Institutional Review Board [IRB]

What is the CTX Institutional Review Board (IRB)?

The Concordia University Texas Institutional Review Board (CTX IRB) oversees, reviews, approves, and monitors all research activities involving human participants conducted by, or with, CTX students, faculty, or staff. The primary goal of the CTX 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. The Concordia University Texas Office for Human Research Protection IRB Registration number is IRB00011507 and Federalwide Assurance number is FWA00026886.

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 activities that do not require IRB review include:

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.

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

How long will it take the IRB to review my application?

The CTX IRB receives applications for review on a rolling basis throughout the year. Based upon the specific details of application, the length of time needed to complete IRB review varies greatly. Researchers are advised to submit complete applications as early as two months ahead of recruiting participants. It is important to note that the CTX IRB should not be expected to rush the review process to conform with the study plans of researchers.

The CTX IRB strives to review submitted applications in a timely manner with the goal of notifying researchers of review action (approved, approved conditionally, unapproved, deferred) within two weeks of a complete application submission for exempt review, within four weeks for expedited review, and within six weeks for full review.

IRB Application Submission & Approval Process

Please use the steps below to successfully submit a research application for review by the Institutional Review Board (IRB).

To submit an application by email, please use the IRB Application Template.
Please direct any questions regarding the IRB submission and approval process to irb@concordia.edu.
Submissions can be made electronically by email to irb@concordia.edu.

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 Application Submissions

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.
Download the following three documents from links provided on this page:
- CTX IRB Application Template – an MS Word formatted file that can be used to complete application submissions
- CTX IRB Research Application Guidelines – a pdf document containing detailed instructions for completing application submissions
- CTX IRB Informed Consent Checklist – a list of essential elements typically needed to provide informed consent to participants
Upon submitting a research application form, you will receive a confirmation email from irb@concordia.edu which will contain an IRB protocol number (e.g., 2023-03) used to identify the submission.
Please allow ten work days for feedback from irb@concordia.edu regarding any additional information or materials needed to complete the initial review of your application.

Once the initial review is complete and a review level is assigned, be aware that it may take up to six (6) weeks for the IRB to act on your application.

IRB Review Level	Description 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.
Expedited Review	Submissions designated for expedited review if it is nonexempt and 1) entails neither foreseeable risk nor harm or 2) does not involve vulnerable 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.
Full Review	Submissions designated for full review if it is nonexempt and 1) entails foreseeable risk or harm or 2) involves vulnerable populations. Copies will be forwarded to the entire membership of the IRB for full review.
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.

Upon completion of its review of nonexempt applications, 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.
Disapproved	Proposed study is rejected 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 application.

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.