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ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects

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Once a project has been approved by an IRB, researchers must adhere to the approved protocol and follow anyadditional IRB instructions. This, unfortunately, is where a few researchers and institutions have occasionally run into problems and temporarily had their “assurance” (FWA - Federalwide Assurance) suspended. The continuing responsibilities that researchers have include:
  • enrolling only those subjects that meet IRB approvedinclusion and exclusion criteria,
  • properly obtaining and documenting informed consent,
  • obtaining prior approval for any deviation from theapproved protocol,
  • keeping accurate records, and
  • promptly reporting to the IRB any unanticipated problems involving risks to subjects or others.
While research institutions are increasingly monitoringthe progress of human subjects research, the primary responsibility for conducting experiments as approved still lies with the individual researchers and staff who conduct the