Institutional Review Board [IRB]

What is the CTX Institutional Review Board (IRB)?

The CTX IRB exists to oversee, review, approve, and monitor all research activities involving human subjects conducted by, or with, CTX students, faculty, or staff. The primary goal of the IRB is to ensure that ethical standards such as privacy, risk, and informed consent are met by all university-related research conducted with human participants. Details regarding the IRB can be found in its policies and procedures manual.

What Needs IRB Approval?

If a research activity involving human participants is designed to develop or contribute to generalizable knowledge, IRB approval is required by CTX policy.

If a research activity involving human participants is not designed to develop or contribute to generalizable knowledge, IRB approval is not required.

Examples of this include:

  • Course or classroom-related research assignments
  • Opinion surveys and institutional assessments
  • Focus groups and interviews for media or journalistic use

Please note that an instructor or supervisor may require IRB approval of a course-related assignment for pedagogical purposes, including research proposals and projects, theses, and dissertations.

Please contact the IRB office at irb@concordia.edu for guidance or clarification regarding this policy.

IRB Proposal Submission & Approval Process

Please use the steps below to successfully submit a research proposal for review by the Institutional Review Board (IRB). Additional details regarding IRB policies and procedures may be found here.

Please direct any questions regarding the IRB submission and approval process to irb@concordia.edu.

Please note that online submission using the IRB Submission Google Form is preferred; however submissions can be made electronically by email to irb@concordia.edu or by hard copy to:

Trey Buchanan, Ph.D.
Director of Institutional Research & Effectiveness, D-202a
Concordia University Texas
11400 Concordia University Drive
Austin, TX 78726

To submit a proposal by email or hard copy, please use the IRB Submission Template.

IMPORTANT: Be aware that research involving human participants conducted without proper IRB approval – including recruitment of human participants or the data collection of any data from human participants – is considered a violation of the university's Policy on Research Ethics.

Step-by-Step Guide for IRB Proposal Submissions

  1. Determine if the proposed study meets that criteria of research defined by the IRB as "a systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If you are unclear whether or not your study meets this definition, please contact the IRB for assistance.

  2. Download the IRB Submission Template and review the information and materials needed to complete this form before you begin the online submission process.

  3. Complete an IRB Submission Google Form. If applicable, have supporting documentation (e.g., Informed Consent, surveys, interview materials) available in .pdf format to upload with your submission.

  4. Upon submitting a research proposal form, you will receive a confirmation email from irb@concordia.edu which will contain an IRB protocol number (e.g., 2017-01) used to identify the submission.

  5. Please allow one week for feedback from irb@concordia.edu regarding any additional information or materials needed to complete the initial review of your proposal.

  6. Once the initial review is complete, your proposal will be designated one of the following four IRB review statuses:

    IRB Review Status Description of Review Process Typical Lengh of Review Process
    Exempt Review Submissions designated exempt will directly approved by the IRB requiring no further action. Common exemptions research includes involving normal educational practices, anonymous surveys, and archival data or materials. For a full listing of exempt research activities please see Appendix A of the CTX IRB policies and procedures manual. 1 week
    Expedited Review Submissions designated for expedited review if it is nonexempt and 1) entails neither foreseeable risk nor harm or 2) does not involve special human populations. Copies will forwarded to three members of the IRB for expedited review electronically. Proposed studies that have prior approval of a recognized IRB external to CTX may also receive expedited review. 2 weeks
    Full Review Submissions designated for full review if it is nonexempt and 1) entails foreseeable risk or harm or 2) involves special human populations. Copies will be forwarded to the entire membership of the IRB for full review. 4 weeks
    Incomplete Submissions are designated as incomplete if additional information, materials, or clarification is required to designate a review status. Please communicate directly with the IRB to resolve this review status.

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  7. Upon completion of its review of nonexempt proposals, the IRB will communicate one of four possible decisions:


    IRB Action  
    Approved Proposed study is approved by IRB and may proceed in accordance with the information submitted to the IRB.
    Approved Conditionally Proposed study is approved under specific conditions imposed by the IRB. For example, a study of adolescent cognitive abilities may be approved under the condition that participants are required to be 18 year or older.
    Unapproved Proposed study is not approved by the IRB and is not allowed to be conducted by a member of the CTX community or with members of the CTX community as participants.
    Action Deferred Proposed study is not approved; review is deferred until additional information or materials are provided or requested revisions are made to the submitted proposal.

 

Important Information for IRB Approved Research Studies

Changes or amendments to an approved study: Any substantive modification of an approved study that increases the potential for risk or harm (including methodology, sampling, or consent procedures) or adds a special human population to the participants must have additional prior approval before proceeding with the study. Notification of such modifications must be provided to the IRB and approved

Extensions or delays in conducting an approved study: The CTX IRB must be notified of any time extensions or delays in conducting IRB-approved research. Unless otherwise informed, IRB approves research studies for a duration on one year.

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