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Protection of Human Subjects

Institutional Review Boards

Institutional Review Boards (IRBs) review all research involving human subjects to ensure that the welfare and rights of these subjects are protected as mandated by federal regulations. No human research may be conducted without prior IRB approval.

There are three IRBs available for College of Nursing investigators:

IRB Required Reading: All investigators and staff at UF involved in research with human subjects must complete the IRB required reading.

Department of Health and Human Services (DHHS) Training: Investigators whose federal grant applications have received fundable scores must complete DHHS training in human subject protections and the ethical conduct of research.

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA Training for Principal Investigators: At the University of Florida, research involving protected health information (PHI) is subject to federal HIPAA regulations, effective April 14, 2003. To conduct research at UF or to use the IRB as a Privacy Board for research review, all principal investigators, research coordinators, and staff with access to research-related PHI must complete computer-based training before research documents are submitted to the IRB.

HIPAA General Awareness Training: Click on Training link on the UF HSC privacy Web site. All members of the UFHSC workforce, including faculty, staff, students and volunteers are required to complete HIPAA 102 (Annual Review) or HIPAA 101 (Privacy General Awareness Training) annually.

Health Information Policy and Confidentiality Statement: All members of the UFHSC workforce, including faculty, staff, students and volunteers are required to read the Health Information Policy, sign the confidentiality statement annually, and give the signed statement to their college or department administrators.

Data Safety and Monitoring

NIH Policy Statement: It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported clinical trials.

Further NIH Guidelines on Data Safety and Monitoring (DSM) : For more information regarding submitting a data safety monitoring plan to NIH.