Procedures for the Protection of Human Subjects
Under the Western State 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, 2013 as outlined below. The policy is under review and will be revised during the 2014-15 academic year by Academic Affairs. Questions regarding the policy can be directed to Dr. Tomany at 970 943-3045 or email@example.com.
NEW PROTOCOL AS OF AUGUST 23, 2013
Western State 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. 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 (firstname.lastname@example.org). Proposals that require full review by the full board must be received at least seven (7) 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 State 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 email@example.com, with c/o HRC Chair in the subject line.
I. GENERAL INSTRUCTIONS FOR ALL FORMS OF REVIEW:
All information provided to the committee must be typed and submitted via email to firstname.lastname@example.org as a PDF that contains all the required documents. Please see the TOC checklist that is the first page of the application. Incomplete submissions and 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
- 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 certificate for all investigators (including sponsoring faculty) involved in the study
What you will receive from HRC:
- An email from the Chair of the HRC indicating approval and a tracking number that must be included in all future email communications with the HRC or IRB, approval with modifications, or denial.
- 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 5 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 30th 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 State Colorado University, Taylor 321C, 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.
II. CALENDAR OF REVIEW FOR 2014-2015 ACADEMIC YEAR
Deadline to submit-Wednesdays
Review meeting- Tuesdays
Determination Announcement- Fridays
August 18, 2015
August 25, 2015
September 4, 2015
September 8, 2015
September 15, 2015
September 25, 2015
October 6, 2015
October 13, 2015
October 23, 2015
November 3, 2015
November 10, 2015
November 20, 2015
January 26, 2016
February 2, 2016
February 12, 2016
February 23, 2016
March 1, 2016
March 1, 2016
March 29, 2016
April 5, 2016
April 15, 2016
III. TYPES OF REVIEW:
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 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 45CFR 46.101.
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 three (3) 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 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 45CFR46.110 [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 45CFR 46 and all federally mandated criteria for approval must be met. The researcher will be notified within three (3) 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.
IV. REQUIRED TRAINING
It is the intention of Western State 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 August 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:
V. RESEARCH CONDUCTED IN UNIVERSITY COURSES AT WESTERN STATE COLORADO UNIVERSITY
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 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 (email@example.com). This form indicates the projects will be 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 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.
VI. STUDENT RESEARCH AND FACULTY RESPONSIBILITY
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:
- 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.
- Students who are conducting human subject research that will likely be incorporated in a thesis project should submit a request for HRC review.
- 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.
Institutional Review Board (IRB) Forms for the protection of human subjects
The forms below are the newly incorporated IRB forms for the protection of human subjects at Western State Colorado University. IRB forms are grouped in 3 tables below: IRB applications, IRB consent/assent forms, and additional IRB-related forms such as template letters of agreement. Please contact Janice Welborn at firstname.lastname@example.org or email@example.com if you have any questions.
All submissions must be as a one PDF document attachment sent via email to firstname.lastname@example.org for consideration. Paper copies of the application will not be reviewed. All submissions must be typed.
Request For Review Forms
Please use this Table of Contents as your cover page when submitting your completed application for Review. Please mark those items you have included in the application.
Submit a request for exempt research to the Western Human Research Committee/IRB.
Submit a human subject research study to the Western Human Research Committee/IRB.
Submit a human subject research study that involves conducting VO2 Max tests on participants who are considered low risk for a cardiovascular event (per the ACSM guidelines) to the Western Human Research Committee/IRB.
Use to request changes (other than personnel) for an IRB approved study. May be used in conjunction with renewal applications, when the renewal involves changes other than personnel. If the study is not up for renewal, and the only change is personnel, send an email to email@example.com with a list of the changes.
Used to seek renewal of IRB approval (annual renewals). The only changes permitted on this application are personnel. Any other changes require a Request for Modification/Addendum form in addition to the renewal.
Use when, during your human subject research, an unanticipated or adverse event occurs requiring notification to the IRB.
Use to notify the IRB that your research is 1) no longer enrolling subjects, 2) all intervention and/or interactions with enrolled subjects have ended, and 3) the collected data does not include private identifiable information (i.e., participant's identity cannot be ascertained and associated with private information).
Researchers submitting requests for review which require expertise to perform study procedures (e.g., blood draws, interviewing participants about sensitive topics) should document experience and training to show that risks to participants are minimized. Other members of the research team (including students) who need to demonstrate similar expertise may also use this form.
Used when participants are under the age of 18 years but capable of reading and understanding the study (e.g., participants age 7-17).
Covers biomedical research, including approved wording for frequently used procedures.
Used for minimal risk research activities other than a survey. (If you are using an online survey, use the "Exempt Survey Consent" template.)
Covers all non-biomedical research including combination activities such as survey/test/interview.
This exempt survey consent can be added to the beginning of any minimal risk survey where documentation of informed consent (signature) is not needed or required.
Used when research activities include only focus groups of participants or a subset of participants.
Used when research activities include only interviews of participants or a subset of participants.
Additional IRB Related Templates and Forms
Used to screen participants for studies involving exercise. The American College of Sports Medicine criteria for risk is included so that investigators can determine which participants are classified as "low risk" for physical activity.
Used when another organization is involved in recruiting participants/allowing access to participants/allowing access to data.
Used when Appalachian student records data is used for research purposes. Explains protections in place as required by FERPA.
Used to cover exempt classroom research that fits into specific restrictions and is monitored by the faculty instructor.
Differences between the Biomedical and Social/Behavioral/Educational (SBE) consent form: The Biomedical consent form template and Social/Behavioral/Educational consent form templates are substantially similar but the Biomedical consent form includes:
- optional language for research that falls under FDA jurisdiction
- optional language describing the risks associated with blood draws and DEXA scans
- an optional section "Are there any reasons you might take me out of the research?" to clearly communicate any withdrawal criteria
- a section for research that is more than minimal risk: "What if I get sick or hurt while participating in this research study?"