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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.

Contacts

IRB Protocol Application and Instructions

Thoroughly review the application instructions 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
IRB Protocol Application

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

Either of the following satisfy initial training requirements and meet the National Institutes of Health (NIH) education requirements.

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.
NIH online training
If you have previously completed the training module and are having difficulty obtaining a new certificate:

  1. Log in to the course at: http://phrp.nihtraining.com/index.php
  2. Click the link labeled "Edit User Info" on the Main Menu page
  3. Click the button labeled "Retake Course".

NOTE: After completing the training, a certificate is issued. A copy of the certificate must be attached to the IRB application. You are strongly advised to retain a paper copy of the certificate for your records. The IIT IRB Office does not issue certificates of training completion.

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.

Deadline for Submission IRB Meeting Date Time Room
10/26/2016 11/15/2016 1:00 TBD
11/30/2016 12/20/2016 1:00 TBD
12/21/2016 1/17/2017 1:00 TBD
1/25/2017 2/21/2017 1:00 TBD
2/22/2017 3/21/2017 1:00 TBD
3/29/2017 4/18/2017 1:00 TBD
4/26/2017 5/16/2017 1:00 TBD
5/31/2017 6/20/2017 1:00 TBD
6/28/2017 7/18/2017 1:00 TBD
7/26/2017 8/15/2017 1:00 TBD

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 in the IRB office for a scheduled meeting and there are no administrative issues to be discussed, the meeting will be canceled.

Clinical Trials

Reminder: Clincial Trials reporting as required by federal regulation:

If you are conducting a "clinical trial," you are responsible to REGISTER your study at the website, ClinicalTrials.gov, which is  registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

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 goverment website ClinicalTrials.gov.

The International Committee of Medical Journal Editors (ICMJE) requires, and recommends that all medical journal editors require, as a condition of consideration for publication, registration of [all] clinical trials in a public trials registry at or before the time of first patient enrollment.

To obtain a login/password to access ClinicalTrials.gov for your IIT study, please email Mariam Othman at IRB@IIT.EDU.

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

Educational Materials for Research with Human Subjects

If you would like to stop by and review these materials, please contact the Executive Officer of the Institutional Review Board at 312.567.7141 or at irb@iit.edu.

Web

Office for Human Research Protections (OHRP)
http://www.hhs.gov/ohrp/
Code of Federal Regulations, Protections of Human Subjects (45 CFR 46)
http://www.hhs.gov/ohrp/humansubjects/guidance/
The Belmont Report:
http://www.hhs.gov/ohrp/policy/belmont.html

CD

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

Video

"Protecting Human Subjects" - all on one video

    • Evolving Concern - Protection for Human Subjects (22 minutes)
    • Balancing Society's Mandates - IRB Review Criteria (36 minutes)
    • The Belmont Report - Basic Ethical Principles and Their Application (28 minutes)

    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.
    ORCPD Director: Glenn Krell, 312.567.7141 or irb@iit.edu.
    ORCPD Coordinator: Mariam Othman, 312.567.5757 or mothman@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.