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.

 

Ethics Training

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:  

Research Determination and Review Level Questionnaire

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

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.

 

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.

 

Policy, Forms, and Federal Regulations

The following list includes more detailed information about the IRB policy, the federal regulations, and appropriate forms.

 

Indiana State Regulations

In addition to complying with federal regulations, human subjects research must also comply with state regulations which generally parallel federal regulations.

IC 1-1-4-5 Definitions for statutes

IC 4-1-10 Provisions re: social security numbers, data, and security breaches

IC 4-1-11 Notice of security breach

IC 5-14-3-4 Public records and public meetings

IC 16-36 Medical consent

  • 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

IC 16-39-6-5 Health Records

IC 31-33 Reporting and investigating child abuse and neglect

  • Chapters and Sections: 5-1, 5-2, 5-4

IC 27-8-25-2 Clinical Trial

IC 35-31.5 Definitions

  • A number of definitions that could be relevant in this section

IC 16-42-20-9 Research

  • On misuse and abuse of controlled substances

IC 16-42-20-11 Anonymity of research subjects 

  • With use/effects of controlled substances in research

IC 16-38-2-5 Access to confidential information for research purposes

  • For cancer patients

IC 9-27-5-3 Test results; dissemination; immunity from liability; practice of medicine

IC 16-37-4-3 Confidentiality; medical research or education use

IC 16-38-2-6 Additional information requests; individual patients; consent

IC 21-45-5 Spinal cord and head injury research centers

IC 16-42-20-10 Contracts for educational and research activities

  • Mental health and addiction

IC 34-26-5 Indiana civil protection order act

IC 21-12-12-2 Liability for breach of confidentiality

  • FERPA/school records

IC 16-38-4-11 Access to confidential information for research

IC 31-39-2-11 Researchers

  • Juvenile court

IC 31-39-4-9 Researchers

  • Law enforcement records

IC 4-1-6-8.6 Requests for access to confidential records; improper disclosure; actions

  • General

IC 16-38-6-6 Access to confidential information

  • Chronic disease patients

IC 11-8-2-9 Research and statistics

  • Correctional facilities and programs

IC 12-21-5-2 Education and treatment of children with an emotional disturbance; provision of training on suicide prevention

IC 16-41-35-35 Authorized exposure to radiation

IC 21-45 Life sciences research and education centers

IC 16-39-7 Maintenance of health records, x-rays, and other tests

IC 16-38-4-12 Requests for additional information

IC 16-21-6-7 Fiscal and patient information reports; personal identification of patients; public inspection; copies

IC 26-2-8-116 Electronic signature involving individual health information

IC 16-39-2-6 Disclosure without patient’s consent; interpretation of records; immunities

IC 16-37-1-10 Confidentiality; disclosure of data in records; conditions for availability; grounds for denial

IC 5-14-3-3 Right to inspect and copy public agency records or recordings; electronic data storage; use of information for commercial purposes; contracts

 

Contact Information

ValpoIRB@valpo.edu

 

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