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- In accordance with Duke Policy
Regarding Reseach with Human Subjects, adopted by the Academic Council,
to conduct research in the pursuit of knowledge, wherever that search
may lead.
- To have their requests for protocol approval reviewed by an IRB with
relevant expertise. The IRB uses expert consultants when needed, for
example, when reviewing Internet security technology.
- To have all decisions of the IRB conveyed to them in writing.
- To engage in dialogue with the IRB if unclear about the rationale
for its decisions. (The institution may not approve a protocol the IRB
has disapproved; however the IRB's strategy is to work with investigators
to ensure that all protocols are approved.)
- Finally, at Duke, investigators are given access to all the flexibility
allowed in the regulations, including the use of exemptions, alterations
or waivers of elements of consent, and waivers of the requirement to
documentation of the consent process.
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