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Human Subjects (IRB)

Protocol for Bringing Human Subjects to IIT (Illinois Tech) for Research Studies

In an effort to support research involving human subjects, with respect to the state of Illinois and Illinois Tech’s progressively relaxed COVID-19 safety precautions, the Office of Research has redeveloped procedures for restoring the option for investigators to invite human subjects to visit campus to participate in research.

Our primary goal continues to be the minimization of COVID-19 risks to the health and safety of our human subjects and the research team members, while preserving the highest level of scientific integrity of the research protocols – note, in order to bring human subjects to campus, you must have an active IRB-approved protocol.

However, our overarching goal going forward is to bolster institutional research activity involving human subjects while maintaining a work environment where IIT recommended COVID-19 safety precautions can be practiced. (Guidance document)

The Institutional Review Board (IRB) reviews research proposals that involve human participants. Even those with minimal participation, such as surveys or questionnaires, require some procedural IRB review. Please submit an email to if you have any questions or would like to submit an application for review.

IRB Submissions

All submissions to the IRB are routed through Cayuse IRB.

Initial IRB SUbmissions

To create an Initial Submission, access Cayuse IRB by following these steps:

  1. Access the myIIT portal and enter your login credentials. After logging in, click on the Research tab.
  2. Locate the Cayuse Research Suite channel in the middle column of the Research tab. Click on Cayuse Research Suite. You will be directed to a new window. Locate the Research Administration Modules heading and click on Cayuse IRB (Human Studies Compliance). The Cayuse IRB Dashboard will appear.
  3. In the upper-right-hand corner of the Dashboard, click the blue box labeled New Study. Enter the Study Title, then click the blue check mark on the far right-hand side of the screen.
  4. A red banner labeled Unsubmitted will appear above the Study Title. For funded projects, click Link Proposal to attach a record from Cayuse SP to the IRB submission. For unfunded IRB projects, click on New Submission in the upper-right-hand corner, then click Initial Submission. To begin filling out the Initial Submission template, click Edit below the red banner labeled Unsubmitted. The submission template will guide you through each question.
  5. If you require assistance with the initial submission form, click on the in-application help icon located at the bottom-right-hand corner of the screen. The help icon is an orange circle with a question mark.

If you do not have access to Cayuse IRB, please send an email to  

Human Subject Training

IIT requires all individuals involved in the conduct of human subjects research to complete initial human subjects protection training. IRB approval will be withheld if these training requirements have not been met.

These requirements apply to all persons with a significant role in the research, such as:

  • Principal Investigators, Co-investigators, other IIT researchers, and
  • Individuals who obtain informed consent from prospective participants in research.

NOTE: Responsible Conduct of Research (RCR) courses DO NOT satisfy the human subject training requirement. The human subjects courses available through CITI that satisfy the requirement are: Social & Behavioral Research Investigators and Biomedical Research Investigators. These courses are listed under Question 1 during the CITI registration process (see #7 below under NEW CITI REGISTRANTS and #4 under RETURNING CITI REGISTRANTS).

Initial Training

CITI Program is IIT's exclusive provider of research compliance and ethics training. The university maintains an organizational subscription that may be accessed by all members of the research community. CITI courses may be accessed through the myIIT portal. To complete required human subjects training, complete the steps below through CITI.

New CITI Registrants

If you do not have an account with CITI, follow these steps to establish one affiliated with the university:

  1. Access the myIIT portal and enter your login credentials. After logging in, click on the Research tab.
  2. Locate the CITI Training channel in the middle column of the Research tab. Click on Access CITI Training Courses. You will be directed to a new window.
  3. Enter your myIIT credentials again and click the Login button. Please be sure that your email address in CITI is the same email address that you use at IIT. 
  4. Agree to the Terms of Service and Privacy Policy. Select an information release consent duration and click the Accept button to continue.
  5. Select ”I don't have a CITI Program account and I need to create one.”
  6. Click on the Create A New CITI Program Account button. Your account will be created.
  7. Click on the View Courses button under the Institutional Courses- Illinois Institute of Technology section. Select Add a Course to add CITI training courses to your account. Question 1 allows you to select which human subjects training course pertains to your research. For biomedical researchers, select the Biomedical Research Investigators course. For social and behavioral researchers, select the Social & Behavioral Research Investigators course.
  8. Select appropriate responses for all additional questions that pertain to your research. When finished, click on the Submit button.

Once you have established an account, you may complete the human subjects training course. Retain a copy of your completion record upon successful completion of each course.

Returning CITI Registrants

If you already have an account, follow the steps below to complete human subjects training:

  1. Access the myIIT portal and enter your login credentials. After logging in, click on the Research tab.
  2. Locate the CITI Training channel in the middle column of the Research tab. Click on Access CITI Training Courses. You will be directed to a new window.
  3. Enter your myIIT credentials again and click the Login button.
  4. If you have already added one of the available human subjects training courses to your profile, select the course from the list and complete all of the modules. If you do not have any human subjects training courses listed, click Add a Course under "My Learner Tools for Illinois Institute of Technology." Select a human subjects training course under Question 1 pertinent to your research, then click Submit. Then, select the course from Illinois Institute of Technology Courses and complete all of the modules.

Retain a copy of your completion record upon successful completion of each course.

Previous Training

If training was completed at another institution, please send a PDF of the training certificate to to determine whether it meets IIT’s training requirements.


Recertification is required every 3 years.

CITI Basic Course

Please note that a CITI refresher course may fulfil this requirement up to 3 times, and then the CITI basic course will be required at the next recertification.

Institutional Review Board (IRB) Meetings and Deadlines

Please review the IRB submission deadlines and full committee meeting dates below. NOTE: these dates apply for IRB applications that require full committee review only. Exempt and Expedited applications are reviewed on a rolling basis.

Fall 2021 - Spring 2022 Meetings and Deadlines

Deadline for Submission

IRB Meeting Date




12.50 PM



12:50 PM



12:50 PM



12:50 PM



12:50 PM


Deadline for submission is 5:00 pm on the date indicated and will be strictly enforced. If you miss the deadline, your IRB submission will be reviewed at the following scheduled meeting. If your project is reviewed by the full committee, you must attend the IRB meeting to present your application. Your presentation should be 3 - 5 minutes long. No additional materials are necessary.

If no IRB applications are received for a scheduled meeting and there are no administrative issues to be discussed, the meeting will be canceled.

Clinical Trials

NIH Definition

Note: The NIH defines "clinical trial" broadly. Please review the NIH Notice of Revised Definition of "Clinical Trial" for more information.

Not sure if your study is defined as a "clinical trial?" Access the NIH clinical trial decision tool.

If your study qualifies as a "clinical trial," you must register your study on the website,, which is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Based on the new definition of a "clinical trial," your study may be impacted by these regulations, even if you are not conducting the study in a clinical setting. The NIH website provides a summary of the new definition to help investigators determine if their study qualifies as a "clinical trial."

FDA Definition

Section 801 of the Food and Drug Amendments Act, known as FDAAA 801, requires registration of studies meeting the definition of "Applicable Clinical Trial" on the website

To obtain a login/password to access for your IIT study, please submit the Request Form. Note that IIT's Organization name is "IllinoisIT" for this website.

More information on the federal requirement for clinical trials is here.

Decision Tools

Decision Tool: Am I Doing Human Subjects Research? |

Research Involving Private Information or Biospecimens - Decision Tree

Decision Tool: Is my study defined as a "clinical trial?" Access the NIH clinical trial decision tool.

Educational Materials for Research with Human Subjects

If you are interested in reviewing these materials, please contact the Executive Officer of the Institutional Review Board at 312.567.7141 or at

Is My Research "HUman SUbjects" Research?

If you are unsure if your research involves "human subjects" as defined by the federal regulations, the Definitions of Human Subject Research will help you.

Research involving private information or biological specimens provided by an outside source (such as a commercial provider) may be considered "human subjects" research. Consult the decision tree to determine if your project is considered "human subjects" research. Note that the IRB still bears the final responsibility in determining whether a research project is considered "human subjects" research or otherwise exempt.

For research protocols funded by the NIH, if you answered "No" to the question "Are Human Subjects Involved?" additional resources are available on the NIH Grants website. If you need additional assistance with grant proposals, please contact the Office of Sponsored Research and Programs.


Office for Human Research Protections (OHRP)
Code of Federal Regulations, Protections of Human Subjects (45 CFR 46) 
The Belmont Report:


"Protecting Human Subjects" - click the links below to view each video

Important Links

IIT Policy for the Protection of Human Research Subjects
IIT Handbook of Procedures for the Protection of Human Research Subjects


IRB Chair: Indika Edirisinghe
Executive Officer - IRB Office:

IIT's federal wide assurance number is 00001463

Human Protections Information From OHRP

The Office for Human Research Protections (OHRP) encourages all members within the research/IRB community to consult with OHRP on matters of human subject protections.
The toll-free number is 866.447.4777.