Hostname: page-component-cd9895bd7-fscjk Total loading time: 0 Render date: 2024-12-18T02:26:48.519Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  29 July 2009

William L. Freeman
William L. Freeman
Affiliation:
Is Director of the Research Program for the Indian Health Services (IHS) and Chair of the National IHS Institutional Review Board, Albuquerque, New Mexico
Get access Rights & Permissions [Opens in a new window]

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).

Type
Special Section: Research Ethics: Ethics at the Borders of Medical Research
Information
Cambridge Quarterly of Healthcare Ethics , Volume 3 , Issue 4 , Fall 1994 , pp. 510 - 521
Copyright
Copyright © Cambridge University Press 1994

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

1. Katz, J. “Ethics and Clinical Research” revisited: a tribute to Henry K. Beecher. Hastings Center Report 1993;23(5):36.Google Scholar

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

3. Division of Program Statistics. Trends in Indian Health – 1993. Rockville, Maryland: Office of Planning, Evaluation, and Legislation, Indian Health Service, Public Health Service, 1993:26. [Hereafter cited as Trends.]Google Scholar

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.Google Scholar

5. See note 3. Trends, . 1993:1,15–23.Google Scholar

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

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

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.Google Scholar

9. Ballantine, B, Ballantine, I, eds. The Native Americans: An Illustrated History. Atlanta: Turner Publishing, 1993.Google Scholar See especially the final chapter (Deloria, PJ. The twentieth century and beyond. 1993:384–462).Google Scholar

10. Faden, RR, Beauchamp, TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1986:303–4.Google Scholar

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.Google Scholar

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

13. Kirsch, IS, Jungeblut, A, Jenkins, L, Kolstad, A. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, D.C.: National Center for Education Statistics, U.S. Department of Education, 1993. [Hereafter cited as NALS.]Google Scholar

14. See note 13. NALS. 1993:3–5.Google Scholar

15. See note 13. NALS. 1993:74–82.Google Scholar

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

17. See note 13. NALS. 1993:42–5.Google Scholar

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

19. Epstein, LC, Lasagna, L. Obtaining informed consent: form or substance. Archives of Internal Medicine 1969;123:682–8.CrossRefGoogle ScholarPubMed

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

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

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.

24. Klare, GB. The formative years. In: Zakaluk, BL, Samuels, SJ, eds. Readability: Its Past, Present, and Future. Newark, Delaware: International Reading Association, 1988:14–34.Google Scholar

25. Zakaluk, BL, Samuels, SJ. Toward a new approach to predicting text comprehensibility. In: Zakaluk, BL, Samuels, SJ, eds. Readability: Its Past, Present, and Future. Newark, Delaware: International Reading Association, 1988:121–44.Google Scholar

26. McCall, WA, Crabbs, LM. Standard text lessons in reading. New York: Bureau of Publications, Teachers College, Columbia University, 1925. [Cited in note 24, Klare, 1988.]Google Scholar

27. Fry, EB. Writeability: the principles of writing for increased comprehension. In: Zakaluk, BL, Samuels, SJ, eds. Readability: Its Past, Present, and Future. Newark, Delaware: International Reading Association, 1988:77–95.Google Scholar

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

29. See note 27. Fry, . 1988:77–95.Google Scholar

30. Peterson, BT, Clancy, SJ, Champion, K, McLarty, JW. Improving readability of consent forms. IRB: A Review of Human Subjects Research 1992; 14(6):6–8.CrossRefGoogle ScholarPubMed

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

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

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

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.CrossRefGoogle ScholarPubMed

35. Mosenthal, PB, Kirsch, IS. Learning from exposition: using knowledge modeling as a basis for assessing student's knowledge. Journal of Reading 1992;35:668–78.Google Scholar

36. Morrow, G, Gootnick, J, Schmale, A. A simple technique for increasing cancer patients' knowledge of informed consent to treatment. Cancer 1978;42:793–9.3.0.CO;2-C>CrossRefGoogle ScholarPubMed

37. Ockene, IS, Miner, J, Shannon, TA, Gore, JM, Weiner, BH, Ball, SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI-phase I) trial. Clinical Research 1991;39:13–7.Google ScholarPubMed

38. Vanchieri, C. Videodisks help patients choose therapy [news]. Journal of the National Cancer Institute 1991;83:1711–2.CrossRefGoogle Scholar

39. Cockett, ATK, Barry, MJ, Holtgrewe, HL, Sihelnick, S, Williams, R, McConnell, J. Indications for treatment of benign prostatic hyperplasia: the American Urological Association study. Cancer 1992;70(Suppl. 1):280–3.3.0.CO;2-E>CrossRefGoogle ScholarPubMed