The University of Florida Institutional Review Board (UF IRB) is a committee responsible for reviewing and approving research projects that involve human subjects. The primary goal of the IRB is to ensure that research is conducted in an ethical and responsible manner, with the welfare and rights of human subjects being protected. In this guide, we will provide an overview of the UF IRB approval process, including the types of research that require IRB approval, the steps involved in submitting a proposal, and the criteria used to evaluate proposals.
Introduction to UF IRB
The UF IRB is established in accordance with federal regulations, including the Common Rule (45 CFR 46) and the Belmont Report, which outline the ethical principles for conducting research with human subjects. The IRB is composed of faculty members, staff, and community representatives who review research proposals to ensure that they meet the regulatory requirements and ethical standards. The UF IRB has the authority to approve, require modifications, or disapprove research proposals.
Types of Research Requiring IRB Approval
The UF IRB reviews research projects that involve human subjects, including:
- Interventional studies, such as clinical trials or experiments
- Observational studies, such as surveys or interviews
- Secondary data analysis, such as analysis of existing datasets
- Biological sample collection, such as blood or tissue samples
However, not all research projects require IRB approval. Exempt research, such as quality improvement projects or research using publicly available data, may not require IRB review.
IRB Approval Process
The IRB approval process involves several steps, including:
- Pre-submission review: Researchers should review the UF IRB website and consult with IRB staff to determine whether their project requires IRB approval and to ensure that all necessary documents are prepared.
- Submission: Researchers submit their proposal, including the research protocol, informed consent document, and other supporting materials, through the UF IRB online submission system.
- Initial review: The IRB conducts an initial review to determine whether the proposal is complete and whether it meets the regulatory requirements.
- Full board review: If the proposal requires full board review, it is presented to the IRB at a convened meeting, where the board members discuss and vote on the proposal.
- Approval or modifications: The IRB either approves the proposal, requires modifications, or disapproves the proposal. If modifications are required, the researcher must revise and resubmit the proposal.
Criterial for Evaluating Proposals
The UF IRB uses the following criteria to evaluate proposals:
| Criteria | Description |
|---|---|
| Risks and benefits | The IRB assesses the potential risks and benefits of the research to determine whether the benefits outweigh the risks. |
| Informed consent | The IRB reviews the informed consent document to ensure that it is accurate, complete, and understandable to the research participants. |
| Subject selection | The IRB evaluates the selection of research participants to ensure that it is fair and equitable. |
| Privacy and confidentiality | The IRB assesses the measures in place to protect the privacy and confidentiality of research participants. |
Post-Approval Requirements
After IRB approval, researchers must comply with the following requirements:
- Protocol deviations: Researchers must report any deviations from the approved protocol to the IRB.
- Adverse events: Researchers must report any adverse events or unanticipated problems to the IRB.
- Continuing review: Researchers must submit a continuing review report to the IRB at least annually, or as specified in the approval letter.
What is the difference between exempt and non-exempt research?
+Exempt research is research that is exempt from IRB review, such as quality improvement projects or research using publicly available data. Non-exempt research, on the other hand, requires IRB review and approval.
How long does the IRB review process take?
+The IRB review process typically takes several weeks to several months, depending on the complexity of the proposal and the availability of IRB members.
In conclusion, the UF IRB plays a crucial role in ensuring that research is conducted in an ethical and responsible manner, with the welfare and rights of human subjects being protected. By understanding the IRB approval process and the criteria used to evaluate proposals, researchers can navigate the review process more efficiently and effectively.
