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: 1. 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. 2. 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. 3. Selection of participants is equitable. 4. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants. 5. There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data Human Subjects Policy Please click here to view Regis University's Policies and Procedures for the Review of Research Involving Human Subjects. Items Prior to Using IRBNet IRB Application Start Here Guide Use this form to determine if your activity involves Human Subjects’ Research Download Which form should I use? Now that you’ve determined your project needs IRB review using the “IRB Application Start Here Guide”, use this form to determine if your research application is exempt or your research is expedited/full-board Download Quality Improvement versus Research Overview of differences between Quality Improvement and Research Download New Protocol Reviewer Form This form will be used by reviewers to evaluate protocols. Download Logging in to IRBNet Since you’ve determined that you need IRB review, and you know which form to use, you’re now ready to login to IRBNet. Log into IRBNet Required CITI Training Required CITI Modules for Regis Log in to Collaborative Institutional Training Initiative (CITI) Guide to Register for CITI Human Subjects Research New CITI Human Subjects Research Requirements CITI provides peer-reviewed, web-based educational courses in research, responsible conduct of research, and other pertinent topics. 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 coursework 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 "Revised CITI Human Subjects Requirements" document. CITI completion reports (which detail the course transcript, 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 coursework 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 "Revised 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. IRBNet Training Resources IRBNet Training New User Registration Download Beginning Researcher For Researchers new to IRBNet Download Subsequent/Revised Packages Instructions for modifications required for approval, continuing reviews, changes to the study team, etc. Download Training Videos IRBNet Training Videos include: 9 minute Instructional Video for New Project Submission 7 minute Instructional Video for Post-Submission Advanced Topics User name: regis Password: training IRBNet Resources Logging in to IRBNet Since you’ve determined that you need IRB review, and you know which form to use, you’re now ready to login to IRBNet. Log into IRBNet Need further assistance? Contact IRB@Regis.edu to evaluate additional training options Email IRB Forms Should I use the Exempt Application Form or Expedited/Full Board Application Form? This guide helps investigators determine if they should use the Exempt Application Form or the Expedited/Full-Board Application form. 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 - Use this if your project was previously approved by IRB and you need to make modifications to the study and/or extend the study. Study Closure Form - Study closure forms should be submitted in IRBNet upon completion of your project. Adverse Event Form - Report any adverse events to IRB using this form. If unsure, err on the side of caution and report the event. New Protocol Reviewer Form - This details the criteria IRB reviewers use when evaluating a study. Regis IRB relies on another IRB - Use this form for a multi-site study in which Regis relies on another IRB as the IRB of record. Regis is the IRB of record - Use this form for a multi-site study in which Regis is the IRB of record and another institution relies on Regis. Quality Improvement (QI) versus Research - Overview of the differences between Quality Improvement and Research. CITI Training Addendum - Use this form to select which CITI courses investigators took. The form should accompany every IRBNet submission is exempt, expedited, or full-board. Use a Pre-Approved Study Protocol (PASP) form when an investigator and/or research group intends to use the same methods/recruitment/protocols on a routine basis. Examples and Templates Cover Letter for Anonymous Surveys Informed consent cover letter for anonymous surveys or research when signed consent is waived Download Debriefing Form Sample debriefing form for research that involves deception. Download Informed Consent Template Basic informed consent document for participants over the age of 18 Download Informed Consent for Minors Template Basic informed consent document for participants under the age of 18 Download Assent Form (Parent/Guardian) Template Sample parental consent for research studies that involve participants under the age of 18 Download Recruitment Email Sample email for recruiting adult participants Download Recruitment Flyer Sample flyer for posting research study around campus, etc. Download IRB Submissions Approximate Timeline of IRB Submissions and Reviews Download Site Approval Sample Sample site approval letter to be used for participants outside of Regis Download Glossary Dictionary of helpful terms Download IRB Members Area Represented Member Name Member Type Degree Anderson College of Business Lorin Mayo Non-scientific Ph.D., Public Administration Anderson College of Business Bob Spagnola Non-scientific Ph.D., Business Administration College of Computer and Information Sciences Mohamed Lotfy Scientific Ph.D. – Applied Management and Decision Sciences College of Computer and Information Science Judit Olah Scientific Ph.D. – Information Sciences College of Contemporary Liberal Studies Roberta Mancuso Scientific; Vice-Chair Ph.D. – Social Psychology College of Contemporary Liberal Studies Vinnie Wincelowicz Non-scientific Ph.D. – Public Administration; D.Ed., Education & Leadership Dayton Memorial Library Kim O'Neill Non-scientific M.S. – Nutrition & Food Sciences Regis College Rebecca Betjemann Scientific Ph.D.— Cognitive Psychology Regis College Jazmin Muro Scientific Ph.D. – Sociology Rueckert-Hartman College for Health Professions Jennifer Cates Scientific Ph.D. Counseling and Educational Psychology Rueckert-Hartman College for Health Professions Erika Nelson-Wong Scientific; Chair Ph.D. – Biomechanics; Ph.D. – Physical Therapy Rueckert-Hartman College for Health Professions Lora Claywell Scientific Ph.D. – Education Unaffiliated member Ed Furlong Community Member Ph.D. – Chemical Oceanography Questions? Contact IRB@regis.edu IRB Meeting Schedule Anticipated IRB Meeting Dates 2019-2020 Final date for submission of materials September 10, 2019 August 20, 2019 October 8, 2019 September 18, 2019 November 12, 2019 October 22, 2019 December 10, 2019 November 18, 2019 January 14, 2020 December 16, 2019 February 11, 2020 January 22, 2020 March 10, 2020 February 20, 2020 April 14, 2020 March 25, 2020 May 12, 2020 April 22, 2020 Notes: 1) IRB meeting dates reflect when the IRB is scheduled to convene. 2) Typically, full-board reviews are the only review types discussed at these meetings. Exempt and expedited reviews are performed outside of the IRB meeting schedule and do not need to be submitted by a certain date in order to be reviewed. Full-board reviews must be submitted in IRBNet 14 business days prior to the next scheduled IRB meeting date. 3) If you have questions, contact IRB@Regis.edu.