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Suggested Citation:"E. Informed Consent Elements of Disclosure." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
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Suggested Citation:"E. Informed Consent Elements of Disclosure." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
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Page 93
Suggested Citation:"E. Informed Consent Elements of Disclosure." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
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Page 94

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Appendix E Informed Consent Elements of Disclosurei § 116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a covered bY this nolicv unless the investigator has nhtainer1 the l~.~nilv subject in research ~ ~ ~ O ~ . , effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that will minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may 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 snnn~nr the institution or its agents from liability for negligence. . _ ~, A-- -r~~~~~' ~ - J - - - -- C7 0 (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject: (I) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 92 Federal Policy for the Protection of Human Subjects (Federal "Common Rule"), Federal Register, Vol. 56, No. 116 Tuesday, June IS, 1991:pp. 28016-17 (Re-typed)

Appendix E 93 (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will--be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (~) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (~) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation In the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) The approximate number of subjects involved in the study. (c) An TRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the TRB finds and documents that: (~) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) Public benefit of service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) The research could not practicably be carried out without the waiver or alteration. (d) An TRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the TRB finds and documents that: (~) The research involves no more than minimal risk to the subjects. (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects. (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

(e) The idled consent re~ircme~s in this policy are Dot lme~ed to preempt am applicable federal, state, or local laws which rewire additional ideation to be disclosed in order far indeed consent to be legaHy c~clive

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During the 1950s, with the Cold War looming, military planners sought to know more about how to keep fighting forces fit and capable in the harsh Alaskan environment. In 1956 and 1957, the U.S. Air Force's former Arctic Aeromedical Laboratory conducted a study of the role of the thyroid in human acclimatization to cold. To measure thyroid function under various conditions, the researchers administered a radioactive medical trace, Iodine-131, to Alaska Natives and white military personnel; based on the study results, the researchers determined that the thyroid did not play a significant role in human acclimatization to cold.

When this study of thyroid function was revisited at a 1993 conference on the Cold War legacy in the Arctic, serious questions were raised about the appropriateness of the activity--whether it posed risks to the people involved and whether the research had been conducted within the bounds of accepted guidelines for research using human participants. In particular, there was concern over the relatively large proportion of Alaska Natives used as subjects and whether they understood the nature of the study. This book evaluates the research in detail, looking at both the possible health effects of Iodine-131 administration in humans and the ethics of human subjects research. This book presents conclusions and recommendations and is a significant addition to the nation's current reevaluation of human radiation experiments conducted during the Cold War.

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