Human Research Protections
Welcome New IRB Member!
This brief presentation covers:
Your Role in the IRB: What to Know
 The IRB Review Process
 Resources
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Your Role in the IRB
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Welcome to the UCI Institutional Review Board (IRB)!
The IRB is a committee of physicians, scientists, advocates and members of the community
who come together to review research protocols.
The IRB has the oversight responsibility for protecting the rights and welfare of research
participants.
The IRB Committees are required to have a minimum of five members each (on average
12-20 members), with varying backgrounds and expertise to provide complete and thorough
review of research activities commonly conducted by the Institution.
Each IRB Committee must include at least one member whose primary interests are in a
scientific area, one member whose primary interests are in a non-scientific area and one
member who is not affiliated with UCI (i.e. not a family member or spouse of an employee,
not an active alumnus).
At least one non-affiliated member and one non-scientist are present at convened meetings.
Your Role in the IRB
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The IRB is responsible for ensuring that any research study conducted at the
institution is appropriate and will not place participants at any undue risk of harm.
The IRB also reviews the procedures to be followed during the conduct of
research to make sure that research participants are treated with dignity and
respect.
Your expertise on the IRB is invaluable & will positively contribute to the review
process!
Your Role in the IRB
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The IRB has the authority to approve a protocol (aka “A”), require specific
changes (aka “M” for minor changes – also known as approved with conditions),
table a protocol (aka “T”) when significant issues are noted or even disapprove a
protocol.
Your Role in the IRB: What to Know
The IRB considers 2 sets of regulations:
1.
Department of Health and Services (DHHS), Office of Human Research
Protections (OHRP), Code of Federal Regulations (CFR) Title 45, Parts 46
2.
Food and Drug Administration (FDA), CFR Title 21, parts 50, 54 and 56, 312
(drugs) & 812 (devices)
Your Role in the IRB: What to Know
Your Role in the IRB: What to Know
Required Elements of Consent*
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A statement that the study involves research
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An explanation of the procedures of the research
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A description of the procedures to be followed & duration
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A description of any reasonably foreseeable risks or discomforts to the subject.
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A description of any benefits to the subject or to others which may reasonably be expected from
the research.
A disclosure of appropriate alternative procedures or courses of treatment, if any
A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained
An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights
A statement that participation is voluntary
*Additional elements may apply
The Full Committee IRB Review Process
Approx. 3 weeks before an IRB meeting the preparation begins
At the IRB meeting: Determinations
IRB Meeting Deadline
Electronic
Submission of
IRB applications
(Apps, CPAs &
MODs)
IRB Analyst imports
applications
IRB Analyst sends out
request for IRB Member
attendance to secure
quorum (1/2 of total
Members + 1)
Agenda Clearance & Pre-Review
Ancillary
Committees: IRB
Administrator
emails Committees
for confirmation of
clearance
See Chart for
Committees and
impact on IRB
review
IRB Full
Committee
Meeting
IRB Administrator determines
what has cleared the
agenda, sets agenda.
“M”
All designated IRB staff
review applications, prepare
checklists, send pre-review
comments to the Lead
Researcher (LR).
Minor
Changes
~ 4 days
The LR responds with revised
documents. All checklists
and final versions of all study
documents uploaded into
agenda for IRB review.
Upon receipt of all LR
responses, the IRB
Analyst finalizes
electronic agenda,
sends e-link to IRB
1 week before IRB meeting
Members.
“T”
Tabled
IRB Staff send
memos on behalf of
the IRB
“A”
Approved
as is
LR responds to
the IRB memo
IRB Chair or Designee
Reviews Response
“M”
Minor
Changes
Approved
IRB Staff finalize
approval documents,
send approval to LR &
designated study team
The IRB Review Process
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If you are assigned as a Primary or Secondary Reviewer, you will need to complete the
Reviewer’s Checklist. This document is uploaded in the e-agenda, along with all pertinent
review materials, such as the Protocol Narrative, Consent Form, Master Protocol and
Investigator’s Brochure.
The Checklist addresses elements of IRB approval and elements of consent.
Specific questions and concerns from Human Research Protection (HRP) Staff will be
included for your response / comments.
Some special determinations will need to be made – may involve Supplemental Checklists.
This will be noted on the Checklist and the agenda.
Make sure all sections are complete; sign the checklist & hand to HRP Staff after the
meeting.
Any questions prior to the meeting? Please contact HRP Staff (the IRB Administrator, Senior
IRB Analyst or IRB Analyst).
The IRB Review Process: Tools
At the Meeting:
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Agenda
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IRB Chair
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IRB Members
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Laminated Sheets Help with Voting / Determinations
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HRP Staff! (at the meeting – or anytime…that’s what we are here for!)
Other Resources:
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Purple Books- Tab Pertinent Sections & Bring Book to Meeting
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ORA Website- page for IRB Members
The IRB Review Process: Tools