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OVPR Home Regulations and Ethical Guidelines AU Policies & Procedures Protocol Submission Forms Sample Documents Training and Resources IRB Meeting Schedule / Protocol Deadlines Contacts
Office of Research Compliance 115 Ramsay Hall
Email: hsubjec@auburn.edu
Phone: (334) 844-5966
Fax: (334) 844-4391 |
Frequently Asked Questions
All members of the research “team” must
complete the appropriate CITI HSR training. This includes the primary
investigator, co-investigators, the faculty advisor, and all
key
personnel.
If members of your research team fit
the definitions of key personnel listed
here, they must be listed in your protocol.
The Auburn University (AU)
Institutional Review Board (IRB) has determined that this training will
be a requirement of all AU researchers involved in human subject
research to comply with federal mandates. The National Institutes of
Health’s (NIH) policy requires that all proposals for contracts and
grants for research involving human subjects submitted certify that all
key
personnel have received training on the protection of human subjects in
research. AU’s FederalWide
Assurance with the Department of Health and Human Services/Office of
Human Research Protections (DHHS/OHRP) mandates that AU will ensure the
protection of the rights and welfare of all human research subjects,
regardless of funding. This means that the same standards for education
of
key
personnel will apply whether a study is funded or not. The AU IRB has
elected to review all protocols involving human subject research.
Protocols will not be approved unless
proof of CITI HSR Training completion is attached.
No, they do not, unless they are
directly involved in the study. If so, they would be listed in "key
personnel" in your protocol. All key personnel do need to complete CITI HSR
training. (Also note that "Outside Readers" do not need to complete
CITI.)
You will now need to complete CITI HSR
training as an affiliate of Auburn University. You will need to follow
enrollment instructions
here. Note that your certificate
will expire in five years from the date you complete all AU modules.
If you are not affiliated with Auburn
University, see
question 7.
The “Learner Group” which you select
determines which modules will be required. Choose the group that best
fits the type of research you normally conduct – or the type of research
specifically described in the protocol you will submit to the IRB. In
general, there are three types of learner groups:
Group 1 - IRB Members – This includes all current and future IRB members.
Group 2- Biomedical – This will usually be research by researchers in the School of
Nursing, the Harrison School of Pharmacy or the Kinesiology Department.
The research will involve
medical, physiological or pharmacological studies that typically involve
direct contact with research subjects.
Group 3 -Social and Behavioral – This generally describes sociological, psychological,
anthropological or educational research.
In addition, members of the research
team must complete any optional modules that apply to their research.
Note:
At this time, completion
of the Responsible Conduct of
Research training is encouraged, but is
not required.
8.
How much time will it
take?
This will depend on your familiarity
with human research issues. Most modules should take between 10 to 20
minutes to complete, with a total time of 3 to 6 hours. Less time will
be needed if you are already familiar with the subject. You do not need
to complete all of the modules at one time. CITI is designed so that you
can stop and begin again at your convenience.
No.
There is no deadline.
However, protocols will not be approved unless proof of CITI HSR
training completion is attached.
You must receive a passing score of 80%
overall. You may retake any quiz for which you did not receive a passing
score, or if you just want to make a better score. Please note that your
score may not change on your CITI HSR training record, but the new score
will be used to determine your average score.
When you have completed all of the
modules, you can print a completion certificate to keep. Please make
copies to attach to any protocol submitted.
CITI will also forward an electronic record of your course
completion to AU's Office of Human Subject Research.
Yes. You will need to complete one or
more of the additional modules if your research area changes.
The IRB will review the protocol if at
least the primary investigator and faculty advisor have completed CITI
HSR training (and provided copies of their certificates). The protocol
will not receive final approval
until all members of the research team listed in “key
personnel” have completed CITI HSR training.
Go to
www.citiprogram.org.
The first time, you will have to go through the registration procedure.
For instructions, click
here. After you have already
enrolled, you will log in with your AU username and created password.
You will access your modules from your “Main Menu”.
The Office of the Vice President for
Research at Auburn University pays an annual fee for all AU researchers.
There is no cost to an individual user to complete the CITI training.
Auburn
University does not currently provide continuing education credits for
this training.
(CME/CEU credits are available through
the University of Miami for completion of the Human Subjects Protection
Basic Course. See the information available on CITI’s website for more
information:
www.citiprogram.org/citidocuments/cme/index.htm. )
You will need to retake the CITI HSR
training course within five years from the date of your completion
certificate.
If you have forgotten your username
(which should be the same username you use at Auburn) or your password
(unique to CITI), there is a link on CITI’s home page to request
assistance.
Check the “Announcements and Frequently
Asked Questions (FAQ)” section on the
CITI web page.
On the CITI home page there is
also a link to
Contact the CITI Helpdesk. Specific questions
relating to AU may be directed to the Office of Human Subject Research
at 334-844-5966,
hsubjec@auburn.edu. |
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Office of the Vice President for Research 202 Samford Hall | Auburn University | Auburn, AL 36849 | Phone: (334) 844-4784 | FAX : (334) 844-5971 © Copyright Regulations |