Human Subjects Institutional Review Board (IRB)
The purpose of the Regis University Institutional Review Board (IRB) is to protect the rights and welfare of participants in research projects as required by federal regulations. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research based on its review.
In conducting the review the IRB assures that:
- Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may be expected to result.
- The selection of participants is equitable.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data
Materials, Resources and Forms
Fillable forms are available in IRBNet by clicking on the 'Forms and Templates' button.
Adverse Event Form - Report any adverse events to IRB using this form. If unsure, err on the side of caution and report the event.
Debriefing Form Template - This form should be used for studies involving deception or to educate by participants about information or resources not provided in the original informed consent document.
Exempt Application - Use this form or the Expedited/Full-Board Application Form when starting a new human subjects research project.
Expedited Full Board Application - Use this form or the Exempt Application Form when starting a new human subjects research project.
Modification and/or Continuation Form - Use this form to make modifications to a previously approved IRB study or to extend the expiration date of a study currently in progress.
New Protocol Reviewer Form - This details the criteria IRB reviewers use when evaluating a study.
Pre-Approved Study Protocol (PASP) Form - Use when an investigator and/or research group intends to use the same methods/recruitment/protocols on a routine basis.
Project Closure Form Study - Closure forms should be submitted in IRBNet upon completion of your project.
Quality Improvement (QI) versus Research - Overview of the differences between Quality Improvement and Research.
sIRB Authorization Agreement - Use this form when multiple organizations are engaged in the same research project, but only need one IRB
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New User Registration |
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For Researchers new to IRBNet |
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Instructions for modifications required for approval, continuing reviews, changes to the study team, etc. |
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IRBNet Training Videos include:
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| Additional Resources | |
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Need further assistance? |
Contact irb@regis.edu to evaluate additional training options |
CITI provides peer-reviewed, web-based educational courses in research, responsible conduct of research, and other pertinent topics. CITI Login Instruction Guide
Regis University requires the following criteria for IRB members, faculty, staff, and students involved in research involving human subjects (certificates are valid for three years after completion of all required modules).
- Regis University students participating in research method classes, capstone classes, and allied course work that involves data gathering from primary sources be currently CITI certified at the level appropriate to the research. CITI requirements, as of January 15, 2019, are detailed in the "CITI Human Subjects Requirements" CITI completion reports (which detail the course transcript, the date the course was taken, and the score received) should be submitted as documentation. CITI completion certificates, or CITI "diplomas" are not acceptable documentation of CITI training. Instructions for attaching CITI completion report in IRBNet
- Regis University Faculty teaching research method classes, capstone classes, and allied course work that involve data gathering from primary sources ("live" human beings, human tissue samples, or privacy protected records/documents) be currently CITI certified at the level relevant to the research (social-behavioral and/or biomedical certification). CITI requirements, as of January15, 2019, are detailed in the CITI Human Subjects Requirements" document. Instructions for attaching CITI completion report in IRBNet
- Regis University IRB members are required to have completed both social-behavioral and biomedical CITI certification as well as any other CITI training as required by the IRB Chair. A 30-day grace period is provided for members whose certifications are expiring.
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Sample parental consent for research studies that involve participants under the age of 18 |
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Informed consent cover letter for anonymous surveys or research when signed consent is waived |
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Sample debriefing form for research that involves deception. |
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Sample HIPAA release for research |
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Basic informed consent document for participants over the age of 18 |
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Basic informed consent document for participants under the age of 18 |
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Sample email for recruiting adult participants |
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Sample flyer for posting research study around campus, etc. |
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This document lists the bare minimum for an informed consent |
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Sample site approval letter to be used for participants outside of Regis |
IRB Members
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Area Represented |
Member Name |
Member Type |
Degree |
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Anderson College of Business and Computing |
Non-scientific |
Ph.D. – Business Administration |
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Anderson College of Business and Computing |
Non-scientific |
Ph.D. – Computer Engineering |
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Regis College |
Scientific |
Ph.D.— Cognitive Psychology; Chair |
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Regis College |
Scientific |
Ph.D. – Child, Family, and School Psychology |
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| Regis College |
Scientific |
Ph.D. – Social Psychology |
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| Regis College |
Non-scientific |
Ph.D. – Systematic Theology |
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Rueckert-Hartman College for Health Professions |
Scientific |
Ph.D. – Education |
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Rueckert-Hartman College for Health Professions |
Scientific |
Ph.D. – Biology/Biological Education |
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Rueckert-Hartman College for Health Professions |
Scientific |
Ph.D. – Physical Therapy |
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Rueckert-Hartman College for Health Professions |
Scientific |
Ph.D. – Counselor Education and Supervision |
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Unaffiliated member |
Kathy Green |
Community Member |
Ph.D. – Psychometrics |
Meeting Schedule
- September 10, 2024
- October 8, 2024
- November 12, 2024
- December 9, 2024
- January 14, 2025
- February 11, 2025
- March 11, 2025
- April 8, 2025
- May 13, 2025
Materials needed for a full-board IRB meeting should be submitted two weeks prior to the IRB meeting date.