E&I additionally recommends that all team members have Good Research or Good Clinical Practices training within 3 years of participating in, or assisting in, the conduct of research.

An exception to this rule has been made for investigators in registry or late phase studies for which there are few training programs yet available. These investigators are strongly encouraged to obtain some relevant training.

Investigators and their staff members enter research with a variety of backgrounds. They have been or are doctors, nurses, city planners, engineers, architects, teachers, TV program evaluators and program evaluators. Few investigators begin this part of their career with adequate training about research and, more importantly, the Responsible Conduct of Research.

 There are three areas of training:

• Good Research Practices / Good Clinical Practices (GCP)
• Responsible Conduct of Research (RCR)
• Administration and management of an institutional or research program

What are the core requirements? You should know:

• The responsibilities of an investigator
• Ethical codes about the conduct of research
• The elements of a good consent process
• The elements of consent information
• The requirements for consent documentation
• Major issues regarding confidentiality
• Measures to protect privacy
• Elements of Good Clinical Practice
• How to recognize vulnerabilities in study population
• Sources of human subject regulation
• Definitions (research, investigation, subject, investigator)
• Requirements for continuing review, modifications, emergencies, and violations
• Adverse event and problem reporting
• Restrictions on publication of results
• Conflict of interest rules
• And more...

Sources of training, and recommended courses:

• CITIProgram: Once logged onto the site, select E&I as your institution.
• University courses are usually accepted if the syllabus is available.
• OHRP has a course for the FWA Institutional Officer