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Institutional Review Board

Information and Application for Approval of Research

North Park University, Chicago (NPU)
Institutional Review Board (NPU IRB)

Introduction: History, Function, Authority

History and Background

Following World War II, international standards were developed for the protection of human research subjects. International and national studies and declarations followed. Then, in 1974 the United States Congress enacted the National Research Act, establishing the Institutional Review Board (IRB) system. The evolving IRB standards are now codified under the Department of Health and Human Services (DHHS) in Title 45 Part 46 of the Code of Federal Regulations. Other federal agencies, including the Food and Drug Administration (FDA), have established specialized standards as well. Further, non-governmental professional guilds (e.g., the American Psychological Association) have codes of ethics to protect subjects of research.

Function, Authority, Policies, and Procedures

Institutional review boards at major research-oriented universities may be large and multifaceted, dealing continuously with many proposals, which may be complicated, elaborate, and formidably funded. At North Park, proposals typically involve behavioral and social science research, but may also involve limited biological research. The NPU IRB uses one standard application process for research involving human and/or animal subjects.

At North Park various departments, schools, or faculties (e.g., education) may have their own IRB committees, which fulfill special requirements for their particular disciplines. Such internal IRB committees function separately from and cooperatively with this institution-wide board, which is differentiated by the unique designation, North Park University Institutional Review Board (NPU IRB). Because the NPU IRB is established by the North Park University Board of Trustees as the only institution-wide IRB body, all research studies involving human and/or animal subjects must obtain NPU IRB approval in advance and following NPU IRB policies and procedures. Any actions by any other internal IRB's must be reported on the NPU IRB application form. Action on any research application by the NPU IRB takes precedence over actions by other IRB's. However, the NPU IRB respects the decisions of other IRB's and will not approve research that has been disapproved by any other IRB.

The 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. Applications that have been approved by the NPU IRB are subject to review and disapproval by university officials, but those officials may not approve applications that have been disapproved by or are in process with the NPU IRB. If a member of the NPU IRB is also the principal investigator or has some other conflict-of-interest with a research application, that member will not participate in the application review or decision except to provide information as requested.

Background, Policies, and Procedures

Purpose

Institutional review boards in United States universities exist to safeguard the rights and welfare of subjects of research. For the same purpose, the North Park University Institutional Review Board (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.

Exemptions

Since NPU curricula include the teaching of research methodologies, principles, and ethics, it is understood that course research projects will be used as part of classroom instruction and training. Such course projects are exempt from NPU IRB application and approval providing that all of the following apply:

  • The aim of the project is to teach and not to contribute to generalizable knowledge or to publish or to report the research outside of the relevant NPU courses and classrooms;
  • Confidentiality is strictly observed in such a way that no individual personal identifying information on subjects can be linked to data collected;
  • The subjects are NPU students or personnel; and
  • The faculty responsible for the research project observe applicable laws and regulations as well as the ethical standards of their professions and any other applicable policies of NPU.

Upon request, the NPU IRB will respond to questions in advance on whether or how the above may apply to a particular proposed course research project; this is offered to assist consideration of whether an application for NPU IRB approval is required or appropriate.

Procedure, Review, and Responsibility

Applicants must provide a certificate of course completion for protection of human research participants issued by one of two agencies: the National Institutes of Health (NIH) or from the Collaborative Institutional Training Initiative (CITI). The latter is a consortium to which North Park does not belong, but we will recognize the certificate of completion. The NIH program is free. The certificate should be attached to the completed application.

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 application.

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.

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. The procedures for expedited review require the applicant to complete sections 2.1.1 through 2.2.4 of the application form. In lieu of section 2.2.2, the applicant should submit a one to two page abstract explaining the purpose, procedures, subjects, and reason the study is eligible for expedited review. Expedited reviews can be rejected, recommended for full review, or accepted. As with full reviews, committee members will exempt themselves from reviews with which they cannot be impartial. 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.

Records

Records of the NPU IRB will be kept confidentially at the office of the NPU academic dean, including but not limited to: applications and attachments thereto; executed consent forms, waivers, and authorizations; documents and minutes as they relate to applications submitted to the NPU IRB. All records filed with the office of the dean are the property of North Park University.

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. 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

Download the application and other Institutional Review Board forms.

Contact the IRB chairperson.