If an IRB has concerns about any part of the research proposal, the board will tell the research director of the study. The research director must resolve these concerns before the study can go forward. Participation in a clinical trial is strictly confidential. Volunteers are not identified by name in published articles. A volunteer must provide written permission for researchers to reveal or discuss their participation in the study with a personal physician, case manager, or any other person.
Participants have certain rights prior to and during a clinical research study.
Ask any question at any time concerning the study design or the study medication. Be told of any significant new finding that may affect their willingness to participate. These costs are usually covered by a health plan, such as Medicare or private insurance. The study sponsor and the participant's health plan resolve coverage of these costs for particular trials. Research costs are those associated with conducting the trial, such as data collection and management, research staffing and testing.