Kutatásetika és kutatásszervezés a SARS-CoV-2 vírus okozta világjárványban
Authors: Mandl József 
Published: October 2021

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.