International Journal of Drug Policy
Volume 20, Issue 1 , Pages 14-27 , January 2009

Ethical and regulatory considerations in HIV prevention studies employing respondent-driven sampling

  • Salaam Semaan

      Affiliations

    • Centers for Disease Control and Prevention, 1600 Clifton Road, NE, E-07, Atlanta, GA 30333, United States
    • Corresponding Author InformationCorresponding author. Tel.: +1 404 639 8870; fax: +1 404 639 8600.
    • ,
  • Scott Santibanez

      Affiliations

    • Centers for Disease Control and Prevention, 1600 Clifton Road, NE, E-73, Atlanta, GA 30333, United States
    • ,
  • Richard S. Garfein

      Affiliations

    • School of Medicine, University of California San Diego, San Diego, CA, United States
    • ,
  • Douglas D. Heckathorn

      Affiliations

    • Department of Sociology, Cornell University, Ithaca, NY, United States
    • ,
  • Don C. Des Jarlais

      Affiliations

    • Beth Israel Medical Center, New York, NY, United States

Received 29 June 2007 ,Revised 28 November 2007 ,Accepted 5 December 2007.

References 

  1. Abdul-Quader AS, Heckathorn DD, McKnight C, Bramson H, Nemeth C, Sabin K, et al. Effectiveness of respondent-driven sampling for recruiting drug users in New York City: Findings from a pilot study. Journal of Urban Health. 2006;83:459–476
  2. Abdul-Quader AS, Heckathorn DD, Sabin K, Saidel T. Implementation and analysis of respondent driven sampling: Lessons learned from the field. Journal of Urban Health. 2006;83:1–5
  3. Akabayashi A, Slingsby BT. Informed consent revisited: Japan and the U.S.. The American Journal of Bioethics. 2006;6:9–14
  4. Boter H, van Delden JJM, de Hann RJ, Rinkel GJE for the home evaluation of stroke induced aid study group. Modified informed consent procedure: Consent to postponed information. British Medical Journal. 2003;327:284–286
  5. Broadhead RS, Heckathorn DD, Grund JP, Stern LS, Anthony DL. Drug users versus outreach workers in combating AIDS: Preliminary results of a peer-driven intervention. Journal of Drug Issues. 1995;25:531–564
  6. Broadhead RS, Heckathorn DD, Weakliem DL, Anthony DL, Madray H, Mills RJ, et al. Harnessing peer networks as an instrument for AIDS prevention: Results from a peer-driven intervention. Public Health Reports. 1998;113:42–57
  7. Catania JA, Gibson D, Chitwood D, Coates T. Methodological problems in AIDS behavioral research: Influences of measurement error and participation studies in studies of sexual behavior. Psychology Bulletin. 1990;108:339–362
  8. Centers for Disease Control and Prevention . Guidelines for defining public health research and public health non-research.. Atlanta, GA: Centers for Disease Control and Prevention; 1999;
  9. Centers for Disease Control and Prevention . Advancing HIV prevention: New strategies for a changing epidemic—United States 2003. Morbidity and Mortality Weekly Report. 2003;52:329–332
  10. Clements-Nolle K, Marx R, Guzman R, Katz M. HIV prevalence, risk behaviors, health care use, and mental health status of transgender persons: Implications for public health intervention. American Journal of Public Health. 2001;91:915–921
  11. Cooper H, Hedges LV. The handbook of research synthesis. New York: Russell Sage Foundation; 1994;
  12. Council for International Organizations of Medical Sciences . International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization; 2003;http:www.cioms.ch/frame_guidelines.htm
  13. Crepaz N, Marks G. Serostatus disclosure, sexual communication and safer sex in HIV-positive men. AIDS Care. 2003;15:379–387
  14. Deci EL, Ryan RM. Intrinsic motivation and self-determination in human behaviour. New York: Plenum; 1985;
  15. Deren S, Stephens RC, Rees Davis W, Feucht TE, Tortu S. The impact of providing incentives for attendance at AIDS prevention services. Public Health Reports. 1994;109:548–554
  16. Des Jarlais DC, Arasteh K, Perlis T, Hagan H, Abdul-Qauder A, Heckathorn DD, et al. Convergence of HIV seroprevalence among injecting and non-injecting drug users in New York City. AIDS. 2007;21:231–235
  17. Des Jarlais DC, Perlis T, Arasteh K, Hagan H, Milliken J, Braine N, et al. “Informed altruism” and “partner selection” in the reduction of HIV infection in injecting drug users entering detoxification treatment in New York City, 1990–2001. Journal of Acquired Immune Deficiency Syndrome. 2004;35:158–166
  18. Des Jarlais DC, Semaan S. Interventions to reduce the sexual risk behavior of injecting drug users. International Journal of Drug Policy. 2005;16S:S58–S66
  19. Eisenberger R, Cameron J. Detrimental effects of reward: Reality or myth?. American Psychologist. 1996;51:1153–1166
  20. Emanuel EJ. Ending concerns about undue inducement. Journal of Law and Medical Ethics. 2004;32:100–105
  21. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases. 2004;189:130–137
  22. Fairchild AL, Bayer R. Ethics and the conduct of public health surveillance. Science. 2004;303:631–632
  23. Fairchild AL. Dealing with humpty dumpty: Research, practice, and the ethics of public health surveillance. Journal of Law, Medicine, and Ethics. 2005;31:615–623
  24. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: An ethical perspective. IRB: Ethics & Human Research. 2003;25:12–19
  25. Festinger DS, Marlowe DB, Croft JR, Dugosh KL, Mastro NK, Lee PA, et al. Do research payments precipitate drug use or coerce participation?. Drug and Alcohol Dependence. 2005;78:275–281
  26. Fisher CB. Ethics in drug abuse and related HIV risk research. Applied Developmental Sciences. 2004;8:91–103
  27. Fitzgerald DW, Wasunna A, Pape JW. Ten questions institutional review boards should ask when reviewing international clinical research protocols. IRB: Ethics & Human Research. 2003;25(2):14–18
  28. Foddy B, Savulescu J. Addiction and autonomy: Can addicted people consent to the prescription of their drug of addiction. Bioethics. 2006;20:1–15
  29. Frost SDW, Brouwer KC, Firestone-Cruz MA, Ramos R, Ramos ME, Lozada RM, et al. Respondent driven sampling of injection-drug users in two U.S.-Mexico border cities: Recruitment dynamics and impact on estimates of HIV and syphilis prevalence. Journal of Urban Health. 2006;83:83–97
  30. Fry C, Dwyer R. For love or money? An exploratory study of why injecting drug users participate in research. Addiction. 2001;96:1319–1325
  31. Fry CL, Hall W, Ritter A, Jenkinson R. The ethics of paying drug users who participate in research: A review and practical recommendations. Journal of Empirical Research on Human Research Ethics. 2006;1:21–36
  32. Gagnon JH, Lindenbaum S, Martin JL, May RM, Menken J, Turner CF, et al. Sexual behavior and AIDS. In:  Turner CF,  Miller H,  Moses L editor. Sexual behavior and intravenous drug use. Washington, DC: National Academy Press; 1989;p. 73–185
  33. Gallagher KM, Denning PD, Allen DR, Nakashima AK, Sullivan PS. Use of rapid behavioral assessments to determine the prevalence of HIV risk behaviors in high-risk populations. Public Health Reports. 2007;122(Suppl. 1):56–62
  34. Galton F. English men of science: Their nature and nurture. London: Macmillan; 1874;
  35. Gardner W, Hoge SK, Bennet N, Roth LH, Lidz CW, Monahan J, et al. Two scales for measuring patients’ perception of coercion during mental hospital admission. Behavioral Sciences & the Law. 1993;11:307–321
  36. Golden MR, Hogben M, Handsfiled H, St. Lawrence JS, Potterat JJ, Holmes K. Partner notification for HIV and STD in the United States: Low coverage for gonorrhea, chlamydial infection, and HIV. Sexually Transmitted Diseases. 2003;30:490–496
  37. Golub A, Johnson BD. How much do Manhattan-arrestees spend on drugs?. Drug and Alcohol Dependence. 2004;76:235–246
  38. Gordon BG, Brown J, Kratochvil C, Prentice ED. Paying research subjects. In:  Amdur RJ,  Bankert EA editor. Institutional review board: Management and function. 1st ed.. Sudbury, MA: Jones and Bartlett Publishers; 2002;p. 185–190
  39. Grady C. Money for research participation: Does it jeopardize informed consent?. American Journal of Bioethics. 2001;1:41–44
  40. Grady C, Dickert N, Jawtez T, Gensler G, Emanuel E. An analysis of U.S. practices of paying research participants. Contemporary Clinical Trials. 2005;26:365–375
  41. Halpern SD. Towards evidence based bioethics. British Medical Journal. 2005;331:901–903
  42. Hawkins JS, Emanuel EJ. Clarifying confusions about coercion. Hastings Center Report. 2005;35:16–19
  43. Hearnshaw H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive international study. British Medical Journal. 2004;328:140–141
  44. Heckathorn D. Respondent-driven sampling: A new approach to the study of hidden populations. Social Problems. 1997;44:174–199
  45. Heckathorn D. Respondent-driven sampling: Deriving valid population estimates from chain-referral samples of hidden populations. Social Problems. 2002;49:11–34
  46. Heckathorn, D. D. (2007). Extensions of respondent-driven sampling: Analyzing continuous variables and controlling for differential recruitment. Sociological Methodology, 27.
  47. Heckathorn DD, Broadhead RS. Rational choice, public policy, and AIDS. Rationality and Society. 1996;8:235–260
  48. Heckathorn DD, Abdul-Quader AS, Sabin K, Mello M, Diaz J, Chinaglia M, et al. Respondent-driven sampling: Quantifying HIV prevalence, HIV risk behaviour, and the network embeddedness of risk behaviour in developing countries. In: Paper presented at the conference on Infectious Diseases in Poor Countries and the Social Sciences. Cornell University, Ithaca, NY, September 7, 2007. 2007;
  49. Heckathorn DD, Semaan S, Broadhead RS, Hughes JJ. Extensions of respondent-driven sampling: A new approach to the study of injection-drug users aged 18–25. AIDS and Behavior. 2002;6:55–67
  50. Holtgrave DR. Estimation of annual HIV transmission rates in the United States, 1978–2000. Journal of Acquired Immune Deficiency Syndrome. 2004;35:89–92
  51. Holtgrave DR, Anderson T. Utilizing HIV transmission rates to assist in prioritizing HIV prevention services. International Journal of STD & AIDS. 2004;15:789–792
  52. Holtgrave DR, Pinkerton SD. Can increasing awareness of HIV seropositivity reduce infections by 50% in the United States?. Journal of Acquired Immune Deficiency Syndrome. 2007;44:360–363
  53. Hughes JH. Paying injection-drug users to educate and recruit their peers: Why participant-driven interventions are an ethical public health model?. Quality Management in Health Care. 1999;7:4–12
  54. Johnson WD, Semaan S, Hedges LV, Ramirez G, Mullen PD, Soglow E. A protocol for the analytical aspects of a systematic review of HIV prevention research. Journal of Acquired Immune Deficiency Syndromes. 2002;30:S62–S72
  55. Joint United Nations Program on AIDS . Opening up the HIV/AIDS epidemic: Guidance on encouraging beneficial disclosure, ethical partner counseling and appropriate use of HIV case reporting. Geneva: UN AIDS; 2000;
  56. Kalton G. Sampling considerations in research on HIV risk and illness. In:  Ostrow DG,  Kessler RC editor. Methodological issues in AIDS behavioral research. New York: Plenum Press; 1993;p. 53–74
  57. Katz D, Caplan AL, Merz JF. All gifts large and small: Toward an understanding of the ethics of pharmaceutical industry gift-giving. The American Journal of Bioethics. 2003;3:39–46
  58. Kish L. Taxonomy of elusive populations. Journal of Official Statistics. 1991;7:340–347
  59. Klein SJ. Screening for risk of domestic violence within HIV partner notification: Evolving practice and emerging issues. Journal of Public Health Management Practice. 2001;7:46–49
  60. Kleinig J. Ethical issues in substance use intervention. Substance Use & Misuse. 2004;39:369–398
  61. Klovdahl AS. Social network research and human subjects protection: Towards more effective infectious disease control. Social Networks. 2005;27:119–137
  62. Knoppers BM, Joly Y, Simard J, Durocher F. The emergence of an ethical duty to disclose genetic research results: International perspectives. European Journal of Human Genetics. 2006;14:1170–1178
  63. Lansky A, Abdul-Quader AS, Cribbin M, Hall T, Finlayson TJ, Garfein RS, et al. Developing an HIV behavioral surveillance system for injecting drug users: The national HIV behavioral surveillance system. Public Health Reports. 2007;122:S48–S55
  64. Latkin CA, Knowlton AR, Forman VL, Hoover DR, Schroeder JR, Hachey M, et al. Injection-drug users’ disclosure of HIV seropositive status to network members. AIDS and Behavior. 2001;5:297–305
  65. Latterman J, Merz JF. How much are subjects paid to participate in research?. American Journal of Bioethics. 2001;1:45–46
  66. Laumann EO, Michael R, Gagnon J, Michaels S. The social organization of sexuality: Sexual practices in the United States. Chicago, IL: University of Chicago Press; 1994;
  67. Lemmens T, Miller P. The human subjects trade: Ethical and legal issues surrounding recruitment incentives. Journal of Law Medicine & Ethics. 2003;31:398–418
  68. Magnani R, Sabin K, Saidel T, Heckathorn DD. Review of sampling hard-to-reach and hidden populations for HIV surveillance. AIDS. 2005;S67–S72
  69. Margolis LH. Taking names: The ethics of indirect recruitment in research on sexual networks. Journal of Law, Medicine, and Ethics. 2000;28:159–164
  70. McKnight C, Des Jarlais D, Bramson H, Tower L, Abdul-Qader AS, Nemeth C, et al. Respondent-driven sampling in a study of drug users in New York City: Notes from the field. Journal of Urban Health. 2006;83:54–59
  71. Miller F, Rosenstein DL. Reporting of ethical issues in publications of medical research. Lancet. 2002;360:1326–1328
  72. National Bioethics Advisory Commission . Ethical and policy issues in international research: clinical trials in developing countries. vol. 1. Bethesda, US: Department of Commerce, Technology Administration, National Technical Information Service; 2003;
  73. Nuffield Council on Bioethics . The ethics of health care related research in developing countries: A follow-up discussion paper. London, UK: Nuffield Council on Bioethics; 2005;
  74. Office of Protection from Research Risk (1991). Protection of human subjects (45 CFR 46). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
  75. Parsons JT, Van Ora J, Missildine W, Purcell DW, Gomez CA. Positive and negative consequences of HIV disclosure among seropositive injection drug users. AIDS Education and Prevention. 2004;16:459–475
  76. Passin WF, Kim AS, Hutchinson AB, Crepaz N, Herbst JH, Lyles CM, et al. A systematic review of HIV partner counseling and referral services: Client and provider attitudes, preferences, practices, and experiences. Sexually Transmitted Diseases. 2006;33:320–328
  77. Paxton S. The paradox of public HIV disclosure. AIDS Care. 2002;14:559–567
  78. Platt L, Wall M, Rhodes T, Judd A, Hickman M, Johnston L, et al. Methods to recruit hard-to-reach groups: Comparing two chain referral sampling methods of recruiting injecting drug users across nine studies in Russia and Estonia. Journal of Urban Health. 2006;83:39–53
  79. Ramirez-Valles J, Heckathorn DD, Vazquez R, Diaz RM, Campbell RT. From networks to populations: The development and application of respondent-driven sampling among IDUs and Latino gay men. AIDS and Behavior. 2005;19:1–16
  80. Rhodes T, Singer M, Bourgois P, Friedman SR, Strathdee SA. The social structural production of HIV risk among injection drug users. Social Science and Medicine. 2005;61:1026–1044
  81. Rivera R, Borasky D, Rice R, Carayon F, Wong E. Informed consent: An international researchers’ perspective. American Journal of Public Health. 2007;97:25–30
  82. Robinson W, Risser J, McGoy S, Becker A, Rehman H, Jefferson M, et al. Recruiting injection drug users: A three-site comparison of results and experiences with respondent-driven and targeted sampling procedures. Journal of Urban Health. 2006;83:29–38
  83. Rose JW. To tell or not to tell: Legislative imposition of partner notification duties for HIV patients. The Journal of Legal Medicine. 2001;22:107–123
  84. Roy DJ. Injection drug use and HIV/AIDS: An ethics commentary on priority issues. Health Canada; 2000;
  85. Salganik MJ. Variance estimation, design effects, and sample size calculations for respondent-driven sampling. Journal of Urban Health. 2006;83:98–112
  86. Semaan S, Des Jarlais DC, Malow RM. Sexually transmitted diseases among illicit drug users in the United States: The need for interventions. In:  Aral SO,  Douglas J editor. Behavioral interventions for prevention and control of sexually transmitted diseases. New York, NY: Springer; 2007;p. 397–430
  87. Semaan S, Klovdahl A, Aral SO. Protecting the privacy, confidentiality, relationships, and medical safety of sex partners in partner notification and management studies. The Journal of Research Administration. 2004;35:39–53
  88. Semaan S, Lauby J, Liebman J. Street and network sampling in evaluation studies of HIV risk-reduction interventions. AIDS Review. 2002;4:213–223
  89. Semaan S, Leinhos M. The ethics of public health practice for the prevention and control of STDs. In:  Aral SO,  Douglas J editor. Behavioral interventions for prevention and control of sexually transmitted diseases. New York, NY: Springer; 2007;p. 517–548
  90. Sharp HM. When “minimal risk” research yields clinically significant data, maybe the risks aren’t so minimal. American Journal of Bioethics. 2004;4:W32–W36
  91. Simic M, Johnston L, Plat L, Baros S, Andjelkovic V, Novotny T, et al. Exploring barriers to respondent driven sampling in sex worker and drug-injecting sex worker populations in Eastern Europe. Journal of Urban Health. 2006;83:6–15
  92. Simmerling, M., Schwegler, B., Sieber, J., & Lindgren, J. (2007). Introducing a new paradigm for ethical research in the social, behavioral, and biomedical sciences: Part I. http://ssrn.com/abstract=897322.
  93. Snider DE, Stroup DF. Defining research when it comes to public health. Public Health Reports. 1997;112:29–112
  94. Stormer A, Tun W, Guli L, Harxhi A, Bodanovskaia Z, Yakovleva A, et al. An analysis of respondent driven sampling with injection drug users (IDU) in Albania and the Russian Federation. Journal of Urban Health. 2006;83:73–82
  95. Sudman S, Sirken M, Cowan C. Sampling rare and elusive populations. Science. 1988;240:991–996
  96. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research (Rep. no. DHEW Publication no. (OS 78-0012)). Washington, DC: U.S. Government Printing Office.
  97. Tiffany JS. Respondent-driven sampling in participatory research contexts: Participant-driven recruitment. Journal of Urban Health. 2006;83:i113–i124
  98. Tishler C, Bartholomae S. The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. Journal of Pharmacology. 2002;42:363–373
  99. Tobin KE, Muessig KE, Latkin CA. HIV seropositive drug users’ attitudes towards partner notification (PCRS): Results from the SHIELD study in Baltimore, Maryland. Patient Education and Counseling. 2007;67:137–142
  100. Wang J, Carlson RG, Falck RS, Siegal HA, Rahman A, Li L. Respondent-driven sampling to recruit MDMA users: A methodological assessment. Drug and Alcohol Dependence. 2005;78:147–157
  101. Warszawski J, Meyer L. Sex difference in partner notification: Results from three population based surveys in France. Sexually transmitted Infections. 2002;78:45–49
  102. Weijer C, Anderson JA. The ethics wars: Dispute over international research. Hastings Center Report. 2001;31:18–20
  103. Wiener L, El Lyon M. HIV disclosure: Who knows? Who needs to know? Clinical and ethical considerations. In:  Lyon M,  D’Angelo L editor. Teenagers, HIV and AIDS: Insights from youths living with the virus. Westport, CT: Praeger; 2007;p. 105–126
  104. Wilkinson M, Moore A. Inducement in research. Bioethics. 1997;11:373–389
  105. World Bank Group . Public health surveillance toolkit. World Bank Group; 2002;
  106. World Medical Association. (2000). Declaration of Helsinki: Ethical principles for medical research involving human subjects. Geneva: World Medical Association. http://www.wma.net/e/policy/17-c_e.html.
  107. World Health Organization . Research Ethics Review Committee. The role of ethics review committees in public health surveillance. Geneva: World Health Organization; 2004;
  108. Yeka W, Maibani-Michie G, Prybylski D, Colby D. Application of respondent driven sampling to collect baseline data on FSW and MSM for HIV risk reduction interventions in two urban centers in Papua New Guinea. Journal of Urban Health. 2006;83:60–72
  109. Zion D. Does autonomy require freedom? The importance of options in international HIV/AIDS research. Health Care Analysis. 2005;13:189–202

☆ An earlier version of this paper was presented at the XV International AIDS conference, Bangkok, Thailand, 15 July 2004 and at the U.S. National HIV Prevention Conference, Atlanta, GA, 4 December 2007.

☆☆ The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.

PII: S0955-3959(07)00265-4

doi: 10.1016/j.drugpo.2007.12.006

International Journal of Drug Policy
Volume 20, Issue 1 , Pages 14-27 , January 2009

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