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OHRP posts new FAQs online
The Office for Human Research Protections has posted new frequently asked questions and answers (FAQs) online at http://www.hhs.gov/ohrp/faq.html.
The new Q&A information includes the following:
Question: If I plan to carry out a quality improvement project and publish the results, does the intent to publish make my quality improvement project fit the regulatory definition of research?
Answer: No. The intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. The regulatory definition under 45 CFR 46.102(d) is "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.
Question: Does a quality improvement project that involves research need to be reviewed by an IRB?
Answer: Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable FWA. (See exempt categories at http://www.hhs.gov/ohrp.)