RESUMEN
Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which will allow all those involved, and especially child patients, to benefit from the advancement of therapeutics.
Asunto(s)
Ensayos Clínicos como Asunto/ética , Países en Desarrollo , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Pediatría/ética , Investigación Biomédica/economía , Investigación Biomédica/ética , Niño , Ensayos Clínicos como Asunto/economía , Países en Desarrollo/economía , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/economía , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Humanos , Pediatría/economíaRESUMEN
The participation of the public in the elaboration of politics has become unavoidable in most countries. The Universal Declaration on Bioethics and Human Rights of UNESCO, adopted by the General conference in 2005, makes the public a paramount aspect in the decision making in bioethics. In the case of explanatory research, based on political analysis and guidelines on the newborn screening programs from different countries, we have examined how the "public" is defined (who is the public?), what are the levels of privileged engagement, and what are the objectives sought out by this public participation? In general terms, we have noticed that the terms "consultation", "engagement", "participation" and "partnership" are often used as though they were synonymous, that the "public" is rarely well defined and that the levels of engagement from the public are variable. However, in spite of these findings, it appears that this willingness to respect the choice of individuals and to implicate the population in the debates or in the elaboration of health policies is motivated by the pursuit of values. These last few, although not frequently explicitly named to justify the initiative to involve the public constitute the source of these initiatives. In summary, it is evident that the moral values result in a significant difference in the answers that a population will give to the issues raised in a given domain and that these are often values that participation of the public looks to better identify and to integrate into health policies.
Asunto(s)
Participación de la Comunidad , Política de Salud , Formulación de Políticas , HumanosRESUMEN
Genetic information can be used to target interventions that improve health and prevent disease. Indeed, the results of population genomics research could be useful for public health and national pandemic plans. Yet, firm scientific evidence originating from such research and the indicators of the role of health determinants, gene-gene and gene-environment interaction remain to be assessed and validated before being integrated into pandemic plans or public health programmes. It is not clear what is the role of the State in research on the elucidation of the determinants of gene-gene and gene-environment interactions and how, when, and if such data can be accessed and used for such planning. Over a period of 3 years, we sought to address these questions by gathering data and literature relevant to research in public health genomics, preparing issues papers and, finally, consulting with stakeholders on a provisional 'points to consider' document at various times. Examining in turn the issues of privacy, State powers, stakeholder perceptions, and public participation, we propose in this article, for each of these themes, a series of recommendations aiming to provide guidance on the role of the State in the use of genomic information for public health research, prevention and planning.