Institutional Review Board (IRB) Overview

Lone Star College System (LSCS) encourages and supports the scholarly endeavors of its students, faculty, and staff. Many of these scholarly activities involve research with human subjects. In accordance with institutional and federal requirements, all research involving human subjects that is conducted at or sponsored by LSC—regardless of funding status or the affiliation of the investigator—must comply with policies designed to protect human participants.

When is IRB Review Required?

IRB review is required before:

• Recruiting participants

• Collecting data

• Administering surveys, interviews, or other research tools

If your project involves human participants, you must obtain IRB approval before beginning any part of your study.

Purpose of IRB Review

The IRB review process is intended to ensure that:

• The rights and welfare of research participants are protected.

• Informed consent is properly obtained and documented.

• The potential risks to participants are minimized and are justified by the anticipated benefits of the research.

Responsibilities of the Researcher

Before submitting your project for review, you are expected to:

• Read all guidance and resources on the IRB website

• Complete the IRB application thoroughly and accurately

• Contact the IRB with any questions or to request additional information

Important Note:
The IRB does not evaluate the scientific merit or quality of a research design. Its role is strictly limited to ensuring ethical standards and regulatory compliance in the protection of human participants.

Submitting a Proposal for IRB Review

Before beginning your IRB submission, please review our Frequently Asked Questions to understand key definitions and responsibilities related to human subjects research.

Once you determine that your project involves human subjects, follow the steps below to complete the IRB review process. Please allow up to one full month from the date of submission for the review to be completed.

Step 1: Complete Required Human Subjects Training

All researchers must provide proof of completing training in the ethical conduct of research with human subjects.

You may submit either of the following:

• A certificate of completion from the CITI Program

• Verification of equivalent training from another institution

If your research is sponsored or reviewed by another institution, please include the IRB approval letter or documentation of institutional awareness with your submission.

Step 2: Submit Notice of Intent (NOI)

Download and complete the IRB Research Application Form, then email the completed application and supporting documents to Pamela Wyatt at LSC-IRB@lonestar.edu .

• Completed IRB Research Application Form

• Training certificate (CITI or equivalent)

• Completed Notice of Intent(s) (NOI)

• Informed consent document(s)

• Survey questions or research instruments (if applicable)

• IRB approval letter from sponsored institution (if applicable)

Note for LSC Faculty Completing a Dissertation or Thesis:
If your research does not involve LSC students, faculty, or staff, you may submit an IRB approval letter from your home institution. However, LSC IRB may still require you to submit an LSC IRB application at its discretion.

Visit the IRB Links/Training page for resources that may assist you in completing your application.

Step 4: IRB Review Process

Once submitted, your proposal will be reviewed and assigned one of the following review categories:

Exempt Review

Some research proposals may fall into one of the Exempt categories as defined by federal regulations and determined by the Institutional Review Board (IRB). These proposals meet specific regulatory criteria and involve minimal risk, making them potentially eligible for a streamlined review process conducted by the IRB Chair or the IRB Administrator.

It is important to note that “Exempt” does not mean exempt from review; rather, these proposals are exempt from full committee voting and, depending on the study duration, may be exempt from continuing review. The final determination of Exempt status can only be made by the IRB.

Exempt reviews typically proceed more quickly than full committee reviews and do not require a formal vote. Investigators will receive written notification of the review outcome, which will also be reported at the next IRB meeting. Additionally, IRB members retain the right to request further discussion of any expedited reviews or to refer a proposal to full committee review if deemed necessary.

Common examples include:

• Educational Research: Studies conducted in established or commonly accepted educational settings that involve normal educational practices, such as instructional strategies or classroom management methods.

• Survey, Interview, and Observational Research: Research involving educational tests, survey procedures, interview procedures, or observation of public behavior, provided the information is not identifiable and its disclosure would not place subjects at risk. (Note: Survey and interview research involving children is never eligible for exemption.)

• Existing Data Research: Studies that involve the use of existing data, documents, records, or biological specimens, where either the sources are publicly available or the information is recorded in such a manner that subjects cannot be identified directly or through linked identifiers.

• Program Evaluation Research: Research and demonstration projects that are designed to study, evaluate, or otherwise examine public benefit or service programs conducted by or subject to the approval of federal agencies.

Expedited Review

An expedited review consists of a review by the IRB Chair and one or more committee members. Expedited reviews are for proposals that meet minimal risk standards as determined by the regulations and the Chair. Expedited reviews are normally faster than the full committee review and do not require a vote. The results will be communicated to the investigator in writing and also reported at the next IRB meeting. IRB members may ask for discussion of any expedited reviews, or the referral to a full committee review.

Full Review

Proposals involving greater than minimal risk require a full Institutional Review Board (IRB) review. Applications that do not meet exempt criteria or cannot be expedited by the IRB Chair, due to the necessity for additional deliberation, will be forwarded to the full IRB Committee. Investigators may be invited to present and discuss their research during the committee meeting.

Step 5: Board Chair and/or Committee Determination

Once the review category has been determined, the IRB Committee or its designees will evaluate the Research Application Form and recommend one of the following actions:

• Approval: The proposal meets all federal regulations and IRB requirements, and research may proceed.

• Conditional Approval: Approval will be granted once specific conditions outlined by the IRB are met. These recommendations will be provided to the investigator in writing. Research may not begin until a revised application addressing these conditions has been submitted and approved.

• Tabled: The application lacks sufficient information for a final decision, requires further discussion, or a quorum of voting members was not present.

• Not Approved: The proposal does not comply with federal regulations or institutional requirements. The reasons for non-approval will be communicated to the investigator in writing.

Step 6: Post-Approval Actions

Once the committee has reviewed the Research Application Form, the Principal Investigator will be notified in writing—typically via email—regarding the status and recommendation. If approved, research may commence immediately upon receipt of the official approval correspondence.

Please note that IRB approval does not equate to authorization from the Office of Analytics & Institutional Reporting (AIR) to access or release student records.

The LSC IRB kindly requests that you share the final results of your research project with the IRB office upon completion. Your study’s data can provide valuable insights to grant writers and others across the LSC system. Full authorship credit will be attributed to you.