Transcript Slide 1

Tips for Completing an
NSU IRB Protocol
The IRB office has created this guide to
facilitate completion of an NSU IRB Protocol
Rev. 04/12/2007
Make sure your
title here
matches the title
of the study on
all your other
Include complete
contact information
for principal and
If your research
team also has
assistants please
attach a list of
these individuals
with the protocol.
The IRB asks that you provide references to the literature to support your study
and/or the proposed experiment; however, this should not be a literature review.
This section should be succinct, clear, and in appropriate language for an
“intelligent lay person.” If you use professional terminology, please explain it.
The location of the study must
match information provided on
your other forms. If there is a
site, the site information has to
be specific and include physical
addresses where the
investigators or site can be
immediately contacted if a
subject has a question or there
is an emergency.
Your start and end dates of the study must be in agreement with the
submission form.
This is one of the most important sections in the research protocol.
In this section, be sure to provide
specifics! This is especially true if
you propose to work with vulnerable
populations. If the subjects have a
particular diagnosis this should be
included and if the site (e.g., a school
system) has a particular
classification system if you use that
terminology it should be explained.
In this section, be sure to
provide specific/detailed
information about
selection of subjects.
Why is someone eligible
for your study? How are
you going to ask
someone to be in the
Here be sure to provide detail as to how the informed consent procedures will occur.
Who will lead the informed consent process? How much time will subjects be given to
consider their participation? Remember, informed consent is an ongoing process that
begins at recruitment and goes throughout the time of the study—it isn’t just a form.
Details you should include:
•Describe all procedures
•Time Commitments (specifics)
•If audio/video recording, how will tapes be secured
•How you will collect data, if there will be identifiers on the data
•How data will be maintained and when data are to be destroyed
•How you will manage adverse reaction/unanticipated problems
•Compensation for injury discussed if applicable
If your study
involves groups of
people, be sure to
discuss how these
will be established
and confidentiality
safeguards. Also
include a detailed
account of what
the groups will be
doing (focus
group, interviews,
All tests
surveys, etc.) are
described. Include
one copy of
included when
Risks are noted as
minimal risk or
greater than minimal
Each risk is listed separately, with the likelihood described as minimal,
moderate, or high. The magnitude/duration and the steps proposed for
minimization are discussed.
This section
does not
benefits to
If no direct
benefits this
is stated.
is not
included in
this section.
The Risk/Benefit ratio should reflect a detailed discussion of
the possible risks and benefits (to science and/or to
subjects) presented by the study.
This section notes whether or not consent forms/assent forms are going to be used.
This section discusses the use or lack of use of protected health
information (PHI). For more information about PHI, researchers
should review the Health Insurance Portability and Accountability Act
(HIPAA) within the IRB manual found at Exact PHI gathered is
noted. If the data are to be de-identified, the specific procedures for
de-identification are noted.
If the study does not involve PHI please mark this section “Not
A completed Credentials/Qualifications of Researcher(s) is provided for the
principal investigator and all co-investigators.
If you have human subjects in your study,
now proceed to creating your
Consent and/or Assent Forms
using the templates and model forms
as guides:
Still need help?
Ready to submit your forms?
Contact your IRB center representative: