Loma Linda University is committed to maintaining the highest ethical and professional standards for the protection of those who volunteer for research studies. As part of this commitment, LLU requires all individuals who participate in Human Studies research to hold a current certification in Human Studies Education. This is satisfied by first completing the Basic Course and then keeping certification current through Renewal training on a periodic basis.
To check an individual’s Human Subjects Research Education, please click here (click Education & Training tab)
Effective August 17, 2018
In response to the research communities’ request for consistent, documented training that will meet the requirements of government agencies, industry sponsors and outside collaborators, the human subjects research education requirements have been revised for all personnel engaged in human subjects research:
1. Please choose one of two tracks:
a. Human Subjects Research – Biomedical Track
i. Initial CITI Biomedical Basic Course and
ii. Initial CITI Good Clinical Practice (GCP-ICH) training
iii. CITI Biomedical and GCP-ICH refresher courses after initial training
b. Human Subjects Research – Social-Behavioral-Educational (SBE) Track
i. Initial CITI SBE Basic and
ii. Initial CITI Good Clinical Practice (GCP-ICH) training for SBE
iii. CITI SBE and GCP-ICH refresher courses after initial training expires
Initial certification for each track will last for three years
Refresher certification for each track will last for three years
2. Equivalent CITI certification from an outside institution will be accepted if the
expiration date of the training will not occur sooner than eighteen months at the time of acceptance.
3. NIH GCP training will be accepted in lieu of CITI GCP if the expiration date of the
training will not occur sooner than eighteen months at the time of acceptance. No other institutional training will be accepted in lieu of CITI GCP.
4. If certification for an HSRE or GCP-ICH refresher course has been expired for greater
than three months, the initial basic course must be taken.
Note: The Biomedical Track includes a social-behavioral component, but the Social-Behavioral Track does not include a biomedical component. Because the certifications last three years and you may engage in a variety of study types during that time period, you are encouraged to carefully consider which track will best benefit you in future studies as well as the current study. Both tracks require approximately the same amount of time to complete.