Kutatásetika és kutatásszervezés a SARS-CoV-2 vírus okozta világjárványban

Összefoglaló. A klinikai orvosbiológiai vizsgálatok elkezdéséhez a kutatásban részt vevők biztonságát ellenőrző Egészségügyi Tudományos Tanács (ETT) kutatásetikai bizottságainak hozzájárulása szükséges. A járványt csak tudományos eredményekkel lehet legyőzni, ezért kitörésekor gyorsították a COVID–19 kutatási protokollok bírálatát. A koronavírus világjárvány szükségessé tett egy megváltozott kutatási adatkezelést is. A járványok megoldása a megelőzés. Bár a vírusellenes vakcinák adása hamar megkezdődött, ami jelentős tudományos teljesítmény, mégis tudományellenes hullám söpör végig a világon, és a kötelező védőoltások körüli jogi, etikai viták fellángoltak. Áltudományos érvelésekkel félrevezetnek embereket. Az ETT nemzeti kutatásfejlesztési programot javasolt a járvány következményeinek leküzdésére. Summary. Biomedical research activities are subjects to prior professional-ethical approval. ETT (the Medical Research Council in Hungary) through its research-ethics committees ensures the safety of people and protects their interests and health in various clinical investigations and trials. Thus, science, ethics, and safety cannot be separated in biomedical research. The ETT operates three national ethics committees. The opinions of ethical bodies are binding; clinical and biomedical research may not be initiated without the consent of the relevant ETT committees. This is in line with international regulations. The ETT has published the “Codex of Bioethics. On the concepts and practice of biomedical research” on its website. When the epidemic broke out, the ETT Presidency initiated immediate legislative changes that allowed for online meetings as well as digital consent to investigations, in addition to the previously exclusive personal ones. In the epidemic, time became the determining dimension, but this and the aim of the research could not be combined with such “lightening” that would endanger the safety and interests of the participants in the COVID studies. Thus, under the still strict requirements, the time for reviewing the COVID-19 protocols had to be radically shortened. However, the ETT research ethics committees also rejected submissions during the epidemic. A total of 171 COVID-19-related research protocols were approved in Hungary in 2020. The ETT Presidency initiated a national Research and Development program on infectious diseases, a call for scientific clinical R&D proposals on COVID-19, and also elaborated its priorities. Throughout human history, the solution to epidemics has always been to prevent the spread of disease through vaccinations. The average production time for traditional vaccines is about 15 years, whereas in the year of the SARS-CoV-2 virus pandemic outbreak, mass vaccinations began with completely new coronavirus vaccines partly made using brand new molecular biology technology that had never been used before. Despite the tremendous professional scientific achievements, a wave of hostilities is sweeping across the world, and the ethos and successes of science, and scientific communities in research are being questioned when their roles are dominant and outstanding. The concept of compulsory vaccination has been arguably classified as a human right. With this, the world of vaccinations was tied to concepts that it really had nothing to do with. Arbitrary pairing and joint treatment of remote concepts favours the spread of fatal diseases such as measles and poliomyelitis, for which there are already vaccines. Meanwhile, pseudosciences are misleading the public. The coronavirus pandemic has also necessitated changes in data management. The ETT has previously initiated a number of legal and professional proposals on health data management and access to research data, and has developed its own data protection rules following the introduction of the GDPR.