Training Requirements

Required Training

Personnel listed on IRB applications are required to complete a training course on the protection of human research participants. The required course is hosted on CITI (Collaborative Institutional Training Initiative). Investigators, Co-Investigators, Faculty Advisors and Additional Personnel must take either the Social & Behavioral Research Basic Course or the Biomedical Research Basics course based on the research they will be conducting.

• Visit CITI Training or watch on how to select the correct required CITI Human Subjects Research - Basic Course (Choose "Social & Behavioral Research-Basic Course" OR "Biomedical Research-Basic/Refresher")

External investigators who do not have access to CITI Training may utilize OHRP's Human Research Protection Training. A printable completion certificate is available at the conclusion of the lesson so investigators can document completion for their records. Note that OHRP does not collect information about who accesses or completes the training.

Research investigators will be knowledgeable of and comply with the following:

• The Belmont Report
•  45 CFR 46
• IRB Practice and Procedures Manual
• The UWF Policy for Determination of Conflict of Interest
• Export Control
• The UWF Policy for Information Security and Privacy Policy
• WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Subjects

Additional Training if Applicable

Protected Health Information (PHI): HIPAA Training

The UWF HIPAA policy extends directly or indirectly to any researcher who is conducting research using Protected Health Information (PHI), whether the researcher's primary appointment is with a UWF Covered Component or not.

Federal statutes require without exception that the confidentiality of the protected health information be maintained throughout the research and thereafter. In proposing a research study, the Principal Investigator shall consider the nature, probability, and magnitude of harms that would be likely to result from a disclosure of collected information outside the research. The PI shall also evaluate the effectiveness of the proposed anonymizing techniques, coding systems, encryption methods, storage facilities, access limitations, and other relevant factors in determining the adequacy of confidentiality protections. It is a requirement of the IRB that the IRB Proposal and consent documentation (if applicable, according to submission category) describe the extent to which confidentiality of records identifying the subject(s) will be maintained (or not maintained).

All principal investigators, co-investigators and other personnel that have access to PHI must complete the CITI UWF HIPAA Training. The HIPAA Training must be completed prior to initiating human subjects research and every three years thereafter.

Additional Training for Clinical Trials: Good Clinical Practice Training

Good Clinical Practice (GCP) training pertains to the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

Who must take GCP Training?
Good Clinical Practice (GCP) training is required for all investigators and staff involved in clinical trials. Investigators and staff on new studies and any new staff on ongoing studies meeting the NIH definition of a clinical trial (definition below) must complete GCP training.

NIH Definition of “Clinical Trial”
A clinical trial is a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. The definition of a clinical trial includes both funded and unfunded research.

GCP training is intended for study staff who collect data through intervention or interaction with a subject or have access to private identifiable information, however, any member of a study team may be asked to take GCP training at the request of the IRB. GCP training certification is required prior to IRB approval.

UWF offers GCP training online through CITI. Valid GCP training certification must have been completed within 5 calendar years of the submission of the new IRB protocol. Any of the following GCP programs will qualify:

• Collaborative Institutional Training Initiative (CITI)
• Academy of Physicians in Clinical Research (APCR)