Before you participate in a research study, you will be given complete information about the study. This is known as “Informed Consent”. The informed consent form provides a potential participant with a summary of the research project including the purpose, procedures, benefits and risks. The document will also explain the individual’s rights as a participant. The informed consent process will also consist of conversations between the research team and the participant. The informed consent process provides participants with ongoing information to help them make a decision whether to begin or continue participating in a clinical research study. The informed consent process also provides participants with an opportunity to ask questions about the study and their participation. Should you want time to review the informed consent, you will be given a copy of the document so that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors before agreeing to participate in the clinical trial.
As a participant you are a partner in the research study. You always have the right to continue to ask questions and get answers at any time during your participation in a trial. It is part of the researcher’s job to help answer your questions and help you understand anything that may not be clear.
Typical contents of an informed consent form include:
- Purpose of the study
- Study procedures and visit frequency
- Subjects’ responsibilities
- Possible risks
- Possible benefits
- Alternative therapy
- Right to withdraw from study
- Reimbursement of expenses
- Contact information