Indigenous Peoples, Consent and Benefit Sharing is the first in-depth account of the Hoodia bioprospecting case and use of San traditional knowledge, placing it in the global context of indigenous peoples’ rights, consent and benefit-sharing. It is unique as the first interdisciplinary analysis of consent and benefit sharing in which philosophers apply their minds to questions of justice in the Convention on Biological Diversity (CBD), lawyers interrogate the use of intellectual property rights to protect traditional knowledge, environmental scientists analyse implications (...) for national policies, anthropologists grapple with the commodification of knowledge and, uniquely, case experts from Asia, Australia and North America bring their collective expertise and experiences to bear on the San-Hoodia case. -/- While much of the focus is on bioprospecting and natural product development, Indigenous Peoples, Consent and Benefit-Sharing also draws important lessons about informed consent and benefit-sharing from the health sciences and sectors such as mining. Policymakers around the world are under significant pressure to resolve the challenges of implementing the CBD. This book’s analysis and recommendations will help them. -/- ‘It is good to see philosophers engaging with the UN Convention on Biological Diversity, and doing so by looking in depth at a real situation in which it has been invoked.’ Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University . (shrink)

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs (...) where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies. (shrink)

In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated with H3Africa (...) (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context. (shrink)

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led (...) to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa. (shrink)

Abstract Benefit sharing as envisaged by the 1992 Convention on Biological Diversity (CBD) is a relatively new idea in international law. Within the context of non-human biological resources, it aims to guarantee the conservation of biodiversity and its sustainable use by ensuring that its custodians are adequately rewarded for its preservation. Prior to the adoption of the CBD, access to biological resources was frequently regarded as a free-for-all. Bioprospectors were able to take resources out of their natural habitat and develop (...) commercial products without sharing benefits with states or local communities. This paper asks how CBD-style benefit-sharing fits into debates of justice. It is argued that the CBD is an example of a set of social rules designed to increase social utility. It is also argued that a common heritage of humankind principle with inbuilt benefit-sharing mechanisms would be preferable to assigning bureaucratic property rights to non-human biological resources. However, as long as the international economic order is characterized by serious distributive injustices, as reflected in the enormous poverty-related death toll in developing countries, any morally acceptable means toward redressing the balance in favor of the disadvantaged has to be welcomed. By legislating for a system of justice-in-exchange covering nonhuman biological resources in preference to a free-for-all situation, the CBD provides a small step forward in redressing the distributive justice balance. It therefore presents just legislation sensitive to the international relations context in the 21st century. (shrink)

Objectives To investigate empirically the motivations for not consenting to DNA biobanking in a Swedish population-based study and to discuss the implications. Design Structured questionnaires and semistructured interviews. Setting A longitudinal epidemiological project (PART) ongoing since 1998 in Stockholm, Sweden. The DNA-collection wave took place during 2006–7. Participants 903 individuals completed the questionnaire (participation rate 36%) and 23 were interviewed. All individuals had participated in both non-genetic waves of the project, but refused to contribute saliva samples during the DNA-collection wave. (...) Main outcome measures Motivations behind refusing to consent to DNA biobanking, with subsequent focus on participants' explanations regarding this unwillingness. Results Public refusal to consent to DNA biobanking, as revealed by the questionnaire, was mainly explained by a lack of personal relevance of DNA contribution and feelings of discomfort related to the DNA being used for purposes other than the respective study. Interviews of individuals representing the second motivation, revealed a significant mistrust of DNA biobank studies. The underlying beliefs and attitudes were associated with concerns about integrity, privacy, suspiciousness and insecurity. However, most interviewees were supportive of genetic research per se and interpreted their mistrust in the light of distressing environmental influences. Conclusion The results suggest a need for guidelines on benefit sharing, as well as trustworthy and stable measures to maintain privacy, as a means for increasing personal relevance and trust among potential participants in genetic research. Measures taken from biobanks seem insufficient in maintaining and increasing trust, suggesting that broader societal measures should be taken. (shrink)

BackgroundDespite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations (...) and practices in biobanking in order to inform current and future policy and practice. MethodsDrawing on the Arksey and O’Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms.Results29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits.ConclusionMost of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research. (shrink)

The Convention on Biological Diversity and its Nagoya Protocol established an Access and Benefit Sharing system between utilizers and providers of genetic resources. ABS is understood as a tool that should promote commutative justice between the involved parties. This essay discusses what exactly it is that is being exchanged in the ABS process. It critically analyses moral claims to compensation that are implied by the ABS system for genetic resources. It argues that with the exception of cases in which traditional (...) knowledge is involved, states are not automatically entitled to compensation in return for the utilization of genetic resources growing within their territory. However, biodiversity-rich states that make an effort to protect biodiversity must be compensated for complying with the requests set out in the CBD. Although it acknowledges that the NP is a step towards recognizing this claim, this essay argues that ABS is not the appropriate method to compensate for biodivers... (shrink)

“Fair and equitable benefit-sharing” is one of the objectives of the UN Convention on Biological Diversity and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture. In essence, benefit-sharing holds that countries, farmers, and indigenous communities that grant access to their plant genetic resources and/or traditional knowledge should share in the benefits that users derive from these resources. But what exactly is understood by “fair” and “equitable” in this context? Neither term is defined in the international treaties. (...) A complicating factor, furthermore, is that different motivations and perspectives exist with respect to the notion of benefit-sharing itself. This paper looks at six different approaches to benefit-sharing that can be extracted from the current debates on “Access and Benefit-Sharing.” These approaches form the basis of a philosophical reflection in which the different connotations of “fair and equitable” are considered, by analyzing the main principles of justice involved. Finally, the various principles are brought together in order to draw some conclusions as to how a fair and equitable benefit-sharing mechanism might best be realized. This results in several recommendations for policymakers. (shrink)

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research. (shrink)

The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept.

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...) benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries. (shrink)