A. The HSC may approve a consent procedure which waives inclusion of or alters some or all of the required elements of information only under the same conditions that apply to waiver of the requirement to obtain informed consent, i.e.., if the investigator documents and the HSC concurs that:
1. the research could not be practicably carried out without the waiver or alteration, 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 (iii) possible changes or alternatives to 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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