Experimental Participants Bill of Rights

Experimental Participants Bill of Rights Form

Short Form Consent Document

  • If approved to use the Short Form Consent Method for enrolling a participant who speaks a non-English language, you may be required to provide the participant with a Bill of Rights in their preferred language. For guidance about the Short Form method and required documentation, go to Consenting Non-English Speakers. 
  • Short From Consent Document (translated)

Subject signatures are not required on the Bill of Rights. According to California Health and Safety code Section 24173 (Bill of Rights is signed and dated by the subject or the subject’s conservator or guardian) does not apply to the University of California. This is due to Section 24178, which states this chapter shall not apply to any person who is conducting a medical experiment as an investigator within an institution that holds an assurance with the United States Department of Health and Human Services pursuant to Part 46 of Title 45 of the Code of Federal Regulations and who obtains informed consent in the method and manner required by those regulations. UCSF has an Federalwide Assurance (FWA), the section requiring signatures on the Bill of Rights does not apply.

Experimental Participants Bill of Rights Form and Short Form Consent Document (Translated)

Translated versions of the form

Document that each participant received the form using one of the methods describe below.

Which Participants Should Be Offered the Form?

California law, under Health & Safety Code §24172, requires all investigators doing a "medical experiment" to offer their participants a copy of the "Experimental Participants Bill of Rights." Failure to do so may result in civil or criminal penalties.

A "medical experiment" is defined as:

The severance or penetration or damaging of tissues of a human participants, 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 participants in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such participants or otherwise directly benefitting such participants. ...

The IRB has interpreted this definition to include almost all studies involving biomedical procedures, placebo controls, innovative therapy and/or normal volunteer participants. 

For these types of studies, you must give a copy of the UCSF Experimental Participants Bill of Rights to participants, along with a copy of the study's consent document and possibly the HIPAA authorization form. Include the following statement at the end of the consent form: "You have been given a copy of this consent form and of the Experimental Participants Bill of Rights to keep."

For non-biomedical studies, the IRB may recommend use of the Experimental Participants Bill of Rights, though it is not required by law.

Documentation

In general, participants do not sign the Experimental Participants Bill of Rights. 

In either case, you should document that each participants received the form by one of the following methods:

  1. For the Short Form consent method, file a copy of the Short Form Consent Document with the participant's signature in their study file. 
  2. Write a note on the consent form confirming that the participant received the Short Form Consent Document/Bill of Rights.
  3. Write a note in the participants research record confirming that the participant received the Bill of Rights. OR
  4. Keep a copy of the Bill of Rights is in the participants research file with the original signed consent form (and HIPAA authorization form, if applicable).

Do not submit the Bill of Rights to the IRB via iRIS.

Resources

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