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.

Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face of (...) entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. (shrink)

At every moment, somewhere in the world, a group of men and women are sitting around a table deliberating about an ethical issue posed by medicine and research, whether as a research ethics committee; a hospital or clinical ethics committee; a stem‐cell review committee; a gene transfer research committee; a biobank ethics committee; an ethics advisory committee for a medical or nursing association or nongovernmental organization; a state, provincial, national, or intergovernmental bioethics committee; or an ad hoc panel examining a (...) particular development or case. However, the last national committee in the United States, the Presidential Commission for the Study of Bioethical Issues, held its final meeting at the end of August 2016 and closed its doors. Should we regret its departure? I believe that the United States would benefit from having another national bioethics advisory body, but I do not think that the commission should simply have continued under a new president in the same form. Instead, looking at the experience of that commission and its six predecessors—who they were, how they worked, the functions they served, and the problems they experienced—we can derive some useful ideas for anyone planning to build the next commission. (shrink)

Biomedical research using data from participants’ mobile devices borrows heavily from the ethos of the “citizen science” movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public. But while grass-roots citizen science (...) projects are often community-based, mHealth research ultimately depends on the individuals who own and use mobile devices. This inflects the ethos of mHealth research towards a celebration of individual autonomy and empowerment, at the expense of its implications for the communities or groups to which its individual participants belong. But the prospects of group harms — and benefits — from mHealth research are as vivid as they are in other forms of data-intensive “precision health” research, and will be important to consider in the design of any studies using this approach. (shrink)

Since the inception of large‐scale human genome research, there has been much caution about the risks of exacerbating a number of socially dangerous attitudes linked to human genetics. These attitudes are usually labeled with one of a family of genetic or genomic “isms” or “ations” such as “genetic essentialism,” “genetic determinism,” “genetic reductionism,” “geneticization,” “genetic stigmatization,” and “genetic discrimination.” The psychosocial processes these terms refer to are taken to exacerbate several ills that are similarly labeled, from medical racism and psychological (...) fatalism to economic exploitation and social exclusion. But as genomic information becomes more familiar in clinical and research settings as well as other life activities, do we need to continue to worry so much about this family of attitudes and their impact on existing problems?In genomics, the underlying anxiety has been that disclosure of genomic information will trigger a series of (seemingly unavoidable) negative responses that will affect individuals, their families, and their communities at large. The fundamental social challenges that hyperbolic genomic messaging, low genomic literacy, and “folk biology” help sustain remain to be addressed. If we hope to break the cycle of genomic isms and ations, we will have to get better at resisting overinterpretations of the relevance that genomics has for people’s future potentials, ancestral vulnerabilities, community memberships, and ethnic affiliations. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

In the last third of the twentieth century, humanists and social scientists argued that attention to genetics would heighten already‐existing genetic determinism, which in turn would intensify negative social outcomes, especially sexism, racism, ableism, and harshness to criminals. They assumed that laypeople are at risk of becoming genetic essentialists. I will call this the “laypeople are genetic essentialists model.” This model has not accurately predicted psychosocial impacts of findings from genetics research. I will be arguing that the failure of the (...) model can be traced to its inability to recognize the complexity of laypeople’s attitudes; its incorrect theory of how beliefs, attitudes, and discourse function; and its blindness to how academics’ own interests can override the available evidence. More specifically, I suggest that the substantial data about laypeople’s deployment of genetics supports what I will call the “laypeople are strategic essentialists model” better than the “laypeople are genetic essentialists model.” The strategic essentialists model holds that people tend to store multiple categories, including multiple causal forces, that they deploy “strategically” to serve context‐dependent goals. It will be difficult for academics to reorient ourselves to model laypeople as sophisticated strategic essentialists rather than as naïve genetic essentialists. Perhaps a little shift, however, will be of value. (shrink)

Volume 19, Issue 5, May 2019, Page 22-24.

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (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)

“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)

Digital medicine—a drug delivered with an ingestion sensor and related data collection system—has potential clinical value, especially for people whose lives are made more disorganized by poverty-related stress. It would be unjust if poor people were effectively barred from this treatment modality. Yet, unless a concerted effort is made to enable access through provision of smartphones to those who cannot afford them, this injustice will aggravate the digital divide in clinical care.