Institutional Review Board

 

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.

• Criteria for IRB approval of research (§46.111)

• Exempt research procedures (§46.104 )

• Expedited review procedures (§46.110)

• Expedited Review Categories

 

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 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.

 

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).

 

 

 

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.

 

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.