Main Line Health has adopted a mandatory initial and on-going educational training program in the ethical principles and guidelines for the protection of human subjects research for all investigators and research personnel involved in research involving human subjects. Research personnel are defined as anyone who has contact with human participants and/or access to research data.
Collaborative Institutional Training Initiative (CITI) is a subscription online service providing research ethics education to all members of the research community. LIMR is one of over 800 institutions participating in the program. There are several groups to choose from as outlined below.
- Group 1: biomedical research – for research personnel who engage in biomedical research.
- Group 2: social and behavioral research – for research personnel who engage in social and behavioral research which does not involvebiomedical procedures.
Research personnel who engage in biomedical research must also complete the Group 1 Module.
- Group 3: data or specimen ONLY research – for research personnel who engage exclusively in secondary data analysis of data, human tissues and/or samples. This group does NOT satisfy the educational requirements for biomedical or social and behavioral research. If you are planning to conduct biomedical or social and behavioral research you are required to take Group 1 and/or Group 2.
- Group 4: IRB members – for IRB members and staff. This group does NOT satisfy the educational requirements for Groups 1, 2 or 3.
Research personnel at the Main Line Health hospitals are required to take one of the BASIC courses. The BASIC training courses are valid for three years. After three years have passed, you are required to re-certify by taking a REFRESHER Course that corresponds with the appropriate Group listed above. Please note that the REFRESHER Courses are for those who wish to continue research upon expiration of the three-year certification period. Refresher courses are also valid for three years.
Financial COI training
All researchers and research staff are required to complete financial conflict of interest training at least every four years online through the Collaborative Institutional Training Initiative (CITI). Please select the course “Financial Conflict of Interest” when you log into CITI using your previously established user name and password. This training is required every four years.
Print a copy of the completion report for your records. You will not receive a certification from LIMR.
The IRB requires all individuals listed on the protocol complete and remain current with the training requirements before approval will be granted.
Please contact the Office of Research Affairs if you need assistance in determining which group is appropriate.
Good clinical practice (US FDA focus)
All NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). This new training requirement is effective Sunday, January 1, 2017, and applies to all new and existing NIH clinical trials. The policy requires basic GCP training and refresher GCP training every three years. In order to satisfy this new federal training requirement, beginning January 1, 2017, all research investigators and staff who are involved in an NIH-funded study meeting the definition of a clinical trial (as defined by NIH) will be required to complete GCP training. To meet these requirements, a Good Clinical Practice (GCP) Module and refresher course has been added to CITI and is now required for all research personnel involved in an NIH-funded clinical trial.