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Institutional Review Board

Information and Application for Approval of Research

²ÝݮӰÊÓ, Chicago (NPU)
Institutional Review Board (IRB)

IRB Forms

The ²ÝݮӰÊÓ Institutional Review Board (NPU IRB) works independently and is comprised of at least five members who are familiar with human-subjects research, sensitive to issues of culture, race, and community attitudes, and who promote respect for NPU IRB efforts to protect research subjects. The authority of the NPU IRB to approve, require modifications in, or disapprove research derives from both federal law and institutional policy. The NPU 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 ²ÝݮӰÊÓ 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 will comply with federal regulations 45 Code of Federal Regulations Part 46 (45 CF$ 46). Our Federalwide Assurance (FWA) number is 00031514. (Expires 7/22/2026)

Procedure, Review, and Responsibility

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. Collaborative Institutional Training Initiative (CITI). CITI is a consortium to which ²ÝݮӰÊÓ subscribes and students, faculty and staff can obtain Human Research Subject training free of charge when they identify their affiliation with ²ÝݮӰÊÓ upon registering for CITI Account Access at the CITI site. The certificate of training should be attached to the completed .

Instructions for registering for CITI Account Access may be found on the IRB Forms page.

Whenever NPU 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 .

The NPU IRB will determine first if the application falls under its purview; if it does not, or if it is for some reason exempt from NPU 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; or 2) provisionally approved pending clarification, completion, and/or recommended changes; or 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 the reason(s) given.

Submission of Application

The application should be submitted to the chair of the NPU IRB at least ten days prior to a regularly scheduled meeting of the NPU IRB. You may contact the NPU IRB chair for the schedule of regular meetings.

Exemptions

Classroom projects designed to teach students about research are exempt as long as they are not being presented outside of the classroom; this includes not presenting information online through blog posts etc. Please complete the Classroom Research IRB Form.

Research on your own teaching or pedagogical research is also often, though not always, exempt. However, it is the IRB that makes this determination and the researcher must complete an IRB Exempt Application.

There are other categories of research that are exempt from continued IRB oversight, but all require the researcher to complete an exempt application and the IRB to make the determination. Any research with prisoners is never able to be exempt and research with minors (<18 years old), or pregnant women is rarely able to be exempt and depends on the exempt category.

Expedited Review

In certain circumstances the application may be eligible for an expedited review. If it does, it will be reviewed by the chair of the IRB and at least one other experienced member of the committee. Expedited reviews can be rejected, recommended for full review, or accepted. Expedited reviews will be conducted within 14 days from the date 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.

Below is a summary of the type of proposals approved by the ²ÝݮӰÊÓ IRB over the past four years:

 

Academic Year	Exempt	Expedited Review	Full Review
2017–18	5	16	2
2018–19	5	16	1
2019–20	12	7	3
2020–21	11	6	2
2021–22	5	8	0

Duration of Approval

Applicants will be informed of approval by written notification. The approval is valid for one calendar year from the date on that notification. The applicant has an obligation to inform the IRB chair 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 duration of the study, and there are little or no modifications, an expedited application should be submitted to the IRB chair at least one month before the approval expires.

Next Steps

the application and other IRB forms.

Contact the IRB Chairperson

Financial Conflict of Interest

The , establishes guidelines for disclosure of Significant Financial Interests and management of resulting Financial Conflicts of Interests in research, sponsored programs, and technology transfer activities at the University.