Protecting the Rights of a Clinical Study or Trial Participant
Informed consent for a research participant provides all key facts about a clinical study or trial before deciding whether to participate. To help people make a decision, the research team provides an Informed Consent Form explaining all aspects of the study. This includes information about a study or trial including its purpose, how long it lasts, what is expected, and key people to contact with questions. Possible benefits and risks also are explained.
Informed consent is more than signing a form. It’s a learning process that continues throughout the study. It is the participants’ right to know everything about their part in the study or trial. Informed consent makes certain that participants can ask questions and get answers before, during, and after the study or trial.
How can I prepare for a meeting with the research coordinator or team?
- Write down your questions ahead of time and bring them to the meeting.
- Ask a friend or relative to come along for support and hear the responses to the questions.
- Bring a tape recorder to record the discussion and replay later.
What questions should I ask during the meeting?
Consider asking:
- What is the purpose of the study?
- What would be asked of me?
- What would be my role in the study: healthy volunteer or participant?
- Who will be in charge of my care?
- Will the study benefit me?
- Will the study benefit others?
- Why do researchers think that this particular drug or treatment might work?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects and benefits compare with my current treatment?
- How might this study affect my daily life?
- How long will the study last?
- Will hospitalization be necessary?
- Who will pay for my participation in the study?
- Will I be reimbursed for any expenses?
- How will I know if the experimental drug is working?
- Will results of the studies be given to me?
- What type of long-term follow-up care will be required?
It’s a good idea to discuss the Informed Consent Form with family members or friends. Talking about options may help when making the decision about whether to join. Those who decide to join should always keep a copy of the form so they can review it at any time. Informed consent is not a contract. Participants can withdraw from the study or trial at any time.
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Updated 05/18/07
