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, 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. Training must be completed before a protocol can be approved by UNL’s Institutional Review Board (IRB) and must be maintained during the life of the project. Additionally, a refresher course must be completed no less than once every three years. Please review UNL HRPP Policy #3.009: Required Training in the Protection of Human Participants here.
Mandatory education of research personnel is consistent with NIH policy, which requires training of key project personnel as a condition of proposal award, and with the recommendations of the AAU Task Force on Research Accountability. UNL’s Human Research Protection Program Policies & Procedures require that all UNL research with human subjects, regardless of funding source, abide by the Belmont principles of respect, beneficence, and justice and the federal regulations at 45 CFR 46. Further, it states that UNL will provide initial and continuing education to personnel conducting research with human subjects to help ensure that these ethical standards are met.
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 towards meeting this joint responsibility. To assist in this process, UNL has subscribed to the Collaborative Institutional Training Initiative (CITI), owned by the Biomedical Research Alliance of New York (BRANY), which offers a self-paced, web-based tutorial.
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 to ensure training information is accurate within NUgrant (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. 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, so your training may not appear in NUgrant immediately after completing a course. Please feel free to contact the Research Compliance Services staff at irb@unl.edu if after 48 hours your training still does not appear in NUgrant.
- A Basic course must always be taken before a Refresher course can be accepted. If you do not have a record of previous course completion, nor can RCS staff find records via CITI, you will not receive previous credit.
- We will accept Group 1 (biomedical) or Group 2 (social/behavioral) courses, 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.
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.
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 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 (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 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 NUgrant 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 RCS staff verify that your course completion record is added to the correct account within NUgrant.
- 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 Services 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 Basic course has been completed.
Note: The following courses are not required to be completed for Human Subjects Research training, nor will they be accepted for this requirement:
- IRB Reference Resource
- Single Institutional Review Board (sIRB) Use and Administration
- You are only required to complete the Stem Cell Research course if instructed to do so.
- You are only required to complete the Responsible Conduct of Research (RCR) Course if instructed to do so.
- You are only required to complete the Export Control Course if instructed to do so.
- You are only required to complete the Information Privacy and Security (IPS) – Information for Researchers course if instructed to do so. 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.
- You are only required to complete the Good Clinical Practice (GCP) course 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.
REGISTERED USER 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 will be able to add a new email address that allows 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 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 NUgrant 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 Services 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.
Note: The following courses are not required to be completed for Human Subjects Research training, nor will they be accepted for this requirement:
- IRB Reference Resource
- Single Institutional Review Board (sIRB) Use and Administration
- You are only required to complete the Stem Cell Research course if instructed to do so.
- You are only required to complete the Responsible Conduct of Research (RCR) Course if instructed to do so.
- You are only required to complete the Export Control Course if instructed to do so.
- You are only required to complete the Information Privacy and Security (IPS) – Information for Researchers course if instructed to do so. 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.
- You are only required to complete the Good Clinical Practice (GCP) course 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.