While there are potential risks involved with being in a research study, there are several rules and regulations that studies must follow to keep patients as safe as possible.
For example, in the United States, each study must first be approved by an Institutional Review Board, or IRB. In Europe, an Ethics Committee approves each study. The IRB or Ethics Committee is designed to protect the patients who participate in research studies.
These groups are made up of scientists, doctors, and people from the local community who are not involved in healthcare. IRBs and Ethics Committees review a study to see that it is well designed, will protect the patients involved, and that the risks are reasonable when compared to the potential benefits. After a study begins, the IRB or committee continues to monitor it to make sure it's still safe for the participants.
Next, any well-run study is carefully reviewed by people at the research facility to make sure it's ethical, safe, and scientifically sound. Every study should monitor the study data and the patients' safety on an ongoing basis.
The informed consent process, which we talk about in the main presentation, also helps protect patients. The consent process is designed to help patients truly understand the study before they decide whether or not to participate.
Finally, while participating in a study, you should NOT be in any other research study without the approval of your healthcare providers. This is to protect you from possible injury from things like extra blood draws or x-rays, bad interactions of the research drugs, or other similar hazards.