Lithuania: Biomedical research authorisation process

2. Part: Biomedical studies

Biomedical study protocol

One of those documents which must be submitted to the Lithuanian Bioethics Committee is the ‘Biomedical Study Protocol’. Some parts of the protocol must of course be drafted by those scientists who are involved in the study (study rationale, methodology, phases, detailed descriptions of the outcomes to be evaluated, and so on). However, there is a real need for a legal approach when it comes to accurately and correctly filling in the entire protocol. This particularly concerns the section which covers the interests of subjects, the handling and protection of personal details, and safeguards to ensure the confidentiality of the data of subjects. This is especially the case if the subject’s health details and/or samples will be transferred to third countries which lie outside of the scope of the GDPR as part of the intended trial.

Who can be an investigator?

It should be noted that the provision of the ‘Law on the Ethics of Biomedical Research’ which regulates the requirements for investigators has in fact changed several times. According to the current regulations, an investigator must have a higher education qualification which is appropriate to the nature of the research. The principal investigator must also have experience in biomedical research which is appropriate to the nature of the study and should have participated as an investigator in at least one study.

Additional requirements are imposed upon the investigator if they are to be using an interventional biomedical study method which poses a risk to the subject’s health, in which case they will also need to hold an appropriate licence as a personal healthcare professional, possess experience in patient care, and be employed in a research centre. Please note that the format for an investigator’s CV is also regulated. Any CV which is not in Lithuanian or is drafted in another format will be rejected by the experts of the Lithuanian Bioethics Committee.

Compensation for possible harm to the subject

An important aspect is to specify compensation procedures in relation to the prospect of harm being suffered as a result of participation in the trial.

Material and non-material damage which may be caused to the subject, unless caused by the wilful misconduct of the subject themselves or for reasons which remain unrelated to the trial, will be jointly and severally compensated by the study sponsor and the investigator in accordance with those procedures which have been laid down by the ‘Civil Code and the Insurance Act’.

Such persons are therefore obliged to insure their civil liability by means of compulsory civil liability insurance for the sponsor and the principal investigator in the event that those interventional methods which are to be used for the purposes of the study pose a risk to the health of the subject.

It is a different situation if the person participating in the study will be subjected to interventional methods which cause only minor adverse temporary effects on their health. The healthcare institution which is itself the sponsor or with which the investigator is an employee, may carry out the study without having in place any compulsory civil liability insurance for the sponsor and the principal investigator.

In such cases compensation for any potential damage which may be caused to the subject will be provided in accordance with the procedure which is laid down in the ‘Law on Patients Rights and Compensation for Damage to Health’, and from an account which is managed by a state body into which are collected contributions from healthcare institutions in the knowledge that such contributions may be used to provide compensation for damage to patient health.

The Lithuanian Bioethics Committee which authorises the study will assess whether the interventional methods which are being used for the purposes of the trial in fact pose a risk to the subject’s health. Therefore the question of whether or not civil liability insurance is necessary in order to avoid making a mistake does in fact require an accurate assessment of the impact on the subject of the interventional study, as well as clarification in regards to whether the research centre is covered by civil liability insurance and whether the insurance contract provides for coverage in connection with biomedical studies.

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