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EthicsCaseStudyForm edit

Title Placebo-controlled Clinical Trial in Third World Country
Long Title Placebo-controlled Clinical Trial in Third World Country…
Contributor/Contact Michele A. Carter, PhD (mcarter@utmb.edu)
Contributor Details Michele A. Carter, PhD
Director, Ethics Support Key Resource, Institute for Translational Sciences
CTSA UTMB Galveston
Case Study Provided TITLE: Conducting a placebo-controlled clinical trial in a Third World country to find an affordable drug to prevent perinatal HIV transmission.

CASE: As part of her dissertation project, Victoria Lake is interested in finding a way to help HIV-infected women in Africa to share the benefits of this knowledge and to further advance the science of HIV prevention. She knows that the gold standard for research investigations is the placebo-controlled clinical trial. Specifically, she is interested in evaluating whether a cheaper anti-viral drug (XYZ) might be effective. Her supervising professor, Dr. Azure has said that in order to get a clear verdict on the value of drug regimens in pregnancy, it will be necessary to assign some women to a "control" group. These women would receive a placebo while those in the "treatment" arm would receive the XYZ.

Victoria is full of excitement and believes that her research could answer an important question: Is the drug regimen (XYZ) better than the current standard of care for these women, which unfortunately is nothing?1
In presenting her proposal to her committee, Victoria is shocked to discover that the committee members do not agree on the merits of her proposal. In fact, one member, Dr. Barry, says it would be totally unethical to do the proposed study. She says that seriously ill subjects should always get at least the best therapy that it is currently available. Additionally, she says that it is wrong to give a placebo to an HIV-infected pregnant women in a country where there is no access to AZT when it is the routine standard of care in the country which is funding the research. Citing the WHO's Declaration of Helsinki of 1964, Dr. Barry reminds Victoria that every patient in a medical study, including those in a control group, "should be assured of the best proven diagnostic and therapeutic method." Her colleague, Dr. Clark disagrees. He thinks that the most important ethical guideline was the one issued in 1992 by the Council for International Organizations of Medical Sciences (CIOMS). He argued in favor of the research, stating that research must be "responsive to the health needs and priorities of the community in which it is to be carried out." Moreover, he said that the university should ensure that at the completion of successful testing, the drug that proved to be most safe and efficacious must be made reasonably available to the people of the communities in which it was tested. He advises Victoria to carry on with her project, believing that it would be unfair to deprive these vulnerable mothers their right to participate in scientific studies on HIV prevention.

Unable to resolve their disagreements, Dr. Azure suggests that Victoria request guidance from the university's IRB before continuing her project.

1 Strictly speaking, an effective treatment might be available in a developing company, but too expensive to be offered in that country.
Data Acquisition, Management, Sharing and Ownership Topics No Data acquisition_management_sharing and ownership Topics
Mentor and Trainee Responsibilities Topics No mentor and trainee responsibilities topics
Publication Practices and Responsible Authorship Topics No publication practices and responsible authorship topics
Peer Review Topics No peer review topics
Collaborative Science Topics No collaborative science topics
Research Misconduct Topics No research misconduct topics
Conflicts of Interest, Law and Policy Topics No conflicts of interest_law_and policy topics
Human Subjects Human subjects research
Citation

URL

RCR Keyword

Other RCR Keywords Human Subjects
AIDs
Placebo-controlled
Perinatal HIV transmission
Epidemic
Drug; Vaccine
AZT
Pregnant Mother
Infant
Third World Countries
Africa
Uganda
HIV
Prevention
Clinical Trial
Anti-viral Drug
Subjects
Seriously Ill
Standard of Care
WHO
Declaration of Helsinki of 1964
Control Group
Council for International Organizations of Medical Sciences (CIOMS)
Community
IRB
Case Difficulty Advanced
Type of Case

Source for Topic Areas Du Bois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70.
References Case Development: Michele A. Carter, PhD, Research Ethicist, University of Texas Medical Branch
Other BACKGROUND: Since the AIDS epidemic began, scientists have been working hard to find a drug or vaccine that will prevent the rampant spread of this dread disease throughout the world. The discovery in 1994 that administering AZT could reduce by two thirds the incidence of HIV transmission from pregnant mother to her infant offers hope, but the expense of the drug makes it unaffordable in most of the world. Thus, it is still the case that approximately 500,000 infants are perinatally infected with HIV each year, the vast majority of whom are born in developing countries such as Africa and Uganda where AZT is either unavailable or too costly for most people to obtain. The average cost of the AZT regimen in the US is approximately $1000.00 per mother.

DISCUSSION QUESTIONS:
1. In your opinion, which committee member has the stronger case? Why?
2. In general, do you think that placebo-controlled studies are required for valid scientific results? Why or Why not?
3. Do you think the standards for research ethics should apply universally, or should each country develop their own standards? Why or Why not?
4. From an ethical point of view, is it acceptable to carry out placebo-controlled trials of anti-retroviral drugs in poor countries where there is no access to the drugs proven to be effective elsewhere? Why or Why not?
5. Do you think the pharmaceutical company that makes AZT and profits from its sales should be required to make it available to all pregnant women with HIV, regardless of where they live? If so, who should demand this of them?
Topic revision: r4 - 13 Nov 2011 - 19:19:52 - MarkYarborough
 
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