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The Clinical Trial Participant's Bill of Rights

The Clinical Trial Participant's Bill of Rights

Any participant who gives consent to participate in a clinical trial or who is asked to give consent on behalf of another has the following rights:

  • To be told the purpose of the clinical trial

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

  • To be told of any benefits that can be reasonably expected

  • To be told what will happen during the trial and whether any procedures, drugs, or devices are different from those that are used as standard medical treatment

  • To be told about available options and how such options may be better or worse than what is being studied in the clinical trial

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

  • To be allowed ample time, without pressure, to decide whether to consent to participate

  • To refuse to participate, for any reason, before and after the trial has started

  • To receive a signed and dated copy of the Informed Consent form

  • To be told of any medical treatments available if complications occur during the trial

Adapted from The Center for Information and Study on Clinical Research Participation, www.ciscrp.org.