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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Experimental Subject's Bill of Rights

California Assembly Bill 1752: Human Experimentation, which became effective January 1, 1979, provides that all investigators doing a "medical experiment" must offer their subjects a copy of the "Experimental Subject's Bill of Rights." Failure to do so may result in civil or criminal penalties.

A "medical experiment" is defined in the bill as:

"The severance or penetration or damaging of tissues of a human subject, or the use of a drug or device as defined in section 26009 of 26010 (of the Health and Safety Code), 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 such subject or otherwise directly benefitting such subject . . . ."

The UCSF Committee on Human Research has interpreted the relevant sections of this bill and the referenced Health and Safety Code to include almost all studies involving biomedical procedures, placebo controls, innovative therapy, and/or normal volunteer subjects.

Thus, for these types of studies, the Experimental Subject's Bill of Rights must be given to subjects along with a copy of the consent form or information sheet for the study. There should be a reference at the end of the consent form indicating that the subject has received or will receive the Experimental Subject's Bill of Rights. This should read, "You have been given a copy of this consent form and of the Experimental Subject's Bill of Rights to keep."

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A UCSF version of the Bill of Rights has been developed which includes all the elements required by this legislation, written in language that is meant to be understood by a wide range of people (See Translation Table for samples of the Bill of Rights, including Spanish, Chinese and Tagalog versions). The UCSF Experimental Subject's Bill of Rights also includes contact information for the office of the Committee on Human Research, to provide an additional resource to subjects for questions or problems related to study participation.

For non-biomedical studies, the CHR may recommend use of the Experimental Subject's Bill of Rights, though it is not required by law. As an alternative, for studies which are not medical, or do not fit the description of a medical experiment as given above, the consent form or information sheet should include a paragraph giving the same CHR contact information as the UCSF Bill of Rights:

"If you have any questions or comments about participation in this study, you should first talk with the investigator. If for some reason, you do not wish to do this, you may contact the Committee on Human Research, which is concerned with protection of volunteers in research projects. You may reach the Committee office between 8:00 AM and 5:00 PM, Monday to Friday, by calling (415) 476-1814, or by writing: Committee on Human Research, Box 0962, University of California, San Francisco, CA 94143."

As is discussed in more detail Those Who Do Not Read, Speak, or Understand English, the consent process may require the use of a translator and/or translated consent documents, including the Bill of Rights. If a translation of the Bill of Rights in needed see Translation Table. If you need a translation not on the list, call the CHR to arrange for additional translations.