Institutional Review Board (IRB)
About the IRB
Valparaiso University is committed to safeguarding the welfare, rights, and privacy of all people who participate as subjects in research projects conducted under its auspices. To this end, Valpo convenes an Institutional Review Board (IRB) which reviews and oversees research protocols involving human subjects conducted by Valpo’s faculty, students, or staff, or by outside investigators using Valpo students, personnel, facilities, or data. The IRB includes both scientists and non-scientists – including a community member – who review applications using criteria designed to protect human subjects and help assure the integrity of the research project.
Guiding Principles and Regulations
The IRB operates using the guidelines of the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The Belmont Report summarizes the ethical principles that guide human subjects research: respect for persons, beneficence, and justice. It also outlines the three main components of applications: informed consent, assessment of risks and benefits, and the selection of subjects.
The IRB also adheres to the regulations of the Department of Health and Human Services (45 CFR 46, as amended and published in the Federal Register on June 18, 1991, and any subsequent amendments), and to the Assurances filed by the University with the Office of Human Research Protections (OHRP).
In 2019, the Federal Policy for the Protection of Human Subjects, or Revised Common Rule, went into effect. Compared to the previous version, the revisions reduce the administrative burden and increase protections for human subjects. The Revised Common Rule provides further guidance on how to protect the well-being of human subjects.
Required Ethics Training
Valparaiso University requires all people involved in the conduct of human subjects research to complete ethics training and to re-certify every 4 years. These requirements apply to ALL people with a significant role in the research, including but not limited to Principal Investigator and Co-investigators (faculty, staff, and students), people who recruit participants or obtain informed consent from participants, and people who gather and analyze data resulting from the research. Researchers involved with NSF-funded projects must complete the relevant “RCR/RECR” class. Ethics training must be completed PRIOR TO contact with prospective participants or handling of data collected as part of the study.
CITI Program training is available to all Valparaiso University faculty, staff, and students. CITI classes are discipline-specific. Each class consists of several modules; learners can take one or more modules at once as time allows. When you register for the program, be sure to affiliate with Valparaiso University by typing “Valparaiso University” in the menu box (we do not appear on the drop-down menu). Once a class is completed, the learner may download a certificate of completion.
Additional no-cost training materials and videos can be found at https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals.
IRB Review Process
IRB Review Process Flow Chart and Levels of Review
Please consult the flow chart for a visual representation of Valpo’s IRB review process. Please consult this graphic for a description of the four levels of IRB review and the questions to consider before completing an application. A narrative description is found on the IRB Policies, Procedures, and Forms page.
Research Determination and Review Level Screening Questionnaire
The Valparaiso University IRB uses a two-step process to evaluate proposed research studies.
The first step requires researchers to complete an online screening questionnaire to help determine whether the study needs to be reviewed by the IRB and, if it does, what level of review is necessary. Many activities that we refer to as “research” do not meet the federal definition of human subjects research that requires IRB oversight. If the project does not meet this definition, no application needs to be submitted to the IRB.
ALL researchers (faculty, staff, and students) MUST start the IRB process by completing the Research Determination and Review Level Screening Questionnaire using the link below. Researchers contacting the IRB verbally or via email will be directed to complete the Screening Questionnaire. After completing the questionnaire, you will be informed if an IRB application is needed and, if so, which one.
Applications for IRB Review
If the IRB informs you that an application is needed, the second step is to complete the appropriate online application using one of the links below. All applications MUST include the consent/assent form(s) that will be used in the study and completion certificates for ethics training for all researchers involved in the project. Please also attach other relevant documents such as survey documents, focus group discussion questions, etc.
During the review process, IRB members may contact the applicant for clarifications and/or additional information. Once the IRB has completed its review, the applicant will be informed of the IRB’s determination.
The IRB uses a checklist to guide its review of applications, helping assure that the review is comprehensive and focuses on the ethical treatment of human subjects as defined by the Belmont Report and subsequent regulations.
Faculty Role in Research Projects with Student Investigators
Student research projects follow the same process as faculty research projects, starting with the Screening Questionnaire mentioned above. Faculty supervisors must sign off on the student’s questionnaire responses before they are submitted. Additionally, if the application is subject to IRB review, the faculty member must review and approve the student’s application. By signing off on the application, faculty members acknowledge that they have educated the student about the IRB process, have guided the student through the application, and have read the student’s completed application and deemed it acceptable prior to submission to the IRB. IRB regulations do not differentiate between students and investigators that are more experienced. Therefore, the IRB will review student applications with the same scrutiny as other applications. Regardless of whether a student’s project is subject to IRB review, faculty should provide ongoing education regarding the principles of the ethical conduct of research and ongoing oversight of student projects.
Collaborative Projects/Single IRB
When a project involves data collection from more than one institution, a “Single IRB Agreement” is required. Each participating institution must agree on which IRB will oversee the entire project, regardless of the site(s) of the work. Single IRB Agreements are legal contracts between the participants. These agreements must be in place prior to any contact with human subjects and any data collection. Please contact the IRB Chair or IRB Administrator for more information.
Federal Registration Numbers
IORG: 0006339
IRB: 00007623
FWA: 00016619
Contact Information
General inquiries: valpoirb@valpo.edu
IRB Chair: michael.watters@valpo.edu