Institutional Review Board (IRB)
Statement of Purpose
Valparaiso University is committed to safeguarding the welfare, rights and privacy of all persons who participate as subjects in research projects conducted under its auspices, and to ensuring that the subjects of such research are aware of the rights and the protections available to them. Moreover, the University is required to assure the federal government that such safeguards are being provided and enforced for all federally funded grants. These safeguards derive from the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.
The Institutional Review Board (IRB) is the body charged with reviewing and approving all proposed research involving human subjects, whether funded or not, conducted under the auspices of Valparaiso University by its faculty, students or staff, or by outside investigators using Valparaiso University students, personnel, facilities, or data collected at the University.
The IRB is comprised of professionals trained in IRB rules, research ethics, and other related matters. The IRB includes both scientists and non-scientists all of whom review applications using specific review criteria designed to protect human subjects and help assure the integrity of the research project.
Research Regulations and the Revised Common Rule
The procedures the IRB uses adhere 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).
On January 21, 2019, the Federal Policy for the Protection of Human Subjects, or Revised Common Rule, went into effect. The explicit goal of these revisions is to reduce administrative burden and better protect subjects in the modern research context. The Revised Common Rule includes significant changes that include new consent requirements, a new “limited review” category, a new definition of research, and new categories of exempt research. The full Revised Common Rule is available on the OHRP website. Researchers should note that the Revised Common Rule reduces the types of research subject to IRB oversight compared to the previous rules. Therefore, if you are conducting a project that previously was subject to IRB oversight, a similar project proposed today may or may not require IRB oversight under the new rules. Please use the Questionnaire below to help you determine whether IRB review is needed and, if so, what type of review is needed.
Valparaiso University requires all individuals involved in the conduct of human subjects research to complete human subjects protection training and to re-certify every 4 years. These requirements apply to all persons with a significant role in the research, including but not limited to Principal Investigator and Co-investigators, individuals named on a proposal, and individuals who obtain informed consent from prospective participants in research.
Below is a link to CITI Program training 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. For step-by-step instructions, click here.
The IRB also accepts training certificates from https://phrptraining.com/ that are less than four years old.
Additional training materials and videos can be found at https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals.
Research Determination and Review Level Questionnaire
The IRB has implemented an online questionnaire to help applicants determine whether their study needs to be reviewed by the IRB and, if it does need to be reviewed, what level of review is necessary. All investigators (faculty, staff and students) MUST start the IRB process by completing the Research Determination and Review Level Questionnaire using the following link:
NOTE: If you complete an application without first completing the Questionnaire, your application will not be reviewed and you will be directed to complete the Questionnaire. This questionnaire helps applicants determine if their project meets the federal definition of research that requires IRB review. Many activities that we refer to as “research” do not meet the federal definition and, therefore, do not require IRB oversight. If the project does not meet this definition, no application needs to be submitted to the IRB.
Any study that meets the federal definition of research requires an application to the IRB. Some projects that meet the federal definition of research are exempt from IRB review while others require review. For exempt studies, investigators complete a brief Application for Exemption from Review so that the IRB chair can make the final determination about whether the study is exempt. Studies that are not exempt from review must undergo either limited, expedited, or full review. The Questionnaire will direct applicants to the appropriate level of review and online forms. The project may not begin until the IRB has approved the application.
Applications for exempt, limited, and expedited/full review are submitted online. The Questionnaire will direct investigators to the appropriate form. The links to the forms are included below but be sure to complete the Questionnaire before completing an application. The IRB requires completion of the Questionnaire before the application will be reviewed.
- Application for Exemption from Review
- Application for Limited Review
- Application for Expedited or Full Review
Faculty Role in Research Projects with Student Investigators
Student research projects follow the same process as faculty research projects, starting with the 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. Finally, as always, review applications for clear writing and proofread for grammar, punctuation, etc. Although applications are not scored on writing, a professional presentation is always helpful. 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.
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.
Policies, Forms, and Federal Regulations
The following list includes more detailed information about the IRB policy, the federal regulations, and appropriate forms.
- IRB Policy Statement Final
- Research Misconduct Policy
- IRB Organizational Chart
- Revised Common Rule
- Office for Human Research Protections
- Informed Consent Template
- Waiver of Informed Consent Form
- Waiver of Documentation of Informed Consent Form
- Request for Changes and Continuing Review Form
- Project Closure Form
Indiana State Regulations
In addition to complying with federal regulations, human subjects research must also comply with state regulations which generally parallel federal regulations.
- Chapters and Sections: 1-1, 1-2, 1-3, 1-4, 1-5, 5-2, 5-4, 5-4.5, 5-5, 1-6, 1-7, 1-8
- Chapters and Sections: 5-1, 5-2, 5-4
- A number of definitions that could be relevant in this section
- On misuse and abuse of controlled substances
- With use/effects of controlled substances in research
- For cancer patients
- Mental health and addiction
- FERPA/school records
- Juvenile court
- Law enforcement records
- Chronic disease patients
- Correctional facilities and programs