IRB Newsletter – Fall ‘13
In this Issue:
Welcome to a new academic year! Let us start by wishing you the best of luck in
your research efforts through this year. As always, we are here to help so if we
can be of any assistance do not hesitate to contact us.
• CITI Training
• Help Sessions
Supervising Student
Applicants
CITI Training
Exemptions
The CITI training site has been upgraded and improved. Among many great new features,
CITI now allows users to print Training Completion certificates, something many of you
have asked about.
• Data Management
• Szende Szabo
Please note that you’ll be required to change your password when you first log in.
ALL IRB applicants must have up-to-date training. Applicants with incomplete or expired
CITI Training will experience delays, as their applications can’t be reviewed until training is
completed.
IRB in the News
Graduate Student IRB Help
Session
Dr. Jon Lasser, IRB Chair
Monday, September 9
th
1:00 – 2:00 pm
JCK 460
Upcoming Help Sessions:
The links below will take you
to the Signup application
where you can register for
these 1 (one) hour classes:
IRB app or Exemption: What's
the Difference and Why Should I
Care?
IRB applicants are required to include CITI training completion dates in their Synopsis at
the time of application to the IRB. Student applicants must also provide training completion
dates of their supervising faculty.
Training is valid for 2 years so be sure to complete the Refresher Course before expiration
or renewal. The CITI system will send you a reminder as your expiration date approaches.
When registering for CITI training, please make sure you choose the CORRECT course
and learner group!!!
o
o
o
Students and faculty should NOT choose “Administration” or “Institutional
Review Board” as their learner group.
Acceptable faculty (or staff) learner groups:
§ Biomedical Research Investigators
§ Social and Behavioral Research
Acceptable student learner groups:
§ Biomedical Research Medical Students
§ Social and Behavioral Research Students
OMG, I have to do an IRB
Application! What IS an IRB
application, anyway?
IRB Application Help Sessions
Your IRB Application: Informed
Consent Isn't Just a Form
Do you have questions related to IRB forms, policies, or review procedures? We have
answers and we are here to help! Please contact our office at 512.245.2314 or join us at
an upcoming help session. Topics are designed especially for faculty researchers,
graduate students and research staff. These are the topics we will be covering this
semester:
Important Forms (attached):
- IRB app or Exemption: What's the Difference and Why Should I Care?
Synopsis
Consent Form Checklist
OMG, I have to do an IRB Application! What IS an IRB application, anyway?
- Your IRB Application: Informed Consent Isn't Just a Form
Supervising Student Applicants
Make sure you provide your students with the following info:
o
Your University NET ID (note: we are not asking for your email, alias, name, but
your net ID)
o
Your CITI training completion date
Make sure you complete the following steps:
o
If you are not current on your CITI training; you will have to retake the CITI
course or complete a refresher.
o
You will have to certify your approval of the student’s IRB submission (i.e.,
application is a complete and accurate representation of research project).
You’ll get an email with instructions when your student submits their application.
Exemptions!!!
ALWAYS check whether you qualify for an exemption before you submit
an IRB application.
WHY?
If you qualify for an exemption it will save you significant time:
1) you do not have to prepare the documentation a full application requires
2) the review process is much shorter (usually 3 days)
3) you do NOT have to take the CITI training
WHAT?
So now that we’ve got your attention, you’re probably asking, “What is
exempt?” Let’s take a look at the Exemption CATegories!
MAKE NOTE OF THESE
Exemption CATegories
The most commonly used exemption categories are 1, 2 and 4. It is
unlikely that your research qualifies for Category 5. If you believe it does,
consult us before choosing this category.
HOW?
In order to submit an Exemption Request just click HERE and login using
your Texas State net ID and password. Once logged in, select ‘Request
for IRB Exemption’ and fill out your form with the requested information.
Do not forget to click the ‘submit’ button when you are finished.
IRB Continuations
Only one IRB continuation can be submitted per project. If you plan to continue research with
human subjects after the continuation expires, you will have to submit a new IRB application.
Data Management
Does your research involve working with data sets obtained from external sources? If so,
you may be required to have an IT Security assessment before IRB approval is granted.
Research Integrity & Compliance staff may contact you to inquire whether your research
involves a data use agreement, contract, or other similar signed transaction that commits the
University to terms and conditions regarding the use or transfer of, or access to, data. If
necessary, personnel from the Vice President of Information Technology's security staff will
meet with you to assess the requirements and conditions of your proposed research.
Please note also that the approval of the Associate Vice President of Research (or in some
cases the Vice President of Information Technology) is required for all data use agreements,
data management plans, or other formalized agreements regarding the use of data.
If you have questions or need assistance with data management please contact bnorthcut@
txstate.edu or call 245-7975.
New IRB Contact
Szende Szabo joined the Research Integrity & Compliance team on August 6
as a Compliance Specialist and she will be the primary contact for IRB.
Szende moved to New Braunfels from Saint Louis where she worked in the
publishing industry and taught Spanish at the high school level. She also
worked for Texas A&M University in their Information Technology Issues
Management office as an IT Policy and Security Program Administrator.
Szende has extensive experience in academic research, project management,
data management and analysis and policy implementation. Szende earned her
Bachelor of Arts in International Relations and Spanish from Austin College
and her Master of Public Administration from Texas A&M University.
To contact Szende email sszabo@txstate.edu or call 512.245.2314
GIVE US YOUR
FEEDBACK
Are you interested in
meeting the IRB Chair
and Reviewers?
Satisfied with the job
we’re doing, or think we
can do better?
TAKE OUR IRB
SURVEY
Human Subjects Issues in the News
HeLa cells, taken in 1951 from Henrietta Lacks without her consent, are among the most widely used cell lines in
biomedical research. These cells grow and replicate indefinitely in the lab and are so important that several laboratories
have spent years trying to sequence their DNA. Last year, German scientists sequenced the full genome of the HeLa
cells and published the results. Despite the fact that it contained potential biomedical information about them, Lacks’
family members were never consulted before the genetic information was made public, and thus never gave their consent
to its release.
Several weeks ago, an agreement between the Lacks family and NIH was reached that gave the family some control
over access to the cells' DNA code. Two family members will join a six-member committee that regulates access to the
code. Henrietta’s family finally has the chance to weigh in on how scientists use HeLa cells.
For more information, read the full article “Decades After Henrietta Lacks' Death, Family Gets A Say On Her Cells” or
Rebecca Skloot’s book The Immortal Life of Henrietta Lacks.