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New NIH Policy Protects Human Subjects in Research

Harvard researchers, students are now faced with the beurocracy in order to conduct research on students

Public attention has been focused on research involving human subjects since 18-year-old Jesse Gelsinger died at the University of Pennsylvania during a gene therapy trial.

"In our recent initiative to strengthen the entire system for the protection of human subjects, one of our initiatives is to require researchers

involved with the design or conduct of research to be educated on regulation and on ethical issues in this area," Seto says.

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The definition of a course of instruction is purposely flexible, according to Seto, which allows online versions like Harvard's to fulfill the requirement.

"We at the NIH did not prescribe what courses they should take but we gave them sufficient flexibility to make that decision," Seto says.

According to Seto, the type of education appropriate would vary by the type of research conducted.

"Beyond the fundamentals, investigators should adapt what is suitable and commensurate with their

areas of interest," she says.

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