• 1
    Chavkin W. Women and clinical research. J Am Med Women's Assoc. 1994;49:99 100.
  • 2
    Allen M. The dilemma for women of color in clinical trials. JAMA. 1994;49:105 9.
  • 3
    Mohiuddin SM & Hilleman DE. Gender and racial bias in clinical pharmacology trials. Ann Pharmacother. 1993;27:972 3.
  • 4
    Swanson GM & Ward AJ. Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst. 1995;87: 1747 59.
  • 5
    Wermeling D & Selwitz A. Current issues surrounding women and minorities in drug trials. Ann Pharmacother. 1993;27:904 11.
  • 6
    Cotton P. Is there still too much extrapolation from data on middle aged white men? JAMA. 1990;263:1049 50.
  • 7
    Dresser R. Wanted: single, white male for medical research. Hastings Cent Rep. 1992;22:24 9.
  • 8
    Robinson SB, Ashley M, Haynes MA. Attitudes of African-Americans regarding prostate cancer clinical trials. J Commun Health. 1996;21:77 87.
  • 9
    Roberson NL. Clinical trial participation: viewpoints from racial/ethnic groups. Cancer. 1994;74:2687 91.
  • 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.
  • 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.
  • 12
    Krueger RA. Focus Groups: A Practical Guide for Applied Research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1994:255.
  • 13
    Kitzinger J. Qualitative research: introducing focus groups. BMJ. 1995;311:299 302.
  • 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.
  • 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.
  • 16
    Denzin NK & Lincoln YS. Handbook of Qualitative Research. Thousand Oaks, Calif: Sage Publications; 1994:643.
  • 17
    Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997;87:1773 8.
  • 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.
  • 19
    Brandt AM. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Cent Rep. December 1987.
  • 20
    Caplan AL. When evil intrudes. Hastings Cent Rep. 1992;22:29 32.
  • 21
    Edgar H. Outside the community. Hastings Cent Rep. 1992;22:32 5.
  • 22
    King P. The dangers of difference. Hastings Cent Rep. 1992;22:35 8.
  • 23
    Jones J. Bad Blood: The Tuskegee Syphilis Experiment. New York, NY: Macmillan; 1993.
  • 24
    Nuremberg Code: Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law; 1949:2:181–2.
  • 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.
  • 26
    Department of Health and Human Services, 40 FR 33528. August 8, 1975.
  • 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.
  • 28
    Pinn VW. The role of the NIH's Office of Research on Women's Health. Acad Med. 1994;69:698 702.
  • 29
    NIH guidelines on the inclusion of women and minorities as subjects in clinical research; notice. Fed Reg. 1994;54:14508–13.
  • 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.
  • 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.
  • 32
    Des Jarlais DC & Stepherson B. History, ethics, and politics in AIDS prevention research. Am J Public Health. 1991;81:1393 4.
  • 33
    Cox J. Paternalism, informed consent and Tuskegee. Int J Radiat Oncol, Biol, Phys. 1998;40:1 2. Editorial; comments.
  • 34
    Wolinsky H. Steps still being taken to undo damage of “American's Nuremberg.” Ann Intern Med. 1997;127:143 5.
  • 35
    Guinan M. Black communities' belief in “AIDS as genocide”: a barrier to overcome for HIV prevention. Ann Epidemiol. 1993;3:193 5.
  • 36
    Thomas SB & Curran JW. Tuskegee: from science to conspiracy to metaphor. Am J Med Sci. 1999;317:1 4.
  • 37
    Dula A. African American suspicion of the healthcare system is justified: what do we do about it? Camb Q Healthc Ethics. 1994;3:347 57.
  • 38
    Gamble V. A legacy of distrust: African Americans and medical research. Am J Prev Med. 1993;9:35 8.
  • 39
    Lidz CW, Meisel A, Osterweis M, Holden JL, Marx JH, Munetz MR. Barriers to informed consent. Ann Intern Med. 1993;99:539 43.
  • 40
    Lantos J. Informed consent: the whole truth for patients? Cancer. 1993;72:2811 5.
  • 41
    Taylor KM & Kelner M. Informed consent: the physicians' perspective. Soc Sci Med. 1987;24:135 43.
  • 42
    Corbie-Smith G. The continuing legacy of the Tuskegee Syphilis Study: considerations for clinical investigation. Am J Med Sci. 1999;317:5 8.
  • 43
    Williams MV, Parker RM, Baker DW, et al. Inadequate functional health literacy among patients at two public hospitals. JAMA. 1995;274:1677 82.
  • 44
    Taylor K, Bezjak A, Fraser H. Informed consent for clinical trials: is simpler better? J Nat Cancer Inst. 1998;90:644 5.
  • 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.
  • 46
    Smith R. Deception in research, and racial discrimination in medicine. BMJ. 1993;396:668 9.
  • 47
    Agre P, McKee K, Gargon N, Kurtz R. Patient satisfaction with an informed consent process. Cancer Pract. 1997;5:162 7.
  • 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.
  • 49
    Aaronson N, Zittoun R. Informed consent and cancer clinical trials. In: Psychological Aspects of Oncology. Berlin, Germany: Springer; 1990.
  • 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.
  • 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.
  • 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.
  • 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.
  • 54
    Brody B, Katz J, Dula A. In case of emergency: no need for consent. Hastings Cent Rep. 1997;27:7; discussion 7 12.
  • 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.
  • 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.
  • 57
    Wilcox M & Schroer S. The perspective of patients with vascular disease on participation in clinical trials. J Vasc Nurs. 1994;12:112 6.
  • 58
    Tangrea JA, Adrianza ME, Helsel WE. Patients' perceptions on participation in a cancer chemoprevention trial. Cancer Epidemiol Biomarkers Prev. 1992;1:325 30.
  • 59
    Cunny KA & Miller HW. Participation in clinical drug studies: motivations and barriers. Clin Ther. 1994;16:273 82.
  • 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.
  • 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.
  • 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.
  • 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.
  • 64
    El-Sadr W & Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA. 1992;267:954 7.
  • 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.
  • 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.
  • 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.
  • 68
    Quinn SC. AIDS and the African American woman: the triple burden of race, class, and gender. Health Educ Q. 1993;20:305 20.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 74
    Barry M. Ethical considerations of human investigation in developing countries: the AIDS Dilemma. N Engl J Med. 1988;319: 1083 5.