Journal of General Internal Medicine

, Volume 14, Issue 9, pp 537–546 | Cite as

Attitudes and beliefs of african americans toward participation in medical research

  • Giselle Corbie-Smith
  • Stephen B. Thomas
  • Mark V. Williams
  • Sandra Moody-Ayers
Original Articles

Abstract

OBJECTIVE: To describe barriers to participation of African Americans in research.

DESIGN: Focus group interviews conducted in 1997.

PATIENTS: Thirty-three African-American adults presenting to an urban public hospital for outpatient medical care participated in one of five focus groups.

MEASUREMENTS AND MAIN RESULTS: African-American patients’ attitudes toward medical research were measured. Mistrust of doctors, scientists, and the government was reported consistently by the participants. Many participants described concerns about the ethical conduct of clinicians and investigators when poor or minority patients are involved and cited examples of exploitation as supporting evidence for their mistrust of the medical establishment. While participants were clear about the violation of human rights in the Tuskegee Syphilis Study, all were misinformed of the historical facts of the study. Few participants understood the concept of informed consent. Participants saw signing the document as relinquishing their autonomy and as a legal protection for physicians. Despite these concerns, participants gave recommendations to improve minority participation in research.

CONCLUSIONS: African-American participants in this study described distrust of the medical community as a prominent barrier to participation in clinical research. Participants described real and perceived examples of exploitation to support their distrust of researchers. The goal of the consent process, to inform patients of risks and benefits so as to facilitate self-determination, was misinterpreted by these participants. Understanding the importance of interpersonal trust within the clinical relationship may prove to be a significant factor in enhancing participation in clinical trials.

Key words

African American research participation trust informed consent 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Chavkin W. Women and clinical research. J Am Med Women’s Assoc. 1994;49:99–100.Google Scholar
  2. 2.
    Allen M. The dilemma for women of color in clinical trials. JAMA. 1994;49:105–9.Google Scholar
  3. 3.
    Mohiuddin SM, Hilleman DE. Gender and racial bias in clinical pharmacology trials. Ann Pharmacother. 1993;27:972–3.PubMedGoogle Scholar
  4. 4.
    Swanson GM, Ward AJ. Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst. 1995;87:1747–59.PubMedCrossRefGoogle Scholar
  5. 5.
    Wermeling D, Selwitz A. Current issues surrounding women and minorities in drug trials. Ann Pharmacother. 1993;27:904–11.PubMedGoogle Scholar
  6. 6.
    Cotton P. Is there still too much extrapolation from data on middle aged white men? JAMA. 1990;263:1049–50.PubMedCrossRefGoogle Scholar
  7. 7.
    Dresser R. Wanted: single, white male for medical research. Hastings Cent Rep. 1992;22:24–9.PubMedGoogle Scholar
  8. 8.
    Robinson SB, Ashley M, Haynes MA. Attitudes of African-Americans regarding prostate cancer clinical trials. J Commun Health. 1996;21:77–87.CrossRefGoogle Scholar
  9. 9.
    Roberson NL. Clinical trial participation: viewpoints from racial/ethnic groups. Cancer. 1994;74:2687–91.PubMedCrossRefGoogle Scholar
  10. 10.
    Harris Y, Gorelick PB, Samuels P, Bempong I. Why African Americans may not be participating in clinical trials. J Natl Med Assoc. 1996;88:630–4.PubMedGoogle Scholar
  11. 11.
    Million-Underwood S, Sanders E, Davis M. Determinants of participation in state-of-the-art cancer prevention, early detection, screening, and treatment trials among African-Americans. Cancer Nurs. 1993;16:25–33.CrossRefGoogle Scholar
  12. 12.
    Krueger RA. Focus Groups: A Practical Guide for Applied Research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1994:255.Google Scholar
  13. 13.
    Kitzinger J. Qualitative research: introducing focus groups. BMJ. 1995;311:299–302.PubMedGoogle Scholar
  14. 14.
    Rask K, Williams M, Parker R, McNagny S. Obstacles predicting lack of a regular provider and delays in seeking care for patients at an urban public hospital. JAMA. 1994;271:1931–3.PubMedCrossRefGoogle Scholar
  15. 15.
    Glaser BG, Strauss AL. The constant comparative method of qualitative analysis. In: The Discovery of Grounded Theory: Strategies for Qualitative Research. Chicago, Ill: Aldine Publishing Co.; 1967:101–15.Google Scholar
  16. 16.
    Denzin NK, Lincoln YS. Handbook of Qualitative Research. Thousand Oaks, Calif: Sage Publications; 1994:643.Google Scholar
  17. 17.
    Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997;87:1773–8.PubMedGoogle Scholar
  18. 18.
    Thomas SB, Quinn SC. The Tuskegee syphilis study. 1932 to 1972: implications for HIV education and AIDS risk education in the black community. Am J Public Health. 1991;81:1498–1505.PubMedGoogle Scholar
  19. 19.
    Brandt AM. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Cent Rep. December 1987.Google Scholar
  20. 20.
    Caplan AL. When evil intrudes. Hastings Cent Rep. 1992;22:29–32.PubMedCrossRefGoogle Scholar
  21. 21.
    Edgar H. Outside the community. Hastings Cent Rep. 1992;22:32–5.PubMedGoogle Scholar
  22. 22.
    King P. The dangers of difference. Hastings Cent Rep. 1992;22:35–8.PubMedCrossRefGoogle Scholar
  23. 23.
    Jones J. Bad Blood: The Tuskegee Syphilis Experiment. New York, NY: Macmillan; 1993.Google Scholar
  24. 24.
    Nuremberg Code: Trials of War Criminals Before the Nuremberg Military Tribunals Under Contol Council Law; 1949:2:181–2.Google Scholar
  25. 25.
    World Medical Association. Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects (1975 revision of original 1964 version). MIT Press: Cambridge, Mass: 1964:328–9.Google Scholar
  26. 26.
    Department of Health and Human Services, 40 FR 33528. August 8, 1975.Google Scholar
  27. 27.
    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Department of Health, Education and Welfare; 1979. DHEW publications (OS) 78-0013 and (OS) 78-0014.Google Scholar
  28. 28.
    Pinn VW. The role of the NIH’s Office of Research on Women’s Health. Acad Med. 1994;69:698–702.PubMedCrossRefGoogle Scholar
  29. 29.
    NIH guidelines on the inclusion of women and minorities as subjects in clinical research; notice. Fed Reg. 1994;54:14508–13.Google Scholar
  30. 30.
    Mouton CP, Harris S, Rovi S, Solorzano P, Johnson MS. Barriers to black women’s participation in clinical trials. J Natl Med Assoc. 1997;89:721–7.PubMedGoogle Scholar
  31. 31.
    Green BL, Maisiak R, Wang MQ, Britt MF, Ebeling N. Participation in health education, health promotion, and health research by African Americans: effects of the Tuskegee Syphilis Experiment. J Health Educ. 1997;28:196–201.Google Scholar
  32. 32.
    Des Jarlais DC, Stepherson B. History, ethics, and politics in AIDS prevention research. Am J Public Health. 1991;81:1393–4.PubMedCrossRefGoogle Scholar
  33. 33.
    Cox J. Paternalism, informed consent and Tuskegee. Int J Radiat Oncol. Biol. Phys. 1998;40:1–2. Editorial; comments.PubMedCrossRefGoogle Scholar
  34. 34.
    Wolinsky H. Steps still being taken to undo damage of “American’s Nuremberg.” Ann Intern Med. 1997;127:143–5.Google Scholar
  35. 35.
    Guinan M. Black communities’ belief in “AIDS as genocide”: a barrier to overcome for HIV prevention. Ann Epidemiol. 1993;3:193–5.PubMedCrossRefGoogle Scholar
  36. 36.
    Thomas SB, Curran JW. Tuskegee: from science to conspiracy to metaphor. Am J Med Sci. 1999;317:1–4.PubMedCrossRefGoogle Scholar
  37. 37.
    Dula A. African American suspicion of the healthcare system is justified: what do we do about it? Camb Q Health Ethics. 1994;3:347–57.CrossRefGoogle Scholar
  38. 38.
    Gamble V. A legacy of distrust: African Americans and medical research. Am J Prev Med. 1993;9:35–8.PubMedGoogle Scholar
  39. 39.
    Lidz CW, Meisel A, Osterweis M, Holden JL, Marx JH, Munetz MR. Barriers to informed consent. Ann Intern Med. 1993;99:539–43.Google Scholar
  40. 40.
    Lantos J. Informed consent: the whole truth for patients? Cancer. 1993;72:2811–5.PubMedCrossRefGoogle Scholar
  41. 41.
    Taylor KM, Kelner M. Informed consent: the physicians’ perspective. Soc Sci Med. 1987;24:135–43.PubMedCrossRefGoogle Scholar
  42. 42.
    Corbie-Smith G. The continuing legacy of the Tuskegee Syphilis Study: considerations for clinical investigation. Am J Med Sci. 1999;317:5–8.PubMedCrossRefGoogle Scholar
  43. 43.
    Williams MV, Parker RM, Baker DW, et al. Inadequate functional health literacy among patients at two public hospitals. JAMA. 1995;274:1677–82.PubMedCrossRefGoogle Scholar
  44. 44.
    Taylor K, Bezjak A, Fraser H. Informed consent for clinical trials: is simpler better? J Nat Cancer Inst. 1998;90:644–5.PubMedCrossRefGoogle Scholar
  45. 45.
    Davis T, Holcombe R, Berkel H, Prammanik S, Divers S. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998;90:668–74.PubMedCrossRefGoogle Scholar
  46. 46.
    Smith R. Deception in research, and racial discrimination in medicine. BMJ. 1993;396:668–9.Google Scholar
  47. 47.
    Agre P, McKee K, Gargon N, Kurtz R. Patient satisfaction with an informed consent process. Cancer Pract. 1997;5:162–7.PubMedGoogle Scholar
  48. 48.
    Onel E, Hamond C, Wasson J, et al. Assessment of the feasibility and impact of shared decision making in prostate cancer. Urology. 1998;51:63–6.PubMedCrossRefGoogle Scholar
  49. 49.
    Aaronson N, Zittoun R. Informed consent and cancer clinical trials. In: Psychological Aspects of Oncology. Berlin, Germany: Springer; 1990.Google Scholar
  50. 50.
    Krynski M, Tymchuk A, Ouslander J. How informed can consent be? New light on comprehension among elderly people making decisions about enteral tube feeding. Gerontologist. 1994;34:36–43.PubMedGoogle Scholar
  51. 51.
    Rikkert M, van den Bercken JH, ten Have HA, Hoefnagels WH. Experienced consent in geriatrics research: a new method to optimize the capacity to consent in frail elderly subjects. J Med Ethics. 1997;23:271–6.PubMedGoogle Scholar
  52. 52.
    Biros M, Lewis J, Olson CM, Runge J, Cummins R, Fost N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995;273:1283–7. Special Communication.PubMedCrossRefGoogle Scholar
  53. 53.
    Truog R, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? N Engl J Med. 1999;340:804–7.PubMedCrossRefGoogle Scholar
  54. 54.
    Brody B, Katz J, Dula A. In case of emergency: no need for consent. Hastings Cent Rep. 1997;27:7; discussion 7–12.PubMedGoogle Scholar
  55. 55.
    Mattson ME, Curb D, McArdle R, AMIS and BHAT Research Groups. Participation in a clinical trial: the patient’s point of view. Control Clin Trials. 1985;6:156–67.PubMedCrossRefGoogle Scholar
  56. 56.
    Blumenthal DS, Sung J, Coates R, Williams J, Liff J. Mounting research addressing issues of race/ethnicity in health care: recruitment and retention of subjects for a longitudinal cancer prevention study in an inner-city black community. Health Serv Res. 1995;30:197–205.PubMedGoogle Scholar
  57. 57.
    Wilcox M, Schroer S. The perspective of patients with vascular disease on participation in clinical trials. J Vasc Nurs. 1994;12:112–6.PubMedGoogle Scholar
  58. 58.
    Tangrea JA, Adrianza ME, Helsel WE. Patients’ perceptions on participation in a cancer chemoprevention trial. Cancer Epidemiol Biomarkers Prev. 1992;1:325–30.Google Scholar
  59. 59.
    Cunny KA, Miller HW. Participation in clinical drug studies: motivations and barriers. Clin Ther. 1994;16:273–82.PubMedGoogle Scholar
  60. 60.
    Aby JS, Pheley AM, Steinberg P. Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Ann Allergy Asthma Immunol. 1996;76:348–54.PubMedCrossRefGoogle Scholar
  61. 61.
    Daughtery C, Ratain M, Grochoowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995;13:1062–72.Google Scholar
  62. 62.
    Bigorra J, Banos JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38:443–6.PubMedCrossRefGoogle Scholar
  63. 63.
    Barofsky I, Sugarbaker P. Determinants of patient nonparticipation in randomized clinical trials for the treatment of sarcomas. Cancer Clin Trials. 1979;2:237–46.Google Scholar
  64. 64.
    El-Sadr W, Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA. 1992;267:954–7.PubMedCrossRefGoogle Scholar
  65. 65.
    Feldman D, Novack D, Gracely E. Effects of managed care of physician-patient relationships, quality of care, and the ethical practice of medicine: a physician survey. Arch Intern Med. 1998;158:1626–32.PubMedCrossRefGoogle Scholar
  66. 66.
    Diaz T, Chu SY, Sorvillo F, et al. Differences in participation in experimental drug trials among persons with AIDS. J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10:562–8.PubMedGoogle Scholar
  67. 67.
    Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDS clinical trials. J Gen Intern Med. 1997;12:150–7.PubMedGoogle Scholar
  68. 68.
    Quinn SC. AIDS and the African American woman: the triple burden of race, class, and gender. Health Educ Q. 1993;20:305–20.PubMedGoogle Scholar
  69. 69.
    Levine DM, Becker DM, Bone LR, Hill MN, Tuggle MB II, Zeger SL. Community-academic health center partnerships for underserved minority populations. JAMA. 1994;272:309–11.PubMedCrossRefGoogle Scholar
  70. 70.
    Foster MW, Bernsten D, Carter TH. A model agreement for genetic research in socially identifiable populations. Am J Hum Genet. 1998;63:696–702.PubMedCrossRefGoogle Scholar
  71. 71.
    Freeman HP. The impact of clinical trial protocols on patient care systems in a large city hospital: access for the socially disadvantaged. Cancer. 1993;72:2834–8.PubMedCrossRefGoogle Scholar
  72. 72.
    Kaluzny A, Brawley O, Garson-Angert D, et al. Assuring access to state-of-the-art care for U.S. minority populations: the first 2 years of the minority-based community clinical oncology program. J Natl Cancer Inst. 1993;85:1945–50.PubMedCrossRefGoogle Scholar
  73. 73.
    Gorelick PB, Richardson D, Hudson E, et al. Establishing a community network for recruitment of African Americans into a clinical trial: the African-American Antiplatelet Stroke Prevention Study (AAASPS) experience. J Natl Med Assoc. 1996;88:701–4.PubMedGoogle Scholar
  74. 74.
    Barry M. Ethical considerations of human investigation in developing countries: the AIDS Dilemma. N Engl J Med. 1988;319:1083–5.PubMedCrossRefGoogle Scholar

Copyright information

© Society of General Internal Medicine 1999

Authors and Affiliations

  • Giselle Corbie-Smith
    • 1
  • Stephen B. Thomas
    • 2
  • Mark V. Williams
    • 1
  • Sandra Moody-Ayers
    • 3
  1. 1.Division of General MedicineEmory University School of MedicineAtlanta
  2. 2.the Department of Behavioral Sciences and Health Education, Rollins School of Public HealthEmory UniversityAtlanta
  3. 3.the Division of GeriatricsYale University School of MedicineNew Haven

Personalised recommendations