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IRB and CITI training
1.research: a systematic investigation designed to develop or
contribute to gen- eralizable knowledge (research development, testing and evaluation
2.human subject: a living individual about whom an investigator
conducting research obtains data through intervention or interaction with in the individual, or identifiable private information
3.IRB: administrative body required by the federal government to
protect the rights and the welfare of people who are recruited to be participants in research
4.HHS regulations, subpart A: Basic HHS policy
-basic IRB and informed requirements -federal departments and agencies
5.HHS regulations, subpart B: pregnant women, fetuses and neonates
6.HHS regulations, subpart C: prisoners
7.HHS regulations, subpart D: children
8.when are the regulations applicable?: research involving human
subjects conducted or supported by HHS, that is not otherwise exempt
9.non-exempt: human subject research covered by the "assurance of
compliance
10.what is exempt research?: -normal educational practices in
established ed- ucational settings -educational tests, surveys, interviews observation of public behavior unless iden- tified and sensitive (exception for children) -research on elected or appointed public officials or candidates for public office 1 / 2
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-research using existing data, if publicly available or recorded without identifiers -evaluation of public benefit service programs -taste and food quality evaluation and consumer acceptance studies
11.how do you determine exemption?: OHRP (office of human rights
protec- tion) -need clear policy on who will determine what research is exempt
under code (ex: at Butler an IRB reviewer is authorized to review and
give approval for research qualifying as exempt -those with the authority to determine exempt are expected to be well acquainted with interpretations of the regulations and the exemptions -investigators do not have the authority to make an independent determination that research involving human subjects in exempt
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