The decision of taking part in clinical trials could bring safety questions to your mind like if there are any risks attached to the process, who watches out in case of any problems, and who ensures participants’ safety. Actually, the safety of participants is vital to the success of any trial, and so great importance is placed on it. There are federal rules set in place to make sure participants are safe. You will be protected through:
The informed consent process
Careful review and approval of the clinical trial protocol by scientific experts and the IRB (Institutional Review Board)
Ongoing monitoring of the trial by: the IRB, the body sponsoring the trial, the research team, and the Data and Safety Monitoring Boards (DSMB)
Of course, every trial is different and each person’s health and risks are unique. Any questions concerning safety or the suitability of any trial should be discusses in-depth with the patient’s care team.