Volunteering for research studies: 15 questions to ask
You found a local clinical trial opportunity that you’d like to participate in, and you passed the trial’s pre-screening process. Now you’re ready to sign an informed consent form and start the study. However, before you sign on, you can ask the study team as many questions as you would like. Here are some ideas to get you started as you’re evaluating the study and making your decision.
15 questions to ask before participating in a research study or a clinical trial
Deciding to take part in a clinical trial is a big decision, so don’t be shy, ask the study team whatever questions you may have. Below, we share some of the most common questions patients want answers to before signing an informed consent form.
How long will the study last? Depending on the clinical trial phase, trials can last anywhere from a few months to several years. Find out how long the study will last, and how often you’ll be expected to come to the study site. Since the COVID-19 pandemic started, many sites have gone virtual, making it even easier to participate from home or by traveling to a more convenient location.
What is the goal of the study? Phase I trials test potential new treatments for safety, while Phase II and III continue testing for safety as well as how effective a treatment is. Find out what symptoms the potential treatment aims to address and if there are any other goals of the study.
Will I be paid for participating and reimbursed for my expenses? Some trials offer payment for time and effort, while others simply reimburse travel costs or childcare. Sponsors don’t typically advertise how much they will pay for participation, so we recommend finding a few trials for which you may qualify, then contacting the sites directly to learn more about the study and about potential payment. Antidote’s clinical trial search tool lets you filter by phase and type, which can help you narrow down your search.
Some clinical trial sponsors will pay for participants' travel costs. Payment for travel can take a few different forms. Trials may offer a stipend to participants to cover transportation costs such as reimbursement for gas, mileage, and mass transit fares. Certain trials may even pay for air travel. Increasingly, research sites are partnering with rideshare services such as Lyft and Uber to coordinate rides to site visits free of cost. A trial may also reimburse patients who use these services on their own. Some sponsors work with a recruitment company that coordinates rides for patients. There are also patient travel companies trained specifically in clinical research. With these companies, drivers may be trained to answer questions about participation.
Does the study include a placebo? A placebo is a medication that has no effect. Some clinical trials measure a potential new treatment against a placebo. Others test a new treatment against the existing standard of care.
How will I receive the treatment and/or be monitored? Find out if the treatment will be given to you orally, through an inhaler, with a needle, or by some other mechanism. It’s also critical to ask what sorts of imaging and monitoring will be in place after you receive a given intervention. If, for example, a clinical trial requires you to get an MRI and you’re claustrophobic, then maybe that trial isn’t the right fit for you.
Can I continue taking the study drug after the trial if it works for me? Some research studies will allow you to continue taking the study drug after the end of the trial.
How will my privacy be protected? This is an important question for many people participating in clinical trials. There are several protections in place to make sure clinical trials are safe for participants. The informed consent form is one of the most important pieces of a trial that protects patients. When participants agree to join a clinical trial, they sign this form, which outlines all relevant details and privacy aspects about the trial. Also, an Institutional Review Board (IRB) assesses the protocol of every trial to make sure it’s ethical and that patient rights are protected. In addition, the FDA provides oversight for clinical trials testing new medicines or medical devices. Before human trials start, the FDA reviews applications for new medications and makes sure studies have protections in place for participants.
What can I expect at each study visit? Some trials can take months or years. Get a sense from the study team of how much time each study visit will take and what you’ll be doing while you’re there.
What happens if I leave the study early? Ask about what happens to your care if you decide to end the study before it’s over and what side effects you might incur from potentially coming off an investigational drug.
What happens if my condition gets worse or I am injured during the trial? It’s important to ask about your personal health and safety before joining a trial.
Who will be conducting the study? Ask questions about the background and credentials of the researchers conducting the trial. It’s important that you get to know the key players when it comes to your site visits.
What did previous studies find out about the treatment? Have the results been published? If you are participating in a Phase II or Phase III study, ask about the results from previous trials. You may be able to read about the studies online if they were published in a journal.
What are the potential risks and benefits of the study drug? Ask what effect researchers hope the study drug will have, as well as any side effects that are anticipated or that prior trials have already demonstrated.
Will I receive follow-up care after the study? Ask any questions you have about what happens after the study is over before signing up, especially if the intervention ends up helping you!
Will the results of the trial be provided to me? Find out how the study team will let participants know about results from the study and where they might be published.
Ready to start searching for a clinical trial in your area? Click below to answer a few questions to see if there is a local match.
