TIPS FOR COMPLETING THE
NEW PROTOCOL SUBMISSION
The Nova Southeastern University Institutional Review Office has
created this guide to facilitate completion of the New Protocol
Form
(http://www.nova.edu/irb/manual/forms.html)
Version August 8st, 2013
New Protocol Submission
• This form (adopted March, 2009 and most recently
revised in August, 2013) replaces the previous New
Protocol Submission Form and the Research Protocol
• Usage of this form is effective immediately
Form Instructions
Please take a moment to review
the instructions.
Helpful Information:
•Please directly answer the
questions that are asked; do not
copy and paste from your
thesis/dissertation proposal or
grant proposal as that may not
directly answer the question.
•If your study is funded by an
external agency, please include a
copy of funded proposal with your New: You will
submission.
note that for Full
Review, 2 copies
plus 1 original
are needed.
You are to complete all BLUE
sections of the form. If something is
not applicable to your study, mark the
section “N/A.”
PROTOCOL GENERAL
INFORMATION
Part 1
Protocol Information
Please be sure to
insert the Principle
Investigator’s last
name and the date of
submission in the
footer area.
In all versions of Word you do this by double-clicking on the footer. This will
open the Header/Footer edit tool which will allow you to provide the information.
Protocol Information
Please provide the complete title of your study.
In the this section, briefly describe the study. Provide a general
overview so that the person reviewing the submission
understands the “big picture”. We will not reject your submission
just because it contains 251 words, but please try to honor the
word limit – keep this an overview. You will be asked for specifics
in later sections of this form.
Research Team Information
Include your complete contact and demographic information.
CITI Training
is valid for
three years.
No resumes or curriculum vitae! Please provide the information requested as a narrative. The purpose is
allow the IRB to determine if you are qualified to carry out the research. Students should include
research courses completed.
Research Team Information
Include the complete contact
information for your co-investigators.
NOTE: If you are a student, CoInvestigator 1 should be your faculty
adviser/dissertation chair.
All Co-Is affiliated with NSU
must have current CITI
certification under one of the
NSU CITI Learner Groups.
For non-NSU affiliated
researchers, please provide a
hardcopy of their CITI certificate
Research Team Information
If the study team includes Research Assistants (RA’s), please list
those here. If there are more than three, please copy the box and
paste another copy in the form.
CITI Training
All individuals affiliated with NSU who are a part of the research team must have
current CITI training. For Co-Is not affiliated with NSU, their home institutions’
human subjects training information should be provided. Your center representative
may ask for a copy of your training certificate(s). As PI you must confirm that any coinvestigators or assistants have completed their training and you should have a copy
of their completion certificates in your research records. For more information on
CITI visit the NSU IRB Web site at http://www.nova.edu/irb/training.html
Funding Information
Indicate whether or not the proposed study is funded.
If the study is funded, or
you are applying for
funding, please complete
this information.
Conflict of Interest
Conflicts of interest, both perceived and actual, are of concern to
the NSU IRB. Please take a moment to review NSU policy. Please
initial that you have reviewed the NSU policy and answer the
question accordingly.
Dates and Phases of Study
Indicate the proposed start date.
While the study may be multi-year, IRB
approval may only be granted for a
maximum of 364 days (or less, as
determined by the IRB).
Dates and Phases of Study
If a study has multiple parts, that function as one research project, then
the IRB may need to review all the parts at one time. If this is a stand
alone study, that if successful may lead to future research, then that is
not “multi-part”. A multipart study might interview people, have focus
groups on the same topic, and then develop and implement a
treatment plan based on that information. We would not wish to review
the survey alone in that case.
Multiple Site Information
Specify
the NSU
location.
Please provide information as to whether the study will be
conducted at a non-NSU locations. The IRB will check for
administrative approval or IRB review by another IRB if the study
takes place at another institution.
Cooperative Research
Complete the cooperative
research information
This section is particularly important if you are a student at NSU but employed
at another organization/institution, especially one with a Federal Wide
Assurance (FWA) as it may mean your research activity will cause that other
organization to be engaged in research.
SUBJECT/PARTICIPANT
INFORMATION
Part 2
Subject/Participant Information
Provide the IRB with a breakdown of the proposed subjects/participants of the study. The IRB
recognizes that there may be variation in the number of subjects in a particular subgroup (i.e., 10-15
children ages 2-6, 10-15 children ages 7-12, etc.). You may elect to either use ranges to indicate
number of subjects or a indicate the maximum number you plan to enroll in a particular category.
Subject Vulnerability
Special consideration is
needed if your subjects are
particularly vulnerable; in this
section we ask the researcher
to think carefully about the
issue of vulnerability.
Vulnerability is not limited to
just the federally recognized
vulnerable groups, but also
includes groups that are
vulnerable because of their
status or relationship to an
investigator -- they may be
vulnerable to coercion.
Please review our policies and
guidelines.
Study Design and Methodology
In this section you are
asked to detail the design
and methodology of your
study. In doing so, you
should provide a detailed
account of the steps
involved in your research
after subjects have
consented to participate.
Provide a detailed
accounting of the time
commitment for the
participants for each study
related activity.
Study Design and Methodology
In this part, provide a detailed list
of all your data collection
instruments. Remember, that
except for instruments that have
restricted access (e.g. SAT, FCAT),
you will need to provide a copy of
each instrument. Surveys and
interview question lists must be
provided with the submission.
Study Design and Methodology
•
In this part, please note that “deidentified” means that the data cannot
be linked back to the participant in any
way.
•
If using a “coding list”, this makes the
data identifiable. Check off “No” to this
question.
•
If you will be removing all identifiers or
collect anonymous data and your
subjects cannot be linked back by any
means, then, check off “Yes” to this
question and describe the deidentification process.
•
For anonymous surveys, do not solicit
potential identifiers in the survey and
Potential Identifiers:
• Name
• Date of birth
• Mailing/Email address
• Phone/Fax #
• Social Security #
• Medical Records
• License, vehicle ID
• IP address
• Biometrics ID
• Photo/image/audio recording
• Signature, handwriting sample
• Any other type of identifier not
mentioned above.
ADDITIONAL STUDY
INFORMATION
Part 3
Clinical Testing
Studies that will use
FDA-regulated
products or will yield
data that is intended
for submission to the
FDA require certain
procedures.
Studies using procedures or devices not routinely used in clinical
care require special attention and may affect level of review.
Sensitive Information
If you are asking about sensitive information, please be sure to provide a detailed account. In
completing this section, PIs should be particularly sensitive to the fact that individuals may view
information differently. While the PI may not consider certain data as sensitive, a participant or
subject may disagree.
Please discuss the type of
recording that will be used.
Additionally, mention how you
plan
to:
safeguard
the
recording(s), how and when the
recordings and transcript(s) will
be stored, and the location of
both the recording and the
transcript (if applicable). Please
also discuss how and when the
recordings and transcripts will be
destroyed.
Non-English Speaking Participants
It is important that
subjects/participants
be presented a
consent form written
in a language that
they readily
understand.
If your study involves translated consent materials, please note the following:
•Translation of forms into languages other than Spanish may necessitate the use
of a certified translator to conduct the translation. PIs are advised to contact
their center representative or the IRB Administrator to discuss this issue.
•Do not translate your forms until the IRB has notified you to do so. We don’t
want you to have to retranslate the forms if the IRB requires revision.
Subject Compensation
This section asks you to outline
any compensation that subjects
will be getting for their
participation. In discussing the
compensation, any prorating or
tiered payment should be
discussed. If payment will be by
check, and you will need to
notify other departments (such
as accounts payable) then this
disclosure process must be
included in the consent form.
Inclusion/Exclusion Criteria
This section should contain a detailed list of exclusion and inclusion
criteria for all potential subjects of your study. In addition, the
section should also reflect how you will determine that a subject
meets the stated criteria.
Subject Recruitment
The IRB should be able to determine exactly how you will recruit all of your
subjects. If your study involves multiple populations that will be recruited using
different procedures, be sure to discuss the procedures for each group in detail.
The IRB should be provided a copy of all fliers, online narrative posts, website
blog entries, and email(s) that will be sent to recruit participants.
Potential for Coercion in Subject Recruitment
This section requires
that you consider and
respond to the
potential for coercion
of subjects. In
completing this
section, consider your
relationship to the
potential subjects.
Informed Consent – Part 1
Describe in detail the process of informed consent. Recall that informed consent is a dialog between you and
prospective subjects that begins at the time of recruitment and ends when the work with participants has
ended. It is not simply handing a subject a consent form to read. If different groups of subjects will have
different processes please describe the process for each group. This section should include who will conduct
the consent process, where, when, and the opportunity participants will have to ask questions and consider
their involvement in the research.
Discuss the study procedures, risks and benefits, confidentiality, the right to withdraw or refuse to
participate. Mention that participants will be allowed to ask questions prior to enrolling in the study. Also,
mention that participants will be provided with an signed copy of the consent form for their records.
Informed Consent – Part 2
There are times when consent forms are not used; this section discusses these
circumstances and provides you with an opportunity to explain why such a
waiver/alteration is applicable to your research. Please note that in order for the IRB
to grant waiver/alteration of the consent process or of the signed document of
informed consent, it must meet certain requirements that are outlined on the IRB’s
Informed Consent Policy
(http://www.nova.edu/irb/manual/forms/informed_consent.pdf) and researchers
are advised to address these items as they describe their rationale.
Informed Consent – Part 3
In this section,
provide
information
about the
actual consent
and assent
documents.
Protected Health Information
Protected Health Information
(PHI) as defined by HIPAA also
affects the conduct of
research. In this section, you
are asked to provide
information related to PHI use
in your study.
NOTE: The NSU IRB now
requires a separate HIPAA
authorization for use and
disclosure of PHI for
research at the NSU Clinics.
For outside institutions, the
PI must verify the
procedures with the
applicable HIPAA officer.
Protected Health Information
The NSU IRB now requires
a separate HIPAA
authorization for use and
disclosure of PHI for
research at the NSU Clinics.
For outside institutions, the
PI must verify the
procedures with the
applicable HIPAA officer.
Student/Academic Information Use
Please provide information as to any student/academic information that you plan to obtain
as a part of the research study.
Risks, Discomforts, & Inconveniences
Discuss the potential risks,
discomforts, and inconveniences one
can reasonably expect are associated
with your study. Carefully
considering risks in advance helps to
avoid the situation where the PI
experiences, and must report,
unanticipated events. One of the
primary roles of the IRB is to assess
the potential risks to the potential
benefits. It can only do so if you
provide a detailed account of the
potential risks.
Benefits to Subjects
As with the risks, the potential benefits one might reasonably expect subjects to receive are
an important element of a comprehensive IRB review. PIs are encouraged to be judicious in
assessing the potential benefits to subjects associated with their research.
Data Analysis Plan
Discuss your tentative plans for data analysis. The IRB recognizes that
actual data analysis may differ as a result of later research activities and the
characteristics of the data. This section may help the reviewer in
determining the scientific benefit of your study. You do not need to submit a
study amendment if the only change is to your data analysis procedures.
Scientific Benefit
In this section, the IRB requests that you describe the scientific benefits that may
result from the research. Recall that one of the responsibilities of the IRB is that it
contrast the risks presented by the study to the potential benefits. Since some studies
do not present benefit to subjects, the only other type of benefit may be scientific.
Therefore, as a PI, you should consider the scientific benefit of the proposed study. As
a part of that process, you should examine the proposed methodology to maximize
the potential benefit of your research.
Risk/Benefit Ratio
In this section, the IRB asks you, as the PI, to consider the ratio between the
potential risks of your study and the potential benefits. In this section you may
include both benefits to subjects, if any, as well as benefits to science. The IRB
may or may not agree with your assessment, but the information you provide
here may further enhance the IRB’s understanding of your study. If there are
only minimal risks, and there are no subject benefit, but scientific benefit, you
can simply state that.
Safety Monitoring Plans
The monitoring of safety of human
subjects is important in research. In many
cases, studies that involve significant risk
have detailed plans associated with data
safety monitoring. Use this section to
provide the IRB with information related
to any safety monitoring plans.
Other Information
We hope that this form has provided you
with the opportunity to completely describe
your proposed research. There may be
information that was not appropriate for one
of the prior sections that you believe is
important for the IRB to have as it considers
your research. Use this section for that
purpose.
Principal Investigator Assurance and
Obligations
In this section,
you are
attesting to
the IRB a
number of
items. Read
each carefully.
Please note
that any
revision to this
document
requires resignature by PI
and Co-I (when
applicable).
Co-Investigator Assurance and
Obligations (for Student PIs)
If the PI is a student, the advisor attests to his/her review of the completed IRB submission
and verifies that the information presented is accurate across all documents and that the
submission is a valid reflection of the proposed research approved by the students
thesis/dissertation committee.
CONTACT YOUR CENTER/COLLEGE REPRESENTATIVE:
HTTP://WWW.NOVA.EDU/IRB/MEMBERSHIP.HTML
WE LOOK FORWARD TO REVIEWING YOUR SUBMISSION!
NOVA SOUTHEASTERN UNIVERSITY INSTITUTIONAL REVIEW
BOARD (IRB) STAFF:
MS. JENNIFER DILLON, IRB DIRECTOR (X25311)
MS. INGA HESS, IRB SUPPORT STAFF (X25369)
MR. RANDY DENIS, IRB SPECIALIST (X25368)
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Tips for Completing the New Protocol Form