The University of Florida Institutional Review Board (IRB) plays a crucial role in ensuring that all research involving human subjects is conducted in an ethical and responsible manner. The IRB is responsible for reviewing and approving research protocols to ensure that they comply with federal regulations and university policies. In this guide, we will walk you through the University of Florida IRB approval process, highlighting the key steps and requirements involved.
Introduction to the University of Florida IRB
The University of Florida IRB is composed of faculty members and staff from various departments, as well as community members. The IRB is divided into three panels: Panel A, Panel B, and Panel C, each with its own area of expertise. The IRB reviews research protocols to ensure that they meet the requirements of the Belmont Report, which outlines the principles of respect for persons, beneficence, and justice.
The University of Florida IRB has the authority to approve, require modifications to, or disapprove research protocols. The IRB also has the authority to suspend or terminate research that is not being conducted in accordance with the approved protocol or that poses a risk to human subjects. It is essential for researchers to understand the IRB approval process and to comply with all relevant regulations and policies.
Step 1: Determining Whether IRB Review is Required
Before submitting a research protocol to the IRB, researchers must determine whether IRB review is required. The IRB reviews research that involves human subjects, which is defined as living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Researchers must use the IRB’s decision tree tool to determine whether their research requires IRB review.
If the research involves human subjects, the next step is to determine the level of review required. The IRB offers three levels of review: exempt, expedited, and full board review. Exempt review is required for research that is exempt from federal regulations, such as research that involves the use of existing data or samples. Expedited review is required for research that involves minimal risk to human subjects, such as surveys or interviews. Full board review is required for research that involves more than minimal risk to human subjects, such as clinical trials or research that involves vulnerable populations.
The IRB Approval Process
Once the level of review is determined, researchers must submit their research protocol to the IRB for review. The submission must include all relevant documents, such as the research protocol, informed consent forms, and survey instruments. The IRB uses a web-based system called IRBManager to manage the review process.
The IRB review process typically takes several weeks to several months, depending on the level of review required and the complexity of the research protocol. The IRB may request modifications to the research protocol or may require additional information before making a decision. Researchers must respond to all IRB requests and must revise their research protocol as necessary to ensure that it complies with all relevant regulations and policies.
Step 2: Preparing the Research Protocol
Researchers must prepare a comprehensive research protocol that includes all relevant information about the research study. The protocol must include a detailed description of the research question, study design, methods, and procedures. The protocol must also include a detailed description of the risks and benefits associated with the research, as well as a plan for ensuring the confidentiality and privacy of human subjects.
The protocol must also include information about the informed consent process, including the content of the informed consent form and the process for obtaining informed consent from human subjects. Informed consent is a critical component of the research process, as it ensures that human subjects are fully aware of the risks and benefits associated with the research and are able to make an informed decision about whether to participate.
| Document | Description |
|---|---|
| Research Protocol | A detailed description of the research study, including the research question, study design, methods, and procedures. |
| Informed Consent Form | A document that informs human subjects about the risks and benefits associated with the research and obtains their consent to participate. |
| Survey Instruments | Questionnaires, surveys, or other instruments used to collect data from human subjects. |
Post-Approval Requirements
Once the IRB approves a research protocol, researchers must comply with all post-approval requirements. These requirements include obtaining informed consent from human subjects, reporting any adverse events or unanticipated problems, and submitting annual progress reports. Researchers must also ensure that their research is conducted in accordance with the approved protocol and that any changes to the protocol are approved by the IRB before they are implemented.
The IRB also requires researchers to maintain accurate and complete records of their research, including documentation of informed consent, data collection, and data analysis. Record-keeping is an essential component of the research process, as it ensures that researchers can demonstrate compliance with all relevant regulations and policies.
Step 3: Maintaining IRB Approval
IRB approval is typically valid for a period of one year, although the IRB may grant approval for a longer or shorter period of time. Researchers must submit a renewal application to the IRB before the expiration date of their approval. The renewal application must include an update on the progress of the research, as well as any changes to the research protocol or personnel.
The IRB may also require researchers to submit a final report at the conclusion of the research study. The final report must include a summary of the research findings, as well as any lessons learned or recommendations for future research. Final reports are an essential component of the research process, as they ensure that researchers can demonstrate the value and impact of their research.
What is the purpose of the IRB?
+The purpose of the IRB is to review and approve research protocols to ensure that they comply with federal regulations and university policies. The IRB is responsible for protecting the rights and welfare of human subjects involved in research.
How long does the IRB review process take?
+The IRB review process typically takes several weeks to several months, depending on the level of review required and the complexity of the research protocol.
What is informed consent?
+Informed consent is the process of informing human subjects about the risks and benefits associated with a research study and obtaining their consent to participate. Informed consent is a critical component of the research process, as it ensures that human subjects are fully aware of the risks and benefits associated with the research and are able to make an informed decision about whether to participate.
In conclusion, the University of Florida IRB approval process is an essential component of the research process, as it ensures that research is conducted in an ethical and responsible manner. Researchers must comply with all relevant regulations and policies, including the Belmont Report and federal regulations. By understanding the IRB approval process and complying with all post-approval requirements, researchers can ensure that their research is conducted in a way that respects the rights and welfare of human subjects.
