Issue |
J Extra Corpor Technol
Volume 29, Number 2, June 1997
|
|
---|---|---|
Page(s) | 88 - 91 | |
DOI | https://doi.org/10.1051/ject/199729288 | |
Published online | 18 August 2023 |
Lecture
Determining When a Clinical Activity Should be Classified as Research Requiring Institutional Review Board Review
1
University of Nebraska Medical Center, Omaha, Nebraska
2
Office of Protection from Research Risks, National Institute of Health, Bethesda, MD
* Address correspondence to: Ernest D. Prentice, PhD Associate Dean for Research University of Nebraska Medical Center 600 South 42nd Street Omaha, NE 68198-6810 Volu
The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.
Key words: Institutional Review Board / research / human subjects / federal regulations
© 1997 AMSECT
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