California law, requires that any individual (or Legally Authorized Representative) asked to participate in a research study defined as a "medical experiment" under California Health and Safety Code, section 24174, must receive a copy of the Research Participant Bill of Rights (also known as the "Experimental Subject’s Bill of Rights") in a language in which the individual is fluent.
A "medical experiment" includes one or more of the following procedures:
- The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
- The investigational use of a drug or device as provided in Sections 111590 and 111595.
- Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
As the Bill of Rights provides a useful summary of the rights of potential participants in the consent conference as well as in the research. The best practice is to provide it (for relevant protocols) in advance of reviewing the content of the consent form.
That the Bill of Rights was provided to a potential participant for the consent conference (for relevant protocols) should be documented in the research files.
The Research Study Participants' Bill of Rights (pdf) has been translated into the following languages:
- Braille - Please call the OHRPP to arrange for a paper copy
- Armenian (Eastern)
- Armenian (Western)
- Bosnian (also use for Croatian and Serbian)
- Khmer (Cambodian)
- Chinese (Simplified)
- Chinese (Traditional)