Author: admin

You are planning to conduct a study on the women’s attitudes
toward birth control in a developing nation. The population you are planning to
work with has a tribal governance structure: All research projects must be
approved by the tribal leaders. You present your proposed research project to
members of the tribe, describing the protocol and consent process. You plan to
conduct a medical history and physical exam on each woman. You will also
conduct a thirty-minute interview in which you ask them questions about their
sexual behavior and attitudes toward sex. Each woman will also receive tests
for HIV, chlamydia, herpes, and other sexually transmitted diseases. The tribal
leaders give their tentative approval to the research with the understanding
that if the research subject is married, her husband must be present for the
consent process and interview. If she is not married, the leading male member
of her family, such as her father or grandfather, must be present. The
husband/leading male family member must also give his approval for the woman’s
participation in the study. You have some serious concerns about these
conditions, because you think that complying with them could bias your data and
compromise the ethical integrity of the project.
• Would it be ethical to conduct the research under the
conditions set forth by the tribal leaders?
• How should you discuss these issues with the tribal
leaders?

A contract research organization (CRO) is planning to move
its operations to a developing nation in Southeast Asia. The CRO specializes in
conducting phase I trials (i.e., dosing studies) on healthy subjects for
pharmaceutical companies. It is moving its operations to this country to save
money on labor costs and to take advantage of a less burdensome regulatory
system. The research subjects will be paid $5 per day for participating in
research, which is about the average daily pay in that country. The CRO has no
plans to compensate research subjects for injuries. Health care in the
Southeast Asian nation is very limited. Most of the drugs tested by the company
are likely to be used to treat chronic diseases that affect people in developed
nations, such as hypertension, congestive heart failure, arthritis, and
depression. Most of the drugs will be too expensive for patients in the country
to afford, at least until their patents expire. The CRO is helping to establish
an IRB to review the research at a local hospital. The CRO will conduct some
educational and training activities for the IRB members and pay them the same
wage as the subjects. Local leaders are delighted that the CRO has moved its
operations to their vicinity, since this will create jobs and stimulate
economic activity. They have reached a deal with the CRO that includes tax
breaks.
• Do you see any ethical problems with the CRO’s plans?
• Is the local population receiving fair benefi ts from this
deal?
• Is this situation exploitative? Unethical?

Investigators sponsored by the NIH and private foundation
are conducting an HIV vaccine trial in a sub-Saharan African nation. In the
trial, HIVnegative adolescents will be randomized to receive either an
experimental vaccine or a placebo. They will be instructed on ways to prevent
HIV infection and provided with condoms. They will be followed for fi ve years
to see if either group has a higher HIV infection rate. They will be tested for
HIV on a regular basis and interviewed concerning their sexual activities and
other risky behaviors. If they develop HIV, they will be treated according to
the standard of care in the sub-Saharan nation, which includes access to only
some of the HIV medications available in the developing world. Subjects who
develop HIV will receive free medication for a maximum of one year. There are
no plans to compensate subjects for research-related injuries. Interviews with
some of the subjects participating in the trial revealed a profound lack of
understanding of the purpose of the study and its procedures. Many participants
thought they were receiving treatment for HIV rather than an HIV vaccine. A
data monitoring committee found that people who received the vaccine had an
increased risk for arthritis and diabetes.
• What are some of the potential ethical problems with this
study?
• Should an HIV vaccine be tested on adolescents?

A U.S. researcher is collaborating with researchers in a
developing nation in South America studying a hereditary disorder found only in
an isolated population living deep in the jungle. The South American
researchers are planning to send genetic samples to the U.S. researcher for
analysis. They hope to identify genes associated with this disorder. The South
American researchers have a protocol and consent form, which have been approved
by a local IRB. They have submitted an amendment to their local IRB to include
the U.S. researcher as a co-investigator. In order for the U.S. researcher to
collaborate with the South American researchers on this project, the IRB at his
institution must also approve the study. The U.S. researcher submits a proposal
to his IRB. The South American consent form includes all the legally required
elements (by U.S. law) for informed consent, such as a description of the study,
the procedures, benefi ts, risks, and confi dentiality protections. However,
the consent form is very sketchy and short on details. It is far below U.S.
standards for consent documents. It is only about one single-spaced, typed page
(400 words). The U.S. researcher presents his proposal at a meeting of the IRB.
IRB members are not receptive to the proposal. The U.S. researcher acknowledges
that the consent document is substandard by U.S. standards, but he urges the
IRB to approve the document on the grounds that the document is acceptable by
the local standards and his role in the research can be very benefi cial to the
local population.
• Should the IRB approve this study?
• What are some of the potential ethical or legal problems
with approving this study?