A. No investigator may involve a human being as a subject in research covered by these regulations without first obtaining the legally effective informed consent of the subject or the subject's legally authorized representative unless the HSC specifically waives the requirement to obtain informed consent.
The HSC may approve a waiver of the consent requirement only if the investigator documents and the HSC concurs that:
1. the research could not practicably be carried out without the waiver, and
a. the research is to be conducted for the purpose of demonstrating or evaluating: (i) Federal, state or local benefit or service programs which are not themselves research programs, (ii) procedures for obtaining benefits or services under these programs, or
b. (i) the research involved no more than minimal risk to the subjects, (ii) the waiver will not adversely affect the rights and welfare of the subjects, and (iii) whenever appropriate, the subjects will be given additional pertinent information after participation.
B. Investigators wishing to obtain a waiver if the informed consent requirement should submit to the HSC with the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f, Attachment A) evidence that the research could not be practicably be carried out without the waiver, and that either A.1a. or A.1b. above applies to the research.
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