As part of the regulatory determinations necessary to approve research, the IRB must find that the investigator responsible for the conduct of the study is qualified by training and experience. To meet this responsibility E&I requires all Principal Investigators to have completed human subjects research protection training within 3 years of the date of their application to E&I.  A copy of the certification of completion will be requested with your application for review.

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.

Some exceptions to this rule may be made, or modified for investigators of minimal risk studies for which there are few training programs yet available, or where their experience includes provision of sufficient training. These exceptions are rare.

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: As a courtesy, E&I provides access to CITI training for all of our clients at no cost. Simply follow the link and enter E&I as your Organization Affiliation. You will be directed on how to log in under Learner Registration from there.
• University courses are usually accepted if the syllabus is available.
• OHRP has a course for the FWA Institutional Officer.