According to the federal regulations ( 45 CFR 46 102.d ) RESEARCH means a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge. Most case reports and much of the Quality Improvement activities that take place do not meet the definition of research. The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
The IRB may review these to assure that they are not research and therefore, do not need to be reviewed. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule. Research. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. NOTE: research involving tissue and/or data, even if it does not meet the federal definition of human subject, must still be submitted to the IRB for review and approval. What is Research ?