To ensure that all Northern Light Health staff involved in research are aware of ethical principles, regulations, and policies and procedures that apply to human subjects research, education – including on-line education for key research personnel – is required. This training includes Protection of Human Subjects, Protection of Animal Subjects (if applicable), Good Clinical Practice, Financial Conflict of Interest, and Responsible Conduct of Research.
CITI and NIH web-based tutorials are required training for all staff conducting research involving human participants. These courses fulfill the the IRB requirement for performing a clinical research study and the NIH human subjects training requirement for obtaining federal funds.
The Clinical Research Center provides education that facilitates our providers in their pursuit of independent research. To accomplish this, the Center:
Supports and fosters scholarly work within the Northern Light Health investigator community, which includes support for junior investigators
Implements tailored education for fellowships and summer internships in clinical research
Provides in-house training in Good Clinical Practice
Investigators, Research Support Staff, Research Fellows, Students, and Volunteers are required to obtain training and pass an exam as part of a comprehensive Responsible Conduct of Research Program. The Northern Light Clinical Research Center offers online training to all staff involved in any aspect of clinical research. The National Institutes of Health (NIH) “Protecting Human Research Participants” and The Collaborative Institutional Training Initiative (CITI) “Responsible Conduct of Research on Human Subjects” are required training.
Who is Required to Complete the Training?
All Northern Light Health medical staff (IRB members, investigators and their support staff, research coordinators, etc.) and any other individuals, including students, in contact with human research subjects and/or human research subject data are required to complete human subjects training.
When Must Training be Completed?
Any investigator and his/her staff conducting research involving humans must complete the training before approval of their proposal is granted by the IRB. The Principal Investigator(s) should ensure that all key personnel have completed the training prior to submitting their new proposals or progress reports on continued projects.
CITI Research Training and Certification
Northern Light Eastern Maine Medical Center is a Collaborative Institutional Training Initiative (CITI) institution. Employees can register and participate in educational sessions. Continuing Education Credits will be available to those who successfully complete a minimum of 12 modules. The Northern Light Health IRB requires proof of CITI training by all investigators submitting an application to the IRB.
NIH Protecting Human Research Participants Training Modules
NIH Financial Conflict of Interest (FCOI) Tutorial