Clinical trials play a key role in the development of new treatments and medical technologies. At the heart of every trial, however, is the patient - the person who voluntarily decides to participate and contribute to the advancement of medicine. His or her rights are therefore strictly protected by uniform ethical standards and legal regulations. What are the rights of a patient as a trial participant?
Prior to the start of participation, each patient is given clear and detailed information about the aims, methods, potential benefits and risks of the trial, and their responsibilities as a participant. It is extremely important that before signing the informed consent form the patient has asked any questions they have of the investigating physician in order to be fully aware of the study in which they are about to participate. Participation begins after the patient has read the details and signed the appropriate form.
However, signing the form does not mean that the patient is obliged to continue participation until the end. The patient has the right to withdraw at any time, without giving an explanation and without this negatively affecting his/her further treatment or the relationship with the healthcare staff.
All participants' personal and medical data is treated confidentially, in accordance with current legislation, including Regulation (EU) 2016/679 (GDPR). Study sponsors take significant measures to comply with data protection regulations - information is stored using encryption so that patient identity remains protected.
During each study, participants' health status is closely and carefully monitored by a qualified medical team. If necessary, action will be taken to protect the patient, including temporary interruption or complete termination of participation if this is considered the safest option. The welfare of each patient is the first priority in all studies.
If new information arises during the trial that may influence the decision to participate - for example, newly discovered risks or alternative therapies - the patient has the right to be informed in a timely manner.
If the participant believes that his/her rights have been violated, he/she can file a complaint with the ethics committee, the study director or the relevant regulatory institution, in this case the Medicines Agency (MAA). The informed consent forms given to patients contain the details of the Bulgarian Ethics Committee for Clinical Trials (ECCT) as well as an independent contact person who can be contacted at any time.
Participation in a clinical trial is an important and personal choice. It should be done on the basis of awareness, voluntariness and mutual respect. Each patient has not only responsibilities but also clearly established rights that guarantee their safety and dignity.
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