Every clinical study is closely regulated by health authorities, and has to follow strict rules to ensure that everyone who participated is safe.
All clinical studies must follow a study protocol. A study protocol is a plan that explains in detail exactly what will happen in the study.
Before a clinical study can start, it also must be checked and approved by an institutional review board (IRB) or an ethics committee (EC).
What does the IRBs and ECs do?
It’s important that everyone who participates in a clinical study has their rights and welfare protected. That’s where the institutional review board (IRB) and ethics committee (EC) come in.
In the IRBs and ECs, many different types of people are represented. Doctors, scientists, representants from religious communities, and other professionals in medicine are some of the people who usually make up IRBs and ECs. They make sure that different scientific and ethical aspects are considered in a clinical study.
How will my privacy be protected?
When you participate in a clinical study, you are anonymous, and no-one in the research team is allowed to talk about you participating without you agreeing to it first.
Any personal information collected about you is confidential both during and after the study. It’s also important to know that your name will not be listed in connection to any reports about the study.
What are the risks of participating in a clinical study?
Every study has different risks connected to it. For example, the medication can have side effects and not all of them might be known beforehand.
Another thing to consider is that some studies give the active trial medication to one group of participants, while the others are given a placebo. The placebo doesn’t have any active medical components, but plays an important part in understanding if the trial medication actually works.
It’s important to know that your care in the study will be the same no matter if you receive the placebo or the active trial medication.
Can I leave the study?
Yes, you can leave a study whenever you want. Make sure to explain to your doctor or research team why you’re leaving.