even to what they themselves freely accept as right and reasonable to do; there is the problem of akrasia/weakness of will or backsliding in moral matters; there are the problems of self-interest and egoism, abuse and misuse of power/expertise and the enticement of economic advantage; social regulation and particularly legislation is a powerful aid to morally correct behavior; the law is one of the ‘road companions’ of morality, the others being religion and social customs.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2014

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BackgroundInternational 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.DiscussionFirstly, 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.SummaryA 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.

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“…Each of the human right treaties produced by the bodies of the African Union and the Organisation of American States contain provisions on protection of human life. As to the matter of regulation of the human embryo research, the African Union does not have any specific legal document for it [27]. The author was not able to find any particular treaty regulation on a legal status of human embryo also within the frames of the Organisation of American States.…”

Section: Regulation Of Human Embryo Research In the Worldmentioning

confidence: 97%

The Human Embryo in the Case-Law of the European Court of Human Rights

2016

Russian Journal of Comparative Law

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This paper presents an analysis of the case-law of the European Court of Human Rights regarding the status of a human embryo. At the beginning, the author makes an overview of the legal documents on the subject-matter produced by intergovernmental organisations on both universal and regional levels. The overview covers also a national legislation of Australia, China, Japan, United States and most of the European states. Further the paper elaborates on the decisions and judgments of the European Court adopted for the last fifty five years. The summary of this case-law is provided in a chronological order from the oldest to the newest one. Finally, the author comments on the practice of the European Court of Human Rights with regard to the issue of the human embryo legal position. The case-law in question certifies that human embryo cannot be considered "a thing", but at the same time it is still not "a person" for the purposes of the Article 2 of the Convention.

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Legal and Ethical Regulation of Biomedical Research in Developing Countries

Cited by 10 publications

References 0 publications

Governance of health research in four eastern and southern African countries

Governance of health research in four eastern and southern African countries

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

The Human Embryo in the Case-Law of the European Court of Human Rights

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