Please note that no physically invasive studies will be allowed at NDNU. Similarly, NDNU IRB will reject any proposal that places the mental/ emotional well-being of participants at jeopardy.
Non-Exempt Research (Needs IRB Approval):
Any research, inclusive of surveys that involves minors, prisoners, clinical populations, inclusive of any clients in any therapeutic setting/relationship with a potential researcher, and any other vulnerable populations, such as older adults, should undergo IRB review. A completed proposal, including an informed consent form and debriefing statement should be provided. If data can be linked to a participant's identity, and thus, there is lack of anonymity or confidentiality and/or if there is explicit or implicit coercion, inclusive of a therapeutic relationship, IRB review would be required. § 46.117.
Researcher needs to ensure the rights of elder population who may be under conservatorship (i.e. family member who is legally responsible for decision-making) are upheld. Informed consent must be obtained from both parties. In addition, for minors in cases where informed consent is required, both the parent/guardian and child should sign the consent form.
IRB review of a proposed study may be full or expedited depending on the nature of the study.
- Expedited Review: Any study entailing any form of manipulation whereby participants are exposed to a form of experimental or non-experimental manipulation (such as viewing a film, playing a video game, observing a behavior, or reading a text) that in some way alters their perception or behavior from how they were prior to participation in the study falls under non-exempt status. Expedited review entails consultation with and approval of the supervisor of the research, who will then arrange a meeting with one member of the IRB to review and potentially approve the proposal (1-2 week turnaround). In the event the IRB committee member is unsure or uncomfortable about approval, he or she may consult with one or more committee members prior to approval. A summary of the Expedited Review Process follows:
- One committee member will review and approve a proposal, after the supervisor, faculty research advisor, and course instructor have read, approved, and signed off on the research project (See Application Cover Page, Non-Exempt Checklist, and Project Details). Please reference the IRB Dates for submission dates and anticipated turnaround time (typically 1-2 weeks).
- Anyone requesting expedited review must first contact the IRB Chair, who will then solicit a committee member to review the proposal(s).
- Submit one original and two copies of the Application Cover Page, Non-Exempt Checklist, and Project Details, with the original to be kept by IRB.
- In expedited review (as per federal guidelines) if there is conflict of interest, an additional (different) IRB member reviews proposals for approval. The IRB grants one member the decision-making and approval power of any proposals undergoing expedited review. Thus, in the case of conflict of interest by an IRB member for expedited review (i.e. if the IRB member is the faculty advisor and/or has other vested interest in said research project) he/she cannot approve said proposal. In such a case an alternate IRB member will be appointed by the IRB Chair and reserve IRB decision-making status.
- Full Review: Any research with vulnerable populations, including children (< 18 years of age), pregnant women, the elderly (> 65 years of age), the homeless, veterans, patients/clients in hospital, health, clinical settings, anyone undergoing any form of physical, emotional, mental treatment, or duress or any study which entails invasive/probing procedures (mental, physical, emotional) or any non-mild form of manipulation with participants requires a full IRB review.
Additional requirements of the full review process follows:
- Written informed consent and debriefing forms are part of the full proposal, as well as the materials used in the testing/data collection phase (including surveys, assessment tools, stimuli, and procedures).
- One original and seven copies of the Application Cover Page, Non-Exempt Checklist, and Project Details letters and materials, should be submitted two weeks prior to the next IRB meeting (see calendar for exact due dates). The original documents and draft of the proposal will be kept by the IRB committee.
Federal policies regarding what constitutes expedited review is available in Non-Exempt Research, subheading Categories of Research that May Be Reviewed by the IRB through an Expedited Review Procedure.