Transcript Slide 1

Tips for Completing the New
Protocol Submission Form
The IRB office has created this guide to
facilitate completion of the New Protocol
Submission Form
(http://www.nova.edu/irb/manual/forms.html)
Rev. 04/11/2007
The top portion of the new
protocol submission form is
to be completed by your
college/center representative.
This person must sign-off on
your protocol (and actually
sign this form—do not wordprocess or fill in the name for
them).
For those protocols needing expedited or full review your center representative
completes this portion before your protocol is forwarded to the IRB office for
review. Remember, if your protocol needs full review, 23 copies of the
submission form (plus the research protocol, consent forms, consent form
checklist, and other supporting documents) must be sent to the IRB office.
Please be sure to put your NSU email address.
The proposed start date must
allow for IRB review. The IRB
recommends putting “Upon IRB
Approval” unless you have a
definite start date, such as the
beginning of a school term.
Please remember that while you
may state that the research will
last longer than one year, IRB
approval cannot exceed one year
(and may even be shorter
depending on the nature of the
study). Regardless of how long
the IRB gives you for conducting
your research, you must submit
for continuing review prior to the
continuing review date
(expiration date of IRB approval).
Duration of the study must
include the time for data analysis,
as this is considered research
with human subjects.
You must provide the
complete contact information
for all co-investigators in your
study. If you’re a student,
typically your
dissertation/thesis adviser is
Co-I 1.
If you have
research
assistants, these
need to be provided
to the IRB on an
attached list.
These folks also
need CITI training.
Remember, everyone you list here must be CITI trained.
For more information about CITI training please visit the
http://www.nova.edu/irb/training.html.
All funding information
must be provided.
You must provide the IRB with information
related to any significant financial interest any
of the researchers on the team may have.
Please visit the link on the form that directs
you to the NSU policy related to significant
financial interest in funded research.
If the research is being
conducted at another site
(non-NSU facility), the IRB
of that organization must
approve your research prior
to submitting to the NSUIRB. If there is no IRB, then
the applicable governing
body/authorizing individual
must approve your
research. This may be a
research committee, a
superintendent of schools,
the owner of a private
practice, etc.
You must provide
a breakdown by
age/population
type of all human
subjects involved
in your research.
Written assent is
required for
children ages 712, verbal assent
for the younger
children.
If your research requires the translation of consent forms, please do not submit
translated consent forms with your initial submission. The IRB will notify you
when the English versions of your forms are acceptable and at that time will ask
you to provide translated documents. For studies requiring full review and
studies reviewed at the expedited level where the IRB is unable to secure an
individual who can read the translated documents, please provide translations
done by a certified translator.
The total number of
subjects must match the
breakdown provided in
Section IV(A) of the form
and all the information in
this section must agree
with what you state in
the protocol.
The time commitment for
each subject is the
cumulated time needed
to complete all the
subject tasks.
The total compensation
provided to each subject
for completing all tasks
must be disclosed.
Please answer the questions
related to protected health
information (PHI). For more
information on HIPAA and what
constitutes PHI, see
http://www.hhs.gov/ocr/hipaa/
The checklist here is intended to assist you in the completion of your IRB packet.
Please review the assurance and
obligations section carefully.
A few items to note:
1. Please note that you must submit a
final/closing report to the IRB 30 days
from when research has ended (when
data analysis has concluded).
2. Research records, including signed
consent forms, must be retained for a
minimum of 3 years (36 months) from
the conclusion of the study.
If you are a student, your
dissertation/thesis adviser must
sign on the last line. If you do
not have an adviser your
department chair must sign
Now proceed to your
Research Protocol
using the template:
http://www.nova.edu/irb/manual/forms.html
Still need help?
Ready to submit your forms?
Contact your IRB center representative:
(http://www.nova.edu/irb/membership.html)