Human Subjects (IRB)

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. Whether your proposal is grant-funded or not, if you plan to work with human subjects, you will either need IRB approval or an IRB waiver.

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 questions and 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.

Decision Tools

Decision Tool: Am I Doing Human Subjects Research? | grants.nih.gov

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.

IRB Submissions

All submissions to the IRB are routed through Cayuse IRB. To create an Initial Submission, access Cayuse IRB by following these steps listed in this document. (Cayuse IRB Instructions)

If you do not have access to Cayuse IRB, please send an email to drichard1@iit.edu  

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, non-affiliates, and
• Individuals who will obtain informed consent from prospective participants in research or analyze data that have participant identifiers.

NOTE: Responsible Conduct of Research (RCR) and Conflicts of Interest courses DO NOT satisfy the human subjects training requirement, but are required in addition to the human subjects courses.

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 3 during the CITI registration process (see #7 below under NEW CITI REGISTRANTS and #4 under RETURNING CITI REGISTRANTS).

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 Illinois Tech Portal and enter your login credentials. After logging in, search for CITI Training. CITI may also be accessed by signing into OKTA and clicking on the CITI Program Tile on the My Apps page.
2.  If you are using the Illinois Tech portal, locate the CITI Training Tool by using the search bar. Click on Access CITI Training Courses. If you are using the tile on the MyApps page, you may skip this step. You will be directed to a new window.
3. Enter your Illinois Tech Portal credentials again and click the Login button.
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 “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.
8. Question 2 allows you to select which RCR training course pertains to your research. Select one of the available courses to add RCR training to your profile.
9. 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 RCR training course selected in Question 2. 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 RCR training:

1. Access the Illinois Tech portal and enter your login credentials. After logging in, search for CITI Training. CITI may also be accessed by signing into OKTA and clicking on the CITI Program Tile on the My Apps page.
2.  If you are using the portal, locate the CITI Training tool by searching for it in the search box. Click on CITI Training. If you are using the tile on the MyApps page, you may skip this step. You will be directed to a new window.
3. Enter your portal credentials again and click the Login button.
4. If you have already added one of the available RCR training courses to your profile, select the course from the list and complete all of the modules. If you do not have any RCR training courses listed, click Add a Course under "My Learner Tools for Illinois Institute of Technology." Select one of the available RCR training course under Question 2, 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 certificate upon successful completion of each course.

Previous Training

If you completed RCR training at another institution, please send a PDF of the training certificate to Office of Research Integrity and Compliance to determine whether it meets Illinois Institute of Technology requirements.

RCR Resources

Students and faculty may reference the resources below to craft RCR instruction to their specific research goals.

• NIH Requirements for RCR Instruction
• NSF RCR Policy
• Office of Research Integrity (ORI) Course: Introduction to the Responsible Conduct of Research
• Illinois Institute of Technology Center for the Study of Ethics in the Professions

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.

Meetings and Deadlines

Meetings are held every four weeks on Thursdays from 12:45 to 1:45 p. m. (CDT) starting on August 22:

Submission Deadline

For the Full Board Review the IRB requires submission of the protocol two weeks before the scheduled IRB meeting. 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, 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 affected 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 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.

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

Video

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

• Evolving Concern - Protection for Human Subjects
• Balancing Society’s Mandates - IRB Review Criteria
• The Belmont Report - Basic Ethical Principles and Their Application

Important Links

NEW RESOURCE FOR INVESTIGATORS

The Investigator Manual below is a comprehensive resource for investigators to prepare research proposals for review by the IRB. The Manual is in continual development and the link will be updated as necessary.

Please direct any questions, queries or comments to irb@iit.edu.

IIT Investigator Manual

IIT Handbook of Procedures for the Protection of Human Research Subjects

Contacts

IRB Chair: Indika Edirisinghe iedirisi@iit.edu.
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 staff on matters of human subject protections.
The toll-free number for OHRP is 866.447.4777.

Click here for a list of OHRP staff.