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Legally Authorized Representative:  An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.  This definition is the same for DHHS and FDA.

For VAMC Research:  A legally authorized representative is an individual or body authorized under applicable law to provide permission on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. A legally authorized representative includes not only a person appointed as a health care agent under a Durable Power of Attorney for Health Care (DPAHC), a court appointed guardian of the person, but also next-of-kin in the following order of priority unless otherwise specified by applicable state law: spouse, adult child (18 years of age or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older).

Life-Threatening Adverse Experience:  An adverse experience that places the patient or subject at immediate risk of death from the reaction as it occurred.