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CITI Online Training: - Effective June 1, 2006
all IRB applicants must complete the CITI Online Human Subjects Training course
before submitting their IRB applications. (see
IRB policy).
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Signature: - Check to make sure your application is complete and
signed by yourself and your advisor. Applications not signed will
be returned.
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Informed Consent(s): - MUST be on your college departments letterhead
upon submission. Applications will no
longer be accepted if informed consent and assent documents are not
on department letterhead.
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Informed Consent Checklist: - Submit informed consent which includes all 8 elements
of the informed consent. See sample informed consent and OHRP
checklist at
Informed Consent Procedures.
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Questions Addressed: - Check to make sure you have answered and addressed
question 9 - 15 in your own words.
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Vulnerable Populations: - Any research involving children requires full board,
no exception. May also include prisoners, pregnant women, people with
impaired decision making capabilities.
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EXEMPT REVIEW CLARIFICATION: - Exempt does NOT mean
exempt from
filing an application for review by the Institutional Review Board
of CSUSB. Exempt means exempt from 45CFR46 of
documentation of informed consent and continuing review. In
all applications, informed consent is a federal requirement to
inform and notify research subjects the nature and purpose of the research. Only the
designated IRB Chair can make the final determination as to your
applications Exempt review status. The IRB Chair may determine that your
application does not follow under the Exempt review criteria category and
therefore require may require Expedited or Full Board review. Should your
application not follow under the Exempt category you will be notified
through correspondence. Please ensure that your application
is indeed Exempt by reviewing your protocol with your advisor and going through the IRB
decision tree. (See decision tree
Do
I need IRB approval?)
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Permission Letters: - Before you conduct the
proposed research you must
include in your IRB appication permission from the organization, agency,
or entity permission to conduct the research at their facility - An
example would be a permission letter from the principle to
conduct the proposed research at a particular school or a permission
letter from a school
district official to conduct your proposed research in a particular school district.
If you are accessing student school records the permission letter should
include the language to use school and/or student records.
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Recruitment and Advertising Materials - Example if you
plan on using flyers/advertisements to establish a list of possible
research participants, you will need to include that
flyer/advertisement.
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Child Assent: - Written at a child's language level.
This informs the child, much like the informed consent, of what
research they will be asked to participate in. Should include 8
elements of the informed consent and the assent can be given in
writing or orally.
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DO NOT INCLUDE YOUR THESIS WITH APPLICATION: A ONE PAGE
ABSTRACT EXECUTIVE SUMMARY IS SUFFICIENT THE REST WOULD BE THROWN OUT.
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IMPORTANT NOTE : Please
note that once you are approved, your research is only good for one year
from the date of stamped IRB approval which is indicated on your
informed consent (for expedited and full board review only). Once that
date passes you may NO longer have any enrollment and you must cease all
data collection. You may continue you research if you submit the IRB
Renewal Form (listed below) to the IRB Secretary 60 days prior to your research ending.
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Application Copies: Submitting the application - We require
one original
and one copy submitted / Single sided copies only. Do not copy on both
sides of paper, do not staple, and please paper clip your application.
