Institutional Review Board
The North Park University Institutional Review Board (NPU IRB) operates independently. It includes at least five members familiar with human-subjects research, sensitive to issues of culture, race, and community attitudes, and committed to respecting IRB efforts to protect research subjects. The authority of the IRB to approve, require modifications in, or disapprove research derives from both federal law and institutional policy. The IRB is established as a standing committee to review all research involving the participation or use of human and/or animal subjects whenever 1) the research uses NPU resources and/or is conducted by NPU personnel (staff, administrators, faculty) or students; and 2) the research is aimed at contributing to generalizable knowledge and is to be published or reported. The North Park IRB is registered with the US Health and Human Services (0010370). Our committee’s work is guided by the ethical principles of the Belmont Report and complies with federal regulations 45 Code of Federal Regulations Part 46 (45 CFR 46). Our Federalwide Assurance (FWA) number is 00031514. (Expires 02/25/2031)
Procedure, Review, and Responsibility
Before initiating a proposed project, investigators should complete the Does my Project Require IRB Review tool to determine whether the activity meets the federal definition of research involving human subjects and requires IRB review and approval.
The IRB will then determine if the application falls under its purview; if it does not, or if it is for some reason exempt from IRB review, the application will be returned to the applicant with notification of the assessment. If the application is reviewed, it may be 1) approved; 2) provisionally approved pending clarification, completion, and/or recommended changes; 3) returned to the submitter requiring that additional safeguards or other significant amendments be incorporated for resubmission; or 4) not approved with notification sent to the applicant with feedback. The PI is expected to use the IRB feedback to revise and resubmit the application.
Required Training
Applicants must provide a certificate of course completion for the protection of human research participants, issued by an agency that provides Human Research Subject training (e.g., the Collaborative Institutional Training Initiative [CITI]).
CITI is a consortium to which North Park subscribes, so students, faculty, and staff can obtain Human Research Subject training free of charge by identifying their affiliation with NPU when registering for CITI account access on the CITI site.
Whenever IRB approval of research is required, the person responsible for the research—typically the principal investigator (PI) — must submit a completed application. There are several components to the application.
Accessing CITI Program Training
- Go to the CITI Program.
- New users: Click Register, choose Organization Affiliation, and search for/select North Park University. Do not register as an Independent Learner.
- Create your CITI username and password, then complete the requested institutional profile information. When prompted, identify your appropriate role (e.g., faculty or student).
- Returning users: Click Log In and use your existing CITI credentials. If your institution uses Single Sign-On, select Log In Through My Organization instead.
- Once logged in, go to My Courses, locate North Park University, and click View Courses.
- If the required training isn’t listed, select Add a Course under Learner Tools and answer the enrollment questions to choose the appropriate training.
- Click Start Now and complete all required modules and quizzes. Your completion record is available under My Records.
Existing CITI users: You do not need to create another account. Log in to your existing account, then use Add an Affiliation to add North Park University. Previously completed modules may transfer when applicable.
Submission of Application
IRB applications can be submitted at any time. The general response time is two weeks for exempt or expedited reviews. For full Board reviews, the response time will be two weeks after the next Board meeting. Contact the IRB for the regular meeting schedule or find it on the IRB page in Confluence.
Exempt Review (not the same as “exempt from review”)
Exempt Review is not the same as “exempt from review”, which is determined by using the “Does My Project Require IRB Review?” tool. Additional tools to assist you in classifying your proposed study for your IRB application can be found here. However, the IRB will ultimately make this determination.
Any research with vulnerable populations, including prisoners, minors (<18 years old), or pregnant women is rarely exempt.
Expedited Review
In certain circumstances, the application may qualify for expedited review. If so, the IRB chair and at least one other experienced committee member will review it. Expedited reviews can be rejected, recommended for full review, or accepted. Expedited reviews will be conducted within 14 days of receipt.
The reasons for eligibility for expedited review may include:
- Collection of data through non-invasive procedures routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
- Research involving materials that have been collected, or will be collected solely for non-research purposes.
- Research that does not involve deception or any potential harm to the subject (either directly or indirectly).
- Continuing review of research previously approved by the convened IRB.
Results of IRB Application Review
Applicants will be informed of the results of their application by written notification from the IRB Chair. Applicants are expected to review the feedback and respond using the IRB Feedback Response Form. The completed IRB Feedback Response Form must be submitted along with the revised application (and accompanying documents) and resubmitted through the same process as the original application, but on page 2 of the application, the denied resubmission box should be checked.
If your application is approved, it is valid for one calendar year from the date of that notification. The applicant has an obligation to inform the IRB of any changes that are made to the procedures or any problems encountered that may increase the risks to subjects and/or may compromise confidentiality and the protection of subject identities. This should be communicated through submitting the Protocol Modification Form. If the applicant wishes to extend the study duration and there are few or no modifications, submit an expedited application to the IRB at least one month before approval expires.
Institutional review board forms
Not all forms on this page are necessary for your submission. If you have questions, please contact the IRB.
Does my project require IRB review?
IRB Feedback Response Form
IRB Application
Faculty Sponsor Form
Protocol Modification Form
Electronic Consent Example
Consent Form Checklist
Sample Consent Form
Classroom Research IRB Form
For more information on the North Park University Institutional Review Board, please contact the IRB via email.