Institutional Review Board

Frequently Asked Questions

The IRB is authorized to review, approve, require modifications in, or disapprove human subjects research activities conducted by or through the College. The following is a list of answers to common questions, however 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.

Q: How do I know if I should submit an application to the Valencia IRB?

A: You should thoroughly read and understand the Valencia IRB process, including the Federal IRB regulations, particularly focusing on whether the proposed project meets the Federal definition of research. Steps to Follow

Q: Who decides whether an IRB application should be submitted?

A: The individual self-determines whether to submit an application to Valencia's IRB based on his/her understanding of IRB regulations and the Valencia IRB process. The IRB Chair and the IRB members may offer guidance, but the individual makes the final decision to submit an application. The "Key Questions" checklist has been developed to help you make this decision. Steps to Follow

Q: If I determine that I don't need to submit an IRB application, may I submit one anyway?

A: Yes. 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.

Q: I am conducting undergraduate research with my students, who should submit the IRB application?
The instructor should submit the application. If the course that you are offering is structured as an undergraduate research project in which multiple students will be supporting or engaging in a research experience or if you are mentoring a student engaged in this kind of research you will be the one to complete the application. We strongly suggest that you discuss the IRB purpose and process with your students. Upon request, slides and related materials can be provided for your class in order to teach students about the IRB process, the responsibilities of researchers, and the ethical conduct of research irb@valenciacollege.edu. Our office has visited classrooms to talk about the history, purpose, and process of IRB review at the college in relation to their own work at the college.

An undergraduate research project within the context of a course would go beyond one assignment to include several aspects of the research process. For example, the experience a student might have reading a research article would not, by itself, mean that the student is engaged in an undergraduate research project. A student who participates in the design of a study along with data collection, however, would be participating in an undergraduate research project.

When faculty members apply for IRB review of an undergraduate research project for an entire class, this means that the students in that class do not have to apply for review of their work in that class. If the project does not change substantially (e.g. if the methods and the scope of the project stays the same, but the title of the project changes) then the review determination can cover multiple sections of a course over time.

When applying for IRB review you will be asked to submit certification of the completion of your online IRB training, which is available without charge online, nationally recognized, and only has to be renewed every three years (see link below). This online training is without cost, lasts approx. 3 hours, and can be completed over time. OHRP In case you completed your certification elsewhere, this is another online IRB training that requires a fee; it is sometimes used at other institutions: CITI

Q: I think my research qualifies for "exempt" status – do I still need to submit an IRB application?
A: Yes. Only the Valencia IRB can officially issue an "exempt" determination.

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 HRP regulations. Investigators who submit incomplete applications will be informed that their applications will not be reviewed until all the information is received. Investigators 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 you may complete prior to submitting an application to the Valencia IRB, but you cannot begin recruiting participants or collecting data until you receive the official IRB determination for your application. We will need a hardcopy with original signatures in order to begin your review.

Q: Do all survey projects have to be submitted to the IRB for review?

A: No. Whether an IRB application needs to be submitted is based on whether the proposed project meets the Federal definition of research; it is not based on the research process.

Q: What happens if I submit my application but the IRB requests changes?
A: The IRB chair, on behalf of the IRB, conducts an initial review of all applications to determine if the application: (1) is complete; (2) is eligible for exemption; (3) is eligible for expedited review; or (4) must receive full IRB review. 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: Does receiving an "exempt" determination mean that I do not have to worry about informed consent?
A: No. All research projects that receive a determination of "exempt" or "approval" (expedited or full) must still comply with informed consent requirements. Projects that do not fall under the Federal definition of research involving human subjects are not required to comply with Federal informed consent regulations, although compliance is encouraged.

Q: What is a waiver of informed consent?
A: A waiver of documentation of informed consent may be requested at the time of application if the research project meets certain conditions. However, this waiver only means that the participant's signature is not required on the informed consent form – informed consent is still required.

Q: How long is IRB approval good for?
A: When you submit your application, you can request any period of time up to 10 years.

Q: Someone has asked me to participate in his/her research. How do I know it has been through IRB review?
A: IRB review is documented by a stamp placed on informed consent forms submitted at the time of application. The stamp contains the IRB application number assigned to the project and the determination given. If no stamp is evident on the informed consent document that you receive, you can send an email to irb@valenciacollege.edu and ask if an IRB application has been submitted for the project in question.

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. Please see the "resources" page for links to training options.

Q: What will I learn in Valencia's IRB training?
A: Protecting Human Research Participants online training consists of seven modules; each addressing the principles used to define ethical research using humans and the regulations, policies, and guidance that describe the implementation of those principles. Four of these modules are followed by a quiz. The entire course will take approximately 3 hours to complete. Register for free to take this assessment at: http://phrp.nihtraining.com/users/login.php if you have not taken it within the past three years.

Q: Do I have to take Valencia's IRB training if I completed IRB training elsewhere?
A: 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.

Q: What happens if my application is disapproved?

A: Before a determination is issued, the IRB strives to communicate with PIs to request or suggest modifications that will bring the application into compliance as needed. Should an application be subject to full review by the IRB, and the Board issues a disapproval, the determination cannot be overidden based on Federal regulations. Based on the pre-determination communication process with PIs, Valencia's IRB does not have an appeals process.

Q: Can I still try to do my research if my application is disapproved?
A: Technically, yes, but not without consequences. The IRB process is designed to place the burden on the investigator – just as with any regulation or policy, ultimately it is the individual's responsibility to comply. Investigators are expected to submit an IRB application, to comply with the regulations when the application is approved, or to not proceed if the application is disapproved.

Receiving a disapproval from the IRB cannot physically stop an investigator from moving forward if he/she so chooses; the IRB can only exempt, approve, disapprove, or terminate IRB approval. However, it is important to be aware that a disapproval or the absence of a formal IRB determination from Valencia's IRB means that the researcher will not be protected from any individual risk or liability that IRB approval provides. In addition, the investigator will be at risk for not having their study accepted for publication or presentation. Also, by having a process whereby a summary of IRB applications and determinations is shared, the Valencia community is informed and thus may take any action that they believe is appropriate separate from the IRB application process.

Q: I have agreed to serve as a project director on a Valencia grant. Do I need to submit an IRB application?
A: Project directors should follow the direction given to them by the Office of Resource Development.

Q: I am a subcontractor on a grant proposal, should I apply for IRB review?
A: No, the Principal Investigator (PI) leading the grant is responsible for submitting the IRB application for research being conducted.

Q: I am conducting research in my classroom as part of my ordinary educational process, should I apply for IRB review?
A: No. If you are uncertain, please take the "Key Questions" checklist (see the "steps to follow" tab).

Q: How long does it take to receive a determination after I submit my application?

A: We request that applications be submitted at least 2 weeks prior to the start date indicated in the 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 longer. PIs 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: What is our human subjects Institutional Review Board (IRB) HRRC (Human Research Review Committee) registration number?

A: IRB00006823 - Every IRB on a campus is registered upon filing for a federal-wide assurance number and each IRB is assigned an IRB (HRRC) number.

Q: What is our human subjects IORG Identifier number?

A: IORG0005669 - The IRB Organization (IORG) number identifies the organization when it files or updates its Federal-wide Assurances (FWA).

Q: What is our human subjects Federal-wide Assurance (FWA) number?

A: FWA00022007 FWA - The Department of Health and Human Services Office for Human Research Protections assigns an FWA approval number to each campus of a university.

Q: What’s the difference between a human subjects IORG (IRB Organization number), an FWA (Federal-wide Assurance) number and an IRB (Institutional Review Board) HRCC (Human Research Review Committee) registration number?

A: The IORG number identifies the institution. The university has only one IORG number. An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with the Office for Human Research Protections (OHRP). Before obtaining an FWA, an institution must either register its own IRB, (an "internal" IRB), or designate an already registered IRB operated by another organization, (an "external" IRB), after establishing a written agreement with that other organization. The IRB HRRC number is the registration number identifying each IRB on campus. Institutions may have multiple IRBs.