Frequently Asked Questions
The following is a list of answers to common questions we receive at the IRB, 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.
Often Asked Questions
What steps are followed in the review of IRB applications?
The IRB follows a set of Written Procedures that are periodically updated and follow guidelines outline in 2018 by the Dept.
of Health and Human Services (HHS). The IRB Chair determines the appropriate designation
for submitted applications using The Valencia College - IRB- Revised Common Rule Checklist, which is based on the revised Common Rule regulations that structure the review
process.
Can I access copies of the online application and signature page forms and the automatic e-mails? Yes.
- FINAL - Form Filled by Researcher – PI – Online Example 11-3-2020
- FINAL - Form Filled by Sponsor - Supervisor Online Example 11-3-2020
- For Website -copy of E-mail sent to supervisor / sponsor when an IRB application is submitted.
- For Website -copy of E-mail sent to supervisor / sponsor when an IRB extension is submitted.
Who determines whether an application is exempt, expedited, or requires full review?
The IRB Chair determines whether or not an application is exempt, expedited, or requires
a full board review following the federal policy outlined by the Office for Human
Research Protections (OHRP). Links to the criteria for each designation are included
below. Please contact the Chair of the IRB with specific questions about the application.
Full board review is required for research that is not eligible for exempt or expedited
review. In short, research that is judged to involve more than minimal risk, or involves
protected populations such as prisoners or disabled individuals in ways that puts
them at risk, must undergo full board review.
Researchers who are employees take the online screening survey- The Key Questions Checklist- to determine if they should submit an IRB application. Non-employees are asked to submit an IRB application; they cannot self-screen using the online survey.
What is the "Online Key Questions Checklist" and how do I access it?
We provide an "Online Key Questions Checklist", so that a researcher can quickly find out if an application needs review. The questions
follow the federal policy and provide a follow-up e-mail so researchers know whether
or not they need to apply for IRB review. The checklist has been developed and periodically
updated and tested. We have found that when researchers report they are not receiving
the automatic e-mails, the problem is the browser, the cookie settings, or the spam
filter. We suggest using the Chrome browser or contacting OIT for technical support.
How do I know if I should submit an application to the Valencia IRB?
If you are an employee, you should take the Key Questions online survey, which will help you to determine if you should submit an application. For non-employees
who do not have access/ need a sponsor, you must first obtain permission from the
office of the Vice President for Analytics and Planning before applying for IRB review.
The application forms are located here: Steps to Follow
I am conducting undergraduate research with my students, who should submit the IRB
application?
If review is needed, then the instructor should submit an application. When applying
for IRB review, you will be asked to submit certification of completion of your online
IRB training. (Please see the "Resources" option for more information)
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, please contact us through: 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.
"Expedited" does not reflect the amount of time taken in our review; it reflects the determination and the subsequent expectations of the researcher. When a researcher submits an application asking for the "exempt" designation, if appropriate the exempt designation is conferred by the IRB. Sometimes researchers submit an application asking for "expedited" when their studies are actually "exempt". Sometimes researchers submit an application asking for "exempt" when their studies are actually "expedited".
Do I have to submit an IRB application if my students are conducting research using worms?
No, because it is not Human Subjects Research. You need only submit an Animal Protocol Form if you use animals that have a vertebrae (backbones). However, currently we do not have an Animal Protocol Form or an Institutional Animal Care and Use Committee (IACUC) review committee, so for the time being we do not anticipate having animal research at the college (this was a faculty decision to limit the scope, not the IRB independently). We advise you to investigate the use of simulations or other alternatives to research with animals, if that kind of activity is needed in your classroom.
If I don't need to submit an IRB application, may I submit one anyway?
Yes. Sometimes individuals elect to submit applications so that they receive an official
IRB determination "just in case" they decide in future that they would like to include
their activities and data in a project that meets the Federal definition of research.
The Process
The application asks for a designated Valencia College Supervisor/Accountable Administrator
Signature. Can a faculty member signs as the supervisor for my research?
No, researchers seeking IRB review must have an administrator at the college who has
agreed to be accountable for the research (such as a dean or a program director)
I plan to conduct research within the local public school system. Who should sign
my application?
You should have your form signed by your supervisor. Once the process of review is
complete, bring your IRB determination (exempt, expedited, or full review) to the
school where you will be conducting your research. It is up to you to get site access
to the school through someone at school. You will want to document that approval.
IRB review at Valencia College does not provide permission to conduct research; it
is only a review of the research and its risk to human subjects.
Why can't a researcher call up the IRB chair to ask that exceptions be made?
Sometimes researchers (investigators) ask that exceptions be made for their studies
(for example, some want to tell the Chair that they do not need to submit an IRB application
because they have done one elsewhere; or they want to inform the IRB Chair that Valencia's
procedures do not apply to them as non-employees or they want to receive a review
over the phone with the IRB Chair and skip the paperwork, etc.). All researchers must
follow the same procedures at Valencia for accountability purposes and to ensure consistent
application of the regulations. We provide an "Online Key Questions Checklist" so that a researcher can quickly determine if an application needs review. The questions
follow the federal policy and provide a follow-up e-mail so researchers know whether
or not they need to apply for review.
How long does it take to receive a determination after I submit my application?
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.
What is a waiver of informed consent?
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 an informed consent form – informed
consent is still required.
How long is IRB approval good for?
When you submit your application, you will be given one year with the option of then
applying for an extension.
Does receiving an "exempt" determination mean that I do not have to worry about informed
consent?
No. 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.
What happens if my application is disapproved?
Before a determination is issued, the IRB strives to communicate with Principal Investigators
(PI) 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 overridden based on federal regulations.
Based on the pre-determination communication process with PIs, Valencia's IRB does
not have an appeals process.
What are the implications of IRB review for researchers at the College?
The IRB implements the steps outlined in federal regulations and the college's related
policy. As with any college activity, employees are expected to comply with all applicable
policies, laws, and regulations; this includes policy 6Hx28:3E-05.2, Ethical Conduct
and Performance. When engaging in research involving human subjects, employees must
act within the scope of their employment and in accordance with any IRB guidelines.
In the case of claims or actions arising out of research, the College reserves the
right to withhold indemnification and/or require reimbursement of defense and other
costs and expenses if the claim results from the employee acting outside the scope
of employment, outside any IRB guidelines, or in violation of any applicable policy,
law, or regulation. Third parties unaffiliated with the college are not permitted
to conduct research without prior college approval; if approval is granted, the parties
will agree to the scope of the research and any applicable guidelines and rules in
a written document executed by both parties.
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?
No. The application is designed to ensure that the IRB has sufficient information
to make a judgment regarding compliance with federal 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.
May I start on my research before receiving an official IRB determination?
You cannot begin recruiting participants or collecting data until you receive the
official IRB determination for your application. We will need a hard copy with original
signatures in order to begin your review.
Do all survey projects have to be submitted to the IRB for review?
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.
What happens if I submit my application but the IRB requests changes?
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.
Why do studies that fall under the definition of "exempt" still undergo expedited
review at Valencia?
While some research studies (for example as part of a grant proposal; external evaluation;
or for a doctoral study) may fall under the federal definition of "exempt", they are
still given expedited review to insure there is follow-up by the researcher and steps
for reporting adverse events or changes. OHRP has directed that IRB approval is the
determination of our IRB that the research has been reviewed and may be conducted
at Valencia College within the constraints set forth (a) by the college's IRB; (b)
within Valencia's Institutional requirements (c) and according to any applicable federal
requirements. HHS regulations allow flexibility in both format and content of written
procedures, which gives our IRB the ability to establish procedure best suited to
our own operations and in compliance with college-specific policies and practices.
Can I still try to do my research if my application is disapproved?
The IRB process is designed to place the burden on the investigator – just as with
any regulation or policy, ultimately it is the investigator'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.
Training and Certification
Who should complete IRB training?
Regulations require that investigators administering research that has been approved
via either expedited or full review must complete training within two weeks of the
start of the data collection. Individuals may complete training even if no research
is currently planned. Please see the resources page for links to training options.
What kind of training certification should accompany an IRB application?
One of three kinds of certifications are acceptable when an investigator (researcher)
submits an IRB application that receives expedited or full IRB review: (1) Collaborative
Institutional Training Initiative (CITI Program) certification or the (2) Protecting
Human Research Participants (PHRP) Online Training. Typically these trainings span
three or more hours and extensively cover the history and policies related to at-risk
research and protecting human subjects.
Individuals may complete training even if no research is currently planned. Please see the resources page for links to training options.
I would like to provide training for a group of faculty or staff members. Can the
IRB help me?
Yes. The IRB Chair customizes workshops for specific groups, collaboratively developing
goals and outcomes that meet the needs of the faculty and staff members.
Why is proof of my official IRB training required of only one researcher, instead
of all researchers?
The IRB review process at Valencia is a review of the proposed research submitted
for review in accordance with the federal regulations. It is not a review of the quality
of the research proposed or the research team working on the project.
Can I skip the certification requirement by providing evidence of one hour workshop
completion?
No. The one hour workshop provided through Faculty Development or through the EDGE
for staff members does not provide this extensive training; instead it provides an
overview of the practices used at the college; examples of best practice in research
at the college that are not specific to the IRB regulations. Selected historical references
related to the development of the IRB are also presented. The workshop completion
is not accepted in place of one of the three official certifications.
I would like to explain the IRB role and process to my students. Can the IRB help
me?
Yes. The IRB Chair visits classrooms upon request and is also able to provide materials
for faculty members to incorporate into their classes. (including slides, videos,
and role play simulations).
Specific Circumstances
I have agreed to serve as a project director on a Valencia grant. Do I need to submit
an IRB application?
Project directors should follow the directions given to them by the Office of Resource
Development.
I am a subcontractor on a grant proposal, should I apply for IRB review?
If you are an employee, you should take the Key Questions online survey, which will help you to determine if you should submit an application. For non-employees,
please ask the Principal Investigator (PI) who is leading the grant. The PI is typically
responsible for submitting the IRB application for research being conducted.
I am conducting research in my classroom as part of my ordinary educational process,
should I apply for IRB review?
No. If you are uncertain, please take the "Key Questions Checklist"
Someone has asked me to participate in a research study. How do I know it has been
through IRB review?
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.
Does the use of animals in labs (for research) involve the Institutional Review Board
(IRB) process?
No. Because the mission of Valencia College is focused on teaching (and not research)
we do not have an institutional animal care and use committee, or IACUC- a self-regulating
entity that reviews all the proposed animal research protocols and ensures that the
researchers make efforts to treat the animals humanely. Questions about acceptable
classroom and lab practices should be directed to the appropriate dean.
Does this apply in research partnerships with the University of Central Florida (UCF) for employees at the Downtown Campus?
Not necessarily. Please refer to the Memorandum of Understanding (MoU) for the terms of our agreement and contact the Chair of the IRB with further questions.
Does Valencia create formal joint review arrangements with IRBs at other institutions?
No. As mentioned prior, Valencia maintains its own IRB process because the practices
and the policies that we follow are specific to our college. In part our process serves
as a way to: (a) document the research being conducted at the college; (b) assure
that there is an official gatekeeper / sponsor/ supervisor at the college; (c) adhere
to institutional specific policies and practices that are required by Valencia.
Does research being conducted in cooperation with other institutions need IRB review
at Valencia ?
Yes. Cooperative research, for example if there is a grant-funded study with a co-principal
investigator (PI) at another college, should be submitted for review and will undergo
the expedited review process, According to federal policy, each institution is responsible
for safeguarding the rights and welfare of human subjects and for complying with the
policy.
Will Valencia's IRB review an application prior to grant submission if required (e.g.
by the funder)?
Yes. If the proposal is funded and the study changes slightly (and / or the PI changes)
an amendment must be filed upon grant award. If the proposal changes substantially,
then a new application must be filed. Please contact the IRB chair for further discussion
of specific applications.
Do studies that have received IRB at another institution still have to be review at
Valencia?
Yes. Valencia maintains its own IRB process because the practices and the policies
that we follow are specific to our college. In part our process serves as a way to:
(a) document the research being conducted at the college; (b) assure that there is
an official gatekeeper/ sponsor/ supervisor at the college; (c) adhere to institutional-
specific policies and practices that are required by Valencia.
About our IRB registration
What is our human subjects Institutional Review Board (IRB) HRRC (Human Research Review
Committee) registration number?
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.
What is our human subjects IORG Identifier number?
IORG0005669 - The IRB Organization (IORG) number identifies the organization when
it files or updates its Federal-wide Assurances (FWA).
Our IORG was renewed November 2021 and our next renewal date is 11-18-2024. Read more about this registration process here.
What is our human subjects Federal-wide Assurance (FWA) number?
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.
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?
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.
Our IORG was renewed November 2021 and our next renewal date is 11-18-2024. Read more about this registration process here.