title: Addressing ethical challenges in the Genetics Substudy of the National Eye Survey of Trinidad and Tobago (GSNESTT).
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 identified 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Paraclinical Sciences, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: Allana N
authors.initials: AN
authors.lastname: Roach
authors.affiliation: Vision and Eye Research Unit, Anglia Ruskin University (ARU), Cambridge, UK.
authors.forename: Tasanee
authors.initials: T
authors.lastname: Braithwaite
authors.affiliation: Department of Preclinical Sciences, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: Christine
authors.initials: C
authors.lastname: Carrington
authors.affiliation: Research Assistant, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: Elysse
authors.initials: E
authors.lastname: Marcellin
authors.affiliation: Optometry Programme, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: Subash
authors.initials: S
authors.lastname: Sharma
authors.affiliation: Institute of Cardiovascular Sciences, University College London (UCL), UK.
authors.forename: Aroon
authors.initials: A
authors.lastname: Hingorani
authors.affiliation: Institute of Health Informatics, University College London, UK.
authors.forename: Juan P
authors.initials: JP
authors.lastname: Casas
authors.affiliation: Department of Medicine, Duke Institute of Molecular Physiology, Duke University, Durham, NC, USA; Department of Ophthalmology, Duke University, Durham, NC, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Hauser
authors.affiliation: Department of Paraclinical Sciences, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: R Rand
authors.initials: RR
authors.lastname: Allingham
authors.affiliation: Department of Preclinical Sciences, Faculty of Medical Sciences, The University of the West Indies (UWI), St. Augustine, Trinidad and Tobago.
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Ramsewak
authors.affiliation: Vision and Eye Research Unit, Anglia Ruskin University (ARU), Cambridge, UK.
authors.forename: Rupert
authors.initials: R
authors.lastname: Bourne
keywords: ELSI; Ethics; Genetics; Human genomics; Trinidad and Tobago