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The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis (1996)

Chapter: F. Principles for the Conduct of Research in the Arctic

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Suggested Citation:"F. Principles for the Conduct of Research in the Arctic." 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 95
Suggested Citation:"F. Principles for the Conduct of Research in the Arctic." 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.
×
Page 96
Suggested Citation:"F. Principles for the Conduct of Research in the Arctic." 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.
×
Page 97
Suggested Citation:"F. Principles for the Conduct of Research in the Arctic." 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.
×
Page 98

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Appendix F Principles for the Conduct of Research in the Arctici INTRODUCTION All researchers working in the North have an ethical responsibility toward the people of the North, their cultures, and the environment. The following principles have been formulated to provide guidance for researchers in the physical, biological, behavioral, health, economic, political, and social sciences and in the humanities. These principles are to be observed when carrying out or sponsoring research in Arctic and northern regions or when applying the results of this research. This statement addresses the need to promote mutual respect and communication between scientists and northern residents and wit! contribute to the development of northern science through traditional knowledge and experience. These "Principles for the Conduct of Research in the Arctic" were prepared by the Interagency Social Science Task Force in response to a recommendation by the Polar Research Board of the National Academy of Sciences and at the direction of the Interagency Arctic Research Policy Committee. This statement is not intended to replace other existing federal, state, or professional guidelines, but rather to emphasize their relevance for the whole scientific community. Examples of similar guidelines used by professional organizations and agencies in the United States and in other countries are listed in the publications. ~.::~.::t hesenr'nc.~.les areto0eobser U - :e - art 7- ~ rso or/ - res r h~: Arct~ :~ .a.~o Northern reetons.or :wnen. aon.~.~.e tee.. results...~..tn~s..resea.rcn.... 95 'Reprinted from Arctic Research of the Unitec! States, vol. 6, fall 1992.

96 The CAL Thyroid Function Study IMPLEMENTATION All scientific investigations in the Arctic should be assessed in terms of potential human impact and interest. Social science research, particularly studies of human subjects, requires special consideration, as do studies of resources of economic, cultural, and social value to Native people. In all instances, it is the responsibility of the principal investigator on each project to implement the following recommendations. T. The researcher should inform appropriate corrununity authorities of planned research on lands, waters, or territories used or occupied by them. Research directly involving northern people or communities should not proceed without their clear and informed consent. When informing the community andJor obtaining informed consent, the researcher should identify: a. All sponsors and sources of financial support; b. The person in charge and all investigators involved in the research, as well as any anticipated need for consultants, guides, or interpreters; c. The purposes, goals, and time frame of the research; d. Data-gathering techniques (tape and video recordings, photographs, physiological measure- ments, and so on) and the uses to which they will be put; and e. Foreseeable positive and negative implications and impacts of the research. 2. The duty of researchers to inform communities continues after approval has been obtained. Ongoing projects should be explained in terms understandable to the local community. 3. Researchers should consult with and, where applicable, include northern communities in project planning and implementation. Reasonable opportunities should be provided for the communities to express their interests and to participate in the research. 4. Research results should be explained in nontechnical terms and, where feasible, should be communicated by means of study materials that can be used by local teachers or displays that can be shown in local community centers and museums. 5. Copies of research reports, data descriptions, and other relevant materials should be provided to the local community. Special efforts must be made to communicate results that are responsible to local concerns. 6. Subject to the requirements for anonymity, publications should always refer to the informed consent of participants and give credit to those contributing to the research project. 7. The researcher must respect local cultural traditions, languages, and values. The researcher should, where practicable, incorporate the following elements in the research design: a. Use of local and traditional knowledge and experience. b. Use of the languages of the local people. c. Translation of research results, particularly those of local concern, into the languages of the people affected by the research. 8. When possible, research projects should anticipate and provide meaningful experience and training for young people. 9. In cases where individuals or groups provide information of a confidential nature, their anonymity must be guaranteed both in the original use of data and in its deposition for future use. 10. Research on humans should be undertaken only in a maimer that respects their

Appendix F 97 privacy and dignity: a. Research subjects must remain anonymous unless they have agreed to be identified. If anonymity cannot be guaranteed, the subjects must be informed of the possible consequences of becoming involved in the research. b. In cases where individuals or groups provide information of a confidential or personal nature, this confidentiality must be guaranteed both in the original use of data and in its deposition for future use. c. The rights of children must be respected. All research involving children must be fully justified in terms of goals and objectives and never undertaken without the consent of the children and their parents or legal guardians. d. Participation of subjects, including the use of photography in research, should always be based on informed consent. e. The use and disposition of human tissue samples should always be based on the informed consent of the subjects or next of kin. ~ 1. The researcher is accountable for all project decisions that affect the community, including decisions made by subordinates. 12. All relevant federal, state, and local regulations and policies pertaining to cultural, environmental, and health protection must be strictly observed. ~ 3. Sacred sites, cultural materials, and cultural property cannot be disturbed or removed without community and/or individual consent and in accordance with federal and state laws and regulations. in implementing these principles, researchers may find additional guidance in the publications listed below. In addition, a number of Alaska Native and municipal organizations can be contacted for general information, obtaining informed consent, and matters relating to research proposals and coordination with Native and local interests. A separate list is available from National Science Foundation's Division of Polar Programs. PUBLICATIONS Arctic Social Science: An Agenda for Action. National Academy of Sciences, Washington, DC, 1989. Draft Principles for an Arctic Policy. Inuit Circumpolar Conference, Kotzebue, 1986. Ethics. Social Sciences and Humanities Research Council of Canada, Ottawa, 1977. Nordic Statement of Principles and Priorities in Arctic Research. Center for Arctic Cultural Research, Umea, Sweden, 1989. Policy on Research Ethics. Alaska Department of Fish and Game, Juneau, 1984. Principles of Professional Responsibility. Council of the American Anthropological Association, Washington, DC, 1971, rev. 1989. The Ethical Principles for the Conduct of Research in the North. The Canadian Universities for Northern Studies, Ottawa, 1982. The National Arctic Health Science Policy. American Public Health Association, Washington, DC, 1984. Protocol for Centers for Disease Control/Inclian Health Service Serum Bank. Prepared by

98 The A~4L Thyroid Function Study Arctic investigations Program (CDC) and Alaska Area Native Health Service, 1990. (Available through Alaska Area Native Health Service, 255 Gambell Street, Anchorage, AK 99501.) Indian Health Manual. :Indian Health Service, U.S. Public Health Service, Rockville, Maryland. 1987. Human Experimentation. Code of Ethics of the World Medical Association (Deciaratior' of Helsinki). Published in British Medical Journal, 2:177, 1964. Protection of Human Subjects. Code of Federal Regulations 45 CFR 46, 1974, rev. 1983.

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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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