Submitting IRB Applications
(or “Do I have to do an IRB?”)
Linda A. Detman, Ph.D.
Research Associate
Lawton & Rhea Chiles Center for Healthy Mothers and Babies
Florida Perinatal Quality Collaborative
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Have you completed training in the protection of
human subjects?
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Have you completed training on HIPAA?
Health Insurance Portability and Accountability Act of 1996
Access training module at https://learn.health.usf.edu
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Have you ever submitted an IRB application?
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Agenda
• Overview of research and when you need IRB
review
• Types of IRB reviews
• Tips for submitting your IRB application
• Resources
• Questions
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What is Research?
Per Federal regulations research is defined as
the systematic investigation, including research
development, testing, and evaluation, designed
to develop or contribute to generalizable
knowledge
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What is Systematic Investigation?
An activity that involves a:
• Prospective research plan which incorporates
• Data collection and
• Data analysis to answer a research question
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What is Generalizable Knowledge?
• Definition for IRB purposes: Contributing to
generalizable knowledge means:
– (1) conclusions are drawn from particular
instances, and
– (2) the information from the investigation is to be
disseminated.
• To be considered research, the generalizable
knowledge must be drawn from the results of
a systematic investigation of human subjects.
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What is a Human Subject?
Per Federal regulations (45CFR46.102(f)), a
human subject is defined as:
– A living individual about whom an investigator
(whether professional or student) conducting
research obtains:
• Data through intervention or interaction with the
individual, or
• Identifiable private information
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So when do I need to submit an IRB?
• You are conducting research (systematic
investigation to develop or contribute to
generalizable knowledge), and
• You are interacting with human subjects to
collect data or obtain identifiable private
information about living individuals
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Types of IRB Reviews
• Exempt
– Does not mean no IRB review required
• Expedited
– Does not mean fast
• Full Board
– Reviewed by fully convened Board
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Exempt Studies
• Must be minimal to virtually no risk
• Cannot involve pregnant women, human
fetuses, or prisoners
– Anonymous surveys
– Existing data (documents, records, pathological or
diagnostic specimens) recorded in de-identified
fashion
– Research comparing standard practice methods in
an educational setting (commonly used in
elementary, secondary, or post-secondary schools)
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Expedited Studies
Must be minimal risk—no greater risk than what is
experienced in everyday life
• Surveys with identifiable information
• Analysis of data collected (or to be collected) for nonresearch purposes
• Research involving noninvasive clinical procedures
• Video or audio recordings
• Focus groups
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Full Board Studies
Greater than minimal risk; involves sensitive
information or is invasive
• Pharmaceutical and medical treatment studies
• Studies involving prisoners or data on prisoners or other
vulnerable populations (children, pregnant women)
• Information that could place participants at risk of civil or
criminal liability or cause harms (stigma, ostracism,
excommunication, etc.)
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Not Human Subject Research
• Research using data or specimens from
decedents
• De-identified secondary data analysis
• Non-private information such as available or
disclosed in a public forum or that is directory
information
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Questions or Comments?
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IRB Application Tips
• Write your protocol first
– Everything in it can be cut and pasted into your
application
– No such thing as TMI
• Provide consistent information in all
submitted documents
• Upload documents in the proper places
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Informed Consent
• Use the USF informed consent templates
• Consider waiver of documentation of
informed consent
• Provide adequate description of how you will
carry out informed consent process
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Final Tips
• If you are collaborating with external agencies or
organization:
– Draft a letter of support for them
– Additional approvals may be necessary (e.g., public
school systems, DOH, other universities)
• All study data must be retained for 5 years
• Last item in eIRB application: Describe your plan
for ensuring the integrity of the data you collect,
including how often you plan to monitor the data
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The eIRB System
• Smart form system—as you answer questions, the
forms will customize to assure only applicable
questions appear
• Answering all questions ensures a smoother review-questions marked * are required
• Click ‘continue’ to move through the application
• Remember to formally submit to the IRB by clicking
‘Submit Study’ under ‘My Activities’ on the left side of
the system workspace
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Principal Investigator
• Ultimately shoulders the responsibility for the
conduct of the study, including the actions or
inactions of the study team, support staff, etc.
• Is responsible for conducting research in the
same ethical manner and with the same
respect for the privacy and confidentiality of
research subjects, no matter what type of IRB
review
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Remember…
• The review of your IRB application requires
careful collaboration with multiple parties—
build in time when planning your study
• Not all studies are approved on first
submission—allow at least 30-45 days to
ensure adequate time for review
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Training is Available!
• USF Student Researcher Workshop
– Tuesday, September 1, 6:30 – 9 p.m.
• eIRB System Training
– Friday, October 9, 9 – 10 a.m.
– Email TRAIN@usf.edu to sign-up (include course
name in email)
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Resources
• Division of Research Integrity and Compliance
http://www.research.usf.edu/dric/ -- click on ARC
Portal
• Applications for Research Compliance (ARC)
system
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Tip sheets
Informed consent templates
Guidelines and procedure manual
Training videos
Sandbox
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Questions?
Linda A. Detman
LRC 116
ldetman@health.usf.edu
813-974-5865
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