Navigating the University of Florida IRB Guidelines: Protecting Human Subjects in Research
The University of Florida (UF) Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of individuals participating in clinical trials and other human subjects research studies. These guidelines ensure that all research activities adhere to federal and state laws, local policies, and ethical principles. This article provides a comprehensive overview of the UF IRB guidelines, covering key aspects such as the review process, training requirements, and exemptions.
IRB Review: A Prerequisite for Human Subjects Research
UWF policy mandates that all research activities involving human participants undergo review by the IRB before participant recruitment and data collection commence. It is a violation of federal regulations to initiate human subjects research prior to receiving IRB approval. Therefore, it is crucial to submit proposals to the IRB in a timely manner, considering upcoming IRB meetings, especially when projects involve completion deadlines for publishing or thesis/dissertation submission.
The UF IRBs are responsible for reviewing research involving human subjects to ensure the protection of their welfare and rights, as mandated by federal and state laws, local policies, and ethical principles. Faculty, staff, and students at the University of Florida, UF Health, and/or the North Florida/South Georgia Veteran’s Health System (NF/SGVHS) must obtain approval from a UF IRB or a certificate of exemption before conducting any human subjects research. This requirement extends to research conducted off-site by University faculty and staff when acting as University employees or in connection with their University affiliation.
Mandatory Training Requirements
If you are involved in research with human subjects, their tissue, data, or medical records, you must complete mandatory training requirements.
Good Clinical Practice (GCP) Training: Effective 12/05/2019, all study staff involved with NIH-funded clinical trials must take Good Clinical Practice (GCP) Training. The myTraining course that meets the requirements is UFGCP100OLT (Good Clinical Practice for Social Behavioral Research). The training module UFCTS904OLT GCP does not meet the NIH requirements for GCP training.
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HIPAA Training: The IRB no longer tracks separate HIPAA training.
Optional Training for Exempt Auto-Determination Tool: If you do not have a current IRB required training IRB803, and you will be using the Exempt Auto-Determination tool, or participate as study staff on a study determined to be exempt by such a tool, you have the option to complete IRB850 training that specifically focuses on exempt research.
Training exception for Non-human research: Mandatory Training is not required for Non-human review types. However, you will be required to complete the mandatory IRB Training if your study is found to be any other review type.
Non-Human or Exempt Study Auto-Determination
If you intend to submit a non-human or exempt study, you might be eligible for an instant auto-determination without submitting a study to the IRB. To get an instant determination, please use the non-human/exempt auto-determination tool. If the study is eligible for non-human exempt auto-determination, you will have an instant approval to begin the project.
Utilizing External IRBs
Research previously approved and conducted under another UF IRB, unless authorized by the Asst.
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Please Note: WIRB is the ONLY central IRB that UF researchers may submit their research to. Not only does UF have a contract with WIRB, but WIRB is also listed on UF’s Federal Wide Assurance (FWA) with the Federal Office for Human Research Protections (OHRP). Sometimes sponsors have received approval for their research at a different central IRB and ask if you can use that one instead of WIRB.
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