Are clinical trials safe?

Every clinical trial must follow strict legal and ethical rules to protect the safety and rights of the people who participate. If you are thinking about volunteering for a mental health clinical trial, it is important to talk with your doctor about the potential risks and benefits.

What are the risks of being in a mental health clinical trial?

The risks involved in participating in a clinical trial will depend on the type of study that you join. Before a clinical trial can even start, it has to be reviewed several times by independent experts to make sure that the risk to participants is as low as possible. Though there can still be some level of risk with any research study.  Volunteering to participate in a clinical trial is something to take seriously, and it is important to discuss the potential risks and benefits with your doctor.

Clinical trials are designed to test the safety and effectiveness of new treatments and interventions in people, to find out what works and what doesn’t. This might mean that you could have side effects or receive a treatment that does not end up working to treat your condition. On the other hand, by not participating in a trial, you could miss out on an opportunity to help increase the understanding of your condition, which could help both you and many others.

Every clinical trial must follow strict guidelines about how the research is done and who can participate, to protect the safety and rights of all participants. These guidelines are set by government agencies, ethics boards, and researchers – and address things like:

• Study design: how to answer the research question without putting participants at unnecessary risk
• Monitoring: plans for regular tests and check-ins with participants throughout the trial to ensure safety
• Emergency planning: what to do if someone has a bad reaction or experiences a mental health crisis during the trial

Independent Review Boards

Independent Review Boards (IRBs) play a key role in ensuring clinical trials meet safety and ethics standards. An IRB is a group of people who aren’t involved with the research itself, who review the detailed plans for how a clinical trial will be done. People with different types of expertise – such as doctors, community members, ethics experts, and scientists – participate in IRBs and ask questions like “Is this research necessary?” and “Are the possible benefits worth the risks?” If an IRB does not think that a study meets scientific and ethical standards, then the trial cannot happen.

Informed consent

Before anyone can participate in a clinical trial, they have to give their informed consent. Informed consent means you must fully understand exactly what you’re agreeing to before participating. It includes receiving clear information about the study and signing forms to show you understand and agree. Giving informed consent also protects you if you change your mind about participating in a clinical trial.

Informed consent forms should explain:

• The purpose or reason for the clinical trial
• What will happen during the trial, or what the process looks like
• Potential risks or side effects of being in the clinical trial
• Your rights as a participant,  including the right to stop your participation at any time

It isn’t just important; it’s legally required that researchers make sure that you understand what it means to participate in a clinical trial. You should always ask questions if something is unclear and never feel rushed or pressured to sign anything you don’t truly understand. If you aren’t sure what questions to ask, the National Institutes of Health has a helpful guide with sample questions.

Ongoing oversight

Safety checks don’t stop when a study starts. At different points during a clinical trial, the information or data collected from participants will be reviewed. This is done by groups like monitoring boards, government agencies, and those who fund the studies. If people are experiencing serious side effects or reactions, a trial will be stopped.

Your rights matter

If you decide to participate in a clinical trial, you have the right to say no. This means that you can decline to answer questions, refuse tests or procedures, or leave the trial entirely. Your decisions will not be held against you. Though if you were being compensated for participating in the study, this may stop.

There may always be some level of risk when you participate in a clinical trial, but systems are in place to protect you and your rights. Remember, if you choose to participate in a clinical trial, what matters most is that you feel safe and comfortable with your decision.

If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat 988lifeline.org. You can also reach Crisis Text Line by texting HOME to 741741.