Patients’ Rights and Safety in Clinical Trials

Learn about Participants Rights in Clinical Trials

You must provide Informed Consent

Before you decide to join any study, you will have to talk with either your doctor or the research team about the study. They will explain everything you need to know about the study, what you’ll do as a participant, and any possible risks involved.
After you understand what’s involved in participating in the study, you'll be asked to sign an Informed Consent Form. This form confirms that you understand everything and agree to take part in the study before you officially join.

Please be prepared;consent forms are long and contain a lot of information. It is best if you review the consent form with your healthcare provider, who can help you understand the information.

Your participation is Voluntary

You have the right to choose whether to continue or leave the study at any time (withdraw consent). If you decide to stop, researchers will follow up with you.

Participating in a clinical trial may require a commitment of your time, but you can always ask your research team for details about the specific time commitments involved.

Although you can leave a clinical trial at any time, be sure to first talk to your doctor or nurse, let them know why you want to leave, and ask for their advice. It is important to have your doctor monitor your health if you decide to stop the clinical trial to make sure you are healthy.

Your Anonymity, Your Confidentiality

Any information you provide during the study will be kept confidential, and your identity will remain anonymous. Your personal details will not be shared with anyone outside of the research team without your permission.

You have the right to receive Support Services to help you while you are participating.

You have the right to request support services throughout the clinical trial.

Depending on the clinical trial, you may have access to language services, transportation services, emotional support services, etc.If you need help or have any questions, reach out to your research team.

*Here are some additional resources if you are interested in learning more about patient safety in clinical trials:

National Cancer Institute’s “Patient Safety in Clinical Trials” video:

Center for Information and Study on Clinical Research Participation, Inc.’s (CISCRP) clinical trial resources here.

Questions to ask the research team (information about the clinical trial)

“Ask these questions as you consider participating in a clinical trial...”

What is the purpose of this clinical trial?
What tests or procedures are involved?
How will my health and safety be monitored while on the treatment?
Why do researchers think the treatment will work better than standard (FDA-approved) treatments?
Is the clinical trial drug better or riskier for me than no treatment?
How many people have tested the drug and what has happened to them?
Will I be told whether I will be receiving the clinical trial’s drug or the current standard of care? How would receiving either affect my health?
What will happen to my hepatitis B infection and liver health when I stop taking the trial drug?
If I do not receive the clinical trial’s drug as part of a randomized trial, will I have the opportunity to do so at a later time, if the drug is approved?
What are the potential benefits of participating?
Are there any specific requirements I need to meet to participate?
How long will the study last, and what will be required of me during that time?
Where is the site located and how often will I need to go there?
What services or support will be offered to me while I participate in the trial?
Will I have to pay for any part of the trial or will my insurance pay for it?
Who will pay for my transportation, accommodation, or meals, if I need them?
Will I get paid for participating?
Will I still be able to see my regular doctor while participating in the trial? How can my regular doctor access my labs and follow up on the progress of my health?
Will I be able to access the results of the study once it's completed?

Learn about Participant Safety in Clinical Trials

Ensuring your safety before participating in clinical trials:

Before you participate in a clinical trial, independent committees, like Institutional Review Boards (IRBs) or ethics review boards, review the trial proposals to ensure they are ethical. These committees make sure your information stays confidential, and your safety is protected.

Patient safety is a top priority. Before recruiting participants, drug sponsors must get IRB approval for their study protocol, which includes detailed safety measures and any potential risks.

Click here to go to the FDA website, to read more information about the IRB rules for clinical trials conducted in the U.S.

Some regulations may differ if you are outside the US. Please ask your research team/ clinical trial doctor about the clinical trial’s safety regulations when deciding to participate.

Inherent risks

What are Inherent risks?

The National Institutes of Health (NIH) explains that “most clinical trials pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research.” *

Risks could range from minor to major health risks. An example of potential risks is:
Minor discomfort for a short time (like redness of an injection site)

Throughout the study, participant safety is monitored by the research team. The study may be changed or stopped if participants’ safety is put at risk.

*Click here if you would like to learn more about the benefits, risks and safety measures for clinical trials. You can also read more here.

Questions you can ask the Research Team (about participation and after enrollment)

“You can ask these questions throughout your enrollment in the clinical trial...”

What are the possible risks and benefits of participating in this clinical trial?
What are some potential side effects I may experience while participating in this study?
Who should I report these (if any) potential side effects to?
Who provides my healthcare treatment if I get any side effects from the trial drug?
What happens if I experience a health issue during the trial?
Will I be able to continue the clinical trial medication after participation? Will I be able to return to my normal medication after participation?
If I experience health issues after stopping the clinical trial, how will the team help me? (For example: if I have any health concerns, or need advice for dealing with side effects?)
How will the research team determine if the new symptoms are caused by the trial drug or by my pre-existing or changing health conditions?
How long does the healthcare coverage provided by the clinical trial team last if I experience side effects after the trial has ended?
What is my follow-up care after the clinical trial ends?