RESEARCH SUBJECT’S BILL OF RIGHTS
The rights explained below are the rights of every person who is asked to be in a research study. As a research participant I have the right:
- To have the purpose of the study clearly explained; to learn what the study is attempting to find out.
- To be told what choices for care I have and how they may differ from participating in the research study.
- To be told what will happen to me and whether any of the procedures, drugs or devices used in the study will be different from the routine care I could expect.
- To be told about any risks, side effects or discomforts that may occur that are due to my research participation and how these may differ from routine care.
- To be told whether I can expect any personal benefit from participating in the research study and the likelihood of such a benefit.
- To ask any questions I have before consenting to participate and throughout my time in the study.
- To know what medical treatments are available to me and how they will be paid for, if any complications arise due to my participation in this study.
- To have all records bearing any information that could identify me held in confidence by the researcher(s) and revealed as is required by law, only for review by appropriate governmental oversight authorities such as the Federal Food and Drug Administration. Authorized representatives of the Advocate Health Care Institutional Review Board and the study sponsor will have access to the research records for review and evaluation purposes and will hold my information confidential.
- To be kept informed of any new medical or technical developments that may affect my condition or my willingness to participate in the research.
- To refuse to participate or to withdraw from the study at any time without affecting my
regular medical care.
- To receive a copy of the complete consent form.
- To be free of pressure while considering whether I wish to agree to be in this study.