Section 1580.20  Definitions

"Certifications" means the official notification by the Authority to the appropriate funding agency that a research project or activity involving human subjects has been reviewed and approved by an IRB; and the official notification by the Authority to the funding agency that applicable laws and regulations regarding confidentiality and privacy of identifiable research information have been adhered to.

"Exempt research" means research that involves human subjects, but according to applicable laws and regulations, including but not limited to 28 CFR 46.101(b), does not require IRB review and approval.

"Human subject" means a living individual about whom a researcher obtains data through intervention or interaction with the individual or identifiable private information.

"IRB" means an institutional review board established in accordance with and for the purposes expressed in this Part.

"IRB approval" means the determination of the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other applicable laws and regulations.

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge.