Should the IRB approve this study?

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?

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