Human Subjects IRB

IRB Steps for Successful Submissions

  • Assess whether you need to submit to the IRB. Review our Do I Need IRB? page or complete and submit Form 106: Human Subjects Research Determination Form. Be sure to read through Form 106 and if prompted to submit to the IRB, you must complete and submit the entire virtual application in Novelution.
  • For information on the difference between standard of practice, quality assurance projects or classroom projects view the guide on the Toolkit for Researchers page under Investigator Guidance Documents (HRP-408 “Classroom Research”) and the Education tab ( and ). 
  • Identify an eligible Principal Investigator (PI). See the Principal Investigator Eligibility Policy.
  • If you are a student, receive approval for your thesis/dissertation proposal.
  • If IRB Review is needed, the PI and all research personnel must complete required Human Research Training.
  • Review 糖心Vlog’s Novelution research submission portal. Watch the or read the .
  • Create an application in Novelution to submit to the IRB. or read the .
  • Use the .

  • Information regarding training required for the IRB can be found on our Human Research Training page
  • Novelution will automatically sync your CITI training to any project where you are on the Research Team
  • Check the Requirements Panel to confirm your or your other research team personnel’s CITI trainings have been synced.
  • Contact researchintegrity@fau.edu if your CITI is not reflected in Novelution.

  • All submissions must be submitted in Novelution. This includes new applications, requests for IRB reliance agreements, amendments, continuing reviews, reporting of new information or adverse events, requests for determinations, and study closures.
  • Create an application in Novelution to submit to the IRB: or read the .
  • Read through each question and help text where applicable and provide thorough responses. Incomplete responses or insufficient information may result in the application being sent back to you for clarification.
  • See the to assist you in selecting the appropriate Review Category or Categories for your study.
  • Upload all supporting documents including recruitment materials, consents, etc. using the appropriate IRB Forms & Templates. It is important to use the most current, 糖心Vlog branded templates on the Forms & Templates webpage. Do not save templates or re-use old consent documents as templates are frequently updated with important, new information that may be missing from outdated templates.
  • Review your application for completeness and accuracy by ensuring responses are consistent across the different sections.
  • Check the Requirements panel in Novelution to identify the status of your application. Watch the or read the to learn how.

  • Submit all supporting documents including recruitment materials, consents, etc. using the appropriate IRB Forms & Templates.
  • In addition to describing your recruitment plan in your protocol, attach any advertising materials (flyers, scripts for radio or television ads, e-mail, texts, etc.) that will be used. Use 糖心Vlog branded materials when developing recruitment flyers.
  • If you are a student, submit confirmation of acceptance of your thesis or dissertation proposal.
  • Use the to guide you in your submission.

  • Write by thinking through the study in a systematic way. Return to the basics and include the who, what, where, how, and why of your research study written in simple terms. Who are the participants, what will they be asked to do, where will the research take place, how much of the participants’ time is required, why is this research being done?
  • Use the help bubbles in Novelution to guide you in how best to address some of the questions asked by the IRB. Students should discuss the details of their research with faculty advisors
  • Use the IRB Forms & Templates page to select from consents, parental permission forms, recruitment flyers, etc. which provide template language that must be included as well as instructions for information you need to edit to the specifics of your study.
  • Describe incentives (money, extra credit, gift cards, etc.) that will be used to attract and retain participants in your protocol and noted in any consent form(s) or procedures.
  • If enrolling students, including K-12 and university students, refer to Policy 10.3.8 “Students and Research Subjects” and Investigator Guidance Document HRP-406, ‘Research with Children” in the Toolkit for Researchers for more information. If extra credit is provided to students, an alternative assignment of equal weighted value must be offered.
  • Due to Florida law, Florida Atlantic researchers are not able to use lotteries for cash or prizes as an incentive for research participation. This includes raffles or games of chance.

  • Write with considerations of all the risks of the study. Guidance on what a risk is and how the IRB considers risk can be found in the Toolkit for Researchers under the Education ab Risks and Benefits.
  • Incentives, compensation, or feelings of doing a good thing are not considered a direct research benefit. Most research offers benefit to science or society through knowledge gained and does not offer a direct benefit to the participant.

  • When writing the consent form, do not copy and paste your grant or proposal procedures into the consent form. The consent form is meant to inform participants about what is being asked of them in the simplest terms possible. Please do not copy and paste lengthy methodology from a proposal or grant application into the consent form.
  • The reading level of a consent form should be at a 6th - 8th grade reading level, or higher depending on the study population. Avoid scientific / technical terms and define or spell out all abbreviations and acronyms. Tip: always ask yourself what would you say if you were explaining your research study to a family member.
  • You can determine the reading level of your consent form using different programs available such as Microsoft Word’s built in feature or AI tools.
  • Not all studies required a signed written consent form. Choose the most appropriate consent process for your study. If you think your study does not require a signed consent, you must provide the IRB with a justification as to why this requirement should be waived. A wavier of signature and waiver of consent are not the same thing. Waiving consent is only granted in cases where the research involves (1) no more than minimal risk to the subjects, (2) it would be impracticable (not possible) to conduct the research without the waiver, (3) the research involves the use of identifiable private information or biospecimens, and it would be impracticable (not possible) to conduct the research without the use of the identifiable information or biospecimens, and (4) the waiver will not adversely affect the rights and welfare of the participants.
  • The 糖心Vlog IRB does not recognize the use of “passive” or “opt out” consent in research.
  • Children cannot legally consent for themselves. Therefore, informing them about the study and asking them to agree to participate is called an assent process. Only parents or guardians can give permission for a child to participate in research, unless the IRB waives this requirement. However, even if a parent agrees, if the child refuses to assent, the researcher generally should not enroll the child in the study.
  • In most cases, minors between ages 7 and 17 can give their written assent to participate in research. An assent must be tailored to the emotional and educational level of the child. Short, simple sentences and friendly, conversational language is preferred. For very young children, such as those under age 7, a verbal assent script that describes what will be said to the child may be more appropriate.
  • If you plan to recruit participants who do not speak English, you will need to translate the written consent document to obtain effective informed consent. However, since the IRB may request changes, please wait until after the IRB has approved the English version of the consent document before seeking translation services. If you are using a verbal consent process, you still need to provide a translated version of the script that will be spoken to the participant. See Policy 10.3.4, “International Research” for more information on engaging non-English speaking participants.
  • Guidance on obtaining effective informed consent or assent are available on the Toolkit for Researchers under Education.

  • If you are not the PI, once you submit, your project will automatically be routed to the named PI for review and certification.
  • If you are the PI, or once the PI has certified the protocol, your project will be automatically routed to the Department Chair or Department Signatory for approval.
  • Your project has not reached the IRB Office until the Current Status reads “IRB Review Pending.”
  • Check the Requirements panel to track the status of your submission. Watch the or read the to learn how.
  • Confirm all listed Research Team personnel have completed their CITI training as the IRB office will not review or receive projects without this required component. See the Human Research Training page for information on requirements.
  • If changes are needed for the IRB to make a decision, you will receive a Modifications Required letter. Follow the instructions in the letter and address all comments from the IRB reviewer. This may take a few iterations. If no changes are required and if the protocol has satisfied all sections, the IRB will issue a decision letter.
  • The review process timeline depends on the completeness and clarity of the research submission. If all fields have been addressed, are consistent throughout the submission, and all required documents are included a review, a decision may be made within a few days to a week. Delays typically come from missing required training, incomplete responses or missing document uploads. Exempt reviews take approximately 2-3 weeks. Expedited reviews take approximately 4-6 weeks.
  • Exempt and expedited reviews are conducted on a rolling basis. There is no deadline for submitting these types of projects. Investigators who will conduct studies requiring review at a fully convened meeting should adhere to the IRB Submission Due Dates and Meeting Schedule for these projects. Studies requiring review at a fully convened meeting may take 4-8 weeks for approval. See the to learn more about your study’s review category and risk level.
  • You cannot start data collection involving human subjects until AFTER the IRB approves your submission as described in an IRB letter.

  • Once the IRB has approved your study, you will receive a notice of approval to your IRB Novelution registered email. It is important to read that approval letter to understand any requirements or limitations of your approval.
  • IRB letters have different meanings depending on the ACTION line. Carefully read your IRB letter to learn whether your research does not fall within the IRB’s purview, whether you can begin your research or whether modifications are required.
  • If Modifications are Required, watch the or read the .
  • Watch the or read the for more information on your IRB letter.
  • See the to learn more about your study’s review category.
  • IRB Letters are saved in the IRB Correspondence panel of your study as well as sent to you via email from the Novelution system.
  • Other IRB approved materials such as consents may be accessed through IRB Novelution. Download and/or print the stamped approved materials to use for your research. Once the IRB has approved your study you can begin your research.

  • For updates involving a Continuing Review on an Approved Expedited or Full Board study, watch the or read the .
  • To make changes to Exempt studies
    • In general, investigators are not required to submit changes to an exempt study unless it is believed the changes will increase the risk to participants.
    • Examples that may substantially change the focus of the research study include: a change in hypothesis, study design, adding or changing an incentive, or adding a new study population. If the study is modified to add additional sites for the research, note that you may not begin the research at those sites until you receive the appropriate approvals/permissions from the sites.
    • Contact the IRB Office at researchintegrity@fau.edu if you have any questions about whether a change must be submitted for IRB review and approval.
  • To make changes to Expedited or Full Board Studies
    • Watch the or read the
  • For updates to study personnel

  • 糖心Vlog’s IRB policies and the Toolkit for Researchers provide information on regulations and guidance such as conducting research with vulnerable populations, students as research subjects, international research, and more.
  • There are special issues you should consider with online research projects, please click on the Internet-Based Human Subjects Research tab on the Toolkit for Researchers page.
  • If you have questions on best practices to secure research data, visit the Research Data Security Additional information on the Responsible Conduct of Research page under Data Management.
  • If you are working with medical records or creating, viewing, handling, or analyzing Protected health Information, HIPAA may apply to your project. See the HIPAA and Research page for information and guidance.
  • In human research we use terms and abbreviations that you may be unfamiliar with. See our Abbreviations & Definitions page to learn more. Other definitions may be found in the Toolkit for Researchers under Investigator Guidance Documents (HRP-401, “Definitions”).
  • A Data Use Agreement (DUA) is a contractual document used for the transfer of nonpublic data that is subject to restrictions on its use. Data Use Agreement forms are available through the Office of Technology Development.
  • There is a distinction between research conducted by students and classroom research. Student research refers to human subjects research conducted by students in pursuit of an Honor's thesis, Master's thesis, dissertation, designated independent study (DIS), or other similar research. Student research projects should be submitted to the IRB and be actively monitored by the faculty advisor, who serves as Principal Investigator.
  • Classroom research refers to students' involvement in course activities that are primarily intended to teach them how to conduct human subjects research, rather than contribute to generalizable knowledge. Results of these activities are generally not published or disseminated outside of an instructional setting. In most cases, classroom research does not need to be reviewed by the IRB. If at a later point, you decide to continue a class project as a research project, submit an IRB application for review and approval. More information can be found on the Toolkit for Researchers page under Investigator Guidance Documents (HRP- 408 “Classroom Research”).
  • Additional Study Tools and considerations for studies using MRI, Research Match, All of Us, and more can be found here 糖心Vlog | Toolkit for Researchers
  • Florida Atlantic's FWA # is FWA00000157

  • You do not need IRB approval before submitting a funding proposal, you can list your IRB status as pending and, with most federal agencies (NIH, NSF, Dept. of Education). Check the specific agency's guidelines on human subjects research.
  • While you do not need to have IRB approval before you submit your proposal, it is best not to delay your IRB application too long since it can hold up the funding decision, and If your grant is ready to be funded but you haven't yet received IRB approval, most funding agencies won't release funds until approval is verified. When you do submit your IRB application for a funded or soon-to-be-funded study, make sure the research described in your funding proposal matches your IRB application (including matching titles), since the IRB must ensure the research it approves aligns with what the sponsor is supporting.

  • If you are working with another university, hospital, or organization to conduct your research, additional considerations and agreements may apply. See the Collaboration and Agreements page for more information and review Policy 10.3.18, “Institutional Authorization Agreements (IIA) and Reliance Agreements”.
  • If you are collecting data from persons at an institution outside of Florida Atlantic, or an outside institution is helping you with recruitment, you are working with cooperating institutions. The IRB requires a letter of cooperation or support from an appropriate person at that institution. Templates for these letters are found in the Toolkit for Researchers under Study Tools.
  • Some agencies, such as 糖心Vlog K-12 schools, county school districts, the Florida Department of Health, the Florida Department of Corrections among others, may have their own separate research review processes. Please contact these agencies regarding their specific procedures. These agencies may require an additional review to ensure the study fits within their mission and is conducted according to their policies and administrative processes. More information can be found in the Toolkit for Researchers under the Resources tab.

If there are Human Subjects (IRB) topics that you would like addressed but don't see on this page, please email researchintegrity@fau.edu.

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