Your rights as a clinical trial participant

Section I

The right to choose freely

Taking part must be your free choice. No one may pressure you, promise you better care for joining or threaten worse care for declining. Payments for time and expenses are allowed, but they should not be so large that they push people to accept risks they otherwise would not.

Section II

The right to leave

You may stop at any time without penalty or loss of benefits you would otherwise have. You do not need to give a reason. The team may suggest a final safety visit and explain what happens to the data already collected, but staying is never required.

Section III

The right to information

You have the right to be told about the study before you join and about significant new findings while you take part, especially anything that might change your willingness to continue. Many studies also share results with participants afterward, and you can ask whether yours will.

Section IV

The right to privacy

Your personal and health information must be protected. The consent form explains who can see your records, such as the study team, the ethics board and regulators, and how your identity is protected in reports. In the U.S., health privacy rules add further protections, and you can ask how your data will be stored and for how long.

Section V

The right to care if you are harmed

The consent form must say what happens if you are injured as a result of the research: whether treatment is provided, who pays for it, and whether compensation is available. Policies differ widely, so read this section carefully and ask questions if it is unclear.

Section VI

The right to raise a concern

Every study has an ethics board, often called an institutional review board in the U.S., that reviewed the study and protects participants. Its contact details are on the consent form. You can contact it with questions or complaints, including anonymously, if you do not feel comfortable raising an issue with the study team.

Section VII

Rights that come with practical help

Rights are easier to use with a little preparation. Keep your copy of the consent form where you can find it, note the coordinator’s number in your phone, and write down the date of each visit. If you ever feel rushed, it is reasonable to say “I would like to think about this and call you back.”

Family members and friends can help you ask questions, but the decision to take part, stay or leave remains yours alone.

Participant rights checklist

• Confirm that joining is voluntary
• Find the sentence on leaving at any time
• Ask how new information will reach you
• Read the privacy section carefully
• Read the injury and compensation section
• Note the ethics board’s contact details
• Ask whether results will be shared with you
• Keep your copy of the form somewhere easy to find

Reference table

Terms used here

Institutional review board

A U.S. ethics committee that oversees research with people.

Without penalty

Without losing care or benefits you would otherwise have.

Undue influence

Pressure or rewards that sway a free choice.

Research injury

Harm caused by taking part in a study.

Privacy officer

The person responsible for protecting records.

Significant new finding

Information that could change your decision.

Questions to put to the study team

1. How will you make sure I hear new information quickly?
2. What happens to my data if I leave?
3. Who can see my records, and how are they protected?
4. What care is available if I am harmed by the study?
5. How do I reach the ethics board?
6. Will I receive the study results?