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Research Information for Participants
What is a clinical research study?
A clinical research study, also called a clinical trial, is a study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled conditions. Observational trials address health issues in large groups of people or populations in large studies.
This study is an interventional trial.
What is informed consent?
The dialogue between potential participants and researchers that takes place before anyone decides whether to take part in a study. This process of communication should be free of pressure or rushing, should include all key information and a chance to ask questions and have them answered. Informed consent can be more than just a one-time conversation. As a study goes on, participants can renew their agreement to be in the study, and they can also decide to quit without penalty. The important thing is open and clear communication.
The Informed Consent Document (ICD) is the form participants sign to agree to be in the study. The ICD includes details about the study, such as its purpose, duration, required procedures, risk, benefits, and who to contact for further information. The ICD is not a contract. Participants do not give up any legal rights by signing an ICD. Participants are free to withdraw at any time. |
