Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps

• Published in: Vaccine 2020-10, Vol.38 (45), p.6975-6978
• Main Authors: van der Graaf, Rieke, Macklin, Ruth, Rid, Annette, Bhan, Anant, Gefenas, Eugenijus, Greco, Dirceu, Haerry, David, Hurst, Samia, London, Alex John, Saracci, Rodolfo, Sprumont, Dominique, van Delden, Johannes J.M.
• Format: Article
• Language: English
• Subjects: Biomedical Research; CIOMS guidelines; Cluster-randomized trials; Community involvement; Community participation; Design; Ethical standards; Ethics; Ethics Committees, Research; Ethics, Research; Guidelines; Humans; Immunization; Informed Consent; International organizations; Intervention; Malaria; Malaria Vaccines; Medical ethics; Meningitis; Mortality; Norms; Parents & parenting; Public Health; Research ethics; Reviews; Vaccines; Vector-borne diseases; Waivers; WHO
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2020.08.077

•It is prudent to apply ethical norms for research involving humans to the WHO MVIP.•The MVIP might not meet the requirements of informed consent, independent ethical review, and social value.•WHO should make the MVIP protocol publicly available.•Independent ethical review should be conducted and fully informed consent obtained.•Communities should be engaged and alterable aspects of the MVIP should be altered. In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans. We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS’s social value requirement. We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.