The U.S. Food and Drug Administration (FDA) regulates the clinical research industry to promote safety for research participants and to ensure reliable study data. The FDA routinely inspects research doctors and will impose swift penalties for those doctors not following the rules. In addition to FDA regulations, the clinical research industry has adopted research standards such as Good Clinical Practice (GCP) to promote safety and reliable study data.
FDA regulations and GCP only touch the surface; the following is a list of additional safeguards that promote safety in research. These safeguards allow researchers and research participants to make the best decisions possible when weighing the benefits and risks of a particular study.
Institutional Review Boards (IRB)
The primary purpose of the IRB is to assure the protection of the rights and welfare of research participants. The IRB determines whether the study should be done at all and whether the anticipated benefit to research participants compares favorably to the potential risks involved. Basically, think of the IRB as an advocate for research participants.
The informed consent is one of the main safeguards for protecting the rights and welfare of research participants. The informed consent document must state that participation in research is absolutely voluntary. If a person chooses to participate, he/she may leave that study at any time for any reason and study doctors will not enroll a person into a study without written consent from the participant indicating voluntary participation in research.
Each research study has its own set of eligibility criteria that a person must meet before participating. Part of these criteria is to minimize potential risk for the research participant. For example, a person may be excluded from participation if they have a history of allergic reaction to drugs similar to the one being researched. Another common practice is to exclude individuals that have a medical condition that may increase the risk of harm if they were to participate in a particular research study. It’s vital that researchers find the right participant for the right study.
There are numerous people involved with safety monitoring but it’s required that qualified doctors — through training and experience — conduct research studies. Throughout the duration of a study, doctors provide routine lab work and examinations to research participants to monitor their safety. Study doctors and their staff can be contacted at any time during a study. In fact, communication with study doctors and their staff is highly encouraged. Similar to how a research participant may leave a study for any reason, study doctors may withdraw a person’s participation if that person is no longer a good match due to safety reasons. When a doctor withdraws a person’s participation, it’s common practice to schedule follow-up visits to continue safety monitoring.
Weighing the Benefits and Risks
If you are considering participation in a research study, know that the safety of research participants should always be priority for the study doctor. When speaking with the doctor, ask him/her to explain the potential benefits and risks of participating in that particular study. Furthermore, ask the study doctor what alternative procedures/treatments may be available if you choose not to participate in the study. It’s also a great idea to discuss the study with family before participating. By asking important questions and encouraging critical conversations with doctors and family, you will be empowered to make the decision that is best for you.