- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect January 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after January 19, 2018 will be reviewed under the revised Common Rule. We are currently evaluating whether the changes will apply to studies existing prior to January 19, 2018.
- The definition of "human subject" has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private data are treated the same in the final rule.
- Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research.
- Overall, there are four new elements of informed consent; one new required element and three new optional (i.e."if applicable") elements. These new elements are generally related to the secondary use of data and samples and genomic research.
- The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
- Some minimal risk studies will no longer be required to undergo annual continuing review.
- Changes to the Common Rule mandate the use of a single IRB for multisite, cooperative studies. This requirement will be effective January 19, 2020.
- The revisions to the Common Rule go into effect January 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 01.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- For existing studies; ORIC is evaluating whether the changes will apply to these studies after the effective date.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
Required Human Research Ethics Training
CITI (Collaborative Institutional Training Initiative) Course Information
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 1. All Biomedical Investigators and Key Personnel: Medical, physiological or pharmacological studies that typically involve direct contact with participants. Includes, but is not limited to, research with drugs, devices or other interventions.
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 years.
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