UNL affirms its commitment to maintaining the highest ethical principles in the conduct of research with human participants. Consistent with this commitment and our own Federal-Wide Assurance, NIH policy, and the AAU Task Force on Research Accountability, UNL requires education of key project personnel, including investigators, students, and other project staff who are engaged in research with human participants, biospecimens, or data. Please review UNL HRPP Policy #3.009: Required Training in the Protection of Human Participants here.
The responsibility for ensuring the rights, safety, and well-being of research participants is shared by the investigator, the Institutional Review Board (IRB), the University, and all research personnel. Education of the research community in the principles and procedures for protecting human research participants is a necessary step toward meeting this joint responsibility.
Contents:
- Who must complete human subjects training?
- What training must be completed?
- Additional Information about CITI
- Additional Information about CIRT
- Documentation of Training Completion
Who must complete human subjects training?
Research personnel 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 are considered to be engaged in the research process per policy #3.001. These individuals must be listed on the IRB application and must complete training associated with the conduct of human subjects research. Research personnel would include:
- Principal Investigator
- Secondary Investigator
- Co-Investigator
- Supervising Investigators (i.e., Faculty Advisor for student-led research)
- Participating Personnel
- Community Partner
- Community research partners are typically from non-academic settings such as community agencies, health care delivery organizations, public health departments, or schools.
- Community research partners may also include UNL-affiliated personnel in staff positions that resemble or take on responsibilities related to community connections, stakeholder communications, and community supports.
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.
What training must be completed?
Currently, there are two options for human subjects training: the Collaborative Institutional Training Initiative (CITI) owned by the Biomedical Research Alliance of New York (BRANY) or Community Involvement in Research Training (CIRT) designed by the Center for Clinical and Translational Science at the University of Illinois Chicago. Most individuals directly affiliated with UNL will be required to complete the CITI training.
CITI offers two human subjects research courses: Group 1 Biomedical or Group 2 Social Behavioral. CIRT offers one course.
| CITI Training – https://about.citiprogram.org/ | Community Involvement in Research Training (CIRT) – https://training.ccts.uic.edu/course/CourseDetails.aspx?CourseID=3 |
|---|---|
| Required for: individuals who are engaged in human subjects research and listed on the IRB application. This includes: principal investigator, secondary investigator, co-investigator, supervising investigators, and participating personnel. Community partners could also complete this training. | Community partners could complete CIRT instead of CITI. |
| Frequency: Once every three years. Refresher course may be taken if basic course has been completed. | Frequency: Once every three years. |
| Two Courses are offered: Group 1 Biomedical, Group 2 Social Behavioral. Individuals should complete the course most related to their research. | One course is offered. Similar topics to those offered in CITI are included. However, the targeted audience of this training is individuals who are not researchers. The information is provided in a non-scientific manner. This is not an alternative to CITI for all personnel. |
Additional Information about CITI
To begin and ensure ease of CITI training registration, first identify whether you are a new user or have already registered as a user through CITI. The process will vary based on this status.
Upon navigating to the CITI 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 and are not tied to UNL credentials.
New User Instructions:
- Create your user account through the CITI website.
- 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 institution 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 the email associated with their Canvas and/or NuRamp account.
- Within the registration form, you will be asked to provide your institutional email address. Please feel free to use the same email address as before. However, it should be noted that adding your university email address here can help RCIS staff verify that your course completion record is added to the correct account within NuRamp.
- It is helpful if you use the same name as which you are registered for class or a preferred name that appears in the UNL Directory. Nicknames or other identifiers that are not associated with official UNL records or NuRamp often delay entry of completion records into NuRamp due to the inability of staff to verify or match user completion records.
- 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:
- Indicate that you conduct human subjects research at UNL.
- Choose “Human Subjects Research – required by the IRB.”
- 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), Conflict of Interest (COI), or Export Control, please refer to the respective RCR training instructions, COI training instructions, or Export Control training instructions pages for further guidance.
- If you have not completed a Basic course for human subjects training before, you must select “No, I am a new investigator at UNL. I have not completed an approved Basic Course previously”.
- You may choose to take either 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, Integrity, and Security accepts either training course.
- Based on these answers, the following screen will place you in either the Basic or Refresher course. Please verify that the correct course is selected. Remember, Refresher courses will not be accepted until a human subjects Basic course has been completed.
Registered User Instructions:
- Login to your user account through the CITI website.
- If you have forgotten your username/password, you can retrieve this through the CITI website.
- IF YOU 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, Integrity, and Security. RCIS staff have administrative access and will be able to add a new email address that allows you to maintain the current account with all past reports.
- IF YOU 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 have forgotten your username/password, you can retrieve this through the CITI website.
- If you are a 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 NuRamp if your training was logged. To select the correct human subjects training course please follow these steps:
- Start by ensuring you have selected the “University of Nebraska – Lincoln Courses” on the Main Menu if you are affiliated with multiple institutions.
- The Refresher course may already be an option for you to choose within your course list. Simply click on “Start Course.”
- 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 and select, “Human Subjects Research – required by the IRB.”
- 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, Integrity, and Security accepts either training course.
- Based on these answers, the following screen will place you in either the Basic or Refresher course. Please verify that the correct course is selected. Remember, Refresher courses cannot be accepted until a Basic course has been completed.
The following CITI courses must be completed only if you are instructed to do so:
- Stem Cell Research course
- Responsible Conduct of Research (RCR) Course
- Export Control Course
- Information Privacy and Security (IPS) – Information for Researchers course:. This course is required for participating personnel who conduct research involving private health information (PHI) that falls under the Health Insurance Portability and Accountability Act (HIPAA).
- Students, staff or faculty in certain departments/centers (e.g. Barkley Memorial Clinic) are required to complete the Information Privacy and Security (IPS) – Information for Clinicians course. Please be sure to check with your department regarding privacy and security training requirements, as additional modules may be required for those who are also conducting research. The IRB will accept either the IPS- Information for Clinicians course (must include the supplemental modules specific to research) or IPS-for Researchers course.
- Good Clinical Practice (GCP) course only if the project has NIH funding and the IRB project meets the NIH definition of a clinical trial.
- Two courses are available: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP for Social and Behavioral Research Best Practices for Clinical Research. The course most related to the research must be completed.
Additional Information about CIRT
As of January 10, 2022, the University of Nebraska-Lincoln Institutional Review Board began providing access to a new training program for community-engaged research. CIRT, or Community Involvement in Research Training, is tailored to meet the unique training needs of community research partners.
In community-engaged research, sometimes referred to as community-based participatory research (CBPR), academic researchers collaborate with partners from non-academic settings including community agencies, health care delivery organizations, public health departments and schools.
IMPORTANT NOTE: CIRT is NOT an alternative to the CITI training courses required for faculty, students and most staff conducting human subjects research at UNL.
CIRT is focused on skills-building and is relevant to the roles and responsibilities community partners may have in research projects. It is important to note that while the audience of CIRT differs, it is no less robust than CITI training. The content considers community partners’ potentially limited experience with research, addresses research ethics and responsible conduct of research issues in plain language, and uses real-world examples.
- CIRT is currently available in both Spanish and English.
- For rural and remote community partners with limited internet access, the curriculum can be printed and utilized for in-person training by the PI.
CIRT Registration
Enroll for CIRT at: https://training.ccts.uic.edu/RegisterType.
- Click on the box “I am not from UIC.”
- Complete the information and on the box next to the “Site” click on the words, “Please select a site” to see a drop-down menu. Scroll down to the University of Nebraska-Lincoln.
- Once you have registered, you will be able to go through the CIRT modules.
- You can pause at any time in the training and log out. When you log back in, you will be able to pick up where you left off. At this time, the training is modular and can be completed multiple sessions, but the modules must be completed in order.
Documentation of Training Completion
NuRamp, CITI, and CIRT are not electronically linked. Training completed by all users is manually recorded and maintained via NuRamp by Research Compliance, Integrity, and Security staff and is updated at least every 48 hours during business days if not more based on individual deadlines. Your training will not appear in NuRamp immediately after completing a course. Please feel free to contact the Research Compliance, Integrity, and Security staff at irb@unl.edu if after 48 hours your training still does not appear in NuRamp.
Note: Projects can still be submitted to the Research Compliance, Integrity, and Security office to begin official IRB review even if training is not accurate within NuRamp. RCIS staff will verify training or notify the research team if training must be completed for all new form approvals.
Documentation of CITI:
- A CITI Basic course must always be taken before a CITI Refresher course can be accepted. If you do not have a record of previous course completion, nor can RCIS staff find records via CITI, you will not receive previous credit.
- 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.
Remember:
- 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 or advisor.
Documentation of CIRT:
For community partners who will be a part of the research team, UNL IRB coordinators will be able to access the training information on the CIRT website to confirm course completion.
Within the NuRamp New Project Form or Change Request form for non-exempt projects, the process to add the community partners who will be participating in the research project and completing CIRT is as follows, as applicable:
- In a New Project Form, check section 1.4 of the protocol as Yes. In section 1.4.a., list the names of the community partners and their respective agencies.
- In a change request form, please list the names of the community partners and their respective agencies in the description of changes.
For projects reviewed as exempt, the list of community partners and their completed training should be maintained by the research team as part of the research record.
