Required human subjects training – CITI

UNL requires all research personnel, including investigators, students and other project staff, who conduct research with human participants, tissue samples or data to complete and maintain training before and during any research conducted with human subjects.  UNL’s IRB will not approve a project without training either completed or updated at least 30 days prior to expiration. Read more about the training policy here.

Training must be completed prior to your research being conducted and must also be maintained through completion of refresher courses no less than once every three years.

The following project staff must complete and maintain training:

• Investigators (e.g., P.I.s, co-investigators) who are responsible for the project as a whole. (Graduate students collecting their thesis data are considered to be investigators.)
• Project staff who have direct contact with human participants (e.g., for subject recruitment, data collection) or who have access to information that links participants’ names with their data.

Exceptions:

• Research staff who work with the non-identifiable data (e.g., data entry, data analysis) AND who have no contact with participants and no means of identifying participants or linking participants’ names to their data.

If you are required to complete human subjects training and in order to ensure training information is up to date and accurate within the NUgrant system (UNL’s electronic research administration system), there are a few key pieces of information to know before you start:

• NUgrant and the CITI website are not electronically linked.  Research Compliance Services is required to manually update the NUgrant system.  We do this at least once every 48 hours, so your training may not “show up” in NUgrant immediately after completing a course.
• A BASIC course must always be taken before a REFRESHER course can be accepted.  If you do not have a record of having completed a course before nor can RCS staff find records via CITI, you will not receive previous credit.
• We will accept the Group 1 or Group 2 course, dependent on your area of research.
• If you have previously completed training at another institution and have affiliated your account with UNL through the CITI website, you must send us an email at irb@unl.edu to notify us of this change.  We do not receive reports of new affiliates.

After having read this information, please feel free to contact the Research Compliance Services staff at irb@unl.edu if your training is still not “showing up” in NUgrant within the appropriate timeframe.

**NOTE:  Projects can still be submitted to the Research Compliance Services office to begin official IRB review even if training is not accurate within NUgrant.  RCS staff will verify training or notify the research team if training must be completed for all new form approvals.**

CITI TRAINING INSTRUCTIONS

To begin your training and to ensure ease of CITI training registration, first identify whether you are a new user or you are already a registered user through CITI.  The process of selecting your course will be different based on your current status.

Upon navigating to the website, please be aware that UNL does not subscribe to the use of Single Sign On (SSO).  Usernames and passwords are chosen by the user.

NEW USER REGISTRATION and COURSE SELECTION INSTRUCTIONS:

1. Create your user account through the CITI website (www.citiprogram.org).
   
   • You will be requested to complete a series of questions or provide information specific to your UNL affiliation. Here are just a few tips to ensure a smooth account set-up:
     • UNL is listed by the full name under the “Participating Institutions” heading. Please select “University of Nebraska – Lincoln.”
     • This training does NOT require payment from the trainee/user if you are completing this training for UNL purposes only. In other words, we do not require CME/CEU credits or registration as an Independent Learner.  If this is selected as an option, this is the responsibility of the user to pay for any fees assessed.
     • The email address you enter does not have to be your UNL email address but it should be one that is used frequently so that you do not miss important reminders to refresh your training. Most UNL users will enter their email associated with their Blackboard/Canvas account.
     • Page 6 of the registration form will ask you to provide your institutional email address. Please feel free to use the same email address as before.
2. Indicate that you conduct human subjects research at UN-L on page 7 of the registration process.
   • Choose “Yes, I conduct human subjects research at UN-L.”
   • More than one selection can be made when signing up through the new user registration process. If you have selected more than one course and it pertains to the Responsible Conduct of Research (RCR) or Conflict of Interest (COI), please refer to the RCR training instructions or COI training instructions page for further guidance.
     
   • If you have NOT completed a Basic course before, you must select that you are a new investigator at UNL on the next screen.
   • You may choose either to take the:
     • Group 1. Basic Course Options for Biomedical Investigators and Key Personnel; OR, you may choose the
     • Group 2. Basic Course for Social/Behavioral Research Investigators and Key Personnel
       depending on your area of research and what fits best.  Research Compliance Services accepts either training course.
   • NOTE: The IRB Reference Resource, Stem Cell Research Course, or the Institutional/Signatory Officials Courses are NOT required to be completed for human subjects research training NOR will they be accepted for this requirement.
   • You are only required to complete the RCR Biomedical Course if you are instructed to do so.
   • You are only required to complete the Privacy and Security (IPS) course if you are instructed to do so or are a student, staff or faculty in certain departments/centers. Please be sure to check with your department regarding privacy and security training requirements.

REGISTERED USER/COMPLETED TRAINING BEFORE and COURSE SELECTION INSTRUCTIONS:

• Login to your user account through the CITI website (www.citiprogram.org).
  
• If you have forgotten your username/password, you can retrieve this through the CITI website.
  • STARTED YOUR CITI ACCOUNT WITH UNL: If you no longer use any emails that are currently registered with your account AND you were originally affiliated with UNL, please contact Research Compliance Services.  RCS staff have administrative access and would be able to add a new email address that will allow you to maintain the current account with all past reports.
  • STARTED YOUR CITI ACCOUNT AT A DIFFERENT INSTITUTION: CITI allows retrieval of account information via their website; however, if you no longer use any emails that are currently registered with your account AND you did not originally affiliate with UNL you should contact CITI to regain access to your previous account.
  • If you can access your previous account, you may receive credit at UNL for any previously completed human subjects training but will not receive previous credit for any COI or RCR training.

• If you are registered user, it is likely that you have already completed a BASIC training course. If your training is set to expire you should have received a reminder through CITI and/or NUgrant if your training was logged.  To select the correct human subjects training course please follow these steps:
  1. Start by ensuring you have selected the “University of Nebraska – Lincoln Courses” on the Main Menu if you are perhaps affiliated with multiple institutions.
  2. The refresher course may already be an option for you to choose “Start Course.”
  3. If the refresher course is not already a choice on your main menu, Click “Add a Course”

• Once on the next screen, please scroll down to the bottom of the page and select, “Yes, I conduct human subjects research at UN-L.”
• More than one selection can be made when signing up through the new user registration process. If you have selected more than one course and it pertains to Responsible Conduct of Research (RCR) or Conflict of Interest (COI), please refer to the RCR training instructions or COI training instructions page for further guidance.
• If you have completed a Basic course before, you can select that you have completed the CITI Basic course previously.
• You may choose either to take the:
  • Group 1. Refresher Course Options for Biomedical Investigators and Key Personnel; OR, you may choose the
  • Group 2. Refresher Course for Social/Behavioral Research Investigators and Key Personnel
    depending on your area of research and what fits best.  Research Compliance Services accepts either training course.
• NOTE: The IRB Reference Resource, Stem Cell Research Course, or the Institutional/Signatory Officials Courses are NOT required to be completed for human subjects research training NOR will they be accepted for this requirement.
• You are only required to complete the RCR Biomedical Course if you are instructed to do so.
• You are only required to complete the Privacy and Security (IPS) course if you are instructed to do so or are a student, staff or faculty in certain departments/centers. Please be sure to check with your department regarding privacy and security training requirements.

ALL USERS

Beginning and Completing a Course

• You must complete the Integrity Assurance Statement to begin the course by clicking on the actual title of the statement.
• All required modules must be completed in order to receive credit for the training course.
• After you have completed the training, you are encouraged save a copy of your completion report for your own records. You may also want to provide a copy of the certificate to your department office or your advisor.

Training Record Maintenance and Updates

• Training completed by all users is manually recorded and maintained via NUgrant by Research Compliance Services staff and is updated at least every 48 hours during business days if not more based on individual deadlines. If you still have questions about training updates, please see more detailed information above or contact the IRB at irb@unl.edu.