If you’re reading this, you may be considering participating in a clinical study. This is an exciting step in your health journey, but it’s crucial you ensure your rights, safety, and well-being are protected throughout the research process. Advocating for yourself and your health is vital to ensure you get the care you need and deserve.
Before you join a study, make sure to understand the study. You can do this by reading the study protocol and informed consent form. A protocol is a detailed document that outlines a study's plan, including its goals, methods, and how it will be conducted. You can learn about the procedures that you may encounter during the study, how often you will need to attend study visits, and the potential risks and benefits.
Then, take the time to read the informed consent form thoroughly. This document outlines the essentials of the study. If you feel comfortable with the information shared, you can sign the form, which indicates you consent to move forward with the study. If you don’t understand something you read, ask the research team or your physician. It can be helpful to write down the answers you receive so you can remember what was shared with you.
As a research participant, you have rights that should always be respected. These include:
• The right to withdraw from the study at any time: You’re in control of your participation and can withdraw your consent at any point in time. You should communicate with the study team so they can ensure your health and safety are monitored as you leave the study.
• The right to confidentiality: Your personal information should always be protected. You can ask the study team how your information is used and kept safe.
Research organizations prioritize participant safety in clinical studies, but it is still normal to be curious about the safety of an investigational medication. It’s important to know there are numerous safeguards in place for your safety. Before a study even begins, an Institutional Review Board (IRB) reviews the study protocol to ensure it is structured to prioritize participant safety. During the study, the Data Safety Monitoring Board (DSMB) monitors for any safety concerns. Finally, the Principal Investigator overseeing the study is responsible for your health and safety and must report any adverse events you may encounter. They are also prepared to administer rescue medication if needed. Once you are enrolled in a study, consider inviting a close friend, family member, or other care partner to your appointments. They can help ask questions, take notes, and provide emotional support, making it easier for you to advocate for yourself.
You should also make sure to communicate clearly and often with anyone involved in the study. If you have concerns, questions, side effects, or feedback, don’t holdback! Be specific about your experiences with the research team. This will help them with the study and ensure your needs are being met. Keeping a symptom journal can help you track any changes in your health and facilitate easier discussions with the research team. You can have your friend, family member, or care partner help with these conversations if that makes you feel more comfortable.
Stay informed of your health by requesting copies of your test results and other relevant documentation. While participating in the study, you will receive care for your condition and are entitled access to this information. Having a record of your results further ensures you’re always in charge of your health and can refer to previous test results in the future.
Study participation is a two-way street. As a participant, you have responsibilities too. Make sure to:
• Attend in-person or virtual study appointments on time.
• Follow study instructions carefully. Remember to ask questions or read instructions if you are not sure about your next steps.
• Be honest when reporting symptoms to the research team.
• Make sure to stay in contact with the research team and answer their calls or emails. They are there to help you!
Once the study wraps up, ask how and when you’ll be informed of the results. Request a summary of the study findings when they become available. It may take months or years to receive these findings, so be patient.
Finally, don’t forget to share your experience with the research team. Your insights can help improve future studies and enhance the experience for other participants.
At the end of the day, you are an essential partner in the research process by helping researchers develop improved treatments for future patients like you! By advocating for yourself, you not only protect your own interests but also contribute to the overall quality and integrity of the clinical study.