Module 4 IRB Flashcards
IRB
The investigator should submit a summary of the trial status to the IRB at least ___
Once per year
According to ICH guidelines, how long must an IRB retain its records for each research project?
3 years
Per 21CFR56, the IRB will review all sections of the initial IRB study application. What must all investigators submit as part of their initial IRB application?
A description of the types of FDA-regulated products involved in the protocol(s) that the IRB is reviewing
T/F An IRB has the authority to suspend IRB-approved research if the research has not been conducted in accordance with the regulations or serious unexpected harm may be associated with the research
True
According to DHHS and FDA regulations, who can conduct expedited review
The IRB chair, other IRB members designated by the chair, or a sub-committee of the IRB
The purpose of an Institutional Review board is to ___
Protect the rights and welfare of human subjects of research
Studies that require IRB review under
FDA 21 CFR 56
(3)
Studies including:
IND
IDE
Food additives, dietary supplements, cosmetics
Studies that require IRB review under
HHS 45 CFR 46
(3)
Studies including:
children, prisoners, those lacking capacity
surveys, interviews, data collection of human research
Biomedical Research involving human subjects
The IRB must have at least ___ members
5
IRB qualifications (Must have’s 4)
varying backgrounds
have experience and expertise
diversity
sensitivity to community
The IRB shall be able to ascertain the acceptability of proposed research in terms of
1.
institutional _ & _
2.
applicable __
3.
and standards of professional _ & _
- commitments and regulations
- law
- conduct
IRB must include at least 1 member
- whose primary concerns are in a __ area and 1 whose primary concerns are in a __ area.
- not __ with the institution and not party of the __ family of a person with the institution.
- scientific and non-scientific
- affiliated and immediate
No IRB member may participate in the IRB’s initial or continuing review of any project in which the member has ___ interest
conflicting
An IRB may, at its discretion, invite individuals with __ in special areas assist in the review of issues. But these individuals may not __ with the IRB.
competence
vote
