Fordham University            The Jesuit University of New York
 



Empirical and Theoretical Articles and Resources
in HIV Prevention and Use Research Ethics


Please click on the links below to view suggested articles and chapters on each topic.
Articles are organized by subject matter and are distinguished between empirical and theoretical.


Please click HERE for a PDF version

RETI Fellows and Faculty can access articles using the RETI Blackboard account

 
Empirical research Ethics on hiv risk and drug use research

Aldridge, J. & Charles, V. (2008). Researching the intoxicated: Informed consent
      implications for alcohol and drug research. Drug and Alcohol Dependence, 93, 191-196.
Anderson, E. E. & DuBois, J. M. (2007). The need for evidence-based research ethics: A
      review of the substance abuse literature. Drug and Alcohol Dependence, 86, 95-105.
Anspach, R. R, & Mizrachi, N. (2006). The field worker’s fields: Ethics, ethnography and
      medical sociology. Sociology of Health & Illness, 28(6), 713-731.
Barnett, P. G., Sorensen, J. L., Wong, W., Haung, N., & Hall, S. M. (2009). Effect of
      incentives for medication adherence on health care use and costs in methadone
      patients with HIV. Drug andAlcohol Dependence, 100, 115-121.
Bell, K. & Salmon, A. (2011). What women who use drugs have to say about ethical
      research: Findings of an exploratory qualitative study. Journal of Empirical Research on
      Human Research Ethics, 6(4), 84-98.
Borek, N., Allison, S., & Caceres, C. (2010). Involving vulnerable populations of youth in
      HIV prevention clinical research. Journal of Acquired Immune Deficiency Syndromes, 
      54, S43-S49.
Brody, J. L. & Waldron, H. B. (2000). Ethical issues in research on the treatment of
      adolescent substance abuse disorders. Addictive Behaviors, 25(2), 217-228.
Brown, E. J. & Hill, M. A. (2005). Perceptions of HIV risks and prevention strategies by
      rural and small city African Americans who use cocaine: Views from the inside. Issues 
      in Mental Health Nursing, 26, 359-377.
Calsyn, R. J., Klinkenberg, W. D., Morse, G. A., Miller, J., & Cruthis, R. (2004).
      Recruitment, engagement, and retention of people living with HIV and co-occurring
      mental health and substance use disorders. AIDS Care, 16(Supp. 1), S56-S70.
Colon, R. A., Deren, S., Guarino, H., Mino, M., & Kang, S. (2010). Challenges in recruiting
      and training drug treatment patients as peer outreach workers: A perspective from the
      field. Substance Use & Misuse, 45, 1892-1908.
DuBois, J. M., O’Leary, C. C., & Cottler, L. B. (2009). The attitudes of females in drug
      court toward additional safeguards in HIV prevention research. Prevention Science, 10,
      345-352.
Dunlap, E., Johnson, B. D., & Randolph, D. (2009). Ethical and legal dilemmas in
      ethnographic field research: Three case studies of distressed inner-city families. In D.
      Buchanan, C. B. Fisher, & L. Gable (Eds.), Research with high-risk populations:
      Balancing science, ethics, and law (pp. 189-206). Washington, DC: APA Books.
DuVal, G. & Salmon, C. (2004). Research note: Ethics of drug treatment research with
      court-supervised subjects. The Journal of Drug Issues, 34(4), 991-1005.
Festinger, D. S., Marlowe, D. B., Dugosh, K. L., Croft, J. R., & Arabia, P. L. (2008).
      Higher magnitude cash payments improve research follow-up rates without increasing
      drug use or perceived coercion. Drug and Alcohol Dependence, 96, 128-135.
Fisher, C. B. (2011). Addiction research ethics and the Belmont principles: Do drug users
      have a different moral voice? Substance Use & Misuse, 46, 728-741
Fisher, C. B. (2010). Enhancing HIV vaccine trial consent preparednessamong street
      drug users. Journal of Empirical Research on Human Research Ethics, 5, 65-80.
Fisher, C. B. (2004). Ethics in drug abuse and related HIV risk research. Applied
      Developmental Science, 8(2), 91-103.
Fisher, C. B. (2003). Adolescent and parent perspectives on ethical issues in youth drug
      use and suicide survey research. Ethics & Behavior, 13(4), 303-332.
Fisher, C. B., Oranksy, M., Mahadevan, M., Singer, M., Mirhej, G., & Hodge, G. D.
      (2009). Do drug abuse researchers have a duty to protect third parties from HIV
      transmission? Moral perspectives of street drug users. In D. Buchanan, C. B. Fisher, &
      L. Gable (Eds.), Research with high-risk populations: Balancing science, ethics, and
      law (pp. 189-206). Washington, DC: APA Books.
Fisher, C. B., Oransky, M., Mahadevan, M., Singer, M., Mirhej, G., & Hodge, D. (2008).
      Marginalized populations and drug addiction research: Realism, mistrust, and
      misconception. IRB: Ethics & Human Research, 30, 1-9.
Forman, R. F., Bovasso, G., Woody, G., McNicholas, L., Clark, C., Royer-Malvestuto, C.,
      & Weinstein, S. (2002). Staff beliefs about drug abuse clinical trials. Journal of
      Substance Abuse Treatment, 23, 55-60.
Fry, C. & Dwyer, R. (2001). For love or money? An exploratory study of why injecting drug
      users participate in research. Addiction, 96, 1319-1325.
Haire, B., & Jordens, C. (2013). Standard of Prevention in the Real World: A qualitative Study of Principal Investigators in HIV Biomedical Prevention Trials. AJOB Primary Research, 4(3), 14-25.
Iguchi, M. Y., London, J. A., Forge, N. G., Hickman, L., Fain, T., Reihman, K. (2002).
      Elements of well-being affected by criminalizing drug use. Public Health Reports,
      17(Supp 1), 146-150.
Kapp, S. A. (2000) Pathways to Prison: Life Histories of Former Clients of the Child
      Welfare and Juvenile Justice Systems. Journal of Sociology & Social Welfare, 27,
      63-74.
Kleinig, J. (2004). Ethical issues in substance use intervention. Substance Use & Misuse,
      39(3), 369-398.
Lucke, J. C. & Hall, W. D. (2012). Under what conditions is itethical to offer incentives to
      encourage drug-using women to use long-acting forms of contraception? Addiction, doi:
      10.1111/j.1360-0443.2011.03699.x
Meyers, K., Metzger, D. S., Navaline, H., Woody, G. E., & McLellan, A. T. (1994). HIV
      vaccine trials: Will intravenous drug users enroll? American Journal of Public Health,
      84(5), 761-766.
•  McCambridge, J., Kypri, K., Bendtsen, P., & Porter, J. (2013). The use of deception in         public health behavioral intervention trials: A case study of three online alcohol trials. The American Journal of Bioethics, 13(11), 39-47.
Oransky, M., Fisher, C. B., Mahadevan, M., & Singer, M. (2009). Barriers and
      opportunities for recruitment for nonintervention studies on HIV risk: Perspectives of
      street drug users. Substance Use & Misuse, 44, 1642-1659.
Rajabiun, S., Mallinson, R. K., McCoy, K., Coleman, S., Drainoni, M., Rebholz, C., &
      Holbert, T. (2007). “Getting me back on track”: The role of outreach interventions in
      engaging and retaining people living with HIV/AIDS in medical care. AIDS Patient Care
      and STDs, 21(Supp. 1), S20-S29.
Rhodes, T., Singer, M., Bourgois, P., Friedman, S. R., & Strathdee, S. A. (2005). The
      social structural production of HIV risk among injecting drug users. Social Science &
      Medicine, 61, 1026-1044.
Roberts, L. W. (2002). Addiction and consent. The American Journal of Bioethics, 2(2),
      58-60.Scott, G. (2008). “They got their program, and I got mine”: A cautionary tale
      concerning the ethical implications of using respondent-driven sampling to study
      injection drug users. International Journal of Drug Policy, 19, 42-51.
Rojas, N. L., Sherrit, L., Harris, S., & Knight, J. R. (2008). The role of parental consent in
      adolescent substance use research. Journal of Adolescent Health, 42, 192-197.
Sarang, A., Rhodes, T., Sheon, N., & Page, K. (2010). Policing drug users in Russia: Risk
      fear, structural violence. Substance Use & Misuse, 45, 813-864
Scott, C. K. & White, W. L. (2005). Ethical issues in the conduct of longitudinal studies of
      addiction treatment. Journal of Substance Abuse Treatment, 28, S91-S101.
Simmons, J. (2006). The interplay between interpersonal dynamics, treatment barriers,
      and larger social forces: An exploratory study of drug-using couples in Hartford, CT.
      Substance Abuse Treatment, Prevention, and Policy, 1(12), open access.
Simmons, J. & Koester, K. (2003). Hidden injuries of research on social suffering among
      drug users. Practicing Anthropology, 25(3), 53-57.
Simmons, J. & Singer, M. (2006). I love you…and heroin: Care and collusion among
      drug-using couples. Substance Abuse Treatment, Prevention, and Policy, 1(7), open
      access.
Singer, M. (2009). Trucking between the bailiwicks: Multidisciplinarity, SAVA, and
      synergies in health (Chapter 2). In M. Singer, Introduction to syndemics: A critical
      systems approach to public and community health. (pp. 27-52). San Francisco: 
      Josey-Bass.
Slomka, J., Ratliff, E. A., McCurdy, S. A., Timpson, S., & Williams, M.L. (2008).
      Decisions to participate in research: Views of underserved minority drug users with or
      at risk for HIV. AIDS Care, 20(10), 1224-1232.
Slomka, J., Ratliff, E. A., McCurdy, S., Timpson, S., & Williams, M. L. (2008).
      Perceptions of risk in research participation among underserved minority drug users.
      Substance Use and Misuse, 43(11), 1640-1652
Slomka, J., McCurdy, S., Ratliff, E. A., Timpson, S., & Williams, M. L. (2007).
      Perceptions of financial payment for research participation among African-American
      drug users in HIV studies. Journal of General Internal Medicine, 22, 1403-1409.
Stirley, C. L. W., Callahan, C., & Cottler, L. B. (2008). Enrolling, retaining, and benefiting
      out-of-treatment drug users in intervention research. Journal of Empirical Research on
      Human Research Ethics, 3(3), 19-25.
Timmermans, S. & McKay, T. (2009). Clinical trials as treatment option: Bioethics and
      health care disparities in substance dependency. Social Science & Medicine, 69,
      1784-1790.
Uuskula, A., Johnston, L. G., Raag, M., Trummal, A., Talu, A., & Des Jarlais, D. C.
      (2010). Evaluating recruitment among female sex workers and injecting drug users at
      risk for HIV using respondent-driven sampling in Estonia. Journal of Urban Health:
      Bulletin of the New York Academy of Medicine, 87(2), 304-317.
Varas-Diaz, N., Negron, S. S., Neilands, T. B., Bou, F. C., & Rivera, S. M. (2010).
      Stigmatization of illicit drug use among Puerto Rican health professionals in training.
      Puerto Rico Health Sciences Journal, 29(2), 109-116.
Wolfe, D., & Cohen, J. (2010). Human rights and HIV prevention treatment and care for
      people who inject drugs: Key principles and research needs. Journal Acquired Immune
      Deficiency Syndrome, 55, S56-S62.
Yin, L., Zhang, Y., Qian, H., Rui, B., Zhang, L., Zhu, J., … Shao, Y. (2008). Willingness
      of Chinese injection drug users to participate in HIV vaccine trials. Vaccine, 26,
      762-768.

 


HIV Prevention Ethics Historical Landmarks and Ethical Principles

• Angell, M. (1997). The ethics of clinical research in the third world. New England Journal
      of Medicine, 337
, 847-849
Annas, G. (2009). Global clinical trials and informed consent. New England Journal of
      Medicine, 360,
2050 – 2053.
Ballantyne, A. (2005) HIV international clinical research: Exploitation and risk.Bioethics,
      19,
476-491.
Fields, L. & Kaplan, C. (2011). Opt-out HIV testing: An ethical analysis of women’s
      reproductive rights. Nursing Ethics, 18, 734-742.
Fisher, C. B. (2011). Addiction research ethics and the Belmont principles: Do drug users
      have a different moral voice? Substance Use & Misuse, 46, 728-741
Fisher, C. B. (2004). Ethics in drug abuse and related HIV risk research. Applied
      Developmental Science, 8
(2), 91-103.
IJsselmuiden, C. B., Kass, N. E., Sewankambo, K. N., & Lavery, J. V. (2010). Evolving
      values in ethics and global health research. Global Public Health, 5, 154-163.
Kleinig, J. (2004). Ethical issues in substance use intervention. Substance Use & Misuse,
      39
(3), 369-398.
Loue, S. & Pike,E. C. (2010). Chapt. 1. Human Rights, International Guidelines & HIV
      Research. In Case studies in ethics and HIV research (pp. 1 – 14) NY: Springer
Loue, S. & Pike, E. C. (2010). Chapt. 2. U.S. regulations and HIV-related research. In
      Case studies in ethics and HIV research (pp 15 – 22). NY: Springer
Macklin, R. (1998). Ethical relativism in a multicultural society. Kennedy Institute of
      Ethics Journal, 8
(1), 1-22.
Macklin, R. (1999). Moral progress and ethical universals. Against relativism: Cultural
      diversity and search for ethical universals in medicine
(250-274). NY: Oxford University
      Press.
Rennie, S., & Sugarman, J. (2010). Developing ethics guidance for HIV prevention 
      research: The HIV Prevention Trials Network approach. J. Med Ethics 36, 810-815.
U.S. Office of Human Subjects Research (1979). The Belmont report: Ethical principles
      and guidelines for the protection of human subjects of research.
Retrieved from
      http://ohsr.od.nih.gov/guidelines/belmont.html
 

 
Empirical Research on Research Ethics Methodologies

Anderson, E. E. & DuBois, J. M. (2007). The need for evidence-based research ethics: A
      review of the substance abuse literature. Drug and Alcohol Dependence, 86, 95-105.
Danis, M., Hanson, L., & Garrett, J. M. (2010). Experimental methods. In J. Sugarman &
      D. Sulmasy (Eds.), Methods in Medical Ethics (2nd ed; pp. 251-272). Washington, DC:
      Georgetown University Press.
Dunlap, E., Johnson, B. D., & Randolph, D. (2009). Ethical and legal dilemmas in
      ethnographic field research: Three case studies of distressed inner-city families. In D.
      Buchanan, C. B. Fisher,& L. Gable (Eds.), Research with high-risk populations:  
      Balancing science, ethics, and law
(pp. 189-206). Washington, DC: APA Books.
Haverkamp, B. E. (2005). Ethical perspectives on qualitative research in applied
      psychology. Journal of Counseling Psychology, 52(2), 146-155.
Loue, S. & Pike, E. C. (2010). Chapt. 8 Clinical trials. In Case studies in ethics and HIV
      research
(pp 103-124). NY: Springer
Loue, S. & Pike, E. C. (2010). Chapt. 9. Observational studies. In Case studies in ethics
      and HIV research
(pp 137-150) NY: Springer
Loue, S. & Pike, E. C. (2010). Chapt.10. Behavioral intervention studies In Case studies
      in ethics and HIV research
(pp. 168-175) NY: Springer
Marshall, P. A. & Koenig, B. A. (2010). Ethnographic methods. In J. Sugarman & D.
      Sulmasy (Eds.),Methods in Medical Ethics (2nd ed; pp. 215-232). Washington, DC:
      Georgetown University Press.
Pearlman,R. A. & Starks, H. E. (2010). Quantitative Surveys. In J. Sugarman & D.
      Sulmasy (Eds.), Methods in Medical Ethics (2nd ed; pp. 233-250). Washington, DC:
      Georgetown University Press.
Perez-y-Perez, M. & Stanley, T. (2011). Ethnographic intimacy: Thinking through the
      ethics of social research in sex worlds. Sociological Research Online, 16(2), 13.
Ponterotto, J. G. (2010). Qualitative research in multicultural psychology: Philosophical
      underpinnings, popular approaches, and ethical considerations. Cultural Diversity and
      Ethnic Minority Psychology, 16
(4), 581-589.
Sugarman, J., Kass, N., & Faden, R. (2009). Categorizing empirical research in bioethics:
      Why count the ways? The American Journal of Bioethics, 9(6-7), 66-103.
Sulmasy, D. P. & Sugarman, J. (2010). The many methods of medical ethics: (Or,
      thirteen ways of looking at a blackbird). In J. Sugarman & D. Sulmasy (Eds.), Methods
      in Medical Ethics
(2nd ed; pp. 3-20). Washington, DC: Georgetown University Press.
Taylor, H. A., Hull, S. C., & Kass, N. E. (2010). Qualitative methods. In J. Sugarman & D.
      Sulmasy (Eds.), Methods in Medical Ethics (2nd ed; pp. 193-214). Washington, DC:
      Georgetown University Press.
 

 
Referrals and Post-Trial Provision of Treatment
in HIV Prevention Research

  
Barsdorf, N., Maman, S., Kass, N., & Slack, C. (2009). Access to treatment in HIV
      prevention trials: Perspectives from a South African community. Developing World
      Bioethics, 10(2), 78-87.
Campbell, C., Nair, Y., Maimane, S., Sibiya, W., & Gibbs, A. (2011). “Dissemination as
      intervention”: Building local HIV competence through the report back of research
      findings to a South African rural community. Antipode. doi: 10.1111/j.1467-8330.2011.
      00938
Gifford, A. L., Cunningham, W. E., Heslin, K. C., Andersen, R. M., Nakazono, T., Lieu, D.
      K., … Bozette, S. A. (2002). Participation in research and access to experimental
      treatments by HIV-infected patients. New England Journal of Medicine, 346(18),
      1373-1382.
Haire, B. G. (2011). Because we can: Clashes of perspective over researcher obligation in
      the failed PrEP trials. Developing World Bioethics, 11(2), 63-74.
Kukla, R. (2007). Resituating the principle of equipoise: Justice and access to care in
      non-ideal conditions. Kennedy Institute of Ethics Journal, 17(3), 171-202.
Lairumbi, G. M., Michael, P., Fitzpatrick, R., & English, M. C. (2012). Forms of benefit
      sharing in global health research undertaken in resource poor settings: A qualitative
      study of stakeholders’ views in Kenya. Philosophy, Ethics, and Humanities in
      Medicine, 7,
doi:10.1186/1747-5341-7-7
Lo, B., Padian, N., & Barnes, M. (2007). The obligation to provide antiretroviral treatment
      in HIV prevention trials. AIDS, 21, 1229-1231.
Macklin, R. (2006). Changing the presumption: Providing ART to vaccine research
      participants. The American Journal of Bioethics, 6(1), W1-W5.
MacQueen, K. M., McLoughlin, K., Alleman, P., Burke, H. M., & Mack, N. (2008).
      Partnering for care in HIV prevention trials. Journal of Empirical Research on Human
      Research Ethics, 3
(4), 5-18.
MacQueen, K. M., Namey, E., Chilongozi, D. A., Mtweve, S. P., Mlingo, M., Morar, N., …
      The HPTN 035 Standard of Care Assessment Team. (2007). Community perspectives
      on care options for HIV prevention trial participants. AIDS Care, 19(4), 554-560.
Merritt, M. & Grady, C. (2006). Reciprocity and post-trial access for participants in
      antiretroviral therapy trials. AIDS, 20(14), 1791-1794.
Millum, J. (2011). Post-trial access to antiretrovirals: Who owes what to whom? Bioethics,
      25
(3), 145-154.
Philpott, S., Heise, L., McGrory, E., Paxton, L., Hankins, C., & The Participants in the
      2009 GCM/CDC/UNAIDS Consultation on Standards of Prevention in HIV Prevention
      Trials. (2011). The challenge of defining standards of prevention in HIV prevention
      trials. Journal of Medical Ethics, 37(4), 244-248.
Schroeder, D. & Gefenas, E. (2011). Realizing benefit sharing – The case of post-study
      obligations. Bioethics, doi: 10.1111/j.1467-8519.2010.01857.x
Shah, S. K., Dawson, L., Dixon, D. O., & Lie, R. K. (2011). Should sponsors and DSMBs
      share interim results across trials? Journal of Acquired Immune Deficiency Syndromes,
      58
, 433-435.
Singh, J. A. (2004). Standards of care in the antiretroviral rollout world. The Lancet, 364,
      920-922.
Stobie, M. & Slack, C. (2010). Treatment needs in HIV prevention trials: Using
      beneficence to clarify sponsor-investigator responsibilities. Developing World Bioethics,
      10
(3), 150-157.
Timmermans, S. & McKay,T. (2009). Clinical trials as treatment option: Bioethics and
      health care disparities in substance dependency. Social Science & Medicine, 69,
      1784-1790.
Weijer, C. & LeBlanc, G. J. (2006). The balm of Gilead: Is the provision of treatment to
      those who seroconvert in HIV prevention trials a matter of moral obligation or moral
      negotiation? Journal of Law, Medicine, & Ethics, 34(4), 793-808.
   
 
Scientific and Ethical Validity in HIV Clinical Trials

Bauman, L. J., Sclafane, J. H., LoIacono, M., Wilson, K., & Macklin, R. (2008). Ethical
      issues in HIV/STD prevention research with high risk youth: Providing help, preserving
      validity. Ethics & Behavior, 18(2-3). 247-265.
Berkley, S. (2003). Thorny issues in the ethics of AIDS vaccine trials. The Lancet, 362,
      992.
Binik, A., Weijer, C.,  McRae, A. D., Grimshaw, J. M., Boruch, R., Brehaut, J. C., …
      Zwarenstein, M. (2011). Does clinical equipoise apply to cluster randomized trials in   
      health research? Trials, 12, 118-129.
Borek, N., Allison, S., & Caceres, C. F. (2010). Involving vulnerable populations of youth in
      HIV prevention clinical research. Journal of Acquired Immune Deficiency Syndromes,
      54,
S43-S49.
Brooks, R. A., Newman, P. A., Duan, N., & Ortiz, D. J. (2007). HIV vaccine trial
      preparedness among Spanish-speaking Latinos in the US. AIDS Care, 19(1), 52-58.
Cherry, M. J. (2010). Non-consensual treatment is (nearly always) morally impermissible.
      Journal of Law, Medicine & Ethics, 38, 789-798.
Clark, J. J. & Walker, R. (2011). Research ethics in victimization studies: Widening the
      lens. Violence Against Women, 17, 1489-1508.
Crane, J. (2010). Adverse events and placebo effects: African scientists, HIV, and ethics
      in the ‘global sciences.’ Social Studies of Science, 40(6), 843-870.
DuVal, G. & Salmon, C. (2004). Research note: Ethics of drug treatment research with
      court-supervised subjects. The Journal of Drug Issues, 34(4), 991-1005.
Franrenet, S., Moutel, G., Raffi, F., Dabis, F., Bruyand, M., Herve, C., …Duchange, N.
      (2011). Information that should be given to HIV cohort participants during ongoing
      research: The viewpoints of patient representatives and research professionals. Journal
      of Empirical Research on Human Research Ethics, 6
(4), 76-83.
Fuchs, J., Durham, M., McLellan-Lemal, E., Vittinghoff, E., Colfax, G., Gurwith, M., &
      Buchbinder S. (2007). Negative social impacts among volunteers in an HIV vaccine
      efficacy trial.  Journal of Acquired Immune Deficiency Syndromes, I, 362-368.
Hyder, A.A., & Dawson, L. (2005). Defining the standard of care in the developing world:
      The intersection of international research ethics and health systems analysis.
      Developing World Bioethics, 5
, 142-152.
Joint United Nations Programme on HIV/AIDS (UNAIDS) & World Health Organization
      (WHO). (2007). Ethical considerations in biomedical HIV prevention trials: UNAIDS/WHO
      guidance document.
Geneva, CH: UNAIDS. Retrieved from
      http://data.unaids.org/pub/Report/2007/jc1399-ethicalconsiderations_en.pdf
Kimmelman, J. (2011). Ethics, ambiguity aversion, and the review of complex translational
      clinical trials. Bioethics (in press, online advanced copy)
Lagakos, S.W., Gable, A., & the Committee on the Methodological Challenges of HIV
      Prevention Trials. (2008). Methodological Challenges in Biomedical and Prevention
     Trials.
Washington, DC: National Academies Press.
Lairumbi, G. M., Michael, P., Fitzpatrick, R., & English, M. C. (2011). Ethics in practice:
      The state of the debate on promoting the social value of global health research in
      resource poor settings particularly Africa. BMC Medical Ethics, 12, doi:10.1186/1472-
      6939-12-22
Lazovski, J., Losso, M., Krohmal, B., Emanuel, E. Z., Grady, C., & Wendler, D. (2009).
      Benefits and burdens of participation in a longitudinal clinical trial. Journal of Empirical
      Research on Human Research Ethics, 4
(3), 89-97.
Levine, C. (2009). Ethics and epidemiology in the age of AIDS. In S. Coughlin, T. L.
      Beauchamp, & D. L. Weed (eds.) Ethics and epidemiology (2nd ed; p 204-226). NY:
      Oxford
London, L., Kagee, A., Moodley, K. & Swartz, L. (2011). Ethics, human rights and HIV
      vaccine trials in low-income settings. Journal of Medical Ethics,
      doi:10.1136/medethics-2011-100227
Macklin, R. (2011). Ethicalchallenges in HIV microbicide research: What protections do
      women need? The International Journal of Feminist Approaches to Bioethics, 4,
      124-143.
Macklin, R. (2008). Standard of care: An evolution in ethical thinking. The Lancet, 372,
      284-285.
Malmqvist, E. (2011). (Mis) understanding exploitation. IRB: Ethics & Human Research,
      33
(2), 1-5.
O’Grady, B. & Schuklenk, U. (2009). Rethinking mandatory HIV testing. Bioethics, 23(8), ii.
Rhodes, T., Singer, M., Bourgois, P., Friedman, S. R., & Strathdee, S. A. (2005). The
      social structural production of HIV risk among injecting drug users. Social Science &
      Medicine, 61,
1026-1044.
Richardson, H. S., & Belsky, L. (2004). The ancillary-care responsibilities of medical
      researchers. An ethical framework for thinking about the clinical care that researchers
      owe their subjects. Hastings Center Report, 34, 25-33.
Schuklenk, U. & Ashcroft, R. (2007). HIV vaccine trials: Reconsidering the therapeutic
      misconception and the question of what constitutes trial related injuries. Developing
      World Bioethics, 7
(3), ii-iv.
Wyatt, G. E., Williams, J. K., Gupta, A., & Malebranche, D. (2011). Are cultural values and
      beliefs included in U.S. based HIV interventions? Preventive Medicine,
      doi:10.1016/j.ypmed.2011.08.021




Multicultural Competence and Cultural Validity in
HIV Prevention Research Ethics


• Bischofberger, I. & Vischer, L. R. (2009). Interviewing sub-Saharan migrants in
      Switzerland about HIV/AIDS: Critical refelections on the interview process. Journal of
      Transcultural Nursing, 21
(1), 23-28.
Boltz, B., McGowan, K., Ramsey, K., & Lapidus, J. (2005). HIV perceptions and testing
      history of American Indians residing in one Northwest Tribal Community. Poster
      presentation.
Brown, E. J. & Hill, M. A. (2005). Perceptions of HIV risks and prevention strategies by
      rural and small city African Americans who use cocaine: Views from the inside. Issues
      in Mental Health Nursing, 26
, 359-377.
Champagne, D. & Goldberg, C. E. (2005). Changing the subject: Individual versus
      collective interests in Indian country research. Wicazo Sa Review, 20(1), 49-69.
Colwell-Chanthaphonh, C. (2006). Self-governance, self-representation, self-determination
      and the questions of research ethics commentary on “protecting the Navajo people
      through tribal regulation of research. Science and Engineering Ethics, 12, 508-510.
Grady, C., Wagman, J., Ssekubugu, R., Wawer, M. J., Serwadda, D., Kiddugav, M., …
      Emanuael, E. J. (2008). Research benefits for hypothetical HIV vaccine trials: The
      views of Ugandans in the Rakai district. IRB: Ethics & Human Research, 30(2), 1-7.
Fisher, C. B., Hoagwood, K., Boyce, C., Duster, T., Frank, D. A., Grisso, T., … Zayas, L.
      H. (2002). Research ethics for mental health science involving ethnic minority children
      and youths. American Psychologist, 57(12), 1024-1037.
Fisher, C. B., Oransky, M., Mahadevan, M., Singer, M., Mirhej, G., & Hodge, D. (2008).
      Marginalized populations and drug addiction research: Realism, mistrust, and
      misconception. IRB: Ethics & Human Research, 30, 1-9.
Fisher, C. B., & Ragsdale, K. (2006). A goodness-of-fit ethics for multicultural research. In
      J. Trimble and C. B. Fisher (Eds.), The handbook of ethical research with ethnocultural
      populations and communities
(pp. 3–26). Thousand Oaks, CA: Sage.
Floyd, A. H. L. & Moyer, A. (2010). Effect of participant preferences in unblinded
      randomized controlled trials. Journal of Empirical Research on Human Research Ethics,
      5
(2), 81-93.
Fortune, T., Wright, E., Juzang, I., & Bull, S. (2010). Recruitment, enrollment and
      retention of young black men for HIV prevention research: Experiences from the 411 for
      Safe Text Project. Contemporary Clinical Trials, 31(2), 151-156.
Fowers, B. J. & Davidov, B. J. (2006). The virtue of multiculturalism. American
      Psychologist, 61
(6), 581-594.
Garber, M., Hanusa, B. H., Switzer, G. E., Mellors, J., & Arnold, R. M. (2007).
      HIV-infected African Americans are willing to participate in HIV treatment trials.  Journal
      of General Internal Medicine, 22
(1), 17-42.
Loue, S. & Pike, E. C. (2010). Chapt. 14. Studies with minority populations, In Case
      studies in ethics and HIV research
(pp.245-260) NY: Springer
McMahon, E., Moreton, R. J., & Luisi, B. N. (2010). Guarding against emerging
      epidemics: Addressing HIV and AIDS among culturally and linguistically diverse
      communities in NSW. NSW Public Health Bulletin, 21(3-4), 83-85.
Ponterotto, J. G. (1998). Charting a course for research in multicultural counseling
      training. The Counseling Psychologist, 26(1), 43-68.
Ponterotto, J. G. (2010). Qualitative research in multicultural psychology: Philosophical
      underpinnings, popular approaches, and ethical considerations. Cultural Diversity and
      Ethnic Minority Psychology, 16
(4), 581-589.
Sahota, P.C. (2007). Research regulation in American Indian /Alaska Native communities:
      Policy and practice considerations. National Congress of the American Indian Policy
      Research Center.

Sahota, P.C. (2007). Research Regulation in American Indian /Alaska Native
      Communities: A guide to reviewing research studies. National Congress of the
      American Indian Policy Research Center.

Slomka, J., Ratliff, E. A., McCurdy, S. A., Timpson, S., & Williams, M. L. (2008).
      Decisions to participate in research: Views of underserved minority drug users with or
      at risk for HIV. AIDS Care, 20(10), 1224-1232.
Slomka, J., Ratliff, E. A., McCurdy, S., Timpson, S., & Williams, M. L. (2008).
      Perceptions of risk in research participation among underserved minority drug users.
      Substance Use and Misuse, 43(11), 1640-1652
Wechsberg, W. M. & Luseno, W. K. (2010). The need for culturally appropriate,
      gender-specific global HIV prevention efforts with vulnerable women. Journal of
      Prevention & Intervention in the Community, 38,
85-88.
Zuniga, M. L., Blanco, E., Palinkas,L. A., Strathdee, S. A., Gifford, A. L. (2010).
      Cross-cultural considerations in the recruitment of Latinos of Mexican origin into
      HIV/AIDS clinical trials in the U.S.-Mexico border region: Clinical and patient
      perspectives. Journal of Immigrant & Refugee Studies, 8, 241-260.
 

 
Neurocognitive and Cultural Factors
Influencing Informed Consent HIV/AIDS Prevention Studies

 
Aldridge, J. & Charles, V. (2008). Researching the intoxicated: Informed consent
      implications for alcohol and drug research. Drug and Alcohol Dependence, 93,
      191-196.
Boga, M., Davies, A., Kamuya, D., Kinyanjui, S. M., Kivaya, E., Kombe, F., …
      Mwalukore, S. (2011). Strengthening the informed consent process in international  
      health research through community engagement: The KEMRI-Wellcome Trust
      research programmeexperience. PLoS Medicine, 8, doi:10.1371/journal.pmed.100108
Bull, S., Farsides, B., & Ayele, F. T. (2012). Tailoring information provision and consent
      processes to research contexts: The value of rapid assessments. Journal of Empirical
      Research on Human Research Ethics, 7
(1), 37-52.
Carter, A. & Hall, W. (2008). Informed consent to opioid agonist maintenance treatment:
      Recommended ethical guidelines. International Journal of Drug Policy, 19, 79-89.
Chaisson, L. H., Kass, N. E., Chengeta, B., Methebula, U., & Samandari, T. (2011).
      Repeated assessments of informed consent comprehension among HIV-infected
      participants of a three-year clinical trial in Botswana. PLoS One, 6,
      doi:10.1371/journal.pone.0022696
Coletti, A. S., Heagerty, P., Sheon, A. R., Gross, M., Koblin, B. A., Metzger, D. S., &
      Seage, G. R. (2002). Randomized, controlled evaluation of a prototype informed
      consent process for HIV vaccine efficacy trials. Journal of Acquired Immune
      Deficiency Syndromes, 32,
161-169.
Corneli, A. L., Bentley, M. E., Sorenson, J. R., Henderson, G. E., van der Horst, C.,
      Moses, A., … Jamieson, D. J. (2006). Using formative research to develop a
      context-specific approach to informed consent for clinical trials. Journal of Empirical
      Research on Human Research Ethics, 1
(4), 45-60.
Cortes, D. E., Drainoni, M., Henault, L. E., & Passche-Orlow, M. K. (2010). How to
      achieve informed consent for research from Spanish-speaking individuals with low
      literacy: A qualitative report. Journal of Health Communication, 15, 172-182.
Festinger, D. S., Ratanadilok, K., Marlowe, D. B., Dugosh, K. L., & Patapis, N. S.
      (2007). Neuropsychological functioning and recall of research consent information
      among drug court clients. Ethics & Behavior, 17(2), 163-186.
Fisher, C. B. (2010). Enhancing HIV vaccine trial consent preparedness among street drug users. Journal of empirical research on human research ethics: JERHRE, 5(2), 65.
Flory, J. & Emanuel, E. (2004). Interventions to improve research participants’
      understanding in informed consent for research: A systematic review. Journal of the
      American Medical Association, 292
(13), 1593-1601.
Gardner, W., Hoge, S. K., Bennett, N., Roth, L. H., Lidz, C. W., Monahan, J., & Mulvey,
      E. P. (1993). Two scales for measuring patient’s perceptions for coercion during
      mental hospital admission. Behavioral Sciences and the Law, 11, 307-321.
Gray, R. H., Sewankambo, N. K., Wawer, M. J., Serwadda, D., Kiwanuka, N., & Lutalo,
      T. (2006). Disclosure of HIV status on informed consent forms presents an ethical
      dilemma for protection of human subjects. Journal of Acquired Immune Deficiency
      Syndromes, 41
, 246-248.
Groves, A. K., Maman, S., Msomi, S., Makhanya, N., & Moodley, D. (2010). The
      complexity of consent: Women’s experiences testing for HIV at an antenatal clinical in
      Durban, South Africa. AIDS Care, 22(5), 538-544.
Hall, W., Carter, L., & Morley, K. I. (2004). Neuroscience research on the addictions: A
      prospectus for future ethical and policy analysis. Addictive Behaviors, 29, 1481-1495.
Hickman, N. J., Prochaska, J.J., & Dunn, L. B. (2011). Screening for understanding of
      research in the inpatient psychiatry setting. Journal of Empirical Research on Human
      Research Ethics, 6
(3), 65-72.
Johnson-Green, D. & the NAN Policy & Planning Committee (2005). Informed consent in
      clinical neuropsychology practice: Official statement of the National Academy of
      Neuropsychology. Archives of Clinical Neuropsychology, 20, 335-340.
Kim, SYH, Holloway, R., Frank, S., Wilson, R., Kieburtz, K. (2008). Trust in early phase research: therapeutic optimism and protective pessimism. Medicine, Health Care, and Philosophy. 11(4), 393-401.
Lindegger, G., Milford, C., Slack, C., Quayle, M., Xaba, X., & Vardas, E. (2006). Beyond
      the checklist: Assessing understanding for HIV vaccine trial participation in South
      Africa. Journal of Acquired Immune Deficiency Syndromes, 43, 560-566.
Loue, S. & Pike, E. C. (2010). Chapt. 3 The informed consent process. InCase studies
      in ethics and HIV research
(pp 23-36). NY: Springer.
Loue, S. & Pike, E. C. (2010). Chapt. 13 HIV-related research with cognitively impaired
      persons. In Case studies in ethics and HIV research (pp. 221-244) NY: Springer
Mandava, A., Pace, C., Campbell, B., Emanuel, E., & Grady, C. (2012). The quality of
      informed consent: Mapping the landscape. A review of empirical data from developing
      and developed countries. Journal of Medical Ethics, doi:10.1136/medethics-2011-
      100178
Marshall, P. (2006). Informed consent in international health research. Journal of
      Empirical Research on Human Research Ethics, 1
(1), 25-42.
Morris, N., Balmer, B. (2006). Volunteer human subjects' understanding of their participation in a biomedical research experiment. Social Science & Medicine. 62(4): 998-1008.
Mystakidou, K., Panagiotou, I., Katsaragakis, S., Tsilika, E., & Parpa, E. (2009). Ethical
      and practical challenges in implementing informed consent in HIV/AIDS clinical trials
      in developing or resource-limited countries. Journal of Social Aspects of HIV/AIDS,
      6
(2), 46-57.
Roberts, L. W. (2002). Addiction and consent. The American Journal of Bioethics, 2(2),
      58-60.
Roberts, L. W., Geppert, C., McCarty, T., & Obenshain, S. S. (2003). Evaluating medical
      students’ skills in obtaining informed consent for HIV testing. Journal of General
      Internal Medicine, 18,
112-119.
Saks, E. R., Dunn, L. B., & Palmer, B. W. (2006). Meta-consent in research on
      decisional capacity: A “catch-22”? Schizophrenia Bulletin, 32(1), 42-46.
Smith, W., Grady, C., Krohmal, B., Lazovski, J., & Wendler, D. (2011). Empirical
      evaluation of the need for ‘on-going consent’ in clinical research. AIDS, 25, 107-114.
Stunkel, L., Benson, M., McLellan, L., Sinaii, N., Bedarida, G., Emanuel, E., & Grady, C.
      (2010). Comprehension and informedconsent: Assessing the effect of a short consent
      form. IRB: Ethics & Human Research, 32(4), 1-9.
Sugarman, J., Paasche-Orlow, M. (2006). Volunteer human subjects' understanding of their participation in a biomedical research experiment. Social Science & Medicine, 21
(8): 898-899.
Sugarman, J., Corneli, A., Donnell, D., Liu, T. Y., Rose, S., Celentano, D., …Metzger, D.
      (2011). Are there adverse consequences of quizzing during informed consent for HIV
      research. Journal of Medical Ethics, 37, 693-697.
Vallely, A., Lees, S., Shagi, C., Kasindi, S., Soteli, S., Kavit, N., … Hayes, R. J. (2010).
      How informed is consent in vulnerable populations? Experience using a continuous
      consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.
      BMC Medical Ethics, 11
(10), doi: 10.1186/1472-6939-11-10.
Woodsong, C., MacQueen, K., Namey, E., Sahay, S., Mlingo, M., Mehendale, S. (2006).
      Women’s autonomy and informed consent in microbicide clinical trials. Journal of
      Empirical Research on Human Research Ethics, 1
(3), 11-26.

 

Informed Consent and Assent for Research Involving
Children and Adolescents

  
• Adler, D. H. (2012). Inclusion of South African adolescents in HIV vaccine trials. Journal
      of AIDS and HIV Research, 4
(2), 30-35.
Ashcroft, R., Goodenough, T., Williamson, E., & Kent, J. (2003). Children’s consent to
      research participation: Social context and personal experience invalidate fixed cutoff
      rules. The American Journal of Bioethics, 3(4), 16-18.
Barfield, R. C. & Kane, J. R. (2008). Balancing disclosure of diagnosis and assent for
      research in children with HIV. Journal of the American Medical Association, 300,
      576-578.
Borek, N., Allison, S., & Caceres, C. F. (2010). Involving vulnerable populations of youth
      in HIV prevention clinical research. Journal of Acquired Immune Deficiency Syndromes,
      54
, S43-S49.
Brody, J. L. & Waldron, H. B. (2000). Ethical issues in research on the treatment of
      adolescent substance abuse disorders. Addictive Behaviors, 25(2), 217-228.
Cameron, M. A., Marsillio, L. E., Cushman, L. F., & Morris, M. C. (2011). Parents’
      perspectives on the consent approach for minimal-risk research involving children. IRB:
      Ethics & Human Research, 33
(6), 6-13.
Clacherty, G. & Donald, D. (2007). Child participation in research: Reflections on ethical
      challenges in the southern African context. African Journal of AIDS Research, 6(2),
      147-156.
De Bruyn, G., Skhosana, N., Robertson, G., McIntyre, J. A., & Gray, G. E. (2008).
      Knowledge and attitudes towards HIV vaccines among Soweto adolescents. BMC
      Research Notes
, doi:10.1186/1756-0500-1-76
Flicker, S. & Guta, A. (2008). Ethical approaches to adolescent participation in sexual
      health research. Journal of Adolescent Health, 42, 3-10.
Jackson, S. & Hafemeister, T. L. (2001). Impact of parental consent and notification
      policies on the decisions of adolescents to be tested for HIV. Journal of Adolescent
      Health, 29,
81-93.
Jaspan, H. B., Cunningham, C. K., Tucker, T. P., Wright, P. F., Self, S. G., Sheets, R.
      L., … The HIV Vaccine Adolescent Trials Working Group. (2008). Inclusion of
      adolescents in preventive HIV vaccine trials: Public health policy and research design
      at a crossroads. Journal of Acquired Immune Deficiency Syndromes, 47, 86-92.
Kopelman, L. M. (2007). When can children with conditions be in no-benefit, higher-hazard
      pediatric studies? The American Journal of Bioethics, 7(3), 15-16.
Lakes, K. D., Vaughan, E., Jones, M., Burke, W., Baker, D., & Swanson, J. M. (2012).
      Diverse perceptions of the informed consent process: Implications for the recruitment
      and participation of diverse communities in the National Children’s Study. American
      Journal of Community Psychology, 49
, 215-232.
Loue, S. & Pike, E. C. (2010). Chapt.12 HIV research with children. In Case studies in
      ethics and HIV research
(pp. 205-220) NY: Springer
Minniear, T. D., Gilmore, B., Arnold, S. R., Flynn, P. M., Knapp, K. M., & Gaur, A. H.
      (2009). Implementation of and barriers to routine HIV screening for adolescents.
      Pediatrics, 124, 1076-1083.
Mustanski, B. (2011). Ethical and regulatory issues with conducting sexuality research
      with LGBT Adolescents: A call to action for a scientifically informed approach. Archives
      of Sexual Behavior, 40
(4), 673-686.
Ott, M. A., Rosenberger, J. G., & Fortenberry, J. D. (2010). Parental permission and
      perceived research benefits in adolescent STI research. Journal of Empirical Research
      on Human Research Ethics, 5
(2), 57-64.
Rojas, N. L., Sherrit, L., Harris, S., & Knight, J. R. (2008). The role of parental consent in
      adolescent substance use research. Journal of Adolescent Health, 42, 192-197.
Rongkavilit, C., Naar-King, S., Chuenyam, T., Wang, B., Wright, K., & Phanuphak, P.
      (2007). Health risk behaviors among HIV-infected youth in Bangkok, Thailand. Journal
      of Adolescent Health, 40
, 358e1-358e8.
Sibley, A., Sheehan, M., & Pollard, A. J. (2012). Assent is not consent. Journal of
      Medical Ethics, 38
, 3.
Strode, A. E. & Slack, C. M. (2011). Using the concept of ‘parental responsibilities and
      rights’ to identify adults able to provide proxy consent to child research in South Africa.
      South African Journal of Bioethics and Law, 4(2), 69-73.
Swenson, R. R., Hadley, W. S., Houck, C. D., Fance, S. K., & Brown, L. K. (2011). Who
      accepts a rapid HIV antibody test? The role of race/ethnicity and HIV risk behavior
      among community adolescents. Journal of Adolescent Health, 48, 527-529.
Vreeman, R. C., Nyandiko, W. M., & Meslin, E. M. (2009). Pediatric assent for a study of
      antiretroviral therapy dosing for children in western Kenya: A case study in international
      research collaboration. Journal of Empirical Research on Human Research Ethics, 4(1),
      3-16.




Ethical Considerations in HIV Prevention Research Recruitment

Borek, N., Allison, S., & Caceres, C. (2010). Involving vulnerable populations of youth in
      HIV prevention clinical research. Journal of Acquired Immune Deficiency Syndromes,
      54,
S43-S49.
Calsyn, R. J., Klinkenberg, W. D., Morse, G. A., Miller, J., & Cruthis, R. (2004).
      Recruitment, engagement, and retention of people living with HIV and co-occurring
      mental health and substance use disorders. AIDS Care, 16(Supp. 1), S56-S70.
Chaudoir, S. R., Fisher, J. D., & Simoni, J. M. (2011). A review and application of the
      disclosure processes model. Social Science & Medicine, 72(10), 1618-1629.
Colon, R. A., Deren, S., Guarino, H., Mino, M., & Kang, S. (2010). Challenges in recruiting
      and training drug treatment patients as peer outreach workers: A perspective from the
      field. Substance Use & Misuse, 45, 1892-1908.
DeJong, J., Mahfoud, Z., Khoury, D., Barbir, F., & Afifi, R. A. (2009). Ethical
      considerations in HIV/AIDS biobehavioral surveys that use respondent-driven sampling:
      Illustrations from Lebanon. American Journal of Public Health, 99(9), 1562-1567.
Fisher, C. B., Oranksy, M., Mahadevan, M., Singer, M., Mirhej, G., & Hodge, G. D.
      (2009). Do drug abuse researchers have a duty to protect third parties from HIV
      transmission? Moral perspectives of street drug users. In D. Buchanan, C. B. Fisher, &
      L. Gable (Eds.), Research with high-risk populations: Balancing science, ethics, and
      law
(pp. 189-206). Washington, DC: APA Books.
Gutierrez-Luna, A., Angeles-Llerenas, A., Wirtz, V, J., Alvarez Del Rio, A., Zamilpa-Majia,
      L., Aranda-Flores, C., … Lazcano-Ponce, E. (2009). Strategies and ethical
      considerations for the recruitment of young men who have sex with men: Challenges of
      a vaccination trial in Mexico. Clinical Trials, 6, 365-372.
Lau, C., Cardinali, M., Sato, P. A., Fix, A., & Flores, J. (2008). Broadening inclusion of
      vulnerable populations in HIV vaccine trials. Expert Reviews Vaccines, 7(2), 259-268.
Meyers, K., Metzger, D. S., Navaline, H., Woody, G. E., & McLellan, A. T. (1994). HIV
      vaccine trials: Will intravenous drug users enroll? American Journal of Public Health,
      84
(5), 761-766.
Newman, P. A., Duan, N., Rudy, E. T., & Anton, P. A. (2004). Challenges for HIV vaccine
      dissemination and clinical trial recruitment: If we build it, will they come? AIDS Patient
      Care and STDs, 18
(12), 691-701.
Newman, P. A., Duan, N., Roberts, K. J., Seiden, D., Rudy, E. T., Swendeman, D., &
      Popova, S. (2006). HIV vaccine trial participation among ethnic minority communities:
      Barriers, motivators, and implications for recruitment. Journal of Acquired Immune
      Deficiency Syndromes, 41,
210-217.
Oransky, M., Fisher, C. B., Mahadevan, M., & Singer, M. (2009). Barriers and
      opportunities for recruitment for nonintervention studies on HIV risk: Perspectives of
      street drug users. Substance Use & Misuse, 44, 1642-1659.
Orellana, E. R., Picciano, J. F., Roffman, R. A., Swanson, F., & Kalichman, S. C. (2006).
      Correlates of nonparticipation in an HIV prevention program for MSM. AIDS Education
      and Prevention, 18
(4), 348-361.
Reed, J. L., Thistlethwaite, J. M., & Huppert, J. S. (2007). STI research: Recruiting an
      unbiased sample. Journal of Adolescent Health, 41, 14-18.
Scott, G. (2008). “They got their program, and I got mine”: A cautionary tale concerning
      the ethical implications of using respondent-driven sampling to study injection drug
      users. International Journal of Drug Policy, 19, 42-51.
Stirley, C. L. W., Callahan, C., & Cottler, L. B. (2008). Enrolling, retaining, and benefiting
      out-of-treatment drug users in intervention research. Journal of Empirical Research on
      Human Research Ethics, 3
(3), 19-25.
Uuskula, A., Johnston, L. G., Raag, M., Trummal, A., Talu, A., & Des Jarlais, D. C.
      (2010). Evaluating recruitment among female sex workers and injecting drug users at
      risk for HIV using respondent-driven sampling in Estonia. Journal of Urban Health: 
      Bulletin of the New York Academy ofMedicine, 87
(2), 304-317.
Yin, L., Zhang, Y., Qian, H., Rui, B., Zhang, L., Zhu, J., … Shao, Y. (2008). Willingness
      of Chinese injection drug users to participate in HIV vaccine trials. Vaccine, 26,
      762-768.

   

  
Ethical Issues in Compensation for HIV Prevention Research

Bagley, S. J., Reynolds, W. W., & Nelson, R. M. (2007). Is a “wage-payment” model for
      research participation appropriate for children? Pediatrics, 119, 46-51.
Barnett, P. G., Sorensen, J. L., Wong, W., Haung, N., & Hall, S. M. (2009). Effect of
      incentives for medication adherence on health care use and costs in methadone
      patients with HIV. Drug and Alcohol Dependence, 100, 115-121.
Emanuel, E. J., (2005). Undue inducement: Nonsense on stilts? American Journal of
      Bioethics, 5,
9-13.
Festinger, D. S., Marlowe, D. B., Dugosh, K. L., Croft, J. R., & Arabia, P. L. (2008).
      Higher magnitude cash payments improve research follow-up rates without increasing 
      drug use or perceived coercion. Drug and Alcohol Dependence, 96, 128-135.
Fry, C. & Dwyer, R. (2001). For love or money? An exploratory study of why injecting drug
      users participate in research. Addiction, 96, 1319-1325.
Klitzman, R., Albala, I., Siragusa, J., Nelson, K. N., & Appelbaum, P. S. (2007). The
      reporting of monetary compensation in research articles. Journal of Empirical Research
      on HumanResearch Ethics, 2
(4), 61-67.
Kwalgala, B., Wassenaar, D., & Ecuru, J. (2010). Payments and direct benefits in
      HIV/AIDS related research projects in Uganda. Ethics & Behavior, 20(2), 95-109.
Largent, E. A., Grady, C., Miller, F. G., & Wertheimer, A. (2012). Money, coercion, and
      undue inducement: Attitudes about payments to research participants. IRB: Ethics &
      Human Research, 34
(1), 1-8.
Lucke, J. C. & Hall, W. D. (2012). Under what conditions is it ethical to offer incentives to
      encourage drug-using women to use long-acting forms of contraception? Addiction, doi:
      10.1111/j.1360-0443.2011.03699.x
Phillips, T. B. (2011). A living wage for research subjects. Journal of Law, Medicine &
      Ethics, 39,
243-253.
Phillips, T. B. (2011). Exploitation in payments to research subjects. Bioethics, 24,
      209-219.
Phillips, T. (2010). Protecting the subject: PDR and the potential for compromised
      consent. The American Journal of Bioethics, 10(3), 14-15.
Slomka, J., McCurdy, S., Ratliff, E. A., Timpson, S., & Williams, M. L. (2007).
      Perceptions of financial payment for research participation among African-American
      drug users in HIV studies. Journal of General Internal Medicine, 22, 1403-1409.



Ethical Issues in HIV and Drug Use Research Involving New Technologies

Battles, H. T. (2010). Exploring ethical and methodological issues in internet-based
      research with adolescents. International Journal of Qualitative Methods, 9(1), 27-39.
Bowen, A. (2005). Internet sexuality research with rural men who have sex with men: Can
      we recruit and retain them? The Journal of Sex Research, 42(4), 317-323.
Buchanan, E. A. & Ess, C. M. (2009). Internet research ethics and the institutional review
      board: Current practices and issues. Computers and Society, 39, 43-49.
Bull, S., Breslin, T. L., Wright, E. E., Black, S. R., Levine, D., & Santelli, J. S. (2010).
      Case study: An ethics case study of HIV prevention research on facebook: The just/us
      study. Journal of Pediatric Psychology, (in press, online advanced copy).
Fernandez, M. I., Varga, L. M., Perrino, T., Collazo, J. B., Subiaul, F., Rehbein, A., …
      Bowen, G. S. (2004). The internet as recruitment tool for HIV studies: Viable strategy
      for reaching at-riskHispanic MSM in Miami? AIDS Care, 16(8), 953-963.
Fitzgerald, T. D., Hunter, P. V., Hadjistavropoulos, T., Koocher, G. P. (2010). Ethical and
      legal considerations for internet-based psychotherapy. Cognitive Behaviour Therapy,
      39
(3), 173-187.
Fortune, T., Wright, E., Juzang, I., & Bull, S. (2010). Recruitment, enrollment and
      retention of young black men for HIV prevention research: Experiences from the 411 for
      Safe Text Project. Contemporary Clinical Trials, 31(2), 151-156.
Fowler-Dixon, S. & Moreno, M. (2008). Internet research raises unique ethical concerns
      for IRBs. IRB Advisor, 8, 25-28.
Glickman, S. W., Galhenage, S., McNair, L., Barber, Z., Patel, K., Schulman, K. A., &
      McHutchinson, J. G. (2012). The potential influence of internet-based socialnetworking
      on the conduct of clinical research studies. Journal of Empirical Research on Human
      Research Ethics, 7
(1), 71-80.
Henry, J., Palmer, B. W., Palinkas, L., Gloriosos, D. K., Caligiuri, M. P., & Jeste, D. V.
      (2009). Reformed consent: Adapting to new media and research participant
      preferences. IRB: Ethics & Human Research, 31(2), 1-8.
Khoshropour, C. M. & Sullivan, P. S. (2011). Risk of disclosure of participating in an
      internet-based HIV behavioral risk study of men who have sex with men. Journal of
      Medical Ethics, 37,
768-769.
Loue, S. & Pike, E. C. (2010). Chapt.7 Recruiting for HIV research: Internet based
      research. In Case studies in ethics and HIV research (pp 79-95). NY: Springer.
Mack, N., Robinson, E. T., MacQueen, K. M., Moffett, J., & Johnson, L. M. (2010). The
      exploitation of “exploitation” in the Tenofovir PrEP trial in Cameroon: Lessons learned
      from media coverage of an HIV prevention trial. Journal of Empirical Research on
      Human Research Ethics, 5
(2), 3-19.
Rosser, B. R. S., Gurak, L., Horvath, K. J., Oakes, J. M., Konstan, J., & Danilenki, G. P.
      (2009). The challenges of ensuring participant consent in internet-based sex studies: A
      case study of the Men’s INTernet Sex (MINTS-I and II) studies. Journal of
      Computer-Mediated Communication, 14,
602-626.
Shankar, G. & Simmons, A. (2009). Understanding ethics guidelines using an
      internet-based expert system. Journal of Medical Ethics, 35, 65-68.
Turow, J. & Hennessy, M. (2007). Internet privacy and institutional trust: Insights from a
      national survey. New Media & Society, 9(2), 300-318.
Tsu, R. C., Burm, M. L., Hilhooly, J. A., & Sells, C. W. (2002). Telephone vs. face-to-face
      notification of HIV results in high-risk youth. Journal of Adolescent Health, 30, 154-160.
Whitehead, E. (2007). “Just chatting” Research ethics and cyberspace. International
      Journal of Qualitative Methods, 6
(2), 1-9.
Whitehead, L. C. (2007). Methodological and ethical issues in internet-mediated research
      in the field of health: An integrated review of the literature. Social Science & Medicine,
      65,
782-791.
Youn, S. (2005). Teenagers’ perceptions of online privacy and coping behaviors: A
      risk-benefit appraisal approach. Journal of Broadcasting & Electronic Media,49(1),  
      86-110.
Youn, S. (2008). Gender and online privacy among teens: Risk perception, privacy
      concerns, and protection behaviors. CyberPsychology & Behavior, 11(6), 763-765.



 
Engaging Communities and Institutions in HIV Prevention Research

Alvarez, R. A., Vasquez, E., Mayorga, C. C., Feaster, D. J., & Mitrani, V. B. (2006).
      Increasing minority research participation through community organization outreach.
      Western Journal of Nursing Research, 28(5), 541-560.
Barsdorf, N., Maman, S., Kass, N., & Slack, C. (2010). Access to treatment in HIV
      prevention trials: Perspectives from a South African community. Developing World
      Bioethics, 10
(2), 78-87.
Boga, M., Davies, A., Kamuya, D., Kinyanjui, S. M., Kivaya, E., Kombe, F., …
      Mwalukore, S. (2011). Strengthening the informed consent process in international
      health research through community engagement: The KEMRI-Wellcome Trust research
      programme experience. PLoS Medicine, 8, doi:10.1371/journal.pmed.1001089
Eshel, A., Moore, A., Mishra, M., Wooster, J., Toledo, C., Uhl, G., & Wright-DeAguero, L.
      (2008). Community stakeholders’ perspectives on the impact of the minority AIDS
      initiative in strengthening HIV prevention capacity in four communities. Ethnicity &
      Health, 13
(1), 39-54.
Essack, Z., Koen, J., Barsdorf, N., Slack, C., Quayle, M., Milford, C., … Mukuka, R.
      (2010). Stakeholder perspectives on ethical challenges in HIV vaccine trials in South
      Africa. Developing World Bioethics, 10(1), 11-21.
Fantuzzo, J., McWayne, C., & Childs, S. (2006). Scientist-community collaborations: A
      dynamic tension between rights and responsibilities. In J. Trimble and C. B. Fisher
      (Eds.), The handbook of ethical research with ethnocultural populations and
      communities
(pp. 27-49). Thousand Oaks, CA: Sage.
Flicker, S., Travers, R., Guta, A., McDonald, S., & Meagher, A. (2007). Ethical dilemmas
      in community-based participatory research: Recommendations for institutional review
      boards. Journal of Urban Health: Bulletin of the New YorkAcademy of Medicine, 84,
      478-493.
Gleason-Comstock, J., Simpson, H. L., Streater, A., Rolack,R., Calhoun, C. B., &
      Norman, S. (2006). Development of a community-based participatory research effort to
      evaluate conventional HIV testing (CHT) and HIV rapid testing (HRT). Journal of
      HIV/AIDS & Social Sciences, 5
(3/4), 201-219.
Harris, G. E. (2006). Practicing HIV/AIDS community-based research. AIDS Care, 18(7),
      731-738.
Loue, S. & Pike, E. C. (2010). Chapt. 5 Researcher-participant relations. In Case studies
      in ethics and HIV research
(pp. 57-68). NY: Springer.
Loue, S. & Pike, E. C. (2010). Chapt. 6 Researcher-community relations. In Case studies
      in ethics and HIV research
(pp. 69-78). NY: Springer.
Loue, S. & Pike, E. C. (2010). Chapt. 11 Ethical issues in multicenter/multisite studies. In
      Case studies in ethics and HIV research (pp. 175-183) NY: Springer.
Loue, S. & Pike, E. C. (2010). Chapt. 18 Training communities. In Case studies in ethics
      and HIV research
(pp. 321-338) NY: Springer.
Melton, G. B., Levine, R. J., Koocher, G. P.,Rosenthal, R., Thompson, W. C. (1988).
      Community consultation in socially sensitive research: Lessons from clinical trials of
      treatments for AIDS. American Psychologist, 43(7), 573-581.
Mohatt, G. V. & Thomas, L. R. (2006). “I wonder, why would you do it that way?”: Ethical
      dilemmas in doing participatory research with Alaska Native communities. In J. Trimble
      and C. B. Fisher (Eds.), The handbook of ethical research with ethnocultural
      populations and communities
(pp. 77–92). Thousand Oaks, CA: Sage.
Newman, S. D., Andrews, J. O., Magwood, G. S., Jenkins, C., Cox, M. J., & Williamson,
      D. C. (2011). Community advisory boards in community-based participatory research: A
      synthesis of best processes. Preventing Chronic Disease: Public Health Research,
      Practice, and Policy, 8
(3), 1-12.
Newman, P. A., Logie, C., James, L., Charles, T., Maxwell, J., Salam, K., & Woodford,
      M. (2011). “Speaking the dialect”: Understanding public discourse in the aftermath of an
      HIV vaccine trial shutdown. American Journal of Public Health, 101, 1749-1758.
NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. (2008).
      The role of Community Advisory Boards (CABs) in Project Eban. Journal of Acquired
      Immune Deficiency Syndromes, 49
, S68-S74.
Noe, T. D., Manson, S. M., Croy, C., McGough, H., Henderson, J. A., & Buchwald, D. S.
      (2006). In their own voices: American Indian decisions to participate in health research.
      In J. Trimble and C. B. Fisher (Eds.), The handbook of ethical research with
      ethnocultural populations and communities
(pp. 93–115). Thousand Oaks, CA: Sage.
Operario, D., Smith, C. D., Arnold, E., & Kegeles, S. (2010). The Bruthas Project:
      Evaluation of a community-based HIV prevention intervention for African American men
      who have sex with men and women. AIDS Education and Prevention, 22(1), 37-48.
Rajabiun, S., Mallinson, R. K., McCoy, K., Coleman, S., Drainoni, M., Rebholz, C., &
      Holbert, T. (2007). “Getting me back on track”: The role of outreach interventions in
      engaging and retaining people living with HIV/AIDS in medical care. AIDS Patient Care
      and STDs, 21
(Supp. 1), S20-S29.
Reddy, P., Buchanan, D., Sifunda, S., James, S., & Naidoo, N. (2010). The role of
      community advisory boards in health research: Divergent views in the South African
      experience. Journal of Social Aspects of HIV/AIDS, 7(3), 2-8.
Ross, L. F., Loup, A., Nelson, R. M., Botkin, J. R., Krost, R., Smith, G. R., & Gehlert, S.
      (2010). Human subjects protections in community-engaged research: A research ethics
      framework. Journal of Empirical Research on Human Research Ethics, 5(1), 5-17.
Ross, L. F., Loup, A., Nelson, R. M., Botkin, J. R., Krost, R., Smith, G. R., & Gehlert, S.
      (2010). Nine key functions for a human subjects protection program for
      community-engaged research: Points to consider. Journal of Empirical Research on
      Human Research Ethics, 5
(1), 33-47.
Ross, L. F., Loup, A., Nelson, R. M., Botkin, J. R., Krost, R., Smith, G. R., & Gehlert, S.
      (2010). The challenges of collaboration for academic and community partners in a
      research partnership: Points to consider. Journal of Empirical Research on Human
      Research Ethics, 5
(1), 19-31.
Sahay, S. & Mehendale, S. (2011). Engaging community to support HIV prevention
      research. Eastern Journal of Medicine, 16, 168-177.
Shagi, C., Vallely, A., Kasindi, S., Chidou, B., Desmond, N., Soteli, S., … Ross, D.
      (2008). A model for community representation and participation in HIV prevention trials
      among women who engage in transactional sex in Africa. AIDS Care, 20(9), 1039-1049.
Shore, N., Drew, E., Brazauskas, R., & Seifer, S. D. (2011). Relationships between
      community-based processes for research ethics review and institution-based IRBs: A
      national study. Journal of Empirical Research on Human Research Ethics, 6(2), 13-21.
Strauss, R. P., Sengupta, S., Quinn, S. C., Goeppinger, J., Spaulding, C., Kegeles, S.
      M., & Millett, G. (2001). The role of community advisoryboards: Involving communities
      in the informedconsent process. American Journal of Public health, 19, 1938-1943.
Thiessen, C., Ssekubugu, R., Wagman, J., Kiddugavu, M., Wawer, M. J., Emanuel, E.,
      … 
Grady, C. (2007). Personal and community benefits and harms of research: Views
      from Rakai, Uganda. AIDS, 21, 2493-2501.
Thomas, F. (2008). Indigenous narratives of HIV/AIDS: Morality and blame in a time of
      change. Medical Anthropology, 27(3), 227-256.
White, R., Chileshe, M., Lawson, L., Donnell, D., Hillier, S., Morar, N., … Dixon, D.
      (2011). Fostering community understanding of sufficient benefit and early stopping for a
      phase 2B HIV prevention clinical trial in Africa. Clinical Trials, 8, 103-111.
Wong, F. Y., Crisostomo, V. A., Bao, D., Smith, B. D., Young, D., Huang, J., … the
      MATH Study Consortium. (2011). Development and implementation of a collaborative,
      multistakeholder research and practice model on HIV prevention targeting Asian/Pacific
      Islander men in the United States who have sex with men. American Journal of Public
      Health, 101,
623-631.

  


Privacy, Confidentiality and Disclosures in HIV Research,
and Potential Violence Against
Women and HIV Discordant Sexual Partners


Andanda, P. (2009). Vulnerability: Sex workers in Nairobi’s Majengo slum. Cambridge
      Quarterly of Healthcare Ethics, 18,
138-146.
Butler, A. M., Williams, P. L., Howland, L. C., Storm, D., Hutton, N., & Seage, G. R.
      (2009). Impact of disclosure of HIV infection on health-related quality of life among
      children and adolescents with HIV infection. Pediatrics, 123, 935-943.
D’Angelo, L. J., Adbalian, S. E., Sarr, M., Hoffman, N., Belzer, M., & The Adolescent
      Medicine HIV/AIDS Research Network. (2001). Disclosure of serostatus by HIV
      infected youth: The experience of the REACH study. Journal of Adolescent Health,
      29
, 72-79.
Ditmore, M. H. & Allman, D. (2011). ‘Who is Helsinki?’ Sex workers advise improving
      communication for good participatory practice in clinical trials. Health Education
      Research, 26
(3), 466-475.
Fendrich, M., Lippert, A. M., & Johnson, T. P. (2007). Respondent reactions to sensitive
      questions. Journal of Empirical Research on Human Research Ethics, 2(3), 31-37.
Jeffreys, E. (2010). Sex worker-driven research: Best practice ethics. Challenging
      Politics: Critical Voices.
Retrieved from
      http://www.polsis.uq.edu.au/challenging-politics-critical-voices-abstracts-and-papers
Klitzman, R., Marhefka, S., Mellins, C., & Weiner, L. (2008). Ethical issues concerning
      disclosures of HIV diagnoses to perinatally infected children and adolescents. Journal
      of Clinical Ethics, 19
(1), 31-42.
Loue, S. & Pike, E. C. (2010). Chapt 15. Research in international settings:
      Serodiscordant couples. In Case studies in ethics and HIV research (pp.274-283) NY:
      Springer
Loue, S. & Pike, E. C. (2010). Chapt. 16. Activity-Defined Populations. In Case studies in
      ethics and HIV research
(pp.285-297) NY: Springer
Macklin, R. (2010). Intertwining biomedical research and public health in HIV microbicide
      research. Public Health Ethics, 3(3), 199-209.
McMahon, J. M., Tortu, S., Torres, L., Pouget, E. R., & Hamid, R. (2003). Recruitment of
      heterosexual couples in public health research: A study protocol. BMC Medical
      Research Methodology, 31
(3), 24-36.
Medical Ethics Advisor. (2011). Voluntary couples HIV testing. Medical Ethics Advisor,
      68.
Miller, R. L., Forte, D., Wilson, B. D. M., & Greene, G. J. (2006). Protecting sexual
      minority youth from research risks: Conflicting perspectives. American Journal of
      Community Psychology, 37
, 341-348.
Mills, E., Nixon, S., Singh, S., Dolma, S., Nayyar, A., Kapoor, S. (2006). Enrolling women
      into HIV preventive vaccine trials: An ethical imperative but a logistical challenge.
      PLoS Medicine, 3
(3), 308-311.
Olivier, C. (2009). Enhancing confidentiality within small groups: The experiences of AIDS
      service organizations. Social Work With Groups, 32(4), 274-287.
Papoutsi, C., Mazanderani, F., & Brown, I. (2010). Researching privacy in HIV care: An
      ethnographic analysis of methods. Privacy and Usability Methods (PUMP) Workshop,
      British HCI 2010 Conference.
Pomfret, S., Karim, Q. A., & Benatar, S. R. (2010). Inclusion of adolescent women in
      microbicide trials: A public health imperative! Public Health Ethics, 3(1), 39-50.
Project Parivartan. (2005). Ethical challenges in conducting research with sex workers: An
      annotated bibliography. Retrieved from www.yale.edu/cira/parivartan
Shagi, C., Vallely, A., Kasindi, S., Chidou, B., Desmond, N., Soteli, S., … Ross, D.
      (2008). A model for community representation and participation in HIV prevention trials
      among women who engage in transactional sex in Africa. AIDS Care, 20(9), 1039-1049.
Simmons, J. (2006). The interplay between interpersonal dynamics,treatment barriers,
      and larger social forces: An exploratory study of drug-using couples in Hartford,CT.
      Substance Abuse Treatment, Prevention, and Policy, 1(12), open access.
Simmons, J. & Singer, M. (2006). I love you…and heroin: Care and collusion among
      drug-using couples. Substance Abuse Treatment, Prevention, and Policy, 1(7), open
      access.
Suhadev, M., Mahadevan, U., Dilip, M., Suryanarayanan, D., Sikhamani, R., & Thomas,
      B. (2011). Percentages, process, and patterns of HIV disclosure among the spouses of
      HIV-infected men in South India. Journal of the International Association of Physicians
      in AIDS Care, 10
(1), 26-29.
Woodsong, C., MacQueen, K., Namey, E., Sahay, S., Mlingo, M., Mehendale, S. (2006).
      Women’s autonomy and informed consent in microbicide clinical trials. Journal of
      Empirical Research on Human Research Ethics, 1
(3), 11-26.

 


Institutional Review Boards
and Human Participant Protections in HIV Research


Brugge, D. (2012). Institutional review boards need to increase their understanding of
      community-based participatory research. The Journal of Nervous and Mental Disease,
      200
, 242.
Buchanan, E. A. & Ess, C. M. (2009). Internet research ethics and the institutional review
      board: Current practices and issues. Computers and Society, 39, 43-49.
Burris, S. & Davis, C. (2009). Assessing social risks prior to commencement of a clinical
      trial: Due diligence of ethical inflation. The American Journal of Bioethics, 9(11), 48-54.
Cook, A. F. & Hoas, H. (2011). Exploring the obligation to inform: Disclosing the purpose
      and benefits of research in an increasingly commercial research environment. AJOB
      Primary Research, 2
(1), 34-41.
Cook, A. F. & Hoas, H. (2011). Protecting research subjects: IRBs in a changing research
      landscape. IRB: Ethics & Human Behavior, 33(2), 14-19.
Chin, L. J., Rifai-Bashjawish, H., Kleinert, K., Saltman, A., Leu, C., & Klitzman, R. (2011).
      HIV/AIDS research conducted in the developing world and sponsored by the developed
      world: Reporting of research ethics committee review in two countries. Journal of
      Empirical Research on Human Research Ethics, 6
(3), 83-92.
Deeds, B. G., Castillo, M., Beason, Z., Cunningham, S. D., Ellen, J. M., Peralta, L., &
      Adolescent Trials Network for HIV/AIDS Interventions. (2008). An HIV prevention
      protocol reviewed at 15 national sites: How do ethics committees protect communities?
      Journal of Empirical Research on Human Research Ethics, 3(2), 77-86.
DuBois, J. M., O’Leary, C. C., & Cottler, L. B. (2009). The attitudes of females in drug
      court toward additional safeguards in HIV prevention research. Prevention Science, 10,
      345-352.
DuBois, J. M., Volpe, R. L., & Rangel, E. K. (2008). Hidden empirical research ethics: A
      review of three health journals from 2005 through 2006. Journal of Empirical Research
      on Human Research Ethics, 3
(3), 7-18.
Eckenwiler, L. (2001). Moral reasoning and the review of research involving human
      subjects. Kennedy Institute of Ethics Journal, 11(1), 37-69.
Fowler-Dixon, S. & Moreno, M. (2008). Internet research raises unique ethical concerns
      for IRBs. IRB Advisor, 8, 25-28.
Flicker, S., Travers, R., Guta, A., McDonald, S., & Meagher, A. (2007). Ethical dilemmas
      in community-based participatory research: Recommendations for institutional review
      boards. Journal of Urban Health: Bulletin of the New York Academy of Medicine, 84,
      478-493.
Guta, A., Nixon, S., Gahagan, J., & Fielden, S. (2012). “Walking along beside the
      researcher”: How Canadian REBs/IRBs are responding to the needs of
      community-based participatory research. Journal of Empirical Research on Humans
      Research Ethics, 7
(1), 17-27.
Klitzman, R. (2008). Views of the process and content of ethical reviews of HIV vaccine
      trials among members of US Institutional Review Boards and South African research
      ethics committees. Developing World Bioethics, 8(3), 207-218.
Klitzman, R. L., Kleinert, K., Rifai-Bashjawish, H., & Leu, C. S. (2011). The reporting of
      IRB review in journal articles presenting HIV research conducted in the developing
      world. Developing World Bioethics, 11, 161-169.
Kimmelman, J. (2011). Ethics, ambiguity aversion, and the review of complex
      translational clinical trials. Bioethics (in press, online advanced copy)
Loue, S. & Pike, E. C. (2010). Chapt. 4. Working with boards and committees: ECs, DSB,
      CABs In Case studies in ethics and HIV research (pp 37-56). NY: Springer.
Macklin, R. (2008). How independent are IRBs? IRB: Ethics & Human Research, 30(3),
      15-19.
Mamotte, N.  & Wassenaar, D. (2009). Ethics review in a developing country: A survey of
      South African social scientists’ experiences. Journal of Empirical Research on Human
      Research Ethics, 4
(4), 69-78.
Roberts, L. W. (1999). Ethical dimensions of psychiatric research: A constructive,
      criterion-based approach to protocol preparation. The Research Protocol Ethics
      Assessment Tool (RePEAT). Biological Psychiatry, 46, 1106-1119.
Ross, L. F., Loup, A., Nelson, R. M., Botkin, J. R., Krost, R., Smith, G. R., & Gehlert, S.
      (2010). Human subjects protections in community-engaged research: A research ethics
      framework. Journal of Empirical Research on Human Research Ethics, 5(1), 5-17.
Ross, L. F., Loup, A., Nelson, R. M., Botkin, J. R., Krost, R., Smith, G. R., & Gehlert, S.
      (2010). Nine key functions for a human subjects protection program for
      community-engaged research: Points to consider. Journal of Empirical Research on
      Human Research Ethics, 5
(1), 33-47.
Sengupta, S., Lo, B., Strauss, R. P., Eron, J., & Gifford, A. L. (2010). How researchers
      define vulnerable populations in HIV/AIDS clinical trials. AIDS and Behavior, 14,
      1313-1319.
Shore, N., Drew, E., Brazauskas, R., & Seifer, S. D. (2011). Relationships between
      community-based processes for research ethics review and institution-based IRBs: A
      national study. Journalof Empirical Research on Human Research Ethics, 6(2), 13-21.
Sirotin, N., Wolf, L. E., Pollack, L. M., Catania, J. A., Dolcini, M. M. & Lo, B. (2010). IRBs
      and ethically challenging protocols: Views of IRB chairs about useful resources. IRB: 
      Ethics & Human Research, 32(
5), 10-19.
Wisner, K. L., Conley, R. R., Taylor, S. F., Kosten, T., Rapaport, M. H., & Brown, L. S.
      (2011). Researcher experiences with IRBs: A survey of members of the American
      College of Neuropsychopharmacology. IRB: Ethics & Human Research, 33(5), 14-20.
     

 
Participant Perceptions of Risk

Bell, K. & Salmon, A. (2011). What women who use drugs have to say about ethical
      research: Findings of an exploratory qualitative study. Journal of Empirical Research on
      Human Research Ethics, 6
(4), 84-98.
Fisher, C. B. (2003). Adolescent and parent perspectives on ethical issues in youth drug
      use and suicide survey research. Ethics & Behavior, 13(4), 303-332.
Grady, C., Wagman, J., Ssekubugu, R., Wawer, M. J., Serwadda, D., Kiddugav, M., …
      Emanuael, E. J. (2008). Research benefits for hypothetical HIV vaccine trials: The
      views of Ugandans in the Rakai district. IRB: Ethics & Human Research, 30(2), 1-7.
Kost, R.G., Lee, L.M., Yessis, J., Coller, B.S., & Henderson, D.K. (2011). Assessing reseasrch participants' perceptions of their clinical research experiences. Clinical and translational science, 4(6), 403-413.
Maek, A.N.W., Pitisuttithum, P., Phonrat, B., Bussaratid, V., Naksrisook, S., Peonim, W., Thantamnu, N., Muanaum, R. (2003). Evaluation of attitude, risk behavior and expectations among Thai participants in Phase I/II/HIV/AIDS vaccine trials. Journal of the Medical Association of Thailand. 86(4): 299-307.
Nunn, A., Zaller, N., Cornwall, A., Mayer, K. H., Moore, E., Dickman, S., … Kwakwa, H.
      (2011). Low perceived risk and high HIV prevalence among a predominantly African
      American population participating in Philadelphia’s rapid HIV testing program. AIDS
      Patient Care and STDs, 25
, 229-235.
Rasinski, K. A., Willis, G. B., Baldwin, A. K., Yeh, W., & Lee, L. (1999). Methods of data
      collection, perceptions of risks and losses, and motivation to give truthful answers to
      sensitive survey questions. Applied Cognitive Psychology, 13, 465-484.
Suhadev, M., Nyamathi, A. M., Swaminathan, S., Venkatesan, P., Sakthivel, M. R.,
      Shenbegavalli, R., … Fahey, J. L. (2006). A pilot study on willingness to participate in
      future preventive HIV vaccine trials. Indian Journal of Medical Research, 124, 631-640.

Wootten, A.C., Abbot, J.M., Siddons, H.M., Rosenthal, M.A., Costello, A.J. (2011). A qualitative assessment of the experience of participating in a cancer-related clinical trial. Supportive Care in Cancer. 19(1): 49-55.
    

ethical challenges for front line research workers
 

Anspach, R. R, & Mizrachi, N. (2006). The field worker’s fields: Ethics, ethnography and
      medical sociology. Sociology of Health & Illness, 28(6), 713-731.
Farmer, P. & Campos, N. G. (2004). Rethinking medical ethics: A view from below.
      Developing World Bioethics, 4(1), 17-41.
Fisher, J. A. (2006). Co-ordinating ‘ethical’ clinical trials: The role of research coordinators
      in the contract research industry. Sociology of Health & Illness, 28, 678-694.
Forman, R. F., Bovasso, G., Woody, G., McNicholas, L., Clark, C., Royer-Malvestuto, C.,
      & Weinstein, S. (2002). Staff beliefs about drug abuse clinical trials. Journal of
      Substance Abuse Treatment, 23
, 55-60.
Namakhoma, I., Bongololo, G., Bello, G., Nyirenda, L., Phoya, A., Phiri, S., …
      Obermeyer, C. M. (2010). Negotiating multiple barriers: Health workers’ access to
      counseling, testing and treatment inMalawi. AIDS Care, 22, 68-76.
Phillip, T. (2010). Protecting the subject: PDR and the potential for compromised consent.
      The American Journal of Bioethics, 10(3), 14-15.
Scott, C. K. & White, W. L. (2005). Ethical issues in the conduct of longitudinal studies of
      addiction treatment. Journal of Substance Abuse Treatment, 28, S91-S101.
Sengupta, S., Strauss, R. P., Miles, M. S., Roman-Isler, M., Banks, B., & Corbie-Smith,
      G. (2010). A conceptual model exploring therelationship between HIV stigma and
      implementing HIV clinical trials in rural communities in North Carolina. North Carolina
      Medical Journal, 71
(2), 113-122.
Simmons, J. & Koester, K. (2003). Hidden injuries of research on social suffering among
      drug users. Practicing Anthropology, 25(3), 53-57.
Varas-Diaz, N., Negron, S. S., Neilands, T. B., Bou, F. C., & Rivera, S. M. (2010).
      Stigmatization of illicit drug use among Puerto Rican health professionals in training.
      Puerto Rico Health Sciences Journal, 29(2), 109-116.
Woodby, L. L., Williams, B. R., Wittich, A. R., & Burgio, K. L. (2011). Expanding the
      notion of researcher distress: The cumulative effects of coding. Qualitative Health
      Research, 21
(6), 830-838.

 
 
Participant perspectives on sensitive topics research

Becker-Blease, K. A. & Freyd, J. J. (2006). Research participants telling the truth about
      their lives: The ethics of asking and not asking about abuse. American Psychologist,
      61, 218-226.
Black, M. C., Kresnow, M., Simon, T. R., Arias, I., & Shelley, G. (2006). Telephone
      survey respondents’ reactions to questions regarding interpersonal violence. Violence
      and Victims, 21, 445-459.
Campbell, R. & Adams, A. E. (2009). Why do rape survivors volunteer for face-to-face
      interviews? A meta-study of victims’ reasons for and concerns about research
      participation. Journal of Interpersonal Violence, 24, 395-405.
Campbell, R., Adams, A. E., Wasco, S. M., Shrens, C. E., & Sefl, T. (2010). “What has it
      been like for you to talk with me today?”: The impact of participating in interview
      research on rape survivors. Violence Against Women, 16, 60-83.
Clark, C. J., Shahrouri, M., Halasa, L., Khalaf, I., Spencer, R., & Everson-Rose, S.
      (2012). A mixed methods study of participant reaction to domestic violence research in
      Jordan. Journal of Interpersonal Violence, 27, 1655-1676.
Decker, S. E., Naugle, A. E., Carter-Visscher, R., Bell, K., & Seifert, A. (2011). Ethical
      issues in research on sensitive topics: Participants’ experiences of distress and
      benefit. Journal of Empirical Research on Human Research Ethics, 6, 55-64.
DePrince, A. P. & Chu, A. (2008). Perceived benefits in trauma research: Examining
      methodological and individual difference factors in responses to research participation.
      Journal of Empirical Research on Human Research Ethics, 3, 35-47.
Edwards, K. M., Kearns, M. C., Calhoun, K. S., & Gidycz, C. A. (2009). College women’s
      reactions to sexual assault research participation: Is it distressing? Psychology of
      Women Quarterly, 33, 225-234.
Ferrier-Auerbach, A. G., Erbes, C. R., & Polusny, M. A. (2009). Does trauma survey
      research cause more distress than other types of survey research? Journal of
      Traumatic Stress, 22, 320-323.
Galea, S., Nandi, A., Stuber, J., Gold, J., Acierno, R., Best, C. L., … Resnick, H. (2005).
      Participant reactions to survey research in the general population after terrorist attacks.
      Journal of Traumatic Stress, 18, 461-465.
Griffin, M. G., Resnick, P. A., Waldrop, A. E., & Mechanic, M. B. (2003). Participation in
      trauma research: Is there evidence of harm? Journal of Traumatic Stress, 16, 221-227.
Hebenstreit, C. L. & DePrince, A. P. (2012). Perceptions of participating in longitudinal
      trauma research among women exposed to intimate partner abuse. Journal of Empirical
      Research on Human Research Ethics, 7, 60-69.
Hoel, N., Shaikh, S., & Kagee, A. (2010). Muslim women’s reflections on the acceptability
      of vaginal microbicide products to prevent HIV infection. Ethnicity & Health, 16, 89-106.
Johnson, L. E. & Benight, C. C. (2003). Effects of trauma-focused research on recent
      domestic violence survivors. Journal of Traumatic Stress, 16, 567-571.
Legerski, J. P. & Bunnell, S. L. (2012). The risks, benefits, and ethics of trauma-focused
      research participation. Ethics & Behavior, 20, 429-442.
Newman, E. & Kaloupek, D. (2009). Overview of research addressing ethical dimensions
      of participation in traumatic stress studies: Autonomy and beneficence. Journal of
      Traumatic Stress, 22, 595-602.
Newman, E. & Kaloupek, D. (2004). The risks and benefits of participating in
      trauma-focused research studies. Journal of Traumatic Stress, 17, 383-394.
Resick, P. A., Iverson, K. M., & Artz, C. E. (2009). Participant reactions to pretreatment
      research assessment during a treatment outcome study for PTSD. Journal of
      Traumatic Stress, 22, 316-319.
Schwerdtfeger, K. L. & Goff, B. S. N. (2008). The effects of trauma-focused research on
      pregnant female participants. Journal of Empirical Research on Human Research
      Ethics, 3, 59-67.
Shorey, R. C., Cornelius, T. L., & Bell, K. M. (2010). Reactions to participating in dating
      violence research: Are our questions distressing participants. Journal of Interpersonal
      Violence. 26, 2890-2907.
Sikweyiya, Y. & Jewkes, R. (2012). Perceptions and experiences of research participants
      on gender-based violence community based survey: Implications for ethical guidelines.
      PLoS One, 7, doi:10.1371/journal.pone.0035495
Weitlauf, J. C., Ruzek, J. I., Westrup, D. A., Lee, T., & Keller, J. (2007). Empirically
      assessing participant perceptions of the research experience in a randomized clinical
      trial: The Women’s Self-Defense Project as a case example. Journal of Empirical
      Research on Human Research Ethics, 2, 11-24.


 

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