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Making Research Consent Forms Informative and Understandable: The Experience of the Indian Health Service

  • William L. Freeman (a1)

Extract

The mission of the Indian Health Service (IHS) affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).

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Notes

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2. Reddy, MA. Statistical Record of Native North Americans. Detroit, Michigan: Gale Research, 1993:224.

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4. Division of Program Statistics. Regional Differences in Indian Health: 1992. Rockville, Maryland: Office of Planning, Evaluation, and Legislation, Indian Health Service, Public Health Service, 1992:21.

5. See note 3. Trends, . 1993:1,1523.

6. See note 3. Trends, . 1993:1.

7. Wilkinson, CEAmerican Indians, Time, and the Law. New Haven, Connecticut: Yale University Press, 1987.

8. American Indian Law Center. The Model Tribal Research Code: With Materials for Tribal Regulation for Research and Checklist for Indian Health Boards. Albuquerque, New Mexico: American Indian Law Center, 1994.

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11. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, Maryland: National Institutes of Health, Public Health Service, 1979.

12. Code of Federal Regulations. Title 45, part 46, §116(a) and §116(b).

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14. See note 13. NALS. 1993:35.

15. See note 13. NALS. 1993:7482.

16. See note 13. NALS. 1993:113.

17. See note 13. NALS. 1993:42–5.

18. See note 13. NALS. 1993:73,78,82.

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20. See note 10. Faden, , Beauchamp, . 1986:323–6.

21. See note 10. Faden, , Beauchamp, . 1986:303–11.

22. See note 12.

23. To estimate readability, I used Corporate Voice by Scandinavian PC Systems, Baton Rouge, Louisiana. It estimates the FOG, Flesch-Kincaid, and Flesch Reading Ease measures and provides the data needed to plot on the Fry graph and to calculate the SMOG measure.

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28. See note 25. Zakaluk, Samuels. 1988:121–44.

29. See note 27. Fry, . 1988:7795.

30. Peterson, BT, Clancy, SJ, Champion, K, McLarty, JW. Improving readability of consent forms. IRB: A Review of Human Subjects Research 1992; 14(6):68.

31. See note 10. Faden, Beauchamp. 1986:314–29.

32. Levine, RJ. Ethics and Regulation of Clinical Research. 2nd ed.Baltimore, Maryland: Urban and Schwarzenber, 1986.

33. See note 10. Faden, Beauchamp. 1986:314–29.

34. Hosey, GM, Freeman, WL, Stracqualursi, F, Gohdes, D. Designing and evaluating diabetes education material for American Indians. The Diabetes Educator 1990;16:407–14.

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Making Research Consent Forms Informative and Understandable: The Experience of the Indian Health Service

  • William L. Freeman (a1)

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