If you are a patient who has just been accepted into a clinical trial, one of the most important things you can do to prepare yourself for the experience is to get to know your rights as a clinical trial participant. Understanding the measures that have been put in place for your safety will help make the trial go more smoothly for you and everyone else involved.
The Patient Bill of Rights
Patients are the most important element of any clinical study, and protecting and upholding their rights is always a top priority. As outlined in the Patient Bill of Rights, your rights as a clinical trial participant include the following:
The right to understand the trial’s risks and benefits
Before agreeing to take part in a clinical trial, you have the right to understand all of its elements, especially the benefits you may receive or the risks you may run as a result of participating. These benefits and risks are outlined for you in the informed consent process. You will also receive a printed document that you can use for reference.
In addition to clearly explaining the study’s potential risks, the study team is required to keep you apprised of any new information that may become available during the trial that could be relevant to your participation. They must also tell you, when applicable, about any recognized alternative medical therapies that you could be using.
As part of the informed consent process, you will be asked to sign a consent form agreeing to participate in the trial. Be sure to ask for clarification about any language or terms in the consent form that you do not understand or that have not been explained to you.
The right to ask questions at any time and have your questions answered
You may feel nervous about asking the study team questions about things that are not clear to you, but this is one of your fundamental rights as a clinical trial participant. You are completely entitled, at any time, to ask questions about the consent form, particular details of the trial itself, potential expenses related to trial involvement or associated procedures, whether patients in other trials experienced adverse reactions, or any other subject related to your treatments.
The right to privacy and confidentiality
Researchers collect a great deal of sensitive personal information from you in a clinical trial, and you have the right to know what steps are being taken to protect your privacy. The only people who will ever have access to your personal details in an identifiable form are the trial doctor and the medical personnel helping the doctor run the study. These include representatives of the trial sponsor, the ethics committee involved in trial approval, and local and foreign regulatory bodies (only when required by law). Beyond these cases, your identity will always be protected through a coded numbering system, and the study will never disclose your name and contact information (again, unless required by law).
Medical data and findings from the trial are submitted to the FDA and to the trial sponsor. However, your personal details will never appear alongside this information. Trial results that are eventually published in scientific journals are completely anonymous, and it is impossible to use those publications to identify individual trial participants.
The right to access your own data
You may request a copy of your trial records, either from the trial doctor or from the facility where the trial took place. However, it is important to understand that you might not be able to access this information until after the end of the study. This is because, until results have been published, clinical trial data are extremely confidential, and the sharing of trial information with anyone beyond selected research and sponsor personnel and review and regulatory individuals could compromise the study’s validity, and potentially jeopardize the confidentiality of other patients. Your clinical trial doctor will be able to let you know what information you can and cannot access before the end of the trial.
The right to withdraw for any reason and at any time
Your participation in a clinical trial is and remains completely voluntary throughout the entire trial process. Even after signing a consent form, you may choose to leave the study at any time and for any reason, and you will still continue to receive care and be counselled on your future care options. However, you may be asked to explain what prompted your decision to leave, as trial personnel will need to know if it was something that could be affecting other patients. You will also be asked to complete a final evaluation, which may include additional laboratory tests and a physical examination.
The right to the best possible care
A clinical trial doctor is responsible for providing you with the highest quality medical care possible, including appropriate follow-up care after the end of the trial. This responsibility applies even if you choose to withdraw from the trial before its end. However, it is important to understand that a clinical trial doctor is not a replacement for your regular health care professional. Your usual health care team should continue to have input on your care during the trial in order to avoid repetition of tests and to ensure consistent treatment.