دانلود رایگان مقاله رسیدگی به چالش های اخلاقی در ژنتیک Substudy

abstract

Background: The conduct of international collaborative genomics research raises distinct ethical challenges that require special consideration, especially if conducted in settings that are research-naïve or resource-limited. Although there is considerable literature on these issues, there is a dearth of literature chronicling approaches taken to address these issues in the field. Additionally no previous ethical guidelines have been developed to support similar research in Trinidad and Tobago. Methods: A literature review was undertaken to identify strategies used to address common ethical issues relevant to human genetics and genomics research in research-naïve or resource-limited settings. Strategies identi- fied were combined with novel approaches to develop a culturally appropriate, multifaceted strategy to address potential challenges in the Genetics Substudy of the National Eye Survey of Trinidad and Tobago (GSNESTT). Results: Regarding the protection of study participants, we report a decision to exclude children as participants; the use of a Community Engagement and Sensitization Strategy to increase the genetic literacy of the target population; the involvement of local expertise to ensure cultural sensitivity and to address potential comprehension barriers in informed consent; and an audit of the informed consent process to ensure valid consent. Concerning the regulation of the research, we report on ethics approvals from relevant authorities; a Materials Transfer Agreement to guide sample ownership and export; and a Sample Governance Committee to oversee data use and data access. Finally regarding the protection of the interests of scientists from the host country, we report on capacity building efforts to ensure that local scientists have access to data collected through the project and appropriate recognition of their contributions in future publications. Conclusion: This paper outlines an ethical framework for the conduct of population-based genetics and genomics research in Trinidad and Tobago; highlights common issues arising in the field and strategies to address these.

5. Conclusion

The diversity of political, sociocultural and infrastructural factors that exist in each country may impede the establishment of a single ethical approach to international collaborative genetics/genomics research that will be effective in all contexts. However, as the GSNESTT experience proves, drawing on the published experiences of other projects, it is possible to identify key areas in HGR that require special attention and then integrate several previously tested mechanisms to address many ethical issues that may arise. Novel approaches integrated into the GSNESTT include the use of a local trained in clinical psychology to lead the informed consent process, and developing an audit protocol to assure the quality and validity of the informed consent process. It is critical that any framework developed also addresses key areas outlined in international guidelines like the CIOMS. Care must also be taken at every step to ensure that study protocols are sensitive to the culture and terrain of each community or subgroup targeted within a country. Community engagement and recruitment is a resource and laborintensive aspect of the project, and required creativity and flexibility to achieve successful implementation. Our experience suggests that for research projects involving genetics to be successful, ethical issues must be integrated into the design and implementation of the project. The value and importance of identifying and meaningfully engaging with all interested stakeholders, prior to a major project, and throughout its evolution, cannot be overstated. Failure to do so can lead to costly delays and may potentially undermine the viability of the research. Building on the GSNESTT, we recommend that further investment is made to develop community education in genetics and the implications of genetics research in Trinidad and Tobago.