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Human Subjects Research

IntroductionBefore SubmissionProtocol SubmissionAfter Approval


Introduction

The Office of Research and Sponsored Projects Operations (ORSPO) administers the human research protection program at UIW. The ORSPO provides administrative support to the University of the Incarnate Word’s Human Subjects Institutional Review Board (IRB). The IRB ensures university compliance with federal, state, local, and university regulations with regard to human subjects research.

The UIW IRB’s policies and procedures can be found in the IRB Manual. 

UIW uses an online IRB review and management system called Ethical Review Manager. Login with your UIW email address at:

Ethical Review Manager

But first, please review the steps below to understand the requirements for conducting human subjects research at UIW. The information below provides an overview guide to the UIW IRB process.


Before Submission

  • Determine if you need to submit your project to the IRB

    Any project undertaken by University of the Incarnate Word faculty, staff, or students that meets the federal definition of “human subjects research” must be submitted to the IRB for review and approval prior to initiation.

    The UIW IRB Manual  (p. 8-16) includes a detailed discussion of the types of projects that meet the definition of “human subjects research.” If, after reviewing the IRB Manual, you are still not sure if your project meets this definition, complete the Human Subjects Research Determination Questionnaire.

  • Review the UIW IRB Manual

    Before submitting a research protocol for IRB approval, refer to the IRB Manual and familiarize yourself with the approval process, regulations for the conduct of human subjects research, and responsibilities of the principal investigator (PI).

  • Complete human subjects training

    All investigators who will be interacting with human subjects or their identifiable data, as well as Faculty Supervisors of student protocols, must complete human subjects training prior to receiving IRB approval. UIW provides access to online human subjects training through the CITI program. For training requirements and registration instructions, see the Research Compliance training section.

  • Determine your project's review category

    Studies submitted to the IRB undergo one of three types of review: exempt, expedited, or full Board. Applicants should determine the level of review their study will require early in the planning process.

    Exempt Status Review

    Research qualifies for exempt status only if it involves no more than minimal risk or no risk to participants and falls within one or more of the exemption categories listed on p. 17-18 of the UIW IRB Manual. Although the category is called “exempt,” this type of research does still require submission of an IRB application and review to confirm exempt status. Exempt protocols undergo administrative review by the Office of Research and Sponsored Projects Operations and can usually be approved within 1 week or less.

    Expedited Review

    Research qualifies for expedited review only if it involves no more than minimal risk to subjects and falls within one or more of the minimally invasive procedures listed on p. 18-20 of the UIW IRB Manual. Expedited protocols are reviewed by a subset of the IRB (usually no more than two members, including the Chair) and can usually be approved within 2 to 4 weeks, or longer, depending on the need for revisions and the current workload of the IRB.

    Full Board Review

    Research which is not eligible for exempt or expedited review must be submitted for full Board review at a convened meeting of the IRB. The IRB meets monthly during the Spring and Fall semesters and as needed during the Summer. If you plan to submit a full Board application, please refer to the meeting dates below and plan to submit your protocol 2 weeks before the meeting date to ensure a spot on the agenda.

    Fall 2018 IRB Meeting Dates

    August 31

    September 28

    October 26

    November 30

    Spring 2019 IRB Meeting Dates

    January 25

    February 22

    March 22

    May 3


 Protocol Submission

  • Create an Ethical Review Manager account

    UIW uses an online IRB review and management system called Ethical Review Manager. In order to use the system, applicants will need to create a New User account. Follow these steps to register for an account:

    • Click on “Log in” at the top right corner of the landing page.
    • Click on “New User”
    • Fill in the applicable information (Note: you can skip fields that aren’t relevant to you), and agree to Terms and Conditions
    • Note: Password must be 8+ characters long, contain both upper and lowercase characters, and contain at least 1 number
    • Click “Register” and an activation email will be sent to the entered address
    • Access email and click the activation link provided
    • Return to the Log in page and click “Log in”

    Note to student applicants: Students must include a Faculty Supervisor on all IRB applications. The Faculty Supervisor must review and sign the application before submission, so be sure your Faculty Supervisor has an Ethical Review Manager account set up.

  • Assemble application

    All applications must be submitted online via the Ethical Review Manager (ERM) system. Guides for submitting IRB applications, study status updates, continuing review requests, amendments, and closures can be found by clicking “Help” tab at the ERM website. The Help section also includes templates for the Research Protocol and consent forms.

    A complete online IRB Application includes the following components:

        Application Form

        Research Protocol

        Recruitment Materials (e.g., emails, flyers, scripts for in-person recruitment)

        Consent Documents (e.g., formal, signed consent, emailed invitations to surveys)

        Instruments for Data Collection (e.g., surveys, interview questions)

    The Application Form and Research Protocol are submitted via online forms. It is recommended that you prepare the Research Protocol ahead of time in Word, then copy and paste it into the online form. Recruitment Materials, Consent Documents, Instruments for Data Collection, and any additional supplementary documents are uploaded to the Documents section of the online application. Please note that the online Research Protocol form cannot accept tables or figures; any tables or figures you would like to include with your Research Protocol should be uploaded as Word files to the Documents section.

  • Submit application

    Follow these instructions to submit a new IRB application: How to Submit a New Application. These instructions, and other guidance documents, are located in the “Help” section of the ERM website.

    Read each section of the application carefully and provide all required information. Incomplete applications will be returned without review. If the PI is a student, the Faculty Supervisor’s contact information must be provided, and the application will be forwarded to the Faculty Supervisor for review and signature before submission. Applications will be automatically submitted after it has been signed by the PI and Faculty Supervisor (if applicable).

  • After submission

    Written notification of the results of IRB review are emailed to the investigator, and requests for revision may be requested. On average, applications will be approved within the time frames indicated below. This is an estimate and meant to serve only as assistance for project planning.

    Estimated Duration of Reviews by the IRB 

    Review Level 

    Risk Level 

    Submission to Approval 

    Exempt Status Review 

    No personal risk of physical, psychological, or social harm 

    1 week 

    Expedited Review 

    No more than minimal risk 

    2-4 weeks 

    Full Board Review 

    More than minimal risk 

    8-10 weeks

    There are many reasons a review may take longer. 

    • Incomplete documents (e.g., missing documents, incomplete sections)
    • Writing quality (e.g., incomplete sentences, grammatical errors) 
    • Clarifications needed (e.g., protocol uses undefined jargon) 
    • Insufficient protection for human subjects (e.g., inadequate consent procedures) 

After Approval

  • Get approval for protocol changes

    PIs are responsible for submitting any changes to the protocol or consent documents to the IRB for review and approval prior to the implementation of the change(s). Such changes include but are not limited to: the addition or elimination of an investigator, changes in consent form, supportive materials, flyers, questionnaires, surveys, script for person-to person or telephone interviews, etc.  This is done with the submission of an IRB Amendment Request. After approval, the principal investigator will receive an amendment approval letter listing the approved changes. The changes cannot be implemented until the approval letter is received.

    To submit an IRB Amendment Request, follow these instructions:  How to Submit an IRB Amendment Request.

  • Request protocol renewal after 1 year

    Protocols are approved for a one year period. Prior to the protocol’s expiry, PI’s must submit either a request for renewal or a notification that the project has been completed. Reminders are sent to PIs 60, 30, and 14 days before the protocol’s expiry.

    There are two forms used to renew protocols: the Study Status Update and the Continuing Review Request form. Exempt protocols require only a brief status update; Expedited and Full Board protocols require annual IRB review.

    • The Study Status Update form should be used for Exempt protocols.
    • The Continuing Review Request form should be used for all Expedited and Full Board protocols.

    To submit a Study Status Update or Continuing Review Request, follow these instructions: How to Submit a Study Status Update or Continuing Review Request.

  • Report problems

    An unanticipated adverse experience or death occurring during the course of a research project, regardless of cause, must be reported to the IRB immediately (within 24 hours). Initial notification of the event can be made by telephone but must be followed promptly (within 5 days) with a signed written report. 

    Contact information for reporting adverse events:

    The Office of Research and Sponsored Projects Operations

    Phone: (210) 805-3565

    Email: wandless@uiwtx.edu AND bilicek@uiwtx.edu

  • Close protocol

    PIs are responsible for promptly notifying the IRB of a project’s completion. This should be done by submission of an IRB Closure form.

    To submit an IRB Closure form, follow these instructions: How to Submit an IRB Closure.


For assistance, please contact:

Mary Jo Bilicek

bilicek@uiwtx.edu

(210) 805-3565