Fordham University            The Jesuit University of New York
 



Empirical and Theoretical Articles and Resources
in HIV Prevention and Drug 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 and Alcohol 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.
(2014). HIV Prevention Research Ethics: An Introduction to the Special Issue.
     Journal Of Empirical Research On Human Research Ethics
, 9(1), 1-5.
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 it ethical to offer incentives to
     encourage drug-using women to use long-acting forms of contraception? Addiction,

     107
(6), 1036-1041.

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.
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.
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.

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). Globalclinical 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.
Baumann, A., Rodriguez, M.D., & Parra-Cardona, J.R. (2011). Community-based applied
     research with Latino immigrant families: Informing practice and research according to
     ethical and social justice principles. Family Process, 50, 132-148.

Beecher, H.K. (1966). Ethics and clinical research. The New England Journal of Medicine,
     274
(24), 1354-1360.
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
 

HIV RESEARCH AND HUMAN RIGHTS

Annas, G. J. (2004). American bioethics and human rights: The end of all our exploring.
     Journal of Law, Medicine and Ethics.
658-663.
Andorno, R. (2009). Human dignity and human rights as a common ground for bioethics.
     Journal of Medicine and Philosophy, 34
, 223-240.
Baker, R. (2001). Bioethics and human rights: A historical perspective. Cambridge Quarterly
     of Healthcare Ethics, 10
, 241-252.
Beyrer, C., & Kass, N. E. (2002). Human rights, politics, and reviews of research ethics.
     The Lancet, 360
(9328), 246-251.
Farmer, P. (2005). Rethinking health and human rights: Time for a paradigm shift. In
     Pathologies of power: Health, human rights, and the new war on the poor (pp 213-246).
     Berkley: University of California Press.
Faunce, T. (2004). Will international human rights subsume medical ethics? Intersections in
     the UNESCO Universal Bioethics Declaration. Journal of Medical Ethics, 31, 173.
Gruskin, S. (2002). Ethics, human rights, and public health. American Journal of Public
     Health, 92
, 698.
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.
Joint United Nations Programme on HIV/AIDS (UNAIDS) Reference Group on HIV and
     Human Rights. (2007). Criminalization of HIV transmission.
London, A J. (2011). Justice and research in developing countries. In S. Benatar & G. Brock
     (eds). Global health and global health ethics (pp. 293-393). Cambridge: Cambridge
    
University Press.
London, L., Kagee, A., Moodley, K., & Swartz, L. (2012). Ethics, human rights and HIV
     vaccine trials in low-income settings. Journal of medical ethics, 38(5), 286-293.
Loue, S. & Pike, E. C. (2010). Chapt. 1. Human Rights, International Guidelines & HIV
     Research. In Case studies in ethics and HIV research. NY: Springer.
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.
Kleinman, A. (2009). Ethic and experience: An anthropological approach to health equity. S.
     Anand, F. Peter, & A. Sen (eds). Public Health, Ethics, and Equity. (269 – 283). New
     York: Oxford
Madhivanan, P., Krupp, K., Kulkarni, V., Kulkarni, S., Vaidya, N., Shaheen, R. Philpott, S. &
     Fisher, C. B. (2014). HIV testing among pregnant women living with HIV in India: are
     private healthcare providers routinely violating women’s human rights? BMC International
     Health and Human Rights,
14(7).

Peel, M. (2005). Human rights and medical ethics. Journal of the Royal Society of Medicine,
     98
, 171-173.
Sarang, A., Rhodes, T., Sheon, N., & Page, K. (2010). Policing drug users in Russia: Risk
     fear, structural violence. Substance use & misuse, 45(6), 813-864.
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. John Wiley & Sons.
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.
United Nations Educational, Scientific and Cultural Organization (UNESCO). (2005).
     Universal Declaration on Bioethics and Human Rights.

 

 


 

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.
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.
Sieber, J.E. (2004) Empirical research on research ethics. Ethics & Behavior, 14,
397-412.
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, 44(3), 702-724.
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
(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
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Multicultural Competence and Cultural Validity in
HIV Prevention Research Ethics


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, 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 alcoholand 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,
38(6), 356-365.
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., 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.
Murphy, D. A., Hoffman, D., Seage, G. R., Belzer, M., … Adolescent Trials Network (2007).
     Improving comprehension for HIV vaccine trial information among adolescents at risk of
     HIV. AIDS Care, 19, 42-51.

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.
Davidson, P., & Page, K. (2012). Research participation as work: comparing the   
     perspectives of researchers and economically marginalized populations. American
     Journal of Public Health, 102(7), 1254-1259.
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 Human Research 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,

     107(6), 1036-1041.

Phillips, T. B. (2011). A living wage for research subjects. Journal of Law, Medicine &
     Ethics, 39,
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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.
Wendler, D., Rackoff, J. E., Emanuel, E. J., & Grady, C. (2002). The ethics of paying for
     children’s participation in research. The Journal of Pediatrics, 141, 166-171.



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,
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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(9), e1001089.

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
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Fisher, C.B., True, G., Alexander, L., & Fried, A.L. (2013).  Moral stress, moral practice,
     and ethical climate in community-based drug use research: Views from the frontline. 
     American Jou
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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.
Pearson, C. R., Parker, M., Fisher, C. B., & Moreno, C. (2014). Capacity Building from the
     Inside Out: Development and Evaluation of a CITI Ethics Certification Training Module for
     American Indian and Alaska Native Community Researchers. Journal Of Empirical
     Research On Human Research Ethics
, 9(1), 46-57.
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
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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.
Rhodes, S. D., Malow, R. M., & Jolly, C. (2010). Community-based participatory research: A
     new and not-so-new approach to HIV/AIDS prevention, care, and treatment. AIDS
     Education and Prevention, 22,
173-183.

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.
Solomon, S., Eakin, B., Kirk, R., Piechowski, P., & Thomas, B. (2014). Piloting a Nationally
     Disseminated, Interactive Human Subjects Protection Program for Community Partners:
     Design, Content, and Evaluation. 
Clinical and translational science.
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
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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
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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
Reed, E., Khoshnood, K., Blankenship, K. M., & Fisher, C. B. (2014). Confidentiality,
     Privacy, and Respect: Experiences of Female Sex Workers Participating in HIV
     Research in Andhra Pradesh, India. Journal Of Empirical Research On Human Research
     Ethics,
9(1), 19-28.
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
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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
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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
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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. (2011). The myth of community differences as the cause of variations among
     IRBs. AJOB Primary Research, 2, 24-33.

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
     research 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.
Colon, R. M., Deren, S., Gaurino, H., Mino, M. & Kang, S. Y. (2010). Challenges in
     recruiting and training drug treatment patients as peer outreach workers. Substance Use
     & Misuse, 45
, 1892-1908.

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.
Fisher, C.B., True, G., Alexander, L., & Fried, A.L. (2013).  Moral stress, moral practice,
     and ethical climate in community-based drug use research: Views from the frontline. 
     American Jou
rnal of Bioethics Primary Research, 4(3), 27-38.

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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