A blank check or a global public good? A qualitative study of how ethics review committee members in Colombia weigh the risks and benefits of broad consent for data and sample sharing during a pandemic

María Consuelo Miranda Montoya; Jackeline Bravo Chamorro; Luz Marina Leegstra; Deyanira Duque Ortiz; Lauren Maxwell

doi:10.1371/journal.pgph.0000364

A blank check or a global public good? A qualitative study of how ethics review committee members in Colombia weigh the risks and benefits of broad consent for data and sample sharing during a pandemic

PLOS Glob Public Health. 2022 Jun 6;2(6):e0000364. doi: 10.1371/journal.pgph.0000364. eCollection 2022.

Authors

María Consuelo Miranda Montoya¹, Jackeline Bravo Chamorro¹, Luz Marina Leegstra², Deyanira Duque Ortiz³, Lauren Maxwell²

Affiliations

¹ Facultad de Salud, Universidad Industrial de Santander, Bucaramanga, Santander.
² Heidelberger Institut für Global Health, Universitätsklinikum Heidelberg, Heidelberg, Germany.
³ Ministerio de Ciencia, Tecnología e Innovación MINCIENCIAS, Bogotá D.C., Colombia.

Abstract

Broad consent for future use facilitates the reuse of participant-level data and samples, which can conserve limited resources by confirming research findings and facilitate the development and evaluation of public health and clinical advances. Ethics review committees (ERCs) have to balance different stakeholder concerns when evaluating the risks and benefits associated with broad consent for future use. In this qualitative study, we evaluated ERC members' concerns about different aspects of broad consent, including appropriate governance, community engagement, evaluation of risks and benefits, and communication of broad consent for future use in Colombia, which does not currently have national guidance related to broad consent for future use. We conducted semi-structured, in-depth interviews with 24 ERC members from nine Colombian ERCs. We used thematic analysis to explore ERC members' concerns related to broad consent for future use. Most ERC members expressed concern about the idea of not specifying the purposes for which data would be used and by whom and suggested that pre-specifying governance procedures and structure would address some of their concerns about broad consent. ERC members emphasized the need for engaging communities and ensuring research participants understood broad consent for future use-related language in informed consent forms. Researchers and research institutions are under increasing pressure to share public health-related data. ERC members play a central role in balancing the priorities of different stakeholders and maintaining their community's trust in public health research. Further work is needed on guidelines for developing language around broad consent, evaluating community preferences related to data sharing, and developing standards for describing governance for data or sample sharing in the research protocol to address ERC members' concerns around broad consent for future use.

Copyright: © 2022 Miranda Montoya et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Grants and funding

This study received funding support from TDR, the Special Programme for Research and Training in Tropical Diseases, grant to LM [P20-00007] and the ReCoDID project, funded by the EU Horizon 2020 research and innovation programme (grant agreement 825746) and the CIHR Institute of Genetics (grant agreement 01886-000) grant to LM. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.