Close Menu

Human Subjects (IRB)

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 irb@iit.edu if you have any questions or would like to submit an application for review.

IRB Protocol Application and Instructions

Review the application instructions thoroughly prior to submitting your protocol application. Protocols intended for full committee review should be sent to the IRB office prior to the monthly deadlines listed in the link below. Protocols intended for expedited review should be sent to the IRB office at least 30 days prior to the project's anticipated start date. 

IRB Application Instructions [under review, for questions please email us at irb@iit.edu or call 312.567.7141]
IRB Protocol Application

Note: Amendments use the same application as the new protocols.

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.

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 offers several course modules targeted for specific research aims. To complete required human subjecs 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. Register your account with CITI. Type "Illinois Institute of Technology" under "Select Your Organization Affiliation." Agree to the Terms of Service and Privacy Policy, and affirm your affiliation. Click Continue To Create Your CITI Program Username/Password.
  2. Enter your personal information. Click Continue To Step 3. NOTE: You must use your university e-mail address (U-ID) so that your training may be matched with your university records.
  3. Enter your university ID (U-ID) in the User Name column. Establish a Password and Security Question. Click Continue To Step 4.
  4. Enter "USA" under Country of Residence. Click Continue To Step 5.
  5. Select all appropriate options under each question prompt. Click Continue To Step 6.
  6. Enter the required information for Illinois Institute of Technology. Click Continue To Step 7. NOTE: You must enter your institutional e-mail address in the appropriate field. Your training certification may not be matched with your university records if you do not enter your institutional e-mail address.
  7. 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 Investgitors course.
  8. Select appropriate responses for all additional questions that pertain to your research. When finished, select Complete Registration.

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. Login to CITI using your credentials. NOTE: IIT does not retain CITI user credentials. Contact CITI for assistance with forgotten usernames and/or passwords.
  2. Click Main Menu/My Courses.
  3. Click Illinois Institute of Technology Courses to expand the list of available courses.
  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 irb@iit.edu to determine whether it meets IIT’s training requirements.

Recertification

Recertification is required every 3 years for both CITI and NIH training.


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

You MUST submit your IRB application no later than forty-five (45) days prior to the start of the research.

Fall 2018 Meetings and Deadlines

Deadline for Submission

IRB Meeting Date

Time

8/7/2018

8/21/2018

1:00

9/4/2018

9/18/2018

1:00

10/2/2018

10/16/2018

1:00

11/6/2018

11/20/2018

1:00

12/4/2018

12/18/2018

1:00

SUBMISSION DEADLINE

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. All forms must be typed. You must submit an original copy. You must attend the IRB meeting to present your protocol to the Committee. Your presentation should be 3 - 5 minutes long. No additional materials are necessary.

Those applying under exempt status are required to submit an original copy at any time, and do not need to attend an IRB meeting.

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

Note: Changes have been implemented to clinical trial definitions and reporting requirements. See herefor 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, ClinicalTrials.gov, 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 here provides a summary of the new definition to help investigators determine if their study qualifies as a "clinical trial."

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

To obtain a login/password to access ClinicalTrials.gov 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.

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 irb@iit.edu.

Is My Research "HUman SUbjects" Research?

If you are unsure if your research involves "human subjects" as defined by the federal regulations, the NIH Decision Tool 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 federal grants, please contact the Office of Sponsored Research and Programs.

WEB

Office for Human Research Protections (OHRP)
http://www.hhs.gov/ohrp/
Code of Federal Regulations, Protections of Human Subjects (45 CFR 46)
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html 
The Belmont Report:
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

CD

Investigator 101: featuring Jeff Cooper, M.D., and Ada Sue Selwitz, M.A.

VIDEO

"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

Contacts

IRB Chair: Patrick Corrigan corrigan@iit.edu.
Executive Officer - IRB Office: irb@iit.edu.

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.