Ethics Training

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IMPORTANT NOTICE

When registering with CITI, it is critical that your UNC-CH PID be entered correctly (9 digits, no hyphen, no spaces). If your PID is not entered correctly, then your CITI training records will nottransfer electronically to the UNC Human Research Ethics Training Database and the IRB information system will notrecognize that your Ethics training is current. If you do not have a UNC-CH PID, enter four zeros (0000) when prompted to enter your UNC-CH PID in CITI.

Revised Policy

The existing University Policy on Education and Certification of Investigators Involved in Human Subjects Research has been revised to reflect changes. See the policy for additional information on new web-base training, continuing education, alternative training under special circumstances, and other matters relating to human subjects education and certification.

The NIH/NCI Training has been phased out

We have adopted new modules (CITI) for web-based training. The NIH/NCI training is no longer valid (it expired March 15, 2005). UNC-CH human subjects researchers must complete new human research ethics training based on the CITI course; details follow below.

CITI Course Information

IMPORTANT NOTICE

When registering with CITI, it is critical that your UNC-CH PID be entered correctly (9 digits, no hyphen, no spaces). If your PID is not entered correctly, then your CITI training records will nottransfer electronically to the UNC Human Research Ethics Training Database and the IRB information system will notrecognize that your Ethics training is current. If you do not have a UNC-CH PID, enter four zeros (0000) when prompted to enter your UNC-CH PID in CITI.

What is CITI?

The Collaborative Institutional Training Initiative (CITI) is a web-based training package on issues relating to human subjects research. The CITI web site is maintained by the University of Miami, with content developed by a national consortium. CITI contains modules on topics like informed consent, vulnerable populations, ethical principles and IRB regulations. Each module has a short quiz at the end to assess understanding. Over 1300 institutions are using CITI for their mandatory training.

Who is required to complete the CITI modules, and when?

This training is required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects.

  • Effective March 15, 2005, completion of the CITI Basic Course is required of all study personnel. Other training previously completed in satisfaction of UNC-Chapel Hill requirements (e.g., NIH tutorials, campus lectures) is no longer accepted or valid.
  • If your CITI record includes your PID (the University’s personal identifier number for faculty, staff, students, and some other associates of UNC-Chapel Hill), the CITI completion record will be automatically linked to the IRB’s information system. Send a hard copy of the training certificate only for personnel listed on IRB application forms who do not have a UNC-CH PID.

Which CITI modules are required?

Modules have been grouped for (1) Biomedical Research, (2) Social and Behavioral Research, and (3) Research Involving Data and Specimens Only. Select the group that best describes your area of research (further defined below). You only need to complete one group of modules. In addition to the required modules, you should complete any “OPTIONAL” modules that apply to your research projects.

Access the CITI modules at the CITI Program Web site.

How will the IRB know training is complete?

When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records. It is not necessary to forward your completed CITI course information to the UNC-Chapel Hill office in order to be entered in to the database. UNC-Chapel Hill is automatically notified once you have completed the CITI Course. Your name will appear in the Human Research Ethics Training Database within 48 business hours. If your CITI record includes your PID (the University’s personal identifier number for faculty, staff, students, and some other associates of UNC-Chapel Hill), the CITI completion record will be automatically linked to the IRB’s information system. Send a hard copy of the training certificate only for personnel listed on application forms who do not have a UNC-CH PID.

To generate a certificate for your research team, go to the Human Research Ethics Training Database.

Frequently Asked Questions ABOUT citi TRAINING

Answers

Why am I required to do this, if I previously took another web course or sat through a lecture on campus?

Human subjects research presents many challenges. As with any complex and evolving area, continuing education is critical. Inadequate training in these issues is recognized as one reason that some researchers and their institutions have experienced problems. UNC-Chapel Hill is committed to upholding the highest standards of ethical conduct and regulatory compliance in research. The enhanced training available through CITI will increase the level of awareness and understanding about these issues across our research community, and help us fulfill these important obligations.

What if I am registering with CITI for the first time, and do not have a UNC-CH PID?

If you are listed as research personnel on a UNC-Chapel Hill based study, but you are not a student, faculty or staff of UNC-CH (or any other academic institution) and therefore do not have a UNC-CH PID: (1) create a new username and password to log-on to CITI, (2) select University of North Carolina at Chapel Hill as your Participating Institution, and (3) enter four zeros (0000) in the UNC PID field.

What if I have completed CITI training at another institution?

  • You have a UNC-CH PID. If you are a new UNC faculty, staff, or student and have completed CITI training at another institution, your CITI training records can be transferred electronically to UNC-CH. (1) log-on to CITI using your current username and password, (2) click “affiliate with another institution,” (3) select University of North Carolina at Chapel Hill as your Participating Institution, and (4) enter your UNC-Chapel Hill PID (9 digits, no hyphen, no spaces). If you have not previously completed all of the training modules required by UNC-CH, you may be prompted to complete additional modules.
  • You do not have a UNC-CH PID. If you are listed as research personnel on a UNC based study, and have completed CITI training at another institution, (1) log-on to CITI using your current username and password, (2) click “affiliate with another institution,” (3) select University of North Carolina at Chapel Hill as your Participating Institution, and (4) enter four zeros (0000) in the UNC PID field. If you have not previously completed all of the training modules required by UNC-CH, you may be prompted to complete additional modules.

When will I be required to complete the CITI modules?

This training is now required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects. CITI replaces earlier requirements, and the following implementation schedule was adopted:

  • Effective March 15, 2005, completion of the CITI Basic Course is required of all study personnel. Other training previously completed in satisfaction of UNC-Chapel Hill requirements (e.g., NIH tutorials, campus lectures) is no longer accepted or valid.
  • CITI training is now required for all study personnel on new IRB applications and on all renewal applications.

Which CITI modules should I complete?

The modules are grouped by categories of research. You only need to complete one group of modules. You should choose the group that best fits the type of research you normally conduct. If in doubt, ask your IRB.

  • Group 1: Biomedical Research: Medical, physiological or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions.
  • Group 2: Social and Behavioral Research: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
  • Group 3: Data and Specimens ONLY: No direct contact with human subjects. Research limited to use of records, data (including secondary data sets), or biological samples.

How much time will it take?

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.

What is the passing score on the quizzes?

You must receive a total passing score of 75% after completing all the required modules. You can track your progress on-line by clicking on the GRADE BOOK. If you do not obtain a total passing score of at least 75%, you can return to the modules and retake the quizzes.

Why I am having trouble viewing the CITI information or modules?

The CITI Course site is best viewed with Microsoft Internet Explorer 5.0 or later.

Is there a fee?

The University pays an annual fee for all UNC-Chapel Hill users. Individual UNC-Chapel Hill users are not assessed a fee for the CITI training unless continuing medical education credit is requested (see below).

Can I obtain Continuing Medical Education Credits?

The University of Miami Office of Continuing Medical Education will provide Continuing Medical Education (CME) credits. This is handled directly with the University of Miami, and not through any offices at UNC-Chapel Hill. For questions regarding Continuing Education Credit please contact:
University of Miami Leonard M. Miller School of Medicine
Division of Continuing Medical Education
305-243-6716
umcme@med.miami.edu
www.cme.med.miami.edu

When do I have to renew my training?

Continuing education is not required at this time.

How do I verify my training to the IRB?

When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records. It is not necessary to forward your completed CITI course information to the UNC-Chapel Hill office in order to be entered in to the database. UNC-Chapel Hill is automatically notified once you have completed the CITI Course. Your name will appear in the Human Research Ethics Training Database within 48 business hours. If your CITI record includes your PID (the University’s personal identifier number for faculty, staff, students, and some other associates of UNC-Chapel Hill), the CITI completion record will be automatically linked to the IRB’s information system. Send a hard copy of the training certificate only for personnel listed on IRB application forms who do not have a UNC-CH PID.

To generate a certificate for your research team, go to the Human Research Ethics Training Database.

What if I have questions?

Please contact the UNC-Chapel Hill IRB Training Coordinator at IRB Training.

Policy on Human Research Ethics Training and Certification of Investigators Involved in Human Subjects Research

See the University policy for additional information on continuing education, alternative training under special circumstances, and other matters relating to human research ethics training and certification.