Texas State University | San Marcos Institutional Review Board
IRB Online Application for IRB applications, Exemptions Requests, and Continuation/Change applications
IRB Application Inquiry Request Form
An Overview for Applicants
What is the Institutional Review Board?
An Institutional Review Board, usually referred to as an IRB, is a diverse group that may consist of faculty, staff and students, plus at least one community representative. All education, research, and medical institutions are required by the federal government to have an IRB in order to do research with human subjects. Each IRB is charged with protecting the rights and welfare of human research subjects. The IRB reviews proposed research to ensure that the proposed project follows federal guidelines and accepted ethical principles to meet that goal. Federal guidelines require academic and cultural diversity of IRB members to ensure that research proposals are given a thorough review by members with varying interests. Additional background information about IRBs and the regulation of human subjects research can be found in the required CITI training, described below.
Institutions enter into a contract with the federal government stipulating the methods by which the organization will protect the welfare of human research subjects. This contract, called a FederalWide Assurance (FWA), must be approved by the federal government in order for the institution to receive federal funding for human subjects research. In the FWA, an institution pledges to follow certain ethical principles and federal regulations in the review of human subjects research proposals. Like many other institutions, Texas State has agreed in its assurance to apply these ethical principles and federal regulations to ALL human subjects research conducted at Texas State, or by Texas State employees and students, whether a project is funded or not. Texas State’s assurance number is FWA00000191.
The federal guidelines require each institution to designate an Institutional Official with oversight of the IRB. At Texas State, the Institutional Official is the Associate Vice President for Research (AVPR). The Office of Sponsored Programs (OSP) provides administrative support for the IRB. The OSP IRB administrator processes all incoming application and review documentation, and is the main point of contact for information about the IRB process.
Anyone requiring information about the IRB, the review or training process, or a specific application is encouraged to first contact the IRB administrator and/or the Director of OSP rather than individual IRB members. Contact information for the AVPR, Director of OSP, and the IRB administrator, as well as the current roster of Texas State IRB members, is on the IRB Contact section of the website.
Determining the need for review: Exemption Request vs. IRB application
Some research with human subjects does not require IRB review. Federal regulations describe six categories of research that may qualify for exempt status. In addition, student classroom projects, surveys by faculty or staff, and other academic studies that do not meet the regulatory definition of research are often exempt from IRB review. However, per federal guidelines, the Texas State IRB policy requires that IRB personnel, not applicants themselves, make determination of exempt status.
Applicants qualifying for exemption are not required to take the required CITI training prior to application and do not have to submit a regular IRB application. Applicants seeking exempt status should first submit an exemption request, available in the Online Submission Forms section of the IRB website. In most cases, exemption requests are processed rapidly and the applicant is informed via email of their status within one or two working days. Therefore, if it seems likely that their project is exempt, applicants are urged to use the exemption request form rather than go through training and the full IRB application process.
If an applicant submits an exemption request but reviewers determine it is not exempt, the project must undergo IRB review. The applicant will also be required to take the required training and submit the supporting documentation required for a regular IRB application. Every effort will be made to review the applicant’s project in the current IRB review cycle.
Required Training – the CITI Course in The Protection of Human Research Subjects
This training must be completed by all faculty/staff members submitting a application to the IRB, or who are supervising students submitting an IRB application, and by all students submitting an IRB application. The link for the CITI website is in the Training section of the website.
The CITI training is completely web-based and self-paced. It consists of a number of course modules followed by short multiple-choice quizzes. Modules do not have to be completed in one sitting. Applicants register themselves, can access their records at any time, request new passwords, and print out their own completion report. Course curriculum varies between learner groups. Students are in a different learner group than faculty, and biomedical/science applicants are in a different learner group than those in the social and behavioral sciences.
The “Basic CITI Course for Faculty and Staff” should take approximately three to four hours to complete. There are two levels of student courses. The “Basic CITI Course for Students” is intended for student researchers or subjects involved in studies that qualify as greater than “minimal” risk or for students requiring a more in-depth education in the protection of human subjects. The course should take approximately an hour to ninety minutes to complete. The other student course, “Students in Research,” is designed for students who may be involved in a human subjects research study as an investigator and/or a subject. It is intended for academic projects and/or research studies that qualify as no greater than “minimal risk.” The “Students in Research” course requires approximately 20-25 minutes to complete.
Applicants submitting a regular IRB application must complete the training course before their application is processed. The applicant’s completion report will accompany the IRB application during the review cycle. The IRB application can be made prior to course completion but it will be held until the OSP receives the applicants’ completion reports. It is not necessary for applicants to notify OSP that they’ve completed the course — the CITI system notifies the IRB administrator and the applicant at the same time.
As previously noted, applicants submitting an exemption request do not have to take the CITI training prior to submission. If however, their research is deemed non-exempt, or if, in rare instances, their research is technically exempt but reviewers determine training is needed, the applicant will be required to take the CITI training.
While OSP can access information about applicants’ course progress, it will not have access to CITI passwords and usernames. Applicants must retrieve that information themselves directly from the CITI website. Applicants needing a copy of their completion report should download it directly from the CITI website.
It is not necessary for applicants to repeat the CITI course every time they submit an IRB application. The applicant’s completion report will remain on file in OSP.
NOTE: Faculty and students who have already completed the previous Texas State HSP training do not have to take the CITI course this year. However, all HSP Certification numbers will expire at the end of the Spring 07 semester.
Types of Review
The majority of applications to the Texas State IRB qualify for expedited review, which means that they do not require review by the full IRB at a convened meeting. A smaller group, usually consisting of the IRB chair and one other member, reviews these applications.
It is possible that, during the review, IRB members may need additional information from the applicant or request changes to the applicant’s research plans and/or documents. If so, the applicant will receive an email from the IRB administrator asking for the additional material or explaining the request.
Applications that do not qualify for expedited review must be reviewed by the entire IRB. The applicant will be informed of the meeting date and location and will be given the opportunity to speak to the IRB regarding their project but may be asked to leave the meeting during the IRB deliberations.
Approval Period and Continuation/Change Applications
Unless otherwise stated in the review decision, IRB approvals are granted for a period of one year. Projects continuing after this initial approved period need an additional review by the IRB. Applicants requesting approval for continuations should submit a continuation/change application.
The same continuation/change application should also be submitted whenever any changes are made to an ongoing project that has already been approved.
The continuation/change/application is located in the Online Submission Forms section on the website.
Additional information
For additional information, For additional information, contact IRB Administration using the IRB Inquiry Form: http://www.txstate.edu/research/irb/irb_inquiry.html
ospirb@txstate.edu 512-245-2314