NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.
The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).
You may review the NIH posting regarding sIRB review by clicking here.
If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your question to email@example.com.
Link to the CITI Online Course - http://www.citiprogram.org/
Review the UMCIRB standard operating practice related to required ethics training by clicking on the following link: Requirements for Human Research Protections Training
All key research personnel must complete the required education. Key
research personnel include principal investigators, sub-investigators,
research coordinators, and any other research team members that have
contact with research participants, and their research data or private
The modules are grouped by categories of research. For UMCIRB purposes,
you only need to complete one of the two groups of modules listed below.
You should select the group that best fits the type of research you
normally conduct. If in doubt, contact ORIC for guidance.
Group 2. Social/Behavioral Research Investigators and Key Personnel: Studies
on sociological, psychological, anthropological or educational
phenomena that typically involve direct contact with participants. Does
NOT include drug or device studies.
Education is vital to conducting ethical research studies. The UMCIRB
recognizes that education is an ongoing process, not a one-time effort.
Completing the CITI modules, reading the Belmont Report, 45CFR46, and
other pertinent regulations provides a solid foundation for which
continuing education can be accomplished. ECU requires this education
based on Health and Human Services (HHS) recommendations.
The required training modules must be completed by all research team
members prior to the UMCIRB granting approval for any research study,
regardless of the level of risk or category of review. The training is
good for three years. After three years, the modules must be updated
utilizing the refresher course available through CITI. The CITI site
will send a notification approximately 90 days prior to the expiration
of your training period. The notification will be sent to the email
address you provide when you register for the training.
This will depend on your experience with human research issues. Most
modules will take about 10-20 minutes to complete. Researchers familiar
with these topics may require three hours or less to complete all of the
required modules. You do not have to complete all the modules at once.
CITI is designed for you to work at your own pace, and allows you to
exit and return at a later date to where you left off.
The required passing score is 70%. The score is based on the overall
score of the quizzes at the end of each of the required modules. You may
check your grade by selecting the grade book link on the welcome page
or at the end of the course. If you do not pass, you can return to the
modules and re-take the quizzes.
If you are a new faculty, staff or student at ECU and have completed the
same CITI training modules at another institution, you may long into
the CITI site with the CITI username and password you created when you
registered to use CITI and you may choose to "affiliate with another
institution". When you do this, select East Carolina University.
Currently UMCIRB recognizes only the CITI training described above. You
will need to log into the CITI site, register as a new user and complete
the training modules required by ECU.
In order to verify successful completion of the required CITI
training you must log the completion date in your ePIRATE profile. Click
on the following link for instructions. How to Add Your IRB Training Completion Date to Your ePIRATE Profile (PPT). Once a person's CITI training data is logged in their ePIRATE profile
it will be automatically populated next to their name in any new study
submission received by the IRB. Do not forget to update your ePIRATE
profile when you complete the required refresher course every three
The CITI program site and ePIRATE ARE NOT
connected in any way. The CITI program is a software platform for
web-based training purposes and is not administered by ECU. ePIRATE is a
software platform administered by ECU for electronic IRB submission,
review and approval.
To make full use of the features of the CITI site, and to do so
securely, use a current browser version when accessing the CITI Program.
The vast majority of browsers made available within the last 3-4 years
will support all CITI Program features. Older versions may not, as they
are often less secure and provide less functionality.
Individual users who are taking the training required by the UMCIRB to
conduct human research are not assessed a fee for the CITI training.
You may contact ORIC at 252-744-2914 or contact us via email at UMCIRB@ecu.edu