Clinical trials play a vital role in advancing medical and nutritional science, but for many potential participants, questions about safety are a natural concern. Fortunately, clinical trials are built on a framework of well-established safeguards designed to protect the health, rights, and well-being of everyone involved.
Understanding these safety measures can help volunteers feel more confident and informed when deciding whether to participate. Let’s take a closer look at some of these safeguards.
Before any clinical trial begins, it must undergo a rigorous review process by an Institutional Review Board (IRB) or Ethics Committee. These independent groups are made up of medical professionals, scientists, and community members who evaluate the study’s design to ensure that it meets ethical standards and that potential risks are minimized.
In addition, regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) often provide oversight, especially in studies involving new drugs, devices, or biologics. These organizations ensure that trials are scientifically sound and ethically conducted.
One of the most important safeguards in any clinical trial is the process of informed consent. Before joining a study, participants are given a clear explanation of the purpose, procedures, potential risks, and benefits. They are also informed of their rights—including the right to withdraw from the study at any time without penalty.
Informed consent isn’t just a one-time form; it’s an ongoing conversation between participants and researchers. This helps ensure that individuals are making voluntary, well-informed decisions throughout the study.
To protect participant safety, researchers use strict inclusion and exclusion criteria when selecting volunteers. These criteria are designed to ensure that only individuals who are likely to tolerate the intervention and benefit from participation are enrolled. For example, someone with certain health conditions or taking specific medications may be excluded to avoid potential complications.
Thorough pre-screening assessments—such as medical history reviews, blood work, or physical exams—help confirm that a participant is a good fit for the study.
Once a trial begins, participant safety remains the top priority. Researchers conduct regular check-ins, lab tests, and health assessments to monitor how individuals are responding to the intervention. Any unexpected side effects or changes in health are documented and evaluated immediately.
In many trials, a Data Safety Monitoring Board (DSMB) is also involved. This independent group periodically reviews trial data and can recommend modifications or even halt the study if safety concerns arise.
Every clinical trial has procedures in place to respond to any adverse events or medical issues. Participants are given contact information for the study team and are encouraged to report any problems, no matter how minor they may seem. In the event of a serious reaction, researchers will provide or coordinate appropriate medical care and may discontinue the intervention if necessary.
Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.