Your rights as a research participant
Regulations and guidelines governing research with humans offer a series of protections to research participants. It is essential for you to know your rights even though compliance with these regulations is closely monitored by the research team, the research sponsor and its representatives, research ethics boards, and regulatory agencies. Take an active role as a participant to uphold your rights and the quality of the research study.
Before agreeing to participate in a study:
Access resources to educate yourself about research
Learn about existing safeguards that protect you
Browse a list of questions you may want to ask
Get all the facts you need to make an informed decision.
An integral part of knowing your rights as a clinical research participant, is also understanding your responsibilities. To protect your welfare and the welfare of others as well as ensure that clinical research is scientifically valid, it is crucial for you to be truthful during the screening process, respect study requirements, follow instructions for drug administration, report all adverse reactions, and be curious so you can ask questions to stay informed.
What you need to know as a research participant
Your participation in a clinical trial is completely voluntary. You can discuss this with your family, friends, or other key people but the decision of whether to participate or not is entirely up to you. It is essential for you to know your rights and have the necessary details to make an informed decision. If you decide to take part in a study and change your mind after giving consent, you have the right to stop without having to explain why. To safely withdraw from the study, some procedures or interventions may be necessary.
What to expect from the consent process:
Information about a study is usually given in writing using an informed consent form written in a language you can understand.
Free and Informed
What if I have questions or concerns about my participation?
Research participants are encouraged to communicate with the research staff about concerns or questions. But if you want to make a complaint or report a violation, the informed consent form should include information about who to contact.
Know your rights
Before you consent to participating in a clinical research study, understand your rights.
You have the right to:
- Know the purpose of the clinical research study
- Know what will be done to you during the clinical research study
- Know the potential risks and discomforts resulting from participating in a clinical research study
- Know the potential benefits resulting from participating in a clinical research study
- Ask as many questions as necessary to make an informed decision and to continue asking questions throughout the clinical research study
- Take the time you feel is necessary to decide whether or not to take part in a clinical research study and to make that decision without being pressured
- Show the informed consent form to your spouse, relatives, friends, or anyone you consider important, before deciding whether or not to take part in a clinical research study
- Receive a copy of the signed informed consent form from the researchers
- Know the name and contact information of the physician conducting the study, in case you have questions
- Know the telephone number of the research ethics board that reviewed and approved the study in case you have questions concerning your rights as a research participant or the study physician’s responsibilities
- Refuse to participate in a clinical research study
- Withdraw from a clinical research study at any time. This decision will not jeopardize your medical care