Navigating the UCF IRB: Guidelines and Procedures for Human Research
The University of Central Florida (UCF) Institutional Review Board (IRB) is crucial for ensuring ethical standards and regulatory compliance in research involving human subjects. This article provides a comprehensive overview of the UCF IRB's guidelines and procedures, designed to support researchers, faculty, students, and staff throughout the IRB process. The IRB is a committee that reviews research involving human subjects to ensure that all research complies with ethical standards and regulations. The mission of this Institution’s Human Research Protection Program plan is to protect the rights and welfare of subjects involved in Human Research.
Understanding the IRB Process
Study Application Submission and Review
Study application processing takes place through the Huron Research Suite. UCF employees/students will be able to access the system once their NID has been created. If you have started a study application, you can access it by logging into the Huron Research Suite. The application consists of uploading documents and information about your study. The University of Central Florida IRB requests that copies of federal grant applications be submitted with IRB protocols. Department of Health and Human Services (DHHS) regulations at 45 CFR 46.103(f) require that each application or proposal for HHS-supported human subject research be reviewed and approved by the Institutional Review Board. Investigators must submit a copy of the entire proposal (exclusive of appendices). If a grant is linked to multiple IRB protocols then the IRB needs to know which protocols so that they can all be reviewed. Only one copy of the grant proposal is required in the IRB office. The grant proposal must be found to be consistent with information related to the protection of human subjects. The IRB protocol must be consistent with the grant proposal. Any discrepancies will require the PI to either amend the current protocol or to submit a new protocol that is consistent with the grant application.
The level of review is determined by a multitude of factors. As research risks increase, the review level goes up. The usual turnaround time for studies is 2-6 weeks from Pre-Review state to Review Complete State. No, you may not begin research activities until your study application is approved/determined.
Review Levels: Determining the Appropriate Path
The IRB employs different review levels based on the nature and risk of the research:
Not Human Subjects Research (NHSR): IRB determination is not required for research that falls under Not Human Subjects Research (NHSR) or does not meet the federal definition of research. 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 review level also encompasses projects that fall under the “Not Research” determination. 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.
Read also: Cultivating Leaders: The Huron University College Way
Exempt Review: Studies fall under the Exempt review level when the research is no more than minimal risk and fits into one of the Exempt categories. Minimal risk is when harm or risk does not exceed ordinary risks encountered in daily life.
Expedited Review: If research is determined to be Expedited, the study poses no greater than minimal risk to research subjects and meets an Expedited category.
Full Board Review: 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. IRB reviewers make the final decision of whether a study will need full board review.
Required Documentation
All review levels require a study protocol (HRP-250, HRP-255, HRP-255SR, or HRP-503), and a participant consent form (HRP-254, HRP-502). Studies that are NHSR do not require a consent form. Use of templates depends on the design of the research study.
Modifications and Continuing Review
Do not modify the Human Research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to participants. Changes to an approved/determined study take the form of a Modification (MOD) request. Researchers can update their study materials and/or study team members through a MOD. A continuing review application as requested in the approval letter. Please note that applications must be received at the specified time prior to expiration of the approval. Failure to submit the application by the specified date may result in a lapse of approval.
Study Closure and Data Retention
I am done with my research. When research activities have ceased, it is important to close your study within the Huron Research Suite. State of Florida law requires all research data to be retained for a minimum of five years after study closures.
Key Roles and Responsibilities
Principal Investigator (PI)
A faculty member or graduate student can be a PI on a study. Undergraduate students cannot serve as PI of a study.
Faculty Advisors
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. Note: Faculty advisors must be core UCF faculty. 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. Yes, all undergraduate researchers must work with a faculty advisor who serves as the PI on the study application.
Study Team Members
Only UCF faculty, staff, and students have access to the Huron Research Suite. Study information can be edited by individuals listed on the local study team. External collaborators are added in the Local Study Team Members section of the study application.
Important Considerations for Researchers
Training Requirements
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. There are also additional modules required for NIH funded clinical trials and FDA clinical trials.
Data Security
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. Note: For all studies that collect human subjects data, there are minimum requirements for data protection. For more information see IRB Guidance 02 - Data Security Best Practices.
Conflict of Interest (COI)
Conflict of Interest (COI) occurs when a researcher’s professional judgment or objectivity is compromised by a financial, professional, or personal interest. When submitting a study application to the IRB, it is required to disclose any conflicts of interest related to the research.
Deception and Incomplete Disclosure
Deception and incomplete disclosure is when human subjects are purposefully misled or withheld information about the research. These practices raise concerns as they can affect a participant’s ability to make a fully informed decision about participating in research.
International Research
What is considered international research? International research is when field work is being conducted in an international setting.
Personally Identifiable Information (PII)
What is Personally Identifiable Information (PII)? Personally Identifiable Information (PII) is any data that could be used to identify an individual or can trace back to a person’s identity.
Agreements with Other Institutions
UCF IRB currently has pre-negotiated agreements with the following institutions and a new agreement is not needed. We also have pre-negotiated agreements for some Department of Defense studies. 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.
Resources and Support
Within the Huron IRB system, the “Help Center” contains quick reference guides and videos. 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? If you need research development assistance, such as proposal support, faculty researchers can utilize UCF’s Research development resources. First try searching by adding “%” in front of and after the first few letters of the funding source.
A clarification request is correspondence from an IRB reviewer in which they request changes to uploaded study application materials. 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. Clarification requests can be made during the pre-review and IRB review phases of the study application process.
“Other attachments” is where you upload study materials that participants will encounter during their participation in the study (measures, questions, visuals, devices). Does the IRB offer workshops? There are numerous considerations for research studies that provide incentives for participation.
Compliance and Oversight
Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the Human Research on each individual administered the investigational drug or device, or employed as a control in the Human Research. Any open protocol is eligible for selection. During an assessment visit, the Compliance Specialist meets with the investigator to review study related documents to ensure that applicable laws and regulations are being followed. After the assessment meeting, the Compliance Specialist will send a completed assessment worksheet to the investigator for review and signature. If there are any compliance findings, the worksheet will be provided to the IRB for review.
Additional Approvals
Research investigators should be aware that other UCF committees approvals may be needed. After the hospital IRB approves the study and issues their IRB approval letter, the UCF PI must make a submission in the Huron system strictly for record-keeping purposes. The submission must include the Huron study application, the approved protocol, the approved Informed Consent, other study documents, as appropriate, and the other institution’s IRB approval letter. When submitting in Huron, be sure to add the faculty advisor (if applicable) and department chair/dean/director as ancillary reviewers.
tags: #huron #irb #ucf #guidelines #and #procedures
