Training

The topics found below will provide various learning resources for common IRB items.

If there is a topic that you would like to learn more about but do not see it listed below, please contact us at 402-559-6463 or at irbora@unmc.edu.

CITI Training

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What is CITI?

Collaborative Institutional Training Initiative (CITI) certification is an institutional requirement for all personnel engaging in Human Subject Research (HSR). It includes three primary modules that are required by the institution to participate in conducting various types of research: Group 1: Biomedical Research, Group 2: Good Clinical Practice (GCP), and Group 3: Social & Behavioral Research.

Faculty, employees, students and other institutional representatives at UNMC, Nebraska Medicine, CHMC, and UNO are required to complete the Human Subjects Research (HSR) course via CITI if they will be working on a research project that involves human subjects. It takes approximately 1-2 hours to complete a Basic course. The training does not have to be completed in one sitting, but can be spread out over time if needed.

Instructions

A PDF with instructions for how to navigate CITI can be found here.

Basic or Refresher?

The Basic course is designed to establish certification and should be taken when:

The Refresher course is designed to re-establish certification for three years and should be taken when:

Course required based on type of research:

Group 1: Biomedical Research – Investigators conducting research about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods must take this course. Types of research:

Group 2: Good Clinical Practice (GCP) – Investigators conducting clinical trials funded by NIH, or utilizing an FDA regulated drug, device, or biologic must take this course. A clinical trial is defined as “a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.

Investigators conducting these types of trials must also take the Biomedical course (Group 1).

This GCP course meets the minimum criteria for training identified by some sponsors. (Check to see if your sponsor is listed.) If so, your CITI completion report can be supplied to the sponsor to meet their GCP training requirement.

Group 3: Social & Behavioral – Investigators conducting research performed with intent to study:

Researchers/Students transferring from other institutions:

Please email all completion reports for previously completed CITI training courses to irbora@unmc.edu. CITI courses are unique from institution to institution and transcript comparison will be required. Only the completion report shows the modules required for transcript comparison. Once previous training has been updated, the IRB will determine if any additional training or Refresher courses will be required.

It is highly recommended that you email the Completion Report prior to beginning the Refresher course. Please do not send completion certificates.

Collaborators with UNMC:

Any independent entity collaborating with UNMC for the purposes of research must also complete CITI training as required by the institution. When registering for CITI, please affiliate with UNMC/UNO and do not register as an independent learner.

If you need assistance with your username and/or password from an institution other than UNMC/UNO, you can contact:

CITI Support: 888-529-5929 (9:00 a.m. to 7:00 p.m. EST/Monday – Friday).

If you have more than one CITI account, you can request that they be merged by calling CITI Support. Once merged, all training completed will be available under one account.

For all questions regarding CITI training, please contact the IRB Office at 402-559-6463 or email irbora@unmc.edu.

Community Partners

All individuals that work on human subject research projects must complete human subject research training. Faculty, students, or employees of UNMC, NM, CHMC, UNO, BMC, or another academic partner institution are required to take CITI training. Community partners who collaborate on research projects may complete the CIRTification program as an alternative to the CITI Program.


Who are Community Partners?

Community partners are non-academic personnel (e.g. community leaders, representatives from supporting community organizations) engaged in research requiring IRB approval. This program is specifically and only for community members collaborating on human subject research studies.

Who is NOT considered a Community Partner?

Students or staff affiliated with UNMC, NM, CHMC, UNO, BMC, or research staff affiliated with other private entities directly engaging in human subject research.

What is CIRTification?

CIRTification is a training program in human research protections created by the University of Illinois Chicago CCTS that is tailored to the unique roles of community research partners. It is interactive and relevant to the roles and responsibilities that community partners have in research projects. The program considers community partners’ limited experience with research, discusses key concepts in research ethics and responsible conduct of research in plain language, and focuses on applying knowledge to real-life scenarios. Ideally, CIRTification Online will not only teach community partners about the importance of protecting research participants, it will also empower them to be active contributors to their respective research teams.

CIRTification introduces learners to the basics of the research - the terminology, people, and methods. It reviews the history of research abuses that have informed current ethical principles, rules, and regulations.

The training program also covers standard and best practices for:

What can I expect?

The program takes about 3-4 hours total to complete and can be completed in multiple sessions. The course is currently available in English, Spanish, and Haitian Creole. The course includes audio, video, text, and interactive activities.

Learners will complete a knowledge quiz at the end of the program and receive a date-stamped certificate of completion. Please save a copy of this certificate for your records and email a copy to IRBORA@unmc.edu.

Online Training Instructions:

Please follow the instructions below to enroll in CIRTification. Please select University of Nebraska Medical Center only from the list.

  1. Go to https://training.ccts.uic.edu/
  2. Click “Register” in the top right-hand corner.
  3. Select “I am not from UIC”.
  4. Complete the registration form. Under “Site”, select “University of Nebraska Medical Center”.
  5. Once the form is filled in, click “Register” at the bottom of the form.
  6. Visit the Course Catalog. Information about CIRTification will appear. Click “Learn More”.
  7. Click “Enroll” to start the CIRTification course.

Frequently Asked Questions (FAQ):

Who can I contact for help?
For assistance, place contact: Megan Berger at mberger@unmc.edu
How long is this training valid?
The training is valid for three years.
How do I access my completion certificate?
After completing the quiz at the end of the training, the option to print and save a date-stamped certificate of completion is available. If for some reason you missed this or are unable to complete this step, Megan Berger can access the completed training certificate. Email her at mberger@unmc.edu.

CIRTification is funded through the University of Illinois at Chicago Center for Clinical and Translational Science and supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR002003. We encourage mention and citation of CIRTification Online in grant proposals, conference presentations, published manuscripts, and other reporting. Suggested citation: CIRTification Online: Community Involvement in Research Training. University of Illinois at Chicago, Center for Clinical and Translational Science.

Consent Forms

Recent changes to the Federal Regulations governing human subject research (the “Common Rule”) have included a focus on improving the readability of consent forms and include regulations requiring understandable language, and organization and presentation of information that facilitates understanding.

In response to these requirements, beginning October 31, 2019, consent forms must satisfy minimum readability standards. We are working on a way to receive proof of PRISM training. Therefore, until further notice, we are not requiring physical proof, but written assurance.

Though we expect to extend the standard to other sections, initially only the readability of the Invitation and Summary section will be assessed.

This section must have Flesch Kincaid reading level ≤8 and Flesch Reading Ease ≥60. Readability may be scored within the RSS application by clicking on the “Readability” button.

CFs not meeting these minimum readability measures will be returned to the investigator for modification.

To assist investigators and their staff in developing necessary skills to write effective consent forms, the PI and the person responsible for writing the consent form, must complete online training through PRISM (Program for Readability in Science and Medicine). The hour-long training covers health literacy and readability, plain language strategies and examples, and interactive editing examples and exercises.

For more information on process, readability standards, and readability tips, see below.

Readability Assessment Process:

Readability Standards:

Tips for writing readable Consent Forms:

Do Do Not
Use short sentences and use words familiar to the non-medical reader. Use medical terminology without explaining it, or use words that an 8th grader would not understand.
Refer to thesauruses and medical glossaries made for children to find alternative ways to refer to medical terminology. Use medical “jargon” or words longer than three syllables, when another word is also appropriate.
Use the second person (“you”) and note that they are asked to participate in a research study. Be personal. Use the third person (“the subject”), and avoid writing “invite” to refer to their participation.
Use pictures and graphs wherever possible. Provide information solely in large blocks of text, with long sentences.
Say “for example” or “so forth.” Say e.g. or etc.
Use tablespoons or teaspoons to refer to the measurement of bodily fluids, and spell them out. Use ml or cc to refer to volumes of bodily fluids, or abbreviate teaspoons/tablespoons.
Say “greater than” or “less than”. Use “>” or “<” or other symbols that an 8th grader might have trouble understanding at first glance.
Describe study terminology such as “randomized”, “placebo”, or “double blind”; such as “like the flip of a coin”. Use medical or study terminology without explaining it in lay terms.
Use the words “study drug” or “study regimen”. Use the terms “therapy” or “treatment” to describe drugs, devices, or procedures.
Refer to investigational drugs or devices as “experimental” or “investigational”, and that it means the FDA has not yet approved it. Refer to investigational drugs or devices as “new.”

Readability Examples and Templates:

UNMC is recommending that study teams utilize the "teach-back" method during the informed consent process for their clinical studies. This method will enhance the informed consent process, ensuring participants are well-prepared before consenting and enrolling in clinical studies.

Our aim is to empower clinical research investigators and coordinators with the tools and knowledge to ensure that research study participants are fully informed and understand all aspects of the informed consent form.

Teach-Back Tool

Ethical Responsibility in Research

The Importance of Health Literacy

"Health literacy plays a crucial role in maintaining a healthy lifestyle and making informed decisions about our health care. Yet, a report from the HHS Surgeon General in 2019 highlighted that only 12% of Americans possess proficient health literacy skills. This underscores the importance of clear communication in the informed consent process."

Reference: HHS Surgeon General Reports and Publications, 2019

The 5 T’s of Teach Back

  1. Triage: Concentrate on one topic at a time.
  2. Tools: Utilize models, written tools, posters, graphics, etc., to aid in explaining the desired information.
  3. Take Responsibility: Phrase it as, “I want to make sure I did a good job explaining…”
  4. Tell Me: Encourage the participant to express their understanding in their own words. Be specific about what you expect them to relay back.
  5. Try Again: If the participant's understanding isn't clear, revisit the topic.

Reference: Anderson, Leister and DeRego, Health Literacy Research and Practice, 2020

Evaluating Understanding with Teach-Back

E-Signature Instructions

The e-signature function in RSS is a way to electronically sign consent forms. It can be used if the consent process is conducted in person (face to face) or remotely (telephone or video as approved by the IRB). RSS e-signature can only be used for certain studies, outlined in the table below.

E-signature can only be used on newly created Narrative Consent Forms.

When can RSS e-signature be used? (as of 2/20/2024)

Study Types
FDA-regulated (drug/device) studies Yes
Non-FDA-regulated studies Yes
Commercially funded studies Yes
Federally funded studies Yes
CIRB (studies relying on an external IRB) No
Multi-site studies where UNMC is the IRB of record No

If you have any questions or would like to schedule a training session, please contact Sue Logsdon at slogsdon@unmc.edu.

IRB Training Videos

Below are training topics related to the IRB, its history, and its function. Please let these videos serve as a training tool for those new to the IRB and research fields. If you need individual assistance with specific issues, or for general information, please contact us at irbora@unmc.edu or through the RSS Message Portal.

Basics: Introduction to the Institutional Review Board (2021)

Basics: New to Human Subjects Research? (5/5/2025)

Ethical Access to Patients as Human Subjects of Research (2021)

Getting Approved by the IRB: Everything You Need to Know (2021)

Human Subject Research vs Not Human Subject Research (5/8/2025)

IRB Considerations in Research Involving Drugs and Devices (2021)

Use of the IRB Short Form (2021)

RSS Training

Guides to assist with RSS procedures:

If there is a topic that does not appear below, please contact irbora@unmc.edu


Adding Personnel

Adding Documents to an Application

Creating and navigating a New Application

Deleting Personnel

Functions within a Consent Form

How to submit an Incident Report

Navigating the RSS Dashboard

Signatures on a Consent Form

Submitting a Change Request

Using the in-person RSS E-Signature

Using the remote RSS E-Signature

Working within an Application 101

Virtual Training/Office Hours

IRB Office Hours

We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri 7am-5pm.

The IRB offers two virtual learning/training sessions each month.

Please direct questions regarding virtual training hours to the IRB Education Coordinator: Megan Berger mberger@unmc.edu or 402-559-6044