Human Research Committee

At Western State Colorado University, research involving human subjects complies with federal policy pertaining to the protection of human subjects (45 CFR part 46, as amended). Under the University's policy, all research protocols proposing the use of human subjects must be submitted to the Human Research Committee.

Procedures for the Protection of Human Subjects

Under the Western State College of Colorado 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 2013-14 academic year by Academic Affairs.  Questions regarding the policy can be directed to Dr. Tomany at 970 943-3045 or mctomany@western.edu.

NEW PROTOCOL AS OF AUGUST 23, 2013

Western State Colorado University Human Research Committee is now being supported by the Office of Sponsored Programs and Grants (OSP&G).  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&G 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 (irb@western.edu).  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 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&G 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. 

I. GENERAL INSTRUCTIONS FOR ALL FORMS OF REVIEW:

All information provided to the committee must be typed and submitted via email to irb@western.edu as one document. Incomplete submissions will be returned without review.

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

A complete submission includes: 
• 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, 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.

II. CALENDAR OF REVIEW FOR 2014-2015 ACADEMIC YEAR

 

Deadline to submit-Wednesdays
Review meeting- Wednesdays
Determination Announcement- Fridays
 
Fall
 

August 13, 2014

August 20, 2014

August 29, 2014

September 10, 2014

September 17, 2014

September 26, 2014

October 8, 2014

October 15, 2014

October 24, 2015

November 5, 2014

November 12, 2014

November 21, 2014

 
Spring
 

January 28, 2015

February 4, 2015

February 13, 2015

February 25, 2015

March 4, 2015

March 13, 2015

April 1, 2015

April 8, 2015

April 17, 2015

 

III. TYPES OF REVIEW:

There are three types of review that are performed on research that involved 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 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 that the exempt status can be validated or changed if the study now 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 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&G websites under Academic Affairs:
http://www.citiprogram.org/citidocuments/welcome/welcome.html


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.

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 that 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 are asked to submit the Instructor’s 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 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 IRB approval. The faculty Sponsor/Instructor of the course is ultimately responsible for the protection of human subjects.

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 approval beforehand 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 IRB prior to execution. It is the responsibility of faculty supervising research by students or staff to ensure that approval of the Board 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 Board, 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 but 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 a IABE to the IRB administrator 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 IRB along with the requested IABE. The HRC Chair will provide a notification back to the instructor verifying the student projects did not require IRB 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 IRB 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 IRB 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 IRB review.
  3. In rare cases data collected in class-based projects that have not undergone prior IRB approval may be used for dissemination. Petition may be made to the IRB 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 943-3400 or jwelborn@western.edu if you have any questions.

All submissions must be as a one 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

Form

Purpose

Version Date

Exemption Request for Research with Human Participants

Submit a request for exempt research to the Western Human Research Committee/IRB.

07-01-2013

Request for Initial Review

Submit a human subject research study to the Western Human Research Committee/IRB.

07-01-2013

Request for Initial Review of VO2 Max Test

Submit a human subject research study that involves conducting VO2 Max tests on participants who are considered low risk for a cardovascular event (per the ACSM guidelines) to the Western Human Research Committee/IRB.

07-01-2013

Request for Modification/Addendum

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 irb@western.edu with a list of the changes.

07-01-2013

Request for Continuing Review

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.

07-01-2013

Event Report Form

Use when, during your human subject research, an unanticipated or adverse event occurs requiring notification to the IRB.

07-01-2013

Study Closure Form

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).

07-01-2013

Research Personnel Form

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.
Note: This form is kept on file so that research personnel do not need to submit a new form with every IRB application unless training has changed.

07-01-2013

 

 

Consent Forms

Form

Purpose

Version Date

Assent for Minors Under 18 Revised 10-23-13.doc

Used when participants are under the age of 18 years but capable of reading and understanding the study (e.g., participants age 7-17).

10-23-2013

Consent to Participate in Biomedical 

Covers biomedical research, including approved wording for frequently used procedures.

10-24-2013

Consent for Exempt Research

Used for minimal risk research activities other than a survey. (If you are using an online survey, use the "Exempt Survey Consent" template.)

07-01-2013

Consent to Participate in Research Revised 10-24-13.doc

Covers all non-biomedical research including combination activities such as survey/test/interview.

10-24-2013

Survey Participant Information

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.

07-01-2013

Focus Group Participant Consent Form

Used when research activities include only focus groups of participants or a subset of participants.

07-01-2013

Interviewee Consent Form 

Used when research activities include only interviews of participants or a subset of participants.

10-23-2013

 

Additional IRB Related Templates and Forms

Form

Purpose

Version Date

Screening Questionnaire for Research Involving Exercise

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.

07-01-2013

Letter of Agreement

Used when another organization is involved in recruiting participants/allowing access to participants/allowing access to data.

07-01-2013

Letter of Agreement for Using Student Data

Used when Appalachian student records data is used for research purposes. Explains protections in place as required by FERPA.

07-01-2013

Instructor’s Approval of Class Research

Used to cover exempt classroom research that fits into specific restrictions and is monitored by the faculty instructor.

07/01/2013

 

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?"