Table 2 Ethical governance and regulations within the NHRS
NHRS and NRES indicators | Costa Rica | El Salvador | Guatemala | Honduras | Panama | Dominican Republic |
|---|---|---|---|---|---|---|
1. Law on HR | Biomedical Research Regulatory Law No. 9234 | No | No | No | Law 84 of 19 May 2019 that regulates and promotes research for health and establishes its stewardship and governance Law 56 of 14 December 2007, which creates the National Research System | No |
2. National policy for HR | National Health Plan 2016–2020 | National Health Research Policy | No | No | National Health Policy and Strategic Guidelines 2016–2025 | No |
3. HR priorities | No | National Health Research Priorities Agenda, 2018–2024 | Research Areas and Priorities for Health in Guatemala 2014–2019 | Research Agenda for Health, Honduras 2015–2020 | National Agenda of Research Priorities for Health (ANPIS) Panama 2016–2025 | No |
4. Decrees, codes, administrative resolutions on HR | Decrees No. 39061-S dated 8 May 2015 and No. 39533-S dated 11 January 2016 Regulation of Law No. 9234 Decree No. 41183-S of 11 May 2018 (Regulation of adult stem cell research) Regulations to the Biomedical Research Regulatory Law—Executive Decrees 39061-S and 39533-S Regulations for the operation of the National Health Research Council (2018) | Inter-institutional cooperation agreement between the Ministry of Health through the National Institute of Health, the National Committee on Health Research Ethics and the National Directorate of Medicines Operating Manual of the National Committee on Health Research Ethics | Ministerial Agreement No. 206-2021 | Decree Number 65-91 (Issued on 28/05/1991) Health Code (Gazette No. 26509 of 06/08/1991) Articles 175 and 176 Health Code, research provisions in Articles 175 and 176 (Decree No. 65-91) Provisions for the Regulation and Sanitary Control of Clinical Trials on Human Subjects | Executive Order No. 179 of 8 June 2018 regulating research with tissues and cells of human origin Regulations of the National Research Bioethics Committee | Administrative Resolution No. 013625 of 2 August 2000. Ministry of Public Health |
5. Governmental agency responsible for research ethics | National Health Research Council (CONIS) | National Health Research Ethics Committee | National Health Ethics Committee | Ministry of Health, General Directorate for the Surveillance of the Regulatory Framework | National Committee on Research Bioethics, Ministry of Health | National Council on Bioethics in Health (CONABIOS) |
6. Budget allocated to sustain the research ethics regulatory work | Yes | Yes | Yes | No | Yes | Yes |
7. Scope of the regulation for RECs | Registry, creation and accreditation | Registry and creation | Registry and creation | Registry and creation | Registry, creation and accreditation | Registry |
8. National mandate to promote research ethics training | Yes | No | No | No | Yes | No |
9. Existence of an accredited national research ethics training programme | No | No | No | No | Yes | No |
10. Training programme available for new members of the NREC | No | No | No | No | Yes | No |