Research

Under the Western Colorado University Policy for the Protection of Human Subjects, all research protocols proposing the use of human subjects must be submitted to the Human Research Committee (HRC) under the Institutional Review Board (IRB) of Academic Affairs. 

The procedure for review has been revised as of July 1, 2023 as outlined below. 

Western Colorado University Human Research Committee is now being supported by the Office of Sponsored Programs (OSP). The process for review has incorporated the use of Sharepoint as a means of collection, communication and storage of applications for review by the HRC. The OSP is managing IRB Sharepoint in collaboration with the Chair of the HRC. 

New forms for submission for a review by the HRC are available on the Human Subjects website under Academic Affairs located below. Old forms will not be accepted by the HRC beginning August 23, 2013. 

Requests for review may be submitted to the HRC (c/o HRC Chair) at any time via email (irb@western.edu). Proposals that require full review by the full board must be received at least seven working days before a board meeting to be considered at the meeting. The scheduled HRC meeting dates are below. 

Anyone submitting a request for review must have completed the CITI training required for Western Colorado University. The information regarding CITI Training and the login information is listed below in Required Training. Information and login for the CITI training is on the Human Subjects website and the OSP website under Academic Affairs. 

All questions can be submitted to the HRC via an email to irb@western.edu, with c/o HRC Chair in the subject line. 

All information provided to the committee must be typed and submitted via email to irb@western.edu as a PDF that contains all the required documents.  Please see the Table of Contents (TOC) checklist that is the first page of the application. Incomplete submissions will be returned without review. Submissions with multiple attachments will be returned with request for proper submission. 

The research investigator must first determine the type of review appropriate for the project and then complete the application. 

A complete submission includes: 

• Table of Contents (TOC) 

• Completed Initial Review Form 

• Consent form(s) 

• Any surveys or questionnaires being used 

• Subject recruitment forms (i.e., posters, email text, verbal script) 

• Grant proposals submitted to federal agencies or private sponsors that require IRB approval 

• Completed CITI certificates for all investigators (including sponsoring faculty and students) involved in the research 

What you will receive from HRC: 

• An email from the Chair of the HRC indicating either approval, approval with modifications, or denial, and a tracking number that must be included in all future email communications with the HRC or IRB. 

• Once approved, any modification of the approved forms must be submitted to the HRC for re-evaluation. 

• Please save all emails and other correspondence with the HRC, all forms, collected data and consent forms for five years in a secure location. 

Following completion of the research, the lead researcher will be required to complete and submit electronically a “Study Closure Form” and all paperwork that includes identifiable information about participants within 30 days of the project end date or April 30 of each academic year. Consent forms and any other data collection artifacts that include names, signatures, photos, video, etc. can be submitted as hard copies mailed to the Office of Sponsored Programs, Attention IRB, Western Colorado University, Taylor Hall 303C, Gunnison, CO  81231. Please include a copy of the Study Closure Form with all hard copies of information submitted. 

Researchers continuing research studies not completed within one year of approval will need to submit a “Continuation Request” for annual review by the HRC per federal guidelines until the study is closed. 

Modifications to an approved study will require the submittal of a “Request for Modification” for review by the HRC before the modification is implemented. 

Fall 

There are three types of review that are performed on research that involve human subjects, depending on the level of risk and whether or not the study fits into certain categories of activities. 

Exempt 

Exempt studies are research activities involving human subjects that are exempt from the federal regulations governing human subject protections. The exemption review process may only be used for research determined to fit within one of the exemption categories defined in 45 CFR 46. 

Exempt studies must still be submitted for review to the HRC. Western has designated the Chair of the HRC as the authorized individual to conduct the review of such studies and determine the exemption. An approval number will be assigned by the HRC to the exempt study and the researcher will be notified within two weeks from submission. Any changes to the study should be submitted to the HRC using the appropriate forms for review so the exempt status can be validated or changed if the study requires a different level of review (expedited or full review) by the HRC committee. 

Expedited 

Expedited review may be used for research that involves no more than minimal risk (as described in one of the federal expedited review categories referenced in 45CFR 46.110 [DHHS] and 21CFR 56.110 [FDA]. When a study is reviewed via the expedited review process only the chair or a designated representative with experience will review the study as submitted. When conducting an expedited review, the reviewer(s) must remember the research in question is subject to 45 CFR 46 and all federally mandated criteria for approval must be met. The researcher will be notified within two weeks from submission via an email of the determination of the submission. Any changes to the study must be submitted to the HRC using the appropriate forms for review so that the status can be validated or if the study now requires a different level of review (full review by the HRC committee). 

Full Committee Review 

Full committee review is required for any research involving human subjects that does not qualify for exempt or expedited review. 

Expedited and full review studies may be granted approval for a maximum of one year. 

It is the intention of Western Colorado University that all individuals engaged in research involving human participants complete an educational program related to the responsible conduct of research prior to initiation of a research project. Effective Aug. 23, 2013, the requirement can only be met by completing the CITI IRB training program. 

The information about how to set up your account and complete training is here, as well as on the IRB/HRC and OSP websites under Academic Affairs. 

Research methods courses and capstone courses at Western require students to complete projects as a way of teaching research methods and skills. Institutional review boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved. The IRB does not require student projects conducted in research methods/capstone courses to be reviewed if the purpose of these projects is educational in nature and will not be published or used in future research. Activities not intended to provide generalizable knowledge are not subject to IRB review. However, the instructor of the course is ultimately responsible for the protection of human subjects. Faculty teaching research methods courses and capstone courses are encouraged to utilize the CITI training as a supplement to the curriculum if HRC review is not applicable. 

Students in graduate methods courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis or dissertation. A project initially conducted to learn research methods may yield data the student subsequently wishes to use to contribute to knowledge. In order to use these data for theses, dissertations or other research purposes, students must either: (1) demonstrate that individuals provided informed consent for the project at the time through procedures approved by the instructor; or (2) obtain consent from the individuals to use previously collected information according to procedures approved by the IRB (i.e. an application for exemption, expedited review or full IRB review). 

Instructors of methods courses requiring student projects not subject to HRC review are asked to submit the Approval and Blanket Exemption (IABE) for Class Research Form via email c/o HRC chair (irb@western.edu).  This form indicates the projects will be conducted under the instructor’s supervision and in accordance with procedures approved by the instructor. The instructor must include the required CITI training for all students in the methods course and provide certificates of completion to the HRC along with required forms in addition to the Instructor’s Approval Form. The HRC Chair will assign an approval number to the exemption and provide notification back to the instructor verifying the student class projects HRC approval. The faculty Sponsor/Instructor of the course is ultimately responsible for the protection of human subjects. Instructors interested in utilizing this approval method are encouraged to contact the Chair of the HRC and discuss the appropriateness prior to submission. 

Student projects in courses are subject to IRB review if they are designed at least partially to provide data for research and publication purposes. For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate in research that will be submitted for publication. These projects constitute research and must be submitted to the IRB for review and receive approval before the project can begin. 

Research conducted by students, such as thesis research and some class projects, requires the approval of the HRC prior to execution. It is the responsibility of faculty supervising research by students or staff to ensure that approval of the HRC Committee is obtained. Individual projects conducted primarily for instructional purposes within the context of a formal class and not designed to contribute to generalizable knowledge do not meet the definition of “research” as defined in the federal guidelines. Thus, they do not require review by the HRC, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class. Under these conditions, no IRB application need be made and it is the instructor’s responsibility to monitor the ethical propriety of these projects, applying the criteria listed in this document. 

Instructors requiring or sponsoring student projects are asked to send an Instructor’s Approval of Class Research Request Form to the HRC listing the student(s) and their research projects and indicating the projects are being conducted under the instructor’s supervision and in accord with procedures approved by the instructor. The instructor must include the required CITI training for all students and provide certificates of completion to the HRC along with the request. The HRC Chair will provide a notification back to the instructor verifying the student projects did not require HRC approval. The faculty Sponsor/Instructor of the course is ultimately responsible for the protection of human subjects. 

The following clarifications for the guidelines for Student Research and Faculty Responsibility are provided: 

1. Faculty members conducting class-based activities involving human subjects should request HRC review of the activities when there is a chance of public dissemination (i.e. presentation/publication outside of the classroom). In most cases, this can be accomplished by submitting a single request for HRC review of the class project. 
2. Students who are conducting human subject research that will likely be incorporated in a thesis project should submit a request for HRC review. 
3. In rare cases data collected in class-based projects that have not undergone prior HRC approval may be used for dissemination. Petition may be made to the HRC requesting such terms. In this case a statement from the instructor of record must include the specific steps taken during data collection that ensured the ethical conduct of this research. Decisions on these requests will be made on a case-by-case basis. 

The forms below are the newly incorporated IRB forms for the protection of human subjects at Western Colorado University. IRB forms are grouped in three tables below: IRB applications, IRB consent/assent forms, and additional IRB-related forms such as template letters of agreement. Please contact the IRB if you have any questions. 

All submissions must be a PDF document attachment sent via email to irb@western.edu for consideration. Paper copies of the application will not be reviewed. All submissions must be typed. 

Request For Review Forms 

Principal Investigators (PIs) planning to conduct research or teach with live vertebrate animals must submit an Animal Use Protocol (AUP) application to the IACUC for review and approval prior to acquisition and use of animals. 

IACUC Application Instructions↗

Please review this checklist to ensure the IACUC protocol application is complete before submitting the application for review:  

• Each member of the research team, including the faculty sponsor, must complete the CITI Laboratory Animal Welfare course and enroll in the Occupational Health Program. 

• All other applicable approvals must have been obtained or are in process (IRB, SCRO, IBC, Radiation Safety Committee, etc.). 

• Preparatory contact with the Department of Animal Research Services to discuss issues of animal sourcing, ordering, housing and husbandry. 

• If research will be funded by an external sponsor (grant, contract or gift), proposal paperwork must be filed with the Sponsored Projects Office. 

• All applicable sections of the IACUC application and protocol narrative are complete, including all specific descriptions of setting up breeding colonies or monoclonal antibody production. 

• Investigators and personnel involved in the protocol preparation process are strongly advised to review the IACUC application instructions before completing the application and protocol narratives. 

As a Western Colorado University researcher who uses animals as a part of a research project, the Office of the Provost and Western Colorado University’s Institutional Animal Use and Care Committee (IACUC) require completion of the CITI online training courses in “Working with the IACUC” and any of the species-specific training courses offered. 

Explore the CITI training website; there are instructions for using the site, including starting and completing training. 

CITI Training Website↗

Once all applicable courses are completed, completion reports will be sent to the IRB electronically. By requiring researchers to complete these training courses, we fulfill our institutional obligation and the federal regulatory requirement to train and educate all researchers and personnel who use animals in the course of their research. Animal use protocols reviewed by the IACUC will not obtain final approval until all individuals listed on the protocol have completed training. 

Fall 

Protocol Application↗

Annual Renewal Form↗

Project Revision/Amendment Form↗

Animal Transfer Form↗