Institutional Research and Course-Based Projects
The following types of institutional research do not require IRB review: internal research to evaluate institutional programs or determine institutional effectiveness, data collection and analysis for accreditation purposes, and reviews of course or instructor ratings. However, if these data are intended for publication or to contribute to generalizable knowledge, then the study requires IRB review.
All dissertation research must be submitted to the IRB for review. Students who are working on course projects that are not designed to contribute to generalizable knowledge do not need to submit to the IRB as these projects are not considered research proposals. NCU faculty and staff involved with designing course projects related to research are strongly encouraged to contact the IRB to verify that the projects will not require IRB oversight.
Unsupported Research
The following types of research applications will not be supported or approved by the NCU IRB:
- Research involving human subjects that is not in accordance with the ethical principles and requirements as set forth in the Code of Federal Regulations (45 CFR 46), the Belmont Report, and the Nuremberg Code.
- Research consisting of the implementation of behavioral, clinical, or medical interventions designed to alleviate a medical or mental health symptom or illness, if the researcher does not have a clinical license and does not have supervised training in patient care.
- If a researcher has a clinical license, the proposal can be approved provided adequate safeguards are in place to protect participants, as determined by the IRB.
- If a researcher does not have a clinical license but the researcher has completed an adequate number of supervised hours with a relevant clinical population, the proposal can be approved provided safeguards are in place to protect participants. The IRB may require a licensed clinician to be present on-site or to perform the clinical interactions with participants.
- Food and Drug /FDA studies (e.g. medical devices, drugs, and food testing)
- Research conducted with fetuses or neonates
- Research conducted with minors, of greater than minimal risk, with no potential for direct benefit to the minor
- Research conducted with pregnant women, if it involves greater than minimal risk or unknown risk to participant or fetus
- Research involving animals as subjects (NCU does not have an Institutional Animal Care and Use Committee)
Researcher Responsibilities
Researchers are responsible for compliance with this policy. Primary responsibilities include:
- All researchers must complete the NCU required Collaborative Institutional Training Initiative (CITI) course modules. These modules review rules, regulations, and the ethical practice of research. Researchers must ensure that every required and completed module within the course is current (not more than two years old) while any research is conducted at NCU. The IRB may require additional CITI modules if relevant to the research topic.
- Researchers must use the current IRB research application form. Failure to use the appropriate form will result in a return of the application without review.
- Researchers may not obtain data for purposes of conducting research without IRB review and approval.
- Researchers may not access identifiable or legally protected information unless the IRB has approved a procedure to obtain appropriate authorization from each participant. Researchers must provide evidence to the IRB that the information will be obtained in compliance with all applicable local, state, and federal laws, policies, and regulations related to privacy and confidentiality of legally protected information.
- Researchers may not contact potential participants about the research before IRB approval. For example, researchers may not advertise the study, may not discuss possible “future interest” with participants, and may not ask a third party to perform either of these roles on their behalf.
- Researchers may not conduct pilot tests without IRB approval. A pilot test involves data collection from human subjects; therefore it must be approved by the IRB before it begins.
- Researchers should conduct expert reviews of questions (or “field tests”) before IRB approval. In an expert review or field test, the researcher can ask for feedback on the clarity or applicability of data collection instruments or interview questions, but the researcher cannot ask individuals to complete the instrument or answer interview questions. If any data will be collected, even if those data will not be used in the final analyses, the study is considered a pilot test, and the IRB must review and approve that research before it begins.
- Researchers may not perform any procedure, intervention, or data collection for future research purposes and then retrospectively deem those data “archival” and not in need of appropriate safeguards to participants (including consent).
- Researchers must submit an IRB application if they intend to change or modify an approved application. The modification request must be approved by the IRB before any changes are implemented in the research.
- Researchers must contact the IRB to report any injuries, problems, or complaints from participants within 24 hours of occurrence.
- Researchers must fully disclose dual roles with sites or participants in their research application. This information is required for adequate risk assessment.
- When performing research with participants who live outside of the United States, it is the researcher’s responsibility to know and comply with local laws, research regulations, and requirements to obtain approval from the appropriate in-country ethics board. The IRB may request additional documentation as evidence of adequate compliance.
- Inclusion of NCU faculty, staff, students, or alumni as research participants may only be approved if the population of interest is NCU itself (not online learning in general), if the focus is on an internal process, if the researcher is NCU faculty or staff, and if an appropriate NCU official has granted written permission. When these criteria are met, the IRB may still require other substantive changes to protect participants.
- Researchers must submit an IRB application for continuing review of an approved IRB protocol before the expiration date on the NCU IRB approval letter if they intend to continue recruitment and/or data collection beyond the approved expiration date. If the continuing review is not yet approved by the IRB at the time of the approved expiration date, the researcher must confirm in writing that all study procedures have ceased, and all study procedures may not resume until the IRB has completed the continuing review and approved the application for an extension with a new expiration date.
- Researchers must submit an IRB study closure form as soon as data collection is complete, all participant contact has ceased, and identifiers have been removed or separated from the data set.
- Student researchers working on their dissertation may not submit an application to the IRB until the final Dissertation Proposal is approved by the committee and Chair.
- Student researchers must be enrolled in an active dissertation course with NCU while any recruitment, consent, and data collection are in-process.
Additional Responsibilities for Faculty
Faculty who are supervising research must:
- Be current (completion dates are not more than two years old) in NCU required modules and any elective and supplemental CITI training modules that apply to their own research or research they supervise.
- Review the student’s IRB application for clarity and accuracy.
- Emphasize student awareness of and compliance with all aspects of this policy.
- Review and sign students’ IRB applications and attest to their awareness of their supervisory responsibilities.
IRB Director Responsibilities
The IRB Director will:
- Ensure the IRB operates in a manner consistent with the statement of principles in section 1 of this policy.
- Assist the IRB Chair with selection of members to the Full Board.
- Assist the IRB Chair with operation of the Full Board, including facilitation of meetings when the IRB Chair is not able to be present.
- Select and supervise IRB reviewers performing minimal risk reviews that are not assigned to the Full Board.
- Oversee and document the selection of IRB membership that complies with the requirements set forth in 45 CFR 46.103(b)(3) and 45 CFR 46.107.
- Maintain written Standard Operating Procedures (SOPs) in accordance with 45 CFR 46.103(b)(4,5).
- Maintain, review, and update additional SOPs as needed to optimize the effective function of the IRB and delivery of timely reviews for researchers.
- Maintain records in accordance with 45 CFR 46.115.
- Facilitate IRB registration in accordance with 45 CFR 46 Subpart E.
- Oversee NCU’s Federal-wide Assurance documentation, compliance, renewal, updates, and requests for applicable addenda (e.g. Department of Defense).
- Appoint IRB reviewers for a term of one calendar year. The appointment is renewed at the discretion of the Director, Institutional Review Board, Dean, Graduate School, the Senior Vice President, Academic Affairs, and the Dean or Department head to whom the reviewer reports.
IRB Chair Responsibilities
The IRB chair is appointed for a term one calendar year. The appointment is renewed at the discretion of the Dean, Graduate School and the Senior Vice President, Academic Affairs.
The IRB Chair will:
- Schedule and facilitate Full Board meetings.
- Oversee completion of minutes of Full Board meetings.
- Collaborate with the IRB Director to communicate Full Board determinations to researchers.
- Coordinate review of resubmissions to verify conditions are met when the Full Board determination is “approval with conditions.”
- Assist with expedited review of minor modifications to studies previously approved by the Full Board in accordance with IRB Standard Operating Procedures.
IRB Member Responsibilities
IRB Members are appointed for terms of one calendar year. Appointments are renewed at the discretion of the IRB Chair and Dean, Graduate School.
In accordance with 45 CFR 46, the IRB members will:
- Maintain awareness of community attitudes and promote respect for the IRB’s advice and counsel in safeguarding the rights and welfare of human subjects.
- Possess professional competence in research, except in the case of the non-scientist member(s).
- Remain knowledgeable about institutional commitments and regulations, applicable laws, and standards of professional conduct and practice.
- Recuse themselves from initial or continuing review of any project in which there is a conflict of interest, except to provide information as requested by the IRB.
- Maintain working knowledge of 45 CFR 46 and approve studies only when required items are met.
- Be current (completion dates are not more than two years old) in all NCU required, elective, and supplemental CITI training modules and the PRIM&R E-ROC course.
- Adhere to the Northcentral University Code of Conduct.
Appeals Process
If a researcher believes an IRB requirement is unduly restrictive and will greatly interfere with the feasibility of the research, the researcher should first informally discuss the concern with the IRB Director. If informal resolution cannot be reached, the researcher should submit a formal appeal letter to the IRB Director. The formal appeal letter must detail rationale for concerns and support proposed alternatives with reference to applicable university policy and federal regulation (i.e. 45 CFR 46).
Appeals of expedited and exempt reviews will be reviewed and determined by the IRB Chair. Appeals for Full Board studies will be reviewed and determined by majority vote of the Full Board. IRB appeal decisions are not subject to further appeal.
Violations
Suspected violations of this policy should be communicated to the IRB Director immediately. The IRB Director will determine if a non-compliance investigation is warranted and initiate an investigation and corrective action plan when needed. Notification of initiation or findings and/or corrective action plan from a non-compliance investigation will be made to the researcher, dissertation committee Chair (when applicable), Dean and/or Director, and Dean, Graduate School. The IRB Director will notify appropriate institutional officials if made aware of violations of other NCU policies or local, state, or federal laws or regulations.
Corrective actions for IRB noncompliance may include, but are not limited to:
- Establishment of more frequent continuing reviews of IRB approved research
- Suspension or termination of IRB approved research
- Referral for a suspected Code of Conduct violation
- Restriction of access to sites or participant groups affected by noncompliance
- Other appropriate actions as determined by the IRB Director and/or Full Board
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