UNCW Institutional Review Board
FY 2015-2016
Changes and Updates
Click to Skip to a Topic:
 What Is Different - New Submissions
 What Is Different - Renewing Ongoing Studies
 What Is Different - Modifying Ongoing Studies
 What Is Different - Timeframe for Reviews
 What Is Different - NHSR (Not Human Subjects Research)
 What Is Different - Conflicts of Interest
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What Is The Same - Required Human Subjects Training
What Is The Same - Consent Forms
What Is The Same - Completed Studies
What Is The Same - Expired Studies
What Is The Same (For Now) - IRB Chair
What Is The Same - IRB Coordinator
What is different??
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NEW SUBMISSIONS
All new human subject protocols must be submitted through IRBIS. Paper protocol forms
are no longer accepted. This is true for all levels of review (exempt, expedited and full).
The link to IRBIS is https://uncw.myresearchonline.org/irb. This link is also posted on the
Human Subjects Compliance website.
UNC-GA will push out an IRBIS upgrade on Wednesday, July 8, 2015 (GA previously
scheduled this upgrade for 7/6). The system will be down on 7/8, but is expected to be
operational on 7/9. Please check the Human Subjects Compliance website for updates on
system status.
IRBIS was developed by UNC and has a similar look and feel to the Sponsored Programs
proposal submission system (“RAMSeS”). Several UNC campuses are now using IRBIS and
find it to be a great improvement over paper forms. We hope you agree!
We are still developing IRBIS training materials and will post them to the Human Subjects
Compliance website ASAP. We still have some work to do to make IRBIS the best system it
can be, so please bear with us and let us know if you have any suggestions on how to make
it easier to use. If you need assistance, please don’t hesitate to contact Lee Prete at
pretel@uncw.edu or 910-962-7774.
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RENEWING ONGOING STUDIES
Ongoing studies originally approved on the paper form will be allowed one more paper
renewal IF the PI is certain the study will end within one year of the renewal date. Projects
that will continue beyond that date must be resubmitted in IRBIS as a new study prior to
the approval expiration date of the existing study.
For example, if your IRB approval expires in October 2015, you may renew the protocol
one more time on the paper annual renewal form if you are certain the study will end by or
before September 2016. A new version of the fillable Word annual renewal form is posted
on the Research Compliance Forms/Templates website and includes a new question
regarding the end date of the study. PIs must use this July 2015 form to renew protocols
that will end within one year. The form will be posted until no longer needed.
If you are uncertain that you will complete the study by September 2016, you must
resubmit the study in IRBIS as a new study.
Studies that were submitted in 2014-2015 through IRBIS can be renewed in IRBIS. Just log
in to IRBIS, open the study, and look for the option “Submit a Renewal.” You will see
questions similar to those included on the paper annual renewal form. You will also have
the option to make changes to the study if needed.
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MODIFYING ONGOING STUDIES
Research approved by the IRB must be conducted as approved. If you need to change any
aspect of an ongoing study, you must seek approval through the IRB prior to making any
changes. Any change, no matter how small, must be approved before implemented. For
example, changing members of the research team, changing approved survey instruments,
or revising the consent form are all changes that require prior IRB approval.
Research approved on the paper protocol form can be modified on the usual protocol
amendment form. This form will remain posted on the Research Compliance
Forms/Templates website until no longer needed.
Research approved on IRBIS can be modified by the PI by logging into IRBIS, opening the
study, and looking for the option, “Submit a Modification.”
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TIMEFRAME FOR REVIEWS
Please allow at least 10 days for the IRB to review and approve new studies. The UNCW
IRB has always taken pride in its efforts to provide PIs and students with timely approvals
so that you can begin your important human subject activities. Please understand that as
IRB submissions continue to increase, and as we adjust to handling this volume on the
IRBIS system, you may see slower response times than we were able to provide in the past.
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NHSR (Not Human Subjects Research)
In the past, PIs or students called or emailed us for a determination of whether or not their
studies fit the IRB definition of human subjects research. The IRB will now make NHSR
determinations through IRBIS. If you are uncertain if your activities (or your student’s) are
subject to IRB review, please begin a new submission in IRBIS. The initial questions are
designed to flag studies that do not fit the IRB definitions of “research” or human subjects.
The IRB will receive a notice that a PI has requested a NHSR determination, and the PI will
receive a response through IRBIS when the IRB completes the determination.
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CONFLICTS OF INTEREST
Prior to granting approval for human subjects research, the IRB will check to ensure that
members of the research team who are subject to the UNCW Conflict of Interest and
Commitment Policy have completed their annual reports in the AIR system. Dr. Ron Vetter
will send faculty and EPA professional staff a reminder regarding this requirement in
August 2015. Please see the Conflict of Interest Compliance website for more information.
This is a quick and easy online form for most subject employees to complete. TIP: if you
do report a potential conflict and a management plan for the conflict exists, please state so
in your report to avoid a follow-up email.
What is the same??
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REQUIRED HUMAN SUBJECTS TRAINING
The IRB still requires all members of the research team to complete the Basic Course for
Human Subjects Research through the CITI program. Please upload in IRBIS training
completion certificates for any research team members who do not already have training
documentation on file with the IRB. The IRB does not accept the Responsible Conduct of
Research course in lieu of the basic human subjects course, as it only touches upon using
subjects in research.
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CONSENT FORMS
Consent/Assent/Permission templates have not changed and will remain posted on the
Research Compliance Forms/Templates website. As always, if you choose to use a
customized format (not one of the posted templates) you may do so, but you must also
upload a completed Informed Consent Checklist to demonstrate that you remembered to
include all of the required elements of consent on your custom form.
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COMPLETED STUDIES
In accordance with IRB Policy, PIs are responsible for closing completed protocols. Closure
forms will remain on the Research Compliance Forms/Templates website until no longer
needed.
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EXPIRED STUDIES
As before, if you do not renew a study and do not resubmit the study in IRBIS, the IRB will
consider it expired and will purge it from IRB records. The PI must submit a new study to
continue the activities. It is a violation of IRB policy to conduct human subjects research
without approval. IRB policy also requires PIs to notify the IRB when a study is completed.
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IRB CHAIR (At least for now!)
Dr. Candace Gauthier remains the IRB Chair for 2015-2016. She will retire effective May
2016. She will train her replacement throughout the 2015-2016 year.
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IRB COORDINATOR
I am here to help! Please let me know if you have questions.
Lee Prete, Research Compliance Manager, 910-962-7774, pretel@uncw.edu.