Frequently Asked Questions

All research involving human subjects must be reviewed by the IRB prior to starting.  If you have questions about if your study meets the federal definition of Human Subjects Research, you can reference HRP-310 in the Huron Library under Worksheets and email the IRB at irb@ucf.edu.

IRB guidance documents and templates can be found in the Huron Library.

Study application processing takes place through the Huron Research Suite. The application consists of uploading documents and information about your study. Visit the Huron Research Suite.

The level of review is determined by a multitude of factors. As research risks increase, the review level goes up. Review levels include:

• Not Human Subjects Research (NHSR)

• Exempt

• Expedited

• Full Board Review

To help determine which review level your research falls under, review IRB guidance 07 – Study Application Instructions in the Huron Library.  You can also set up a meeting with the IRB staff during Office Hours to discuss your project.

Within the Huron IRB system, the “Help Center” contains quick reference guides and videos. You can access the Help Center by clicking the IRB tab in the top navigation then clicking the Help Center tab.

CITI Training is required for all key study personnel completing research that is considered Human Subjects Research. Researchers are required to complete either Human Subjects Research-Group 1 Biomedical Research Investigators and Key Personnel or Human Subjects Research- Group 2 Social/Behavioral Research Investigators and Key Personnel. Training is required prior to approval of any review levels apart from Not Human Subjects Research (NHSR).

There are also additional modules required for NIH funded clinical trials and FDA clinical trials. See additional information about CITI in the Huron IRB Library under IRB> Library> General> IRB Guidance 4 – CITI Training.

UCF employees/students will be able to access the system once their NID has been created. All users can create studies and be listed on studies.

 If additional access is needed for an employee or you are not in the system, create a GRIT help desk ticket (GRITservicedesk@ucf.edu) with your name, employee ID, and title. The ticket will be routed to the GRIT team to have the appropriate user roles/offices assigned.

Faculty Advisors are UCF faculty or staff members who oversee student-led research. A thesis chair, dissertation chair, or faculty mentor are all examples of appropriate Faculty Advisors. In all student-led research regardless of the level, faculty advisors have the responsibility of guiding the student through the IRB application process.

 Note: Faculty advisors must be core UCF faculty. Volunteer faculty are not eligible to serve as advisors.

The IRB relies on faculty advisor’s (FA) scholarly expertise to review student’s research. FA’s are accountable for the review, approval, and execution of student-led research projects. This includes:

• Verifying the qualifications of a student as an investigator.

• Ensuring student’s submission documents meet basic application requirements.

• Assessing the scientific and scholarly validity of the research.

See IRB Guidance 16 – Faculty Advisor Ancillary Review for guidance on faculty advisor review of student submissions.

Yes, all undergraduate researchers must work with a faculty advisor who serves as the PI on the study application. Undergraduate students can still create an initial application and author application materials, but the listed PI takes responsibility and is expected to review all application materials prior to submission.

No, only the Principal Investigator (PI) can submit a study application in the Huron Research Suite.

Only UCF faculty, staff, and students have access to the Huron Research Suite. If you need to add an external team member, complete and upload the HRP-253 External Members and additional documents as needed under external team member information within the local study team members page of the study application.

Study information can be edited by individuals listed on the local study team. This includes the principal investigator, faculty advisor, co-investigatoris, and research assistants.

Note: Although a study application can be changed by individuals listed on the local study team members page, only the listed PI can submit.

Not Human Subjects Research (NHSR) means your project does not meet the federal definition of Human Subjects Research. Very often, we see NHSR submissions that involve research with existing, de-identified information or human biospecimens. This de-identified data can come from other researchers, hospital/medical records, public dataset/ repositories, biobanks, or commercial vendors.

This review level also encompasses projects that fall under the “Not Research” determination. “Not Research” includes non-generalizable research such as:

• Case Studies

• Quality Improvement Projects

• Program Evaluation Activities

• Oral Histories

• Journalistic activities

Studies fall under the Exempt review level when the research is no more than minimal risk and fits into one of the Exempt categories. Examples of studies that fit this review level include:

• Educational Research

• Survey/Interview Research with no psychological risk

• Brief Benign Behavioral Interventions

If research is determined to be Expedited, the study poses no greater than minimal risk to research subjects and meets an Expedited category. Minimal risk is when harm or risk does not exceed ordinary risks encountered in daily life. Studies that fit the Expedited review categories include:

• Studies with vulnerable populations

• Low-risk clinical trials

• Small quantity blood collection

• Non-invasive collection of human biospecimens or health metrics (blood pressure, heart rate, etc.)

• Research with data requiring consent.

• Survey, Interview, or interventional research that may include health or psychological risks.

Research that requires Full Board Review uses the same templates as an expedited review level, but the research could be considered more than minimal risk. This means research participants could encounter harm or discomfort greater than what is anticipated in daily life.

IRB reviewers make the final decision of whether a study will need full board review. When a study goes to the board, it is reviewed by a diverse group of experts who vote on the final determination.

It depends. If the secondary data being used includes identifiable private information or biospecimens that do not require consent, it is recommended to use the protocol template HRP-255SR.

Note: Secondary research involving social media data requires an exempt determination despite the data seeming to be publicly available.

For more information on the use of secondary data in human subjects research, review IRB Guidance 13 – Guidance on Secondary Analysis of Existing Data and Data Sets.

Research involving vulnerable populations must be reviewed at the Expedited level and could be assigned to the board for review.

Recent developments on the use of personal data extracted from social media no longer fits the definition of publicly available data and is not considered to be de-identified. Researchers should complete the HRP-255SR (Protocol) if they are not recording identifiers or complete the HRP-503 (Protocol) if they plan to record identifiers, including usernames, for research purposes. Be sure to upload a data points document to share what types of information will be recorded from the social media data.

Guidance documents and templates can be found in the Huron Library.

The IRB holds office hours to assist researchers navigating the IRB application process. Faculty researchers should utilize the IRB office hours. Student researchers should utilize the IRB Ambassador office hours for any clarifications or guidance on the IRB application process. Want to reserve a meeting time? Use the following links to reserve a meeting:

• Meet with the IRB Ambassador (student researchers).

• Meet with the IRB Administrative Assistant (pre-submission assistance for faculty and staff).

• Meet with IRB staff (faculty and staff).

No, the IRB refrains from offering research design guidance apart from considerations inherent to the protection of human subjects.

If you need research development assistance, such as proposal support, faculty researchers can utilize UCF’s Research development resources. Student researchers should consult their thesis chair or committee members for guidance on research design.

Department chairs can be added by selecting the “Manage Ancillary Reviews” on the study workspace page, searching for the department chair/director/dean’s name, and selecting “Department” under “Review Type.”

First try searching by adding “%” in front of and after the first few letters of the funding source. For example, if searching for NSF, type “%National%.” If you are still unable to find the funding source, you will need to email the Graduate and Research Information Technology (GRIT) help desk at GRITServiceDesk@ucf.edu so that the funding source can be added to the Huron IRB system.

“Other attachments” is where you upload study materials that participants will encounter during their participation in the study (measures, questions, visuals, devices). Additional documents such as letters of support should be submitted under other attachments as well.

You can request an IRB presentation for your class or program by emailing irb@ucf.edu. For HUT students, an IRB workshop is offered by the Burnett Honors College and meets the workshop requirement for the HUT program.

UCF’s IRB offers tutorial videos through the UCF IRB Learning Center on YouTube. 

There are also guidance videos located within “Help Center” under the IRB tab of the Huron Research Suite.

There are numerous considerations for research studies that provide incentives for participation. Federal regulations do not specify the level of payment that should be offered to research subjects; however, payment should be equitable (equal pay for equal time and effort), and confidentiality of information related to payments must also be protected.

For more information related to compensation in research studies see IRB Guidance 09 – Payment Guidance.

International research is when field work is being conducted in an international setting. There are various considerations when submitting an application for international research and it is recommended to start the application process at least 4 months prior to the expected start of research.

See IRB Guidance 01 – International Research Guidance Document for more information.

Note: If research is directed at international participants but takes place online, the research is not considered “international.”

When study is in pre-review, IRB review, and post review, it is on the side of the IRB.  When a study is in pre submission, clarification requested or modifications required, it is on the researcher’s side. When you add a study comment, the reviewer will receive an email notifying them of the comment.

The usual turnaround time for studies is 2-6 weeks from Pre-Review state to Review Complete State. Approval time is dependent on the current queue of studies in review, the complexity of the study, and the amount of time it takes to address clarification requests.

No, you may not begin research activities until your study application is approved/determined. Beginning study procedures prior to IRB approval can result in negative consequences such as potential harm to participants, loss of funding, inability to publish results, etc.

If you have started a study application, you can access it by logging into the Huron Research Suite. Individual study applications are located under the “All Submissions” section of the IRB page.

Clarification requests can be made during the pre-review and IRB review phases of the study application process. Common reasons for study clarification requests include:

• Incomplete documents

• Incorrect templates

• Track changes/comments left on documents.

• Incomplete/expired CITI training

• Consistency errors

• Documents uploaded in the incorrect location of the application.

To ensure that a study application meets basic study submission requirements, review IRB Guidance 07 -Study Application Instructions.

Yes, you can make a copy of a study by selecting “Copy Submission” on the bottom left side of the study workspace.

Reach out to the IRB if you are working with another institution. Sometimes agreements need to be completed, and sometimes each IRB reviews their own research. Reach out to the UCF IRB at irb@ucf.edu with information on the funding associated with the research, the type of review (is it exempt, expedited, etc.) the reviewing IRB and UCF’s role in the research.

External collaborators are added in the Local Study Team Members section of the study application. They are not listed in the Huron system however, they can be added in the separate section for External Team Members.

When adding new external team member(s), upload the HRP-252 – Individual Investigator Agreement for each investigator added, and the HRP-253 External Members to list each external research member on your study.

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that protects health information such as medical records, billing information, and other details related to an individual’s health and medical data.

HIPAA regulations apply to human-subjects research if study data is:

• Personal Health Information (PHI) derived from medical records.

• Created and or collected during healthcare.

Used to make treatment decisions.

Informed Consent is the process by which individuals are thoroughly informed on the benefits and risks associated with a research study so that participants may make an informed decision of whether to participate in said research.

The mission of this Institution’s Human Research Protection Program plan is to protect the rights and welfare of subjects involved in Human Research. This system is in place to ensure that all research involving human subjects is conducted in a safe and ethical manner.

 You can learn more about the purpose of the HRPP by reviewing the HRP-101 – Human Research Protection Program Plan in the Huron Library.

Assent is an agreement from someone who is not able to give legal consent, such as children or individuals with impaired decision-making capacity.  Instead, they provide an affirmative agreement to participate in research.

IRB’s take age, psychological state, and proposed research activities into account when making the final determination on the assent process.

Assent does not take the place of consent in research studies involving individuals who cannot formally agree to participate by legal standards (children, impaired, etc.), but instead is meant to confirm that those individuals in fact agree to participate rather than passively comply.

Personally Identifiable Information (PII) is any data that could be used to identify an individual or can trace back to a person’s identity. PII can include but is not limited to:

• Names

• Contact information (email, phone number, address, etc.)

• Identification numbers (SSN, IP address, etc.)

• Video and voice recordings

• Protected Health Information (PHI)

• Biospecimens

Defined by the Common Rule, research is “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§ 46.102(d).

According to the Common Rule, human subjects are “living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information” (§ 46.102(f).

An intervention includes physical procedures in which data are gathered and manipulations of the human subject or human subject’s environment for research purposes.

The Common Rule defines research as being designed to develop or contribute to generalizable knowledge. Research is considered generalizable when findings are intended to be applied beyond a study population and contribute to a broader understanding of the research topic. If a researcher is planning to publish and contribute scientific knowledge about their research topic, the research is likely to be generalizable.

 Research that does not considered generalizable includes:

• Case Studies

• Quality Improvement Projects

• Program Evaluation Activities

• Oral Histories

• Journalistic Activities

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 Examples of minimal risk data collection procedures include:

• Surveys and Interviews

• Observational Studies

• Blood draws within a certain amount in a certain time period, swabbing, and imaging

 Note: Minimal risk standards can vary depending on the research population, especially if the research involves vulnerable populations (children, pregnant women, prisoners, adults unable to consent, etc.)

Conflict of Interest (COI) occurs when a researcher’s professional judgment or objectivity is compromised by a financial, professional, or personal interest. COI only implies potential for bias due to the presence of conflicting objectives.

 When submitting a study application to the IRB, it is required to disclose any conflicts of interest related to the research. This disclosure does not halt research activities for the researcher but allows the IRB to implement a plan to ensure that the research is designed, conducted, and reported in an objective manner.

Human subjects research always involves the collection of data. As researchers, we must pay close attention to the ways we protect participant data so that it does not fall into the wrong hands and put participants at risk. Some general areas of concern are:

• Network security and data transmission.

• Data storage

• Data transcription

• Data retention

Note: For all studies that collect human subjects data, there are minimum requirements for data protection. For studies that collect data that is potentially harmful (places the participant at risk of criminal or civil liability or be damaging to the participants financial standing, employability, educational achievement, reputation, etc.) the IRB may ask for additional data protections.

For more information see IRB Guidance 02 – Data Security Best Practices.

Deception and incomplete disclosure is when human subjects are purposefully misled or withheld information about the research. This is only acceptable when such practices are key to research design and research cannot be performed without deception or incomplete disclosure.

 These practices raise concerns as they can affect a participant’s ability to make a fully informed decision about participating in research. It is required to thoroughly justify these practices in the study protocol and include a debriefing form to make up for the lack of fully informed consent.

 See IRB Guidance 11 – Deception or Incomplete Disclosure for more information.