The Research Subjects' Bill of Rights
- To be informed of the purpose of the research study
- To be informed about all risks, side effects or discomforts that might be reasonably expected
- To be informed of any benefits that can be reasonably expected and if there are no personal benefits that can be reasonably expected
- To be informed what will happen in the study and whether any procedures, drugs or devices are different than those that are used as standard medical treatment
- To be informed about other options that may be available and how they may be better or worse than being in a research study
- To be allowed to ask any questions about the trial both before giving consent and at any time during the course of the study
- To be allowed sufficient time, without pressure, to decide whether to consent or not to consent to participate in a study
- To refuse to participate, for any reason, before the study has started or at any time during the study
- To receive a signed and dated copy of the informed consent form
- To be informed of any medical treatment(s) available if complications occur during the study
Based on Getz K & Borfitz D (2002) “Informed Consent” Thomson/Centerwatch
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