Subject’s Bill of Rights

To be told the nature and purpose of the study

To be told about the procedures in the research study, and any drug or device to be utilized, and what would vary from standard medical treatment

To be told of any benefits the subject reasonably could expect from participation in the study if applicable

To be told of all the risks, side effects or discomforts that might reasonably be expected

To be told about options of alternative procedures, medications, or devices that might be helpful, and their risks and benefits compared to the study

To be allowed to ask any questions about the study before giving consent and at any time during the course of the study

To be allowed ample time to freely decide to consent or not to consent to the research study without any force, coercion, or undue influence

To be told that consent to participate in the study is voluntary and may be withdrawn at any time and that the subject may discontinue participation in the study without prejudice

To receive a signed and dated copy of the informed consent form

To be told of other medical treatments available, if any, to the subject after the study if complications should arise