THE
INSTITUTIONAL
REVIEW BOARD
WHAT IS AN IRB?
• An IRB is committee set up by an
institution to review, approve, and regulate
research conducted under its jurisdiction.
PURPOSE OF THE IRB
• To protect the rights of human subjects in research
• To ensure human subjects are informed of their rights
as participants and understand the consequences of
the research
• The IRB is not charged with evaluating or modifying
the science of a research project beyond protecting
the rights of human subjects
WHO ARE THE MEMBERS?
•
UMKC faculty and staff (scientists and non-scientists)
from various academic disciplines (10 schools or
departments represented) and Truman Medical
Center (legal and medical) employees.
•
Two individuals not affiliated with UMKC who
represents the concerns of the community and
vulnerable populations.
LEGAL STRUCTURE
• IRBs are governed by - OHRP (Code of Federal Regulations
Title 45, Part 46) and FDA (21 CFR 50 & 56)
• This covers all institutions receiving funding from or
operating on behalf of the Federal government
• In practice, all research involving human subjects is
reviewed by the IRB, whether it is federally funded or not
TYPES OF IRB REVIEW
Full
Board
• More than minimal risk
Expedited
• No more than minimal risk
• Fits one of the 9 categories
Exempt
Not Human
Subjects Research
• Less than minimal risk
• Fits one of 6 categories
• Does not meet the federal definition
of “Research” and/or “human
subject”
CRITERIA FOR IRB
APPROVAL
1) Risks to subjects are minimized
2) Risks to subjects are reasonable in relation to anticipated benefits
3) Selection of subjects is equitable
4) Informed consent will be sought from each prospective subject or the
subject's legally authorized representative
5) Informed consent will be appropriately documented
6) Data collection is monitored to ensure subject safety
7) Privacy and confidentiality is protected
8) Additional safeguards are included for the protection of vulnerable
subjects
IRB SUBMISSIONS
2014 (Initial applications only )
• Not Human Subjects Research
– 34
• Exempt
– 102
• Expedited Review
– 55
• Full Board
– 10
IRB Review Process (Cycles)
Principal Investigator
Other Committee Review
Application
submitted via
eProtocol
Application returned to PI for
additional
information/revisions
PI makes changes requested by
IRB or “Other Committees”
Once “complete” the application is:
IRB Staff
Determination made by IRB staff (NHSR &
IRB staff screens application for
completeness
Administrative screening
Application Analysis
Exempt applications)
Scheduled for full board meeting
Sent to IRB members for review
Full Board IRB Meeting
Approved
Approved with conditions
Tabled
IRB
Or
Expedited Review
Approved
Recommended for Full Board
PI notified
IRB REVIEW CYCLES
• Snapshot of 43 current submissions
Cycle
1
Cycle
2
Cycle
3
Cycle
4
NHSR
4
1
1
Exempt
5
5
1
1
Expedited
Review
9
7
1
1
Full Board
1
Cycle
5
Cycle
6
1
Cycle
7
Cycle
8
1
COMMON ISSUES TO DELAY
IRB REVIEW
• Informed Consent
– Waiver of consent vs waiver of documentation
– Multiple types of consent
• Privacy vs Confidentiality
• Incomplete responses to IRB comments and questions
UPDATES TO THE IRB
WEBSITE
• http://ors.umkc.edu/research-compliance-(iacuc-ibc-irbrsc)/institutional-review-board-(irb)
– IRB Metrics
– Informed Consent
– Exempt Determinations
– Collaborations with other institutions
– Vulnerable populations
– Privacy and Confidentiality