Human Subjects Institutional Review Board (IRB) The role of the Regis University Human Subjects Institutional Review Board (IRB) is to verify and approve research involving human subjects. The IRB convenes monthly. The IRB reviews three types of research activities involving human subjects: Research studies which are exempt from formal IRB review, but need an IRB representative to verify their eligibility for exemption Research studies which qualify for an expedited review process performed by two designated IRB members Research studies which require formal review by a quorum of the IRB in regular session To contact the IRB, please send an email to firstname.lastname@example.org. IRB Membership The IRB is comprised of Regis University faculty, staff and members of the Denver community. The membership composition reflects the intent of federal guidelines and the University's research interests. Each University college appoints three regular voting and three alternate voting members. The library faculty appoint one regular voting and one alternate voting member. One University staff member is appointed as an at-large voting member, and one representative from the Denver metro area is appointed as a voting member. Membership Requirements Requirements for IRB members include the following: All IRB members (regular and alternate) are required to complete the Collaborative Institutional Training Initiative (CITI) modules for social-behavioral and biomedical research before they may vote on or participate in research review. CITI certification entails approximately 15 to 20 hours of online education and tests. CITI certification is considered valid for three years by the Regis University IRB. All IRB members (regular and alternate) are required to attend 12 monthly IRB meetings (presently scheduled as two-hour sessions). Ad hoc meetings may be called at the discretion of the chair or vice-chair. All IRB members (regular and alternate) serve as points of contact for their various college schools/divisions/departments that conduct research involving human subjects. Members provide advice for researchers or review services for low-level research projects involving human subjects (45CFR46.101(b) exempt categories). All IRB members (regular and alternate) serve as first reviewers for expedited research projects involving human subjects (OHRP categories of research). Key IRB members serve as second reviewers (approval grantors) for expedited research projects involving human subjects that originate within that member's college. IRB members discuss and vote on full review research projects involving human subjects, requests for expedited research projects presenting issues that cannot be resolved between the reviewers and the applicants, exempt research projects presenting issues that cannot be resolved between reviewers and the applicants, and any administrative concerns impacting the IRB's process or membership. Regular members vote on research projects. An alternate voting member provides quorum voting membership during the absence of a regular voting member. All members (regular and alternate) vote on administrative issues. At present, excluding the required CITI training, IRB membership requires a 20 to 30 hour commitment per semester for most members, and up to 40 hours per semester for members serving special needs situations. IRB Committee Members Patricia Cullen, Chair CV Rona McCall, Vice Chair CV Tristen Amador CV Heidi Barker CV Dan Berleau CV Rebecca Betjemann CV Richard Blumenthal CV Sonia DelReal CV Keyu Jiang Linda Lange Surendra Mahapatro CV Roberta Mancuso CV Erika Nelson-Wong CV Eve Passerini CV Shari Plantz-Masters CV Thomas Riedel CV Laurie Sperry Dennis Steele Daniel Taylor CV Vincent Wincelowicz CV Catherine Witt CV IRB Meeting Schedule (AY 2014-2015) September 9 and September 23 October 14 November 11 and November 18 December 9 January 13 January 20 February 10 April 14 March 10 May 12 IRB Resources Office for Human Research Protections (OHRP) OHRP Website OHRP Categories of Research Eligible for Expedited Review OHRP Policy & Guidance OHRP FAQs: Quality Improvement Activities Regis University IRB Regis University IRB Guidelines IRB Decision Flowchart IRB Forms and Sample Documents IRB Exempt Application IRB Expedited or Full Board Application Exempt Study Statement/Letter of Consent Modifications to IRB Approved Research Protocols Request for Continuation of IRB Approved Research Protocol Proxy Application Regis IRB Submission Checklist Course Proxy FAQ Sheet Exempt Research Qualifications The following types of research are normally exempt from the approval processes of the IRB (as long as the research does not involve greater than minimal risk to participants): Research conducted in an educational setting involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless confidentiality is not protected and any exposure of the subjects' responses outside the research could place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research and demonstration projects designed to study or evaluate public benefit or service programs. Taste and food quality evaluation and consumer acceptance studies. A risk is considered minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine daily activities including, but not limited to, conversations, employment, and physical or psychological examinations or tests. Please Note: Even if your project falls into a category above designated as exempt, you still need to submit an IRB form to an approved representative of the IRB. Student researchers submit applications through their faculty advisor/course instructor. The IRB committee or its properly designated/appointed IRB representative decides the status of an IRB application as exempt, expedited or full board. All research involving human subjects, their biological samples, or protected information (HIPAA, FERPA) must submit an IRB application. One last note of importance: There are additional considerations when children, prisoners or pregnant women are targeted as subjects in research projects. In addition, special consideration must be given to other groups deemed to be populations vulnerable to undue influence such as students, those with diminished or impaired mental capacity, or those in the lower socioeconomic tier of the population. If any protected or vulnerable group is to be targeted (specifically involved) in your research (or if you have any other questions), please contact the IRB at email@example.com. Overseas Studies All studies conducted in foreign countries, regardless of exempt/expedited/full board status, require review by the IRB to ensure that the researcher has obtained all required permissions and relevant visa status from the host country to conduct the study, and that all human subjects protection requirements of the host country are equal to or greater than those of 45CFR46 or other applicable US federal regulations governing human subjects protections and Regis University's human subjects protections program. It is the researcher's responsibility to contact the host country's embassy to obtain information on the process for requesting permission to conduct research in that country. Failure to obtain proper permission can result in fines, imprisonment and visa exclusions (being barred from reentry into that country). A copy of the approval letter from the host country's embassy, a copy of the appropriate visa, and a copy of the host country's IRB approval(s) must be submitted to the IRB chair. Persons conducting research in foreign countries should also review the following sites: Department of the Treasury Sanctions Programs and Country Information U.S. Department of State Current Travel Warnings U.S. Department of State Websites of Foreign Embassies in the U.S. U.S. Customs and Border Patrol Tip: Register Items Before You Leave The United States Taking a computer, digital camera or other hi-tech equipment or storage device? Check out the following websites: U.S. Department of Commerce: Introduction to Commerce Department Export Controls U.S. Department of Commerce: Applying for an Export License PLEASE NOTE: Research conducted in foreign countries that evades or fails to abide by the research application and approval protocols of the host country (host countries) and U.S. federal guidelines for human subjects research is a potential violation of Regis University research integrity policy in addition to being a potential violation of the laws of the host country and the United States. Required CITI Training The Collaborative Institutional Training Initiative (CITI) is an IRB certification housed by the University of Miami. Currently it is serving over 1600 higher learning institutions and organizations worldwide. Based on federal guidelines and, moreover, the basic grounding principle of Regis University, "How ought we to live?", 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): All Regis University IRB members are required to have completed both social-behavioral and biomedical CITI certification. A 30-day grace period is provided for members whose certifications are expiring. All 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). All students at Regis University 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. All faculty and students at Regis University engaging in primary independent research that involves human subject participation be currently CITI certified at the appropriate level for the research. All Regis University Faculty who wish to obtain an authorized proxy (formerly omnibus approval qualification) and thus serve as a Proxy for a specific course at Regis University must be currently CITI certified at the appropriate level, recommended for approved by their school dean (or equivalent), and approved by the Regis University IRB Chair.