Frequently Asked Questions
The HCC IRB is authorized to review, approve, require modifications in, or disapprove human subjects research activities conducted by or through Houston Community College. The following is a list of answers to common questions. Please keep in mind that these responses are general in nature, and each potential research activity has unique features that could impact the answer shown.
Institutional Review Board FAQs
Q: How do I know if I should submit an application to the HCC IRB?
A: Researchers should thoroughly read and understand the HCC IRB process, including the Federal IRB regulations, particularly focusing on whether the proposed project meets the Federal definition of research. The Federal definition of research is: a systematic investigation which is intended to develop or contribute to generalizable knowledge. If the activity meets this definition, then an IRB application should be submitted.
Q: What are some examples of intending "to develop or contribute to generalizable knowledge"?
A: HCC interprets this to be when the intent is to use the outcomes of an activity to contribute to an action that is broad in scope. Examples include: submitting an article for publication (including dissertations), developing and delivering a conference or workshop presentation, or contributing to a process that ultimately would impact a decision made by HCC regarding major programs and services. It does not include routine classroom assignments or the performance of regular job duties.
Q: Who decides whether an IRB application should be submitted?
A: HCC Board policy E.2.4 indicates researchers must submit any project that involves HCC students, faculty, or staff for IRB review. The individual self-determines whether to submit an application to HCC's IRB based on his/her understanding of IRB regulations and the HCC IRB process. The IRB Chair and the IRB members may offer guidance, but the individual makes the final decision to submit an application.
Q: As part of my research protocol, I need access to HCC student records or a list of students to contact. What do I do?
A: Open records requests are made through the Office of General Counsel. Information is located here.
Q: Do my students need to submit IRB applications if I assign them to do research projects as part of my class?
A: No, unless the projects meet the Federal definition of research
Q: I don’t know how to answer some of the questions on the IRB application but I am in a hurry to get started – can I submit it anyway to begin the process and take care of the details later?
A: No. The application is designed to ensure that the IRB has sufficient information to make a judgment regarding compliance with Federal regulations. Researchers who submit incomplete applications will be informed that their applications will not be reviewed until all the information is received. Researchers are encouraged to build sufficient time for IRB review into their research timetable.
Q: May I start on my research before receiving an official IRB determination?
A: Yes, there are certain steps in the research process that may be completed prior to submitting an application to the HCC IRB, but participants cannot be recruited or data collected until official IRB determination for the application is received.
Q: What happens if I submit my application but the IRB requests changes?
A: Based on the Federal regulations, changes to the application may be requested in any of these situations. If changes are needed to meet compliance requirements, a detailed explanation is provided; a determination cannot be issued until the investigator submits additional information and/or materials that satisfy the changes requested.
Q: What happens if my application is disapproved?
A: Before a determination is issued, the IRB strives to communicate with researchers to request or suggest modifications that will bring the application into compliance as needed. Should an application be subject to review by the IRB, and the Board issues a disapproval, the determination cannot be overridden based on Federal regulations. HCC's IRB does not have an appeals process.
Q: How long does it take to receive a determination after I submit my application?
A: In most cases a minimum of four to six weeks will be required to review an application. The timing of the determination will vary based upon the completeness of the application, current workload, whether the application is subject to full board review, and other factors. Determinations for some applications involving complex protocol, needing input from special resources, and/or going to the full Board for review could take several months. Researchers should not begin the participant recruitment process or data collection until they receive their official IRB determination, but they may work on other aspects of their research while waiting.
Q: Who should complete IRB training?
A: Regulations require that investigators administering research that has been approved via either expedited or full review must complete training in a timely manner as a condition of the approved research. However, individuals may complete training even if no research is currently planned.
Q: Where can I complete IRB training?
A: HCC recommends completing the training provided by theNational Institutes of Health.
Q: Do I have to take HCC’s required IRB training if I completed IRB training elsewhere?
A: No. Federal regulations indicate that other formal IRB training may satisfy the training requirement imposed on investigators of approved research protocols as long as the training was completed within the past three years. Verification of this training must be submitted with the application.
Q: If I determine that I don't need to submit an IRB application, should I submit one anyway?
A: Yes, for the protection of the researcher and human subjects, it is strongly recommended that the project be submitted to the IRB. Even if their current intent does not involve contributing to generalizable knowledge, sometimes individuals elect to submit applications so that they receive an official IRB determination "just in case" they decide in the future that they would like to include their activities and data in a project that meets the Federal definition of research.