Ministry of Health Resolution No. 908/2020: ethical and operational guidelines for the accelerated ethical evaluation of research in human beings related to COVID-19.
Healthcare & Life Sciences Department report | Ministry of Health Resolution No. 908/2020: ethical and operational guidelines for the accelerated ethical evaluation of research in human beings related to COVID-19
Dear Sir or Madam,
On May 11, 2020, the Ministry of Health of Argentina (Ministerio de Salud de la Nación) issued the Resolution No. 908/2020, published at the Official Gazette today (“Resolution”), by means of which the ethical and operational guidelines for the accelerated ethical evaluation of research in human beings related to COVID-19 are approved.
Under these guidelines, research ethics committees (RECs) should formulate procedures for a rigorous evaluation of research in human beings that, in turn, ensure the existence of quick and flexible mechanisms to respond efficiently to the times and needs of a sanitary emergency. These recommendations seek to guide the RECs in developing operational procedures for an accelerated evaluation of research projects related to COVID-19.
In accordance with these guidelines, the RECs should especially ensure that:
1. The research does not compromise the response to the health emergency generated by the pandemic.
2. The research has social value and is relevant, that is, respond to the health needs or priorities of the people and communities affected.
3. The studies are designed in such a way as to produce scientifically valid results.
4. The participants are selected fairly when a particular group is prioritized over another and adequate public and transparent justification for such prioritization is provided.
5. The uncertainty, risks, and possible individual benefits of experimental interventions are realistically evaluated considering the existing evidence, especially when they are in the early stages of development.
6. A plan to minimize risks due to the health emergency is presented for participants, researchers, and health professionals who carry out research in the context of the pandemic.
7. The informed consent is obtained from the participants or their legal representatives unless the conditions for the exceptions are met in accordance with the Patient Rights Law No. 26,529.
8. It is promoted the obtaining of broad consent for future uses of the samples and data of the participants and affected patients in research aimed at the pandemic.
9. Research results are disseminated, data is shared, and any effective interventions developed, or knowledge generated is made available to affected communities.
The Resolution will enter into force as of May 12th, 2020.
Should you require any further information on this matter, please do not hesitate to contact us.