78613754.1-3442.2Virginia Decodedhttps://vacode.org2016Professions And OccupationsProfessions And Occupations Regulated By Boards Within The Department Of Health ProfessionsDrug Control ActExpanded Access To Investigational Drugs, Biological Products, And Devices.Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment2015, cc. 655, 656.http://law.lis.virginia.gov/vacode/54.1-3442.2//54.1-3442.2/54.1/III/34/4.1/54.1-3442.254.1-3442.354.1-3442.4A person shall be eligible for expanded access to investigational drugs, biological products, or devices if:sectionAA1 He has a terminal condition, attested to by his treating physician and confirmed by a second physician not previously involved in the treatment of the person who has conducted an independent examination of the person;sectionA1A12 He has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for him to participate in an ongoing clinical trial for his terminal condition;sectionA2A22 The potential benefits of use of the investigational drug, biological product, or device to treat his terminal condition are greater than the potential risks of the use of the investigational drug, biological product, or device to treat his terminal condition;sectionA3A32 He has received a recommendation from his treating physician for use of an investigational drug, biological product, or device for treatment of his terminal condition; andsectionA4A42 He or, if he is incapable of making an informed decision, his legally authorized representative has given written informed consent to use of the investigational drug, biological product, or device for treatment of his terminal condition or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian has given written informed consent to the use of the investigational drug, biological product, or device for treatment of his terminal conditisectionA5A52Written informed consent to use of an investigational drug, biological product, or device shall include:sectionBB1 A statement that the person has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for the person to participate in an ongoing clinical trial for his terminal condition;sectionB2B22 A statement that the person may be required to pay any costs associated with use of the investigational drug, biological product, or device; andsectionB5B52 A statement that the person or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian consents to the use of the investigational drug, biological product, or device for treatment of his terminal condition.sectionB6B62