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IRB New Protocol Submission |
For clinical survey design and IRB
submission, we have to go through the following steps:
- Find topic and search literature (see attached)
- Get idea for hypothesis and write the outline for background
and objectives
- Design clinical survey
- Generate survey questionnaire
- Process IRB submission
General Information for IRB Submission
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General
Information |
IRB
review is required for all research that involves human subjects IRB
(773) 702-3344 http://bsdirb.bsd.uchicago.edu/
New Protocol Submission
Guidelines (now online at IRBwise, see below) http://bsdirb.bsd.uchicago.edu/forms-guidelines/new-protocol.html What do I include with a
new protocol submission? http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/what-to-include.pdf
Frequently Asked
Questions |
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Submission
Process |
IRBwise/Online Protocol Submission: https://irbwise.bsd.uchicago.edu/ Types
of IRB Review include: 1)
Full IRB Review: research involving
vulnerable populations (ie: children), greater than minimal risk, involves invasive sample
collection 2)
Expedited Review: primary data collected
from adults, secondary data that includes identifiers 3)
Exempt Review: research uses secondary
data from public access databases that do not include identifying information Reason
for requesting an expedited or exempt review process will be selected from
several category options on IRBwise. Note
and describe any potential conflicts of interest on the part of the primary
investigator or any research personnel. List
the primary investigator and all research personnel on the submission. Clarify
all sources of funding that will be used to support the study. |
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Research
Protocol Narrative |
Background/Literature
Review:
What is already known about the topic? Why is the current research
important/relevant? Where would the
findings of the current research fit into existing literature? Purpose (including
hypothesis): Why has the current project been developed? What are the aims of the research? What do the investigators expect/hope to
find? Methodology/Protocol (include headings): 1)
Subjects: Who is being studied? (gender, age, population) How
many subjects? How will subjects be recruited to join the study? 2)
Data collection: What data will be collected? What tools will be
used to collect data (validated survey, procedures, etc)? Who will be
collecting the data? 3)
Consent: How will patients be consented (written vs. oral)? How will the assent of children be
obtained? 4)
Payment: How will patients be compensated for participation? 5)
Risks/Benefits: What are the risks/benefits? How do the risks
outweigh the benefits? How will patient safety be assured? 6)
Confidentiality: What are the risks to confidentiality? How will
confidentiality be protected during the course of the study? 7)
Recruitment: How will subjects be recruited? Statistical analysis: What measures are being
analyzed? What statistical techniques will be used? Bibliographic references Guidance: http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/detailed-protocol-narrative.pdf |
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HIPAA
and Consents |
Written consent form
template http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/UofCcftemplate.doc
IRB Form C – Research
involving children http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/FormC.doc HIPAA Compliance Elements http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/hipaacompliancelements.pdf
Required Elements for
Informed Consent http://bsdirb.bsd.uchicago.edu/forms-guidelines/documents/requirements-informed-consent.pdf Protected Health
Information ( Make
sure that the consent form includes a “lay summary” of the research protocol,
which includes non-technical language to describe the study. Make sure the language is appropriate for
the target audience. In 1-2
paragraphs, this section of the consent form should describe to the
participant the purpose of the study, who is included
in the study, and what is expected of him/her. |
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Online Protocol Submission |
Go to IRBWise https://irbwise.bsd.uchicago.edu/ |
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Full
IRB approval of any clinical research project after |