Experimental Participants Bill of Rights

Experimental Participants Bill of Rights Form

Experimental Participants Bill of Rights Form (without signature) (updated 1/22)

Experimental Participants Bill of Rights Form (with signature): Use this form in the appropriate language when the Short Form method is used to enroll a non-English-speaking participant. (updated 11/21)

You must offer research participants participating in a "medical experiment" (defined below) a copy of this form in a language in which the participant is fluent.

Document that each partipant 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. The only time a participant should sign the Experimental Participants Bill of Rights is when the Short Form method is used to enroll a non-English-speaking participant.

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

  1. For the Short Form consent method, file a copy of the Experimental Participants Bill of Rights with the participant’s signature in their study file.
  2. Write a note on the consent form confirming that the participant received the 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.

Last updated: April 28, 2022