What research is eligible for exemption?Research that involves greater than minimal risk: Research eligible for exemption usually involves negligible risks to subjects. When reviewing an application for exempt status, OPHS staff apply the “minimal risk” standard.
What qualifies as human subjects research?Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable is considered “research involving human subjects.”
What is exemption research?Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
What is not considered human subjects research?Not Human Subjects Research Description
Under some circumstances, research involving only unidentifiable/de-identified or coded private information or biological specimens is not human subjects research because investigators cannot readily ascertain the identities of the individuals to whom the data or samples belong.
|