How Good Is “Good Enough”? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jonathan Jenkins Ichikawa
Jack Alan Reynolds
Learn more about PhilPapers
American Journal of Bioethics 12 (6):21-30 (2012)
In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
Franklin G. Miller & Howard Brody (2003). A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials. Hastings Center Report 33 (3):19-28.
Alex John London & Kevin J. S. Zollman (2010). Research at the Auction Block: Problems for the Fair Benefits Approach to International Research. Hastings Center Report 40 (4):34-45.
Ruth Macklin (1999). Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine. Oxford University Press.
Ruth Macklin (2001). After Helsinki: Unresolved Issues in International Research. Kennedy Institute of Ethics Journal 11 (1):17-36.
Richard Ashcroft (1999). Equipoise, Knowledge and Ethics in Clinical Research and Practice. Bioethics 13 (3-4):314-326.
Citations of this work BETA
Bridget Haire (2015). It’s Time: The Case for PrEP as an Active Comparator in HIV Biomedical Prevention Trials. Journal of Bioethical Inquiry 12 (2):239-249.
Bridget Haire & John M. Kaldor (2013). Ethics of ARV Based Prevention: Treatment‐as‐Prevention and PrEP. Developing World Bioethics 13 (2):63-69.
Sarah J. L. Edwards, Sapfo Lignou & Elizabeth Oduwo (2012). Evidence of Efficacy and Human Right to Health. American Journal of Bioethics 12 (6):35-37.
Quarraisha Abdool Karim & Ronald Bayer (2013). Anti‐Retrovirals for Treatment and Prevention – Time for New Paradigms in Our Response to the HIV/AIDS Epidemic? Developing World Bioethics 13 (2):ii-iii.
Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee & Mitchell Warren (2013). Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP. Developing World Bioethics 13 (2):87-94.
Similar books and articles
Bridget G. Haire (2011). Because We Can: Clashes of Perspective Over Researcher Obligation in the Failed Prep Trials. Developing World Bioethics 11 (2):63-74.
Melissa Stobie & Catherine Slack (2010). Treatment Needs in Hiv Prevention Trials: Using Beneficence to Clarify Sponsor-Investigator Responsibilities. Developing World Bioethics 10 (3):150-157.
R. Macklin (2010). Intertwining Biomedical Research and Public Health in HIV Microbicide Research. Public Health Ethics 3 (3):199-209.
Charles Weijer & Guy LeBlanc, Revisiting the Ethics of HIV Prevention Research in Developing Countries.
B. M. Meier, K. N. Brugh & Y. Halima (2012). Conceptualizing a Human Right to Prevention in Global HIV/AIDS Policy. Public Health Ethics 5 (3):263-282.
S. Philpott, K. West Slevin, K. Shapiro & L. Heise (2010). Impact of Donor-Imposed Requirements and Restrictions on Standards of Prevention and Access to Care and Treatment in HIV Prevention Trials. Public Health Ethics 3 (3):220-228.
Joseph-Matthew Mfutso-Bengo, Eva-Maria Mfutso-Bengo & Francis Masiye (2008). Ethical Aspects of Hiv/Aids Prevention Strategies and Control in Malawi. Theoretical Medicine and Bioethics 29 (5):349-356.
Udo Schuklenk (2007). HIV Vaccine Trials: Reconsidering the Therapeutic Misconception and the Question of What Constitutes Trial Related Injuries. Developing World Bioethics 7 (3).
Jennifer Koen, Zaynab Essack, Catherine Slack, Graham Lindegger & Peter A. Newman (2012). 'It Looks Like You Just Want Them When Things Get Rough': Civil Society Perspectives on Negative Trial Results and Stakeholder Engagement in HIV Prevention Trials. Developing World Bioethics 12 (3):138-148.
Timothy F. Murphy (1994). Health Care Workers with Hiv and a Patient's Right to Know. Journal of Medicine and Philosophy 19 (6):553-569.
Charles Weijer & Guy J. Leblanc (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.
Keymanthri Moodley (2007). Microbicide Research in Developing Countries: Have We Given the Ethical Concerns Due Consideration? BMC Medical Ethics 8 (1):1-7.
Christine Grady (1994). Hiv Preventive Vaccine Research: Selected Ethical Issues. Journal of Medicine and Philosophy 19 (6):595-612.
Yanguang Wang (2000). A Strategy of Clinical Tolerance for the Prevention of Hiv and Aids in China. Journal of Medicine and Philosophy 25 (1):48 – 61.
Added to index2012-06-01
Total downloads9 ( #389,314 of 1,938,441 )
Recent downloads (6 months)1 ( #440,814 of 1,938,441 )
How can I increase my downloads?