Part 3: the legal aspects of the authorisation itself
If the authorisation has not been granted by the Bioethics Committee
If the Bioethics Committee refuses authorisation or withdraws it, the sponsor and/or principal investigator have the right to appeal against the decision through the ‘Lithuanian Bioethics Committee’ (LBEK) but must do so within fifteen calendar days of the date upon which the decision is received. The LBEK decision may be appealed through the courts in accordance with procedures which are laid down by the appropriate legal acts.
If the study was planned to be conducted throughout all of Lithuania and the decision not to grant authorisation was taken by the LBEK, that decision may be appealed in court within thirty calendar days.
You already have authorisation but there is a need to modify the study
If you plan to make any modifications to the trial, you must submit any modifications to the dossier to the authorising Bioethics Committee, duly documented, and thereafter obtain approval by the Bioethics Committee. Following an assessment of the dossier, authorisation will either be provided in a letter which is issued by the Bioethics Committee, or the decision will provide reasons for any refusal to approve the requested modifications.
Authorisation for a biomedical study will remain valid until the date upon which the relevant study is completed as specified in the study application. The need may arise to extend the duration of a study. In this case, an updated application must be submitted by the clinical study centre, signed by the study centre head, along with an interim summary of the study report.
Authorisation withdrawal
In the event of any violation of biomedical ethics, the Bioethics Committee may decide to withdraw authorisation, which implies the immediate termination of the study and has obvious negative consequences for the sponsor (whether financial, reputation-based, or otherwise).
At the end of the investigation
Following the conclusion of the study period, the sponsor or principal investigator is obliged to notify in writing the authorising Bioethics Committee within thirty calendar days of the end of the trial, and to submit a summary study report in the required format within a time limit of ninety calendar days.
Conclusions
In summary, the smoothness and duration of the authorisation process depends to a large extent upon the quality of the documents being submitted, and overall knowledge of the legal requirements and deadlines. Mistakes increase the length of the authorisation process and, consequently, the duration of the study period, and can sometimes lead to a refusal to issue authorisation. It is therefore advisable to take legal advice in connection with any and all issues which may arise during the authorisation process.
If you have any specific questions about filling in the paperwork for a study authorisation or if a permit has been refused and you wish to appeal against the decision, please contact us for an individual consultation. We are looking forward to hearing from you.