Surgical Clinical Research Ethics
What is surgical clinical research?
- Most publications in the surgical professional literature involve clinical research (in order of occurrence: case reports, case series, case-control studies, and least often, randomized controlled clinical trials)
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Clinical research is defined by the organized use of human subjects to gather data using a method (surgical or otherwise) performed on (a) human(s) in order to create generalizable knowledge.
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As with all clinical research, surgical research requires the development of a formal protocol, which the investigator must submit for IRB consideration and approval prior to implementation. Some forms of clinical research may be found exempt from further review by an IRB, such a retrospective chart reviews or use of anonymous tissue samples. This however still may require an initial IRB review or consultation by an IRB official to determine if the research is indeed exempt. Some research may also be eligible for expedited review by the IRB.
