Training and education in the ethical conduct of human research is an essential part of protecting the rights and welfare of humans participating in research studies.
The FDA Information Sheet, Guidance for Sponsors, Clinical Investigators, and IRBs- FAQ’s states that “the regulations require that sponsors select investigators who are qualified by training and experience as appropriate experts to conduct a clinical investigation. The qualifications, training and experience include familiarity with human subjects protection regulations (21 CFR Parts 50 and 56) and practices, as well as good clinical practices (GCP) regulations (21 CFR Part 312) and standards (e.g. ICH E6 Good Clinical Practice Guidance) for the conduct of clinical studies.
The eMedicus IRB expects the investigator and the research staff to understand and comply with all applicable national, state and local laws, regulations, and guidance documents relating to the conduct of clinical research.
The eMedicus IRB requires the Principal Investigator and all key members of the research study team listed on FDA Form 1572 and involved in consenting research subjects to have received training and education in human research participant protections.
The eMedicus IRB accepts the following training programs:
- National Institutes of Health (NIH) Office Extramural Research: Protecting Human Research Participantion
an online training program which is accessible free of charge to all in English and Spanish.
- CITI Program: Course in the Protection of Human Subjects Research Subjects
an online training program that requires organizational membership or affiliation through a CITI participating institution.
Please note that HIPAA Privacy Rule training alone or Good Clinical Practice (GCP) training alone does not satisfy this requirement for training in human subject protections.
Documentation of successful completion of human research participant training by each research team member listed on the Form 1572 and involved in consenting research subjects must be provided to the eMedicus IRB as part of the initial site submission. The eMedicus IRB will not approve the site to conduct research until training certificates have been received.