Human Subject Research Mandatory Education
Central to the St.Vincent mission of fostering excellence in research is a commitment to ensuring that all individuals conducting a research study involving human subjects receive adequate education in the protection of those human subjects.
What are the training requirements?
The St.Vincent Investigator Manual defines the educational requirements for the conduct of human subject research as follows:
- Investigators and staff conducting human subject research must complete either the online Collaborative Institutional Training Initiative (CITI) human subjects online training program.
- The CITI site can be accessed at www.citiprogram.org
- Training is valid for a three-year period, after which time the training must be repeated.
The St.Vincent IRB will not approve a request for a new or continuing research study until all members of the Research Team have met the education requirements.
Who must complete this training?
All Research Team members (individuals who conduct research involving human subjects, or who assist in the performance of such research activities) where that research will be performed at or under the auspices of any St.Vincent Health system hospital or subsidiary ministry (Ministry) must complete this training. The term "research involving human subjects" includes any research-related procedure conducted at the Ministry or any Ministry-controlled facility
How do I know whether my research involves human subjects?
For the purposes of the educational requirement, a human subject means a living individual about whom a person conducting research obtains 1) data through intervention or interaction with that individual; or, 2) information that is both private and identifiable.
What is CITI and how do I access it?
CITI is a web based human research protections training program created by the Collaborative Institutional Training Initiative. Individuals affiliated with St.Vincent Health can access the CITI program at www.citiprogram.org
Existing CITI Users: Use your CITI username and password to access the system.
NOTE: If you have already registered with CITI, even if that registration was with an organization other than St.Vincent, you do not need to re-register. Just use the username and password you had from your prior registration to access the system. Once you have logged onto the CITI system, you will have the option of changing your institutional affiliation. To do so, click the option for "Affiliate with another institution", and choose Ascension Health as your Participating Institution.
New CITI Users: At the main CITI login page, click the New Users "Register Here", and chose Ascension Health as your Participating Institution. Complete the remainder of the registration steps as instructed on the CITI page, and click the "Submit" button. NOTE: CME/CEU credits can be obtained for your CITI coursework, but St.Vincent does not currently provide the funding for obtaining these credits.
Do students, residents, and fellows need to complete the human subject research education requirement?
Yes. All students, residents, and fellows who are investigators, co-investigators, or members of a Research Team must complete the mandatory education.