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Institutional Review Board (IRB)

Ottawa University’s Institutional Review Board (OU-IRB) governs research involving human participants. For animal research, OU’s Institutional Animal Care and Use Committee (IACUC) governs the educational uses of animals (including research) by faculty and students, ensuring compliance with federal, state, and local mandates for animal research.

The OU-IRB prioritizes safeguarding the rights and well-being of research participants while scrutinizing, granting authorization for, and any research human research conducted. Governed by federal regulations, the OU-IRB serves as a crucial initial checkpoint for Ottawa University faculty, staff, and students who intend to engage in research, whether on or off-campus. 

OU IRB and the Belmont Report

Ottawa University’s research policies pertaining to human subjects are guided by The Belmont Report, an official federal government document. This report assigns investigators conducting research involving human subjects the duty to demonstrate three core principles: respect for persons, beneficence (maximizing benefits while minimizing risks), and justice. 

These policies are grounded in the following fundamental principles: 

Voluntary Participation: In any research project, participation must be entirely voluntary, ensuring individuals freely choose to take part. 

Risk-Benefit Assessment: The assessment of risks associated with participation must be deemed acceptable when weighed against potential benefits for participants or the significance of the knowledge gained. 

Qualified Supervision: Research and training endeavors involving human subjects must be under the supervision of a qualified individual who possesses the requisite expertise. 

IRB Approval: Before commencing the research protocol, all research programs involving human subjects must undergo review and approval by Ottawa University’s Institutional Review Board (OU-IRB). 

Ongoing Compliance: In accordance with Federal Regulations, certain research may necessitate annual continuation assessments such as longitudinal research, clinical trials, studies with vulnerable populations, research on sensitive topics, investigations with changing risk profiles, or research funded by certain agencies. 

It is important to emphasize that these principles are applicable to all research involving humans, extending beyond clinical research and irrespective of whether the research receives funding. 

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: 

Classroom Research: 

  • 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. 

Data Sets: 

  • The analysis of de-identified, publicly available data falls outside the scope of human subjects’ research as defined by federal regulations and does not necessitate OU-IRB review. 

Oral History: 

  • 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 irb@ottawa.edu.  

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.

Submission to the OU-IRB 

Ottawa University's Institutional Review Board (OU-IRB) submission process is designed to comply with all relevant statutory and regulatory requirements while effectively accommodating various research submissions to the OU-IRB. 

Researchers conducting research involving human subjects at Ottawa University are required to follow specific procedures. They must submit a request to the OU-IRB using either  

OU-IRB Form 1 (Request for Exemption from IRB Review)  

OU-IRB Form 2 (Research Project Approval Request) 

Additionally, any proposed changes to the initial application must be submitted for IRB approval using OU-IRB Form 3 (Protocol Amendments Request). 

Upon receiving these application documents, the Chair of the OU-IRB will assess whether the research project has been submitted through the appropriate channels, qualifies for exemption from OU-IRB oversight, or requires either expedited or standard review. 

Some classroom research projects, due to their limited scope, impact, and public visibility, may not necessitate OU-IRB review. In such cases, the role of the OU-IRB is to oversee the receipt of applications from students and grant approval to projects that satisfy all the conditions outlined in OU-IRB Form 4 (Classroom Research Project Approval Request). This form must be submitted to the OU-IRB. 

While the OU-IRB provides Form 4 for classroom use by Ottawa University's faculty, the application process for classroom research projects is not governed by the OU-IRB. Instead, this responsibility is delegated to the course instructor, as detailed in OU-IRB Form 4. 

Review the IRB Policy Procedures Document for further information on the submission process to the OU-IRB. 


Submission to the IACUC 

The process for reviewing and approving animal research typically includes: 

  1. Proposal Submission: Researchers who plan to use animals in their research projects must submit a detailed proposal to the IACUC. This proposal outlines the research objectives, methods, the number, and species of animals to be used, housing and care arrangements, and the measures taken to minimize animal discomfort and suffering. 

  1. IACUC Review: The IACUC reviews the proposal to ensure it complies with ethical and regulatory standards for the use of animals in research. This review includes an assessment of the scientific and ethical aspects of the study. 

  1. Site Inspection: In some cases, the IACUC may conduct a site inspection to verify the animal housing and care facilities meet required standards and the proposed procedures are feasible and humane. 

  1. Ethical Considerations: The IACUC assesses the ethical aspects of the research, including the necessity of using animals, the potential benefits of the research, and the steps taken to minimize harm and discomfort to the animals. 

  1. Approval or Modifications: Based on their review, the IACUC may approve the research proposal, require modifications to the protocol to ensure animal welfare, or reject the proposal if it does not meet ethical and regulatory standards. 

  1. Continuing Oversight: Once approved, the IACUC provides ongoing oversight to ensure the research is conducted as approved and animals are treated ethically throughout the study. This includes periodic reviews and inspections. 

  1. Reporting and Record Keeping: Researchers are required to report any unexpected adverse events or deviations from the approved protocol to the IACUC. The committee also maintains detailed records of all animal research activities. 

The review and approval of animal research are governed by various laws, regulations, and ethical principles. In the United States, for example, the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals establish the regulatory framework for animal research oversight. 

Researchers conducting animal research should work closely with the IACUC and adhere to all relevant ethical and legal requirements to ensure the responsible and ethical use of animals in research. 

  1. Chair & Business School Member: Associate Professor – Dr. Stephen Weiss  

  1. School of Arts & Science Member: Director of Master of Science in Applied Psychology (MSAP) – Dr. Pilar Galiana Abal 

  1. School of Education Member: Kansas Education Licensure Specialist – Dr. Kasey Johnson 

  1. School of Business Member: Professor – Dr. Kayong Holston 

  1. Institutional Effectiveness Member: Dean of Institutional Research & Planning – Dr. Karen Ohnesorge 

  1. Library Member: Director of Library Services – Danielle O'Barto 

  1. Ex Officio Members: Associate VP of Compliance – Carrie Stevens 

  1. Chair & School of Arts and Sciences Member: Professor – Dr. Steve Boese 

  1. School of Business Member: Dean of School of Business – Dr. Marylou DeWald 

  1. School of Arts and Science Member: Associate Professor – Dr. Justin Clarke 

  1. External Member: Veterinarian – Dr. Trent Lancaster 

  1. Ex Officio Members: Associate VP of Compliance – Carrie Stevens 



I STILL HAVE INQUIRIES. WHOM SHOULD I REACH OUT TO? 

Stephen Weiss, Ph.D., CPA 
Associate Professor, Angell Snyder School of Business, OU-Online  
IRB Director, OU-IRB  
IRB@ottawa.edu 

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