Be informed. Protect yourself and others.
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
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.
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.
The consent process should be conducted in a private setting and each element of consent should be explained in detail.
The Investigator should be available to answer all your questions without pressuring you to make a decision on the spot.
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.
Before you consent to participating in a clinical research study, understand your rights.
You have the right to:
