Mandatory Training for Investigators

To comply with federal laws, it is the policy of UWF to require that all key personnel involved in the conduct of human subjects research complete training in the protection of human research participants.


All investigators and co-investigators must complete a training course on the protection of human research participants.

There are two options for completing the training requirement. The content and format of these two training courses are similar. 

1. Recommended: CITI (Collaborative Institutional Training Initiative): Human Subjects Research Training Modules

First time users must register to complete the training. These instructions will guide you through the registration process.

The CITI training program contains many educational modules. You will only be required to complete the modules that correspond with your IRB application. 

** CITI Training must be updated every 3 years in order for your certificate of completion to remain active. **

2. NIH Office of Extramural Research: Protecting Human Research Participants Training Course

First time users must register to complete the training. Access the course through the NIH Office of Extramural Research.


All investigators and co-investigators are also required to complete the following mandatory readings:

The Belmont Report 

Ethical Principles and Guidelines for the protection of human subjects of research

UWF IRB Policy and Procedures 

Other Educational Materials

IRB Guidebook Online
The Declaration of Helsinki
The Nuremburg Code


HIPAA


The Federal privacy regulations of the Health Insurance Portability and Accountability Act (HIPAA) went into effect on April 14, 2003. As a result, certain researchers and research institutions are required to be in compliance with the HIPAA regulations that are known as the “HIPAA Privacy Rule.” Among other provisions, the Privacy Rule sets requirements for the use and disclosure of protected health information (PHI) in research. Updates to this rule, known as the HIPAA/HITECH Omnibus Final Rule, went into effect in March 2013. The UWF HIPAA policy extends directly or indirectly to any researcher who is conducting research using 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 personally identifiable 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.

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