Rights and Obligations of the participants in a clinical trial
Every participant in a clinical trial has their rights defined by law.
The clinical trial itself can only be conducted when it guarantees the rights and safety of the participants.
The Bulgarian Drug Agency is in control of every clinical trial and guarantees the rights of every participant. Conducting clinical trials without approval is out of the question.
All participants have the right to receive the full information about the clinical trial they are part of. The medical staff needs to describe every step of the procedure and to allow the participants to take their time and make a final decision.
What kind of information should clinical trial candidates receive?
The information participants receive usually includes the following details:
- Purpose of the clinical trial;
- Description of the process;
- Details about the investigated medicinal product;
- All procedures that need to be conducted during the trial;
- Participants’ obligations;
- Possible risks and benefits related to the clinical trial;
- Compensations and possible expenses for the participants;
- Confirmation of the voluntary nature of the event (all participants can withdraw at any given time);
- Explanation of the monitoring process conducted by the relevant regulative entities that have full access to the information related to the clinical trial;
- Briefing about the personal data processing and the discreet procedures related to storing it;
- All possible options for connecting with people and institutions that are directly or remotely related to the clinical trial;
- All possible reasons for preliminary termination of the clinical trial;
- Duration of the process and the exact number of participants.
Private data protection
All participants in a clinical trial are not obliged to inform anyone about their participation. Their decision cannot be involuntary. The participants have the right to receive all the details related to changes in the process, the risks, the benefits, and the range of the trial.
All clinical trials are conducted in compliance with the EU 2016/679 Regulation (GDPR). The personal data collected is confidential and in case a participant doubts the process, they should contact the relevant authority immediately.
Responsibilities of participants in clinical research
Every candidate must follow the approved schedule and complete every step from the protocol. Taking the medicinal products in the specified time frame and the accurate dosage is essential. In case of unexpected reactions, adverse events, side effects, or other problems, the participants must report immediately.
Learn more about your rights and obligations here.