New blog post with info on clinical trial participant rights

All About Clinical Trials: Participant Rights

Clinical trials are research studies that test new treatments for diseases, such as medications, procedures, and devices. There are also studies to learn about how to detect, screen for, and prevent diseases. Today, there are many regulations, safeguards, and protections to ensure that clinical trials are as safe as possible. Clinical trial participants have rights, and it is extremely important to protect those rights for patient safety and ethics.

Informed Consent 

Many organizations have a participant bill of rights that will list all of a participant’s rights while participating in a study. The study team should show you the organization’s bill of rights or describe your rights to you during the informed consent process. 

Informed consent is the process of ensuring study participants are fully informed about the study before they enroll to participate. In this process, the study team will inform participants about the study protocol, the treatment or intervention involved, possible risks and side effects, and more. They will also go over the participant’s rights and emphasize that participating is voluntary and a participant may choose to withdraw from the study at any time. Participants can also ask any questions of the study team. After going over this information, the participant can choose to consent to participate or not.

Participant Rights

While organizations may have their own specific participant bill of rights, there are some agreed upon rights in the clinical research field. In general, clinical trial participants can expect to have the right to:

  • Be told the purpose of the study, what participation will involve in detail, and how long the study is expected to last
  • Ask questions
  • Change their mind and/or say no at any time
  • Be informed and aware of any potential risks and/or benefits and any discomfort or side effects related to the study
  • Receive a copy of the informed consent document and information on who to contact with questions
  • Receive a treatment if participating a treatment trial (ie a study intervention or standard of care)
  • Keep their private health information safe, protected, and confidential
  • Withdraw from the study at any time without any consequences or judgment and without any effects to their treatment, care, or relationship with healthcare providers