A. Federal regulations impose specific conditions under which informed consent must be obtained from research subjects. These conditions may not be waived unless the requirement for obtaining informed consent is waived. They are:
1. The prospective subject or the subject's representative must be provided sufficient opportunity to consider whether or not to participate.
2. The consent must be obtained under circumstances which minimize the possibility of coercion or undue influence.
3. The information that is given to the subject or representative shall be in language understandable to the subject or the representative.
4. The informed consent presentation, whether oral or written, may not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from the liability for negligence.
B. Investigators should include in the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f, Attachment A) a description of the procedures to be used in obtaining informed consent sufficient to assure the HSC that the above conditions will be met.
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