For additional important information on this subject, see
headings I-IV.
A. Long-Form Signed Consent. Either of the following methods may be used:
1. Investigator-designed form.
a. The form must include all applicable elements of information (see heading III) and is to be signed and dated by the subject or the subject's legal representative
b. If the research falls within the definition of "medical experiment" contained in Section 24174 of the California Health and Safety Code, the "Human Subjects' Bill of Rights" (UCSB Form 213)
2. If the Investigator-designed form is used with Subject Information Sheet(112d) or the Bill of Rights(213)
a. Basic Elements 1,7, 8 9, 10,11, and 12 are omitted from the investigator-designed form;
b. A statement is added to the form to inform the subject that UCSB/ORDA Form 112d (or 112e as appropriate) is attached to and is a part of the consent form;
B. Short-Form Signed Consent.
1. This consent procedure consists of an oral presentation, which includes all applicable elements of information (heading III), and a short form to be signed and dated by the subject or the subject's representative. The short form states that the required elements of information have been presented orally to the subject or the subject's legal representative.
2. A copy of the summary and of the short form must be attached to each copy of the application to the Human Subjects Committee for approval of the use of the subjects.
3. A copy of UCSB/ORDA Form 112d or Form 112e, as appropriate, should be made available to the person signing the form.
C. Regardless of which of the above methods is used,
1. The presentation of consent information (whether written or oral) must be addressed to the person who will be giving consent (e.g., you are requested. . ., your child will be. . ., your signature indicates . . .). The short form may be written in the first person.
2. The investigator should consult information under heading I. and V. for further information about procedures.
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