The mission of the SHSU IRB is to protect the rights and welfare of human research subjects conducted or supported by SHSU. To accomplish this, the IRB shall review, approve the initiation of, conduct periodic review, and monitor research involving human subjects.
Frequently Asked Questions
Welcome to the IRB Application Walkthrough. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way.
What You'll Need
Prior to beginning your IRB application, it is important to make sure that you have all of your papers in order, including all relevant supporting documentation and certifications from all required CITI training.
Tasks to complete
Complete your CITI Training
Final IRB submission and approval requires you to have completed research ethics training through CITI. Be sure to download a copy of your completion certificate for upload to the IRB form system.
Evaluate expedited review and exempt review options
Many research projects are eligible for expedited review, which allows researchers to have their IRB applications approved outside of a meeting of the full IRB. Some projects are also eligible for exempt review, which if approved allows research to be carried out without continuing review, unless a change in the project has occurred.
For more information about expedited review and exempt review, or for help in determining whether or not your research is eligible for either of these categories, please consult the IRB FAQ, or contact Sharla Miles.
After You Submit Your Application
Tasks to complete
Reporting Adverse Events/Unanticipated Problems to the IRB
Federal regulations require PIs to promptly report any unanticipated problems involving risks to subjects or others to the IRB, appropriate institutional officials, and federal agencies. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. See Academic Policy Statement 140427 for further information.
Resources for Investigators:
For IRB Reviewers
IRB Determination Request
When to use this form:
- If you are unsure whether or not you need to submit your research for either an exemption determination or IRB review.
- If you are unsure if your activity is research under the federal definition.
- If you are unsure if your research involves human subjects.
- If you need a formal documented determination that IRB review is not required. Increasingly sponsors (e.g., funding agencies, device and drug manufacturers, etc.), faculty advisors, collaborators, vendors, or journal editors want verification from an impartial source that activities do not require IRB approval.
- IRB Templates
Sam Houston State University, by action of the President, has established an institutional review board (IRB) to review human subject research. This board is supported by Research & Sponsored Programs (ORSP). The IRB reviews research that is conducted or supported by the SHSU faculty, students or staff in order to determine that the rights and welfare of the human subjects are adequately protected. The IRB is guided by the ethical principles described in the 'Belmont Report' and by the regulations of the U.S. Department of Health and Human Services found at Title 45 Code of Federal Regulations, Part 46. Texas State maintains an approved Federal wide Assurance (FWA00002405) of Compliance with the Office for Human Research Protection (OHRP).
- Review Process
The IRB review schedule for regular and expedited applications, Continuing Review/Amendment requests, and requests for exemptions follows the academic semester schedule. In most cases, review of applications starts the first week of each semester and ends on the last day of classes, and is conducted in the order received. The IRB review and approval process typically takes two to three weeks to complete from the time the application comes out of routing (i.e., once the application receives approval from a PI's department and college), although some applications require additional time.
Please note that in all cases, it is in your best interest to submit applications as far in advance as possible. If your graduation is dependent on research that requires IRB review and approval during the current semester, ideally your application should be submitted shortly after the beginning of the semester, or immediately after a successful defense of a Thesis/Dissertation proposal, and no later than one month prior to the start date of your research.
What can delay the review process?
- Failure to complete the required CITI Training; for more information, please review the CITI Training section of this website.
- Lack of adherence to IRB submission instructions; please review the Application Walkthrough section of this website.
- Submitting an application between academic semesters.
- Your application requires full board review and approval; the full board typically meets every two to three weeks during Fall and Spring semesters and once per summer session during the Summer.
- An IRB reviewer may request modifications to no-more-than-minimal-risk studies.
- Failure to complete requested modifications or answer questions posed by the IRB prior to re-submitting the application for additional IRB review.
IRB Application Approval Chain
If you are submitting a:
Your approval chain is:
- Sharla Miles
- Faculty Sponsor (if applicable)
- Department Chair
- College Dean
- Sharla Miles
Upon submission of the application, it must always route through the aforementioned list and receive approval from each designated reviewer. As Sharla Miles is designated twice at differing points, she must also approve the form twice at those points in the timeline.
If any approver on this list finds that information within the submitted application must be updated prior to approval being granted, it would stop routing through the chain and would be returned to the PI. Reviewers have the option of sending the PI a note that reflects the requested changes. The PI will then need to resubmit the application once those changes have been made. At this point, routing must be reinitiated. Once all departmental and College approvals are received, the application is prepared for IRB review.
- Guidance for Student-Led Research and Class Projects
Student Research Requiring IRB Approval
Federal regulations and university policies require IRB approval for research with human subjects. This applies whether faculty or students conduct research. Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that collect data through interactions with living people or access to private information fall under the jurisdiction of the IRB.
All student-led protocols must be reviewed and submitted to the IRB by the faculty advisor. In addition, all IRB applicants are required to complete CITI IRB training prior to submitting their applications. Research applications will not be approved until all training requirements are fulfilled.
Research Integrity and Compliance (RIC) understands that student projects are usually very time sensitive. Therefore, students are encouraged to begin their discussions with their Faculty Advisor about the nature of their intended research and its potential IRB review as soon as possible.
IRB review times vary and are effected by the following factors:
- Level of review and risks to research participants: One or two reviewers can read low risk studies, while higher risk studies may require Full Board Review.
- Complete information: Follow the information on the RIC webpage and closely review your application to ensure that it is complete. All applications should be submitted in Kuali Protocols. Incomplete protocols and missing documentation will delay the review process.
- Attention to detail: Creating a clear and detailed application will greatly affect the reviewer's ability to make a determination in a timely manner. Information presented in more than one location should be consistent. Inconsistent information will result in additional information requests to ensure that regulatory requirements are met. Reviewers cannot make determinations based on assumptions, so clearly and consistently state your research plan throughout all your submission materials.
Faculty advisor review: Faculty advisors play a vital role in student-led protocols. They serve as active mentors for student researchers and share responsibility for the ethical conduct of research conducted by students. All research proposals from undergraduates, graduate students, and postdoctoral fellows must include a faculty advisor as members of the research team.
- Discuss general principles of research ethics with students prior to the initiation of any project involving human subjects
- Help students determine whether their project requires IRB review
- Guide students through the IRB application process
- Support students in the conduct of research after a project has attained IRB approval.
- Time of Year: The volume of student IRB submissions peak in the middle of the fall and spring semesters. Consequently, due to the high volume, applications submitted in the second half of the semester tend to take longer to review. The chart below details a month-by-month account on the number of student IRB submissions. Additionally, RIC suspends operation during the Holiday Break. Applications submitted immediately prior to the break will take longer to process and approve.
Classroom Research Projects
Research conducted as part of an in-class or course assignment generally does not require IRB review. These projects typically fulfill course requirements, are often completed in one semester, and are designed to teach research methods. Course instructors design these assignments to engage students in interaction with individuals, gather data about individuals, and/or illustrate concepts covered in the course. Therefore, they do not require IRB oversight.
The purpose of an IRB is to provide oversight of all research activities involving human subjects on campus, ensuring that all research participants are treated ethically and in compliance with all federal and state regulations.
For the purposes of SHSU’s IRB, research is defined as:
- A Systematic investigation, including research development, testing, and evaluation, designed to create generalizable knowledge.
- Generalizable knowledge means new information intended to be shared, published, presented, and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, or future research designs are contributing to generalizable knowledge.
Knowledge that can be generalized is collected under systematic procedures that reduce bias, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected. Most in-class projects where research is conducted using human subjects is not systematic or generalizable. In general, if the project is meant to complete an assignment for a class and has no relevance beyond the class, it does not require IRB review.
If students or instructors are uncertain if a research activity or classroom project requires IRB, they should contact RIC or submit an IRB Determination Request Form .