What Research Requires OU-IRB Approval?
Approval from Ottawa University’s Institutional Review Board (OU-IRB) is mandatory for all research involving human subjects conducted by Ottawa University students, faculty, or staff. If your research aligns with the criteria for research and human subjects, you must submit your research proposal to undergo the OU-IRB process.
Ottawa University mandates the approval of the OU-IRB for all Human Subjects Research aligning with the criteria outlined in Federal Regulation §46.102. Research without OU-IRB approval cannot serve as a foundation for publication, and retroactive approval is not possible.
Therefore, it is highly advisable to undergo OU-IRB review if there is any potential your research may be utilized in a future publication.
Exceptions to the OU-IRB review requirement include:
Research that will not generate generalizable knowledge (e.g., no intent for publication or conference presentation).
Research not involving children, prisoners, pregnant women, or individuals with disabilities.
Research poses minimal risk to participants, where anticipated harm or discomfort is no greater than daily life or routine examinations.
Students engaging in independent research (e.g., independent study, capstone, theses, dissertations, etc.), however, their faculty advisors are encouraged to submit an OU-IRB application. Whether an independent study is exempt depends on several factors, including the nature of the research, the involvement of human subjects, and the institutional policies and federal regulations that apply.
Many oral history projects aim to provide in-depth insights into specific historical events and actions and do not qualify as "research" per federal IRB regulations. However, oral history projects seeking to contribute to generalizable knowledge or presenting more than minimal risk to participants must undergo OU-IRB submission. Additionally, funding agencies may require OU-IRB review even if an oral history project meets exemption criteria.
In cases where research entails children (those under the age of 18), vulnerable populations (such as prisoners, individuals with impaired decision-making capacity, or those facing economic or educational disadvantages), sensitive inquiries, deceptive practices, or potentially harmful interventions, it is probable a comprehensive board review will be necessary. When involving children, the informed consent document must include a section for the child's assent and the parent's consent.
If the research falls within the category of minimal risk, involves adults (aged 18 or older), pertains to secondary data analysis, non-sensitive queries, or standard educational or cognitive assessments, the possibility of expediting the review process exists. This expedited review is conducted by the IRB Chair or a designated representative and obviates the need for a full review.
External researchers wishing to conduct human subject research at Ottawa University must adhere to federal human subject regulations. This includes obtaining approval from their affiliated IRBs. To demonstrate compliance, external researchers should electronically submit their IRB-approved protocol and Record of Review to Ottawa University at email@example.com.
Approval from an external IRB does not necessarily replace OU-IRB review, which may conduct its own comprehensive assessment of the research plan.
OU-IRB members are obligated to maintain strict confidentiality regarding all information and documents shared during the OU-IRB review process, and these confidentiality requirements are perpetual.
To further understand the relevant federal regulations, familiarize yourself with essential terms and definitions. Additionally, you can utilize the National Institute of Health’s (NIH) determination tool titled, “Decision Tool: Am I Doing Human Subjects Research?” to assess whether your study necessitates OU-IRB approval.