Is a Researcher Responsible for the Harm to the Participants Health Which Arises from Clinical Research, If the Participant Has Been Properly Informed About the Risks and Agreed to Participate in the Clinical Research?

Tarptautiniai, Europos Sąjungos bei Lietuvos Respublikos teisės aktai reglamentuoja tiriamųjų asmenų priežiūrą vykdant biomedicininius tyrimus. Prieš įtraukiant asmenį į biomedicininį tyrimą privaloma gauti informuoto asmens sutikimą, kuriuo asmuo informuojamas apie galimas rizikas būti sužalotu dalyvaujant biomedicininiame tyrime bei kompensacijos už tai skyrimą. Nagrinėjant informuoto asmens sutikimo institutą išsiaiškinta, kad jis įgyvendina asmens autonomijos principą, bet nepaneigia teisės į kompensaciją už patirtą žalą, susijusią su dalyvavimu biomedicininiame tyrime. Teisės aktuose įtvirtintas aukščiausio atsargumo ir rūpestingumo standartas tyrėjui prilygsta gydytojui keliamiems reikalavimams. Galima daryti išvadą, kad tyrėjas kaip ir gydytojas privalo atsakyti už padarytas klaidas, kurios lėmė neigiamas pasekmes tiriamojo sveikatai. Išanalizavus Europos Sąjungos direktyvas bei Lietuvos teisės aktus nustatyta, kad įtvirtintas privalomas tyrėjo bei užsakovo civilinės atsakomybės draudimas, kuris užtikrina minimalią kompensaciją tiriamajam už patirtą žalą. LR Pagrindinių tyrėjų ir biomedicininių tyrimų užsakovų civilinės atsakomybės privalomojo draudimo taisyklėse nustatyta, kad tyrėjas bei užsakovas gali apsidrausti dvigubu draudimu, taip sudarant teisėtą galimybę tiriamajam tikėtis ir reikalauti visos žalos atlyginimo, kurios kilimas susijęs su dalyvavimu biomedicininiame tyrime. Tačiau pastebėtas teises aktų prieštaravimas vienas kitam, todėl lieka neaišku, už kurias kilusias neigiamas pasekmes tiriamajam privalo būti atlyginta. Teisės aktai tik bendrai pateikia nurodymą, kad tyrėjas bei užsakovas atsako solidaria atsakomybės forma, nedetalizuojant kiekvieno teisinio subjekto atsakomybės skirstymo konkrečiu sužalojimo atveju. Iš teisės aktų analizės galima daryti išvadą, kad egzistuoja galimybė reikalauti žalos atlyginimo iš tyrėjo, remiantis civilinės atsakomybės forma. Lietuvos teismuose nėra nagrinėta, kokia apimtimi tyrėjas atsakytų nustačius jo kaltus veiksmus. JAV teismų praktikoje rasta bylų, kuriose civiline atsakomybės forma atsako tyrėjas arba užsakovas. JAV nėra nustatytas privalomas tyrėjo ar užsakovo civilinis draudimas, todėl sužalotas asmuo siekdamas kompensacijos gavimo - privalo kreiptis į teismą ginčo teisena.A doctor’s work consists of using available knowledge to help patients recover as soon as possible. This is achieved by applying already tested methods, drugs and equipment. Medicine is always improving and new treatments are constantly being created by applying new technologies and drugs. Medical treatment always involves some form of intervention to the person’s body, but before it can be applied to the patient, it must be tested and evaluated. That is why we have biomedical research, with the aim to check the effectiveness of new drugs and discover the negative side effects they may have. The treatment and participation in biomedical research always includes a certain intervention to the person's body, but the lawyers and the judiciary are in agreement that the patient has the right to redress, which arises from improper and careless medical mistakes. Therefore, the aim of the work is to find out whether the person taking part in the biomedical study is entitled to compensation following illegal or careless actions by the researchers. The work raises the question whether a person is deprived of compensation for the damages suffered, because he gave informed consent, since the Lithuanian legislation does not provide information about the extent of responsibility of the researcher and sponsor Biomedical research and the supervision of subjects in biomedical research is governed by international laws, European Union laws and the laws of the Republic of Lithuania. A Large majority of protections to subjects is contributed by the Nuremberg Code, which enshrines the 4 principles that must be upheld in order to allow persons to be involved in biomedical research: 1. The person must voluntarily agree to participate in the test. 2. The test must be for the good of the public. 3. The test must strive to avoid unnecessary physical and emotional suffering. 4. The patients do not face a higher risk than the possible benefits of testing. Later legislation laid down the details about the protection of research subjects, such as the Helsinki Declaration, the Belmont Report and Good Clinical Practice. They established the mandatory informed consent of persons participating in biomedical studies. By examining the institute of informed consent it was found that it implements the principle of personal autonomy. This means that the person, who is the subject of biomedical research, decides what suits him best. Before enrolling in biomedical research, informed consent must be given, the person shall be informed about the potential risks of being injured in the course of biomedical study. This means that the person must be presented with all the available information regarding the studies carried out with people or animals. The person must be informed about compensation for injuries sustained in the biomedical study. The consent to the test means that a person voluntarily agrees to participate in the biomedical study and accepts the risks involved, but does not waive the right to compensation for the damages he may suffer. The law enshrines the highest standard of care and diligence for a researcher, equivalent to the requirements for doctors. It can be concluded that the researcher, just as the doctor, must answer for his mistakes which led to the subject's negative health consequences. The analysis of the European Union directives and Lithuanian legislation shows the existence of mandatory liability insurance for the researchers and the sponsors, which guarantees the minimum compensation for the damages suffered by the subject of the research. However, each country establishes a different minimum insurance award. This implies that subjects may receive a different amount of compensation, even though they are involved in the same sponsor's biomedical study. Researchers and biomedical research sponsors' civil liability insurance rules provide that the researcher and the sponsor can take out multiple insurance policies, thus, persons can expect to receive all damages that can be associated with participation in a biomedical study. However, there is a conflict of law, and it is not clear who is responsible for the negative consequences of the biomedical research. Legislation provides only a general indication that the researcher and the sponsor are responsible under joint and several liability, however terms for distribution of liability, according to specific injuries, are not provided. The legislative analysis leads to the conclusion that a possibility of claiming damages from the researcher, based on the conditions of civil liability, exists. The paper also examines the conditions of the researchers' responsibility. It was found that the researcher will not be responsible for a person's health problems if the person has neglected their health. Also the researchers or other medical practitioners treating the person will not be responsible if the person did not provide necessary information about his state of health, as in such a case, the researcher's decision to allow the person to participate in the biomedical test would be influenced by incorrect information. If the sponsor terminates biomedical research, and because of that, the subject suffers negative health consequences, the researcher will not be liable for the damages, since such actions do not depend on the will of the researcher. US regulation provides that a person, who has given informed consent, is not entitled to compensation. The person should have been aware that there may be a risk of getting injured. The US legal system does not require the researcher or the sponsor to have liability insurance. In order to get redress, the injured person must go to the courts and engage in legal proceedings. Examination of US case law has revealed cases in which civil liability was applied to researchers or developers. Lithuanian courts do not have any practice from which a conclusion could be drawn about the responsibility of a researcher if he was held to be liable for the harm done to the subject in the course of biomedical research.Teisės fakultetasVytauto Didžiojo universiteta