4. As used in this act, "informed consent" means the authorization given pursuant to this act to participate in medical research performed on a subject after each of the following conditions has been satisfied: a. The subject or his guardian, or authorized representative as provided in section 5 of this act, as applicable, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject's guardian or authorized representative is fluent, of the following facts that include:
(1)an explanation of the procedures to be followed in the research and any drugs or devices to be utilized, including the purposes of the procedures, drugs, or devices and, when applicable, the use of placebo controls and the process by which pers
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4. As used in this act, "informed consent" means the authorization given pursuant to this act to participate in medical research performed on a subject after each of the following conditions has been satisfied: a. The subject or his guardian, or authorized representative as provided in section 5 of this act, as applicable, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject's guardian or authorized representative is fluent, of the following facts that include: (1) an explanation of the procedures to be followed in the research and any drugs or devices to be utilized, including the purposes of the procedures, drugs, or devices and, when applicable, the use of placebo controls and the process by which persons will be assigned to control groups; (2) a description of any attendant discomfort and reasonably foreseeable risks to the subject; (3) an explanation of any potential direct benefits to the subject. If no such direct benefits are reasonably expected, that fact should be made clear; (4) a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits; (5) an estimate of the expected duration of the research procedure or study; (6) an offer to answer any inquiries concerning the research or the procedures involved and an explanation of whom to contact for answers to pertinent questions about the research and the research subject's rights, and whom to contact in the event of a research-related injury; (7) an instruction to the subject or his guardian or authorized representative, as applicable, that he is free to withdraw his prior consent to the medical experiment and discontinue participation in the research at any time, without prejudice to the subject; (8) the name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the research; (9) the name of the sponsor or funding source, if any, or manufacturer if the research involves a drug or device, and the organization, if any, under whose general aegis the research is being conducted; (10) the name, address, and phone number of an impartial third party, not associated with the research, to whom the subject may address complaints about the research and the contact information for the institutional review board connected with the research; and (11) the material financial stake or interest, if any, that the investigator or research institution has in the research. For purposes of this section, "material" means $10,000 or more in securities or other assets valued at the date of disclosure, or in relevant cumulative salary or other income, regardless of when it is earned or expected to be earned or as otherwise determined by the research institution. b. The subject or his guardian or authorized representative, as applicable, has signed and dated a written consent form. c. The written consent form is signed and dated by a person, who is not the subject, his guardian or authorized representative, or the researcher, and who can attest that the requirements for informed consent to the medical research have been satisfied. d. Consent is given voluntarily and freely by the subject or his guardian or authorized representative without the intervention of force, fraud, deceit, duress, coercion or undue influence. L.2007, c.316, s.4.