Equitable Design

Background

The Dominican Republic is a middle-income country with a population of about 10 million. Approximately 74% of the population is covered by a health insurance, the health expenditure is about 6% of the gross domestic product, and the percentage of out-of-pocket health expenditures is about 44%. The Ministry of Higher Education, Science and Technology (MESCyT) is the main public funding agency for biomedical research, however, most of the health research projects are funded by the international pharmaceutical industry. The Ministry of Health (MoH) is responsible for establishing health research policies and priorities. The National Council on Bioethics in Health (CONABIOS, in Spanish) is the authority to approve or reject research protocols. Local research ethics committees have been in place since the early 80s, however, they are not subject to any regulations as health research itself is not regulated by a law but only through an administrative disposition.

In the Dominican Republic, most health research activities are conducted by the international pharmaceutical industry, other international institutions and universities. The implication of this trend is that funds are not allocated towards the diseases and conditions affecting the most vulnerable nor are they directed towards improving outcomes of the healthcare system, and policy development. At the same time, local personnel are contracted as 'principal investigators' when in practice they are only dealing with data collection. Where research is conducted by pharmaceutical companies, confidentiality requirements are in place to protect industry rights and the data are not shared with local researchers nor do they participate in data analyses.

This systematic neglect to build research capacity has real consequences. For instance, in 2016 the Dominican Republic reported one of the largest Zika virus outbreaks in the Americas. The first case of Zika was confirmed in January 2016 and decreased by May 2017. Incidence of Guillian-Barré Syndrome was high, however most of the cases had an uncomplicated course. Yet despite the scale of the outbreak in the Dominican Republic, national researchers were not participating as meaningful collaborators.

The National Research Ethics Committees Survey

The National Research Ethics Committees Survey was implemented to identify the number of existing research ethics committees (RECs) in the Dominican Republic, their compositions, organization, activities, ethics review and decision-making processes. Around 400 organizations including health care organizations, academic and research based institutions, both from the public and private sector were contacted. The data collection took place from March 2017 to September 2018. A total of 25 RECs were identified and 20 REC representatives were interviewed using a semi-structured questionnaire with questions about their written policies, composition, activities of REC and ethics review practices such as requesting from researchers a data sharing plan.

The study showed that in the last decade, the number of REC's increased over 3-fold, from 7 in 2009 to 25 in 2018, half of them from public institutions. Of these, 70% of them have written policies, 30% review clinical trials, 40% meet only twice a year and 45% approved protocols in the first meeting. The study also found none of the RECs involved mentioned that they request a data sharing plan as part of their ethics review practices. Their written policies did not include requirements for data sharing.

Selected ethical concerns and suggestions for ways forward

1. The survey showed that RECs in the Dominican Republic were not requesting data sharing plans as part of their review process. Would it not be reasonable for RECs to request a data sharing plan even though it is not a legal requirement at the moment? Even when many international ethics guidelines suggest that there are compelling reasons to share data, it is still not clear in which instances a REC will have the authority to request a data sharing plan or even mandate data sharing. CONABIOS has the authority to do so, but they do not yet have any policy in this regard.

We think that it would be beneficial for RECs in LMICs to request information regarding data ownership, data management and data sharing as part of their review. In some instances, data sharing should be mandated, for example in research that is looking to solve important local public health issues.

2. In the Dominican Republic, there is a lack of technological and data science capacity to analyse secondary data. Sharing of data with local researchers who do not have the capacity to analyse the data will not be beneficial. In this regard, we think that capacity building (and retention) is necessary in order for LMIC researchers to benefit from the research and the data collected. For example, a local data scientist or statistician could be included as part of the research team. International collaborative work should include the local research teams in all phases of the research project, not just in the data collection phase.

CONABIOS should offer guidance to REC in terms of policies and standards on data sharing. The MoH and the MESCyT should work together in the development of a platform for data access including consideration on policy development, organizational structure, central platforms (local and regional) to access and analysis the data, and capacity building agreements.