Abstract
Background. The clinical and scientific importance of biobanks has been highlighted. Ethical governance and regulatory oversight for biobanks should be in place to preserve and promote ethical and responsible conduct of research. Methods. This is an analytical documentary study of the regulatory scope concerning biobanks in Central America and the Dominican Republic. From the International Compilation of Human Research Standards 2020 edition of the Office of Human Research Protection Department of Health and Human Services of the United States of America identified the existing guidelines applicable to human research in each of the eight SICA member countries. Regulatory aspects searched for and the analysis was based on the recommendations set forth in Guideline 11 on the collection, storage, and use of biological materials and related data in the International Ethical Guidelines for Research Related to Human Health. Results. There is a lack of specific guidelines for the collection, use, and storage of human biological materials for research purposes, and the creation of biobanks in the countries been studied. No country in Central America and the Dominican Republic region has specific regulations for the creation of biobanks for research purposes. The term "biobank" was not found in the revised regulations. However, there are good examples of ethical governance of research in general in the region been Costa Rica, Panamá, and Guatemala examples of advances towards this direction. Conclusions. There is a need to move forward the governance and regulatory framework of biobanks in Central America and the Dominican which can be seen as an opportunity for international cooperation and regulatory collaborative agenda within this region.
Highlights
Health research involving the use of human biological materials and related data is subject to widely recognised ethical considerations
The present study aimed to analyse the guidelines for collection, storage and use of biological materials, and related data and analysis regarding the creation of biobanks for research purposes in the Member States of the Central American Integration System and the Dominican Republic (SICA)
The legislation in place is based on fundamental principles of research ethics with human beings and does not incorporate elements contained in current international ethical norms
Summary
Health research involving the use of human biological materials and related data is subject to widely recognised ethical considerations. Biorepositories and biobanks offer many advantages to scientific activity, such as resource efficiency, access to biological materials, and the ability to reference related data that enables research that would otherwise not be possible. These advantages, as well as necessities, justify the increasing creation and use of these resource centres. There is a lack of specific guidelines for the collection, use, and storage of human biological materials for research purposes, and the creation of biobanks in the countries been studied. No country in Central America and the Dominican Republic region has specific regulations for the creation of biobanks for research purposes. There is a need to move forward the governance and regulatory framework of biobanks in Central America and the Invited Reviewers version 1
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