On 30 April 2021, the Clinical Trials Department of the Turkish Medicine and Medical Devices Authority (“TITCK”) published their updated ‘Frequently Asked Questions’ information regarding Clinical Trials (“FAQ”), which was first introduced on 1 December 2019. The updated FAQ can be seen here (available in Turkish only).
The Clinical Trials Department previously published an FAQ on Precautions to be Taken by the Ethics Committee Due to the COVID-19 Pandemic on 5 May 2020, and an FAQ regarding Measures to be Taken in Clinical Trials Due to the COVID-19 Pandemic on 25 July 2020, in order to eliminate uncertainty stemming from the COVID-19 pandemic.
What does the FAQ Say?
In the updated FAQ, TITCK has considered the current needs of clinical trials in practice, introducing 34 new questions and answers, which brings the FAQ’s total to 139.
In general, the updated FAQ reveals the following:
the insurance coverage required if a clinical trial involves pediatric volunteers,
- the definition of the protocol code,
- the requirements for making applications and related processes regarding investigator-initiated research,
- conditions for making applications and revisions made by TITCK,
- the scope of treatment methods in TITCK’s mandate, and the paperwork required for these treatment methods,
- whether refugees/immigrants should be included in clinical research,
- procedures and principles that should be considered in Clinical Trial Applications to the Ethics Committee and the activities of the Ethics Committee.
What are the highlights?
In addition to those already mentioned, the updated FAQ also answers to-the-point questions frequently encountered in practice by clinical trial parties.
- Should Updated Consent Forms be Obtained from Volunteers?
Volunteers or their legal representatives should be informed immediately of new information obtained during research that may affect their decision to continue. The new information must be duly documented, and updated consent forms should be obtained as soon as possible.
- Can electronic informed consent forms be used in Turkey?
Regarding the question of whether electronic informed consent can be used for the purpose of the clinical trials, TITCK has stated it can only be used during the notification phase of the process. Therefore, in accordance with related regulations in Turkey, TITCK has emphasized the use of printed consent forms as the only valid means for consent transactions.
For the purposes of the FAQ, electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent.
- Can informed consent be obtained remotely?
Due to restrictions relating to COVID-19, and in an effort to maintain social distancing, clinical trial parties expected to be given permission to obtain informed consent remotely. However, on the grounds that there is no procedure to obtain informed consent remotely in Turkey and consent procedures should be carried out at research centers with research teams and volunteers (including legal representatives, impartial witnesses, etc.), TITCK has stated that methods such as obtaining consent by telephone, cargo, courier, etc., are not valid.
The aim of the updated FAQ is to meet the needs of clinical trials practice that have arisen since its original publication. TITCK continues to guide parties involved in clinical trials. Accordingly, it is strongly recommended that clinical trial parties regularly review the TITCK and its related departments’ announcements, guidelines, and instructions.
Kemal Altuğ Özgün