Consenting Participants

Once the protocol is IRB approved and you have received an IRB-approved, stamped informed consent document (discussed later in this training), you are ready to enroll participants on the protocol.

The research staff have the responsibility to discuss the following issues with potential participants prior to their decision to participate.

• What is the purpose of the study and how will it affect the participant’s daily life?
• Will this study involve any painful or uncomfortable procedures?
• What will it cost the participant to participate in this study?
• Does this study include investigational drugs or medical devices not approved by the FDA?
• What are the known or potential risks and side effects?
• Who is responsible for monitoring the participant’s well-being and to make sure proper safeguards are being followed?
• What are the participant’s alternatives to participating in this study?
• Who is authorized and available during non-business hours (e.g., at night, during a holiday, or weekend) to help the participant if problems arise or should the participant wish to withdraw from the study?
• Can the participant leave a research study once they have started?