How to Prepare an IRB Application

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How to Prepare an IRB Application
Timothy J. Williamson, MPH, CHES, CPH
for The Writing Center, Claremont Graduate University • 6/19/2013
Some images from Google Images; Some material adapted from http://www.cgu.edu/pages/1837.asp and
http://www.pitzer.edu/irb
Hello, nice to meet you!!!
§ A little bit about me…
§ Background in Psychology
§ Recently graduated with a Master of Public Health from
the School of Community & Global Health
§ Headed towards a PhD in Clinical Health Psychology next
year at UCLA
§ Emphasis will be on how to write an IRB
application rather than specific content
Why prepare an IRB application?
§  The IRB stands for the Institutional Review Board and is comprised of a
diverse panel of members
§  “If your research involves the use of human participants (either directly or
through records), your research requires human participant review.
Focused on a specific topic of interest, sometimes leading to a research
question”
§  Class projects vs. independent research
§  Not sure? Contact IRB office in Harper Hall
§  WWW.CGU.EDU/IRB
Step by Step on the Form:
Beginning Stages
§ Name of Study (concise)
§ Information about Principal Investigator
§ Vulnerable or special populations (minors, clinical,
prisoners, impaired, etc.)
§ Nature of Information
§  CONFIDENTIAL vs. ANONYMOUS
§ Project summary (200 characters)
§  Must be concise! (shorter than an abstract)
Research Summary
§ Brief description of the research (500 words or less)
specifically written for IRB review
§  Extract from proposal, but do not use verbatim
§ Role of human subjects (why are you incorporating human
participants?)
§ What will participants be told about the project? (is there any
deception used?)
§ Do not use scientific language
§ No jargon
Participants and Recruitment
The WHO
§ What is the population being studied? Who do you
expect to have in your study? (Be specific about
expected sample sizes)
§ What is the recruitment procedure? Will there be
any incentives or compensation offered? (ALL
recruitment materials must be prepared and
included upon submission)
§ Reasonable compensation vs. undue influence
Informed Consent
§ Attach your consent form (sample
consent form can be found at CGU
IRB website)
§ Outline benefits and risks (we’ll go
over these later in the
presentation)
§ Will temporary deception be used?
Justification MUST be provided.
§ Consent vs. Assent
Procedures and Methods
The WHAT and HOW
§  What materials will be used to collect data? (attach all
questionnaires, materials, forms, etc. if possible).
§  Interview scripts/protocol, media to be shown, pictures of
equipment, etc.
§  Re-visit confidentiality (vs. anonymity) especially when
recordings, photographs, or voice recordings are used
§  Debriefing form (particularly when temporary deception is
used)
Potential Risks and Benefits
The WHY (and how come?)
§  Risks to the participant
§  No risk vs. Minimal risk
§  What is minimal risk? What procedures are in place to minimize
adverse effects that may arise?
§  Benefits to the participant
§  Potential benefits to a group or institution (beyond)
§  Scientific benefits (justify risks)
§  Compensation is NOT a benefit
Tips of the Trade
§ Familiarize yourself with the
application
§ Use resources available at the Writing
Center and the IRB Office
§ NIH Human Subjects Training
§ Be clear and concise! Use linear logic.
Thank you! Questions?
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