Tips for Completing the New Protocol Submission

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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
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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

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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 submission.

You are to complete all BLUE sections of the
form. If something is not applicable to your
study, mark the section N/A.
New You will note that for Full Review, 2 copies
plus 1 original are needed.
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Protocol General Information

• Part 1

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Protocol Information
Please be sure to insert the Principle
Investigators 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.
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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.
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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.
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Research Team Information
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
Include the complete contact information for your
co-investigators. NOTE If you are a student,
Co-Investigator 1 should be your faculty
adviser/dissertation chair.
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Research Team Information
If the study team includes Research Assistants
(RAs), please list those here. If there are
more than three, please copy the box and paste
another copy in the form.
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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 co-investigators 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
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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.
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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.
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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).
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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.
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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.
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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.
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Subject/Participant Information

• Part 2

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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.
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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.
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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.
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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.
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Study Design and Methodology

• In this part, please note that de-identified
  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
  de-identification process.
• For anonymous surveys, do not solicit potential
  identifiers in the survey and turn-off IP
  address recording.

• 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.

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Additional Study Information

• Part 3

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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.
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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.
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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 dont want you to have
  to retranslate the forms if the IRB requires
  revision.

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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.
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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.
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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.
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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.
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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.
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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 IRBs Informed Consent Policy
(http//www.nova.edu/irb/manual/forms/informed_con
sent.pdf) and researchers are advised to address
these items as they describe their rationale.
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Informed Consent Part 3
In this section, provide information about the
actual consent and assent documents.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 IRBs understanding of
your study. If there are only minimal risks,
and there are no subject benefit, but scientific
benefit, you can simply state that.
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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.
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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.
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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
re-signature by PI and Co-I (when applicable).
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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.
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Contact your Center/College Representativehttp/
/www.nova.edu/irb/membership.htmlWe look
forward to reviewing your submission!Nova
Southeastern university institutional review
board (IRB) staffms. Jennifer dillon, irb
director (x25311) Ms. inga hess, irb support
Staff (x25369)Mr. randy denis, irb specialist
(x25368)