David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Developing World Bioethics 9 (2):81-87 (2009)
To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.
|Keywords||research ethics research trial developing world informed consent drug trial bioethics consent|
|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
No references found.
Citations of this work BETA
Joia Mukherjee (2010). Post-Approval Translational Research Itself Has Diverse Ethics. American Journal of Bioethics 10 (8):43-44.
Similar books and articles
Judy Allen & Beverley Mcnamara (2011). Reconsidering the Value of Consent in Biobank Research. Bioethics 25 (3):155-166.
David Wendler & Christine Grady (2008). What Should Research Participants Understand to Understand They Are Participants in Research? Bioethics 22 (4):203–208.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
Eric R. Pedersen, Clayton Neighbors, Judy Tidwell & Ty W. Lostutter (2011). Do Undergraduate Student Research Participants Read Psychological Research Consent Forms? Examining Memory Effects, Condition Effects, and Individual Differences. Ethics and Behavior 21 (4):332 - 350.
A. T. Nuyen (2007). Knowing the Unknown and Informed Consent. International Journal of Applied Philosophy 21 (2):213-223.
Asya Al-Riyami, Deepali Jaju, Sanjay Jaju & Henry J. Silverman (2011). The Adequacy of Informed Consent Forms in Genetic Research in Oman: A Pilot Study. Developing World Bioethics 11 (2):57-62.
Janet L. Brody, John P. Cluck & Alfredo S. Aragon (1997). Participants' Understanding of the Process of Psychological Research: Informed Consent. Ethics and Behavior 7 (4):285 – 298.
James R. P. Ogloff & Randy K. Otto (1991). Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research. Ethics and Behavior 1 (4):239 – 252.
David S. Festinger, Kattiya Ratanadilok, Douglas B. Marlowe, Karen L. Dugosh, Nicholas S. Patapis & David S. DeMatteo (2007). Neuropsychological Functioning and Recall of Research Consent Information Among Drug Court Clients. Ethics and Behavior 17 (2):163 – 186.
Benedetto Vitiello (2008). Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research. Ethics and Behavior 18 (2 & 3):182 – 198.
Added to index2009-01-28
Total downloads25 ( #65,711 of 1,096,509 )
Recent downloads (6 months)2 ( #139,663 of 1,096,509 )
How can I increase my downloads?