Cooperative Research Flashcards
(6 cards)
1
Q
What is Cooperative Research?
A
research involving more than one institution
2
Q
When did the NIH begin requiring sIRB?
A
2020
3
Q
When is sIRB not required?
A
When:
- The research isn’t federally funded, or
- The funding agency grants an exception (e.g., for tribal sovereignty or impracticality)
4
Q
What does a reliance agreement do?
A
It documents agreement between institutions to designate one IRB to serve as the IRB of record.
5
Q
What must a reliance agreement outline?
A
Roles and responsibilities of each institution
How local context (e.g., local laws, population characteristics) will be considered
How communication and reporting will flow (e.g., reporting noncompliance or adverse events)
6
Q
Does use of an sIRB eliminate the need to consider local context?
A
No — the sIRB must still evaluate local context, with input from the relying institutions.
