What are the rights and obligations of a clinical trial participant?

Participants of clinical trials have rights and they are protected under law when participating in a clinical trial.

A clinical trial may be conducted only if:
(a)  the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests; and
(b)  it is designed to generate reliable and robust data.

To ensure the above conditions are followed all clinical trials in Bulgaria are reviewed and approved by the Ethics Committee for Clinical Trials and the Bulgarian Drug Agency. This is the first level of protection of participant’s rights.  No study can start prior to the appropriate ethical and scientific review and approval. Once the trial is approved, the investigator can start looking for potential suitable patients to take part.

The trial participants have the right to be thoroughly informed about all aspects of the study. This process is managed by the medically qualified site staff, who should explain all aspects of the trial and should ensure people have enough time to consider their participation.

Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects includes explanations of the following:
•    That the trial involves research.
•    The purpose of the trial.
•    The trial treatment(s) and the probability for random assignment to each treatment.
•    The trial procedures to be followed, including all invasive procedures.
•    The subject's responsibilities.
•    Those aspects of the trial that are experimental.
•    The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
•    The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this.
•    The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
•    The compensation and/or treatment available to the subject in the event of trial-related injury.
•    The anticipated expenses, if any, to the subject for participating in the trial.
•    That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
•    That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legal representative is authorizing such access.
•    That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
•    That the subject or the subject's legal representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial.
•    The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.
•    The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
•    The expected duration of the subject's participation in the trial.
•    The approximate number of subjects involved in the trial.

The decision to volunteer is individual and noone may influence or try to persuade a person to consent to grater than a reasonable risk. Participants have the right to know what is going to happen with them. They have the right to refuse to participate in the study. The participant may wish to inform/not to inform his general practitioner about the participation in the study. When new information becomes available either about potential benefits, or risks, the investigator is obliged to share it with the participant.
During the trial the privacy and confidentiality of the participants are maintained. Data collected from the subjects is pseudonymized and coded. The General Data Protection Regulation (Regulation (EU) 2016/679) and the Bulgarian Personal Data Protection Act are followed strictly by the sponsors of clinical trials. In case of doubts, anyone may contact the Commission for Personal Data Protection.

What are the responsibilities of a clinical trial participant?
1.    Adherence to the schedule of events, visits at the clinical research center, or to procedures to be performed at home as instructed by the investigator.
2.    Both schedule of investigational drug intake and doses are important. If any issues arise, the study doctor must be notified as soon as possible.
3.    Reporting about any observation or unwanted medical event and providing all details without delay.