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(2) An organization must not, as a condition of supplying a product or service, require an individual to consent to ... Informed Consent in Psychotherapy & Counseling: Forms, Standards & Guidelines, & References. Kenneth S. Pope, Ph.D., ABPP. PLEASE NOTE: I created this site to be fully accessible for people with disabilities; please follow this link to change text size, color, or contrast; please follow this link for other accessibility functions for those with visual, mobility, and other disabilities. FOOTNOTES. I. INTRODUCTION. This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA's informed consent regulations. 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