BMC Medical Ethics 8 (1):1-7 (2007)
Background HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Discussion Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
References found in this work BETA
No references found.
Citations of this work BETA
National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden.Bernard Gallagher, Anne H. Berman, Justyna Bieganski, Adele D. Jones, Liliana Foca, Ben Raikes, Johanna Schiratzki, Mirjam Urban & Sara Ullman - forthcoming - Ethics and Behavior:1-21.
CQ Sources/Bibliography.Bette Anton - 1999 - Cambridge Quarterly of Healthcare Ethics 8 (4):348-350.
To What Did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia.Esther Munalula‐Nkandu, Paul Ndebele, Seter Siziya & J. C. Munthali - 2015 - Developing World Bioethics 15 (3):248-256.
Similar books and articles
Intertwining Biomedical Research and Public Health in HIV Microbicide Research.R. Macklin - 2010 - Public Health Ethics 3 (3):199-209.
Inclusion of Adolescent Women in Microbicide Trials: A Public Health Imperative!S. Pomfret, Q. A. Karim & S. R. Benatar - 2010 - Public Health Ethics 3 (1):39-50.
How Informed is Consent in Vulnerable Populations? Experience Using a Continuous Consent Process During the MDP301 Vaginal Microbicide Trial in Mwanza, Tanzania.Andrew Vallely, Shelley Lees, Charles Shagi, Stella Kasindi & Selephina Soteli - 2010 - BMC Medical Ethics 11 (1):10-.
The Unique Ethical Challenges of Conducting Research in the Rehabilitation Medicine Population.Jeff Blackmer - 2003 - BMC Medical Ethics 4 (1):1-6.
HIV Vaccine Trial Participation in South Africa - an Ethical Assessment.Keymanthri Moodley - 2002 - Journal of Medicine and Philosophy 27 (2):197 – 215.
Stakeholder Perspectives on Ethical Challenges in Hiv Vaccine Trials in South Africa.Zaynab Essack, Jennifer Koen, Nicola Barsdorf, Catherine Slack, Michael Quayle, Cecilia Milford, Graham Lindegger, Chitra Ranchod & Richard Mukuka - 2010 - Developing World Bioethics 10 (1):11-21.
'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.Jennifer Koen, Zaynab Essack, Catherine Slack, Graham Lindegger & Peter A. Newman - 2012 - Developing World Bioethics 12 (3):138-148.
Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions.Lisa R. Stines & Norah C. Feeny - 2008 - Ethics and Behavior 18 (2 & 3):234 – 246.
Impact of Donor-Imposed Requirements and Restrictions on Standards of Prevention and Access to Care and Treatment in HIV Prevention Trials.S. Philpott, K. West Slevin, K. Shapiro & L. Heise - 2010 - Public Health Ethics 3 (3):220-228.
Enrolling Adolescents in HIV Vaccine Trials: Reflections on Legal Complexities From South Africa.Catherine Slack, Ann Strode, Theodore Fleischer, Glenda Gray & Chitra Ranchod - 2007 - BMC Medical Ethics 8 (1):1-8.
Ethical Challenges in HIV Microbicide Research: What Protections Do Women Need?Ruth Macklin - 2011 - International Journal of Feminist Approaches to Bioethics 4 (2):124-143.
Added to index2010-08-24
Total downloads10 ( #429,066 of 2,164,581 )
Recent downloads (6 months)1 ( #347,995 of 2,164,581 )
How can I increase my downloads?