Institutional Review Board (IRB)
● ensures the protection of human subjects’ rights on the government & the entity
● reviews and approves/disapproves/requires modification of protocol
● ensures researcher compliance with regulations and follows through on the federal wide assurance
● Typically at the site of the research study but not always
How many voting members of IRB board
atleast 5 & The IRB chair may not vote
Requirements for IRB board composition
Diversity
o At least one scientist
o At least one non-scientist
o Most include one physician
o At least one community member who (or his/her immediate family) has no employment or contractual relationships with the entity
If regularly going to be reviewing vulnerable populations, IRB needs
At least one member who has knowledge and experience on at least one or more vulnerable categories if regularly reviewed
When is IRB Approval Required
At the bare minimum, IRB approval is required from an entity when seeking funds or contracts from an agency that has accepted the common rule.
If research involves human subjects should be reviewed by IRB (ensured by Federal Wide Assurance)
Federal Wide Assurance is renewed every five years or when information changes.
definition of research
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o A systematic investigation (including research development, testing and evaluation), designed to develop or contribute to generalizable knowledge
Does it meet the definition of human subject
A living individual about whom an investigator about whom an investigator either:
o Obtains information or data through intervention or interaction with the individual or
o Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Exemptions
- normal practices in educational setting
2.educational tests, surveys, interviews or observations of public behavior - benign behavioral interventions in adults
- pubicly available or deidentified data
- public service/demonstration
- food
- storage/maintenance for secondary use
- secondary research
