[ANSWERED] A U.S. researcher is collaborating with researchers in a developing nation in South America studying

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?