HCA-HealthONE requires all individuals who conduct human subject research to be appropriately trained prior to conducting human subject research. In addition, continuing education is required every three years. Because investigators and their staffs assume different roles and responsibilities in the conduct of human subject research, HCA-HealthONE has developed training requirements that take into consideration the different roles assumed in the research project.
If an investigator has not completed initial or the required continuing education training, an initial protocol submission or continuing review will not be approved. If a staff member listed on the protocol has not completed training, the staff member must complete the training in order to remain on the protocol, or his or her name will be removed from the protocol at the time of approval.
If a name is removed it may be added in the form of an amendment at a later date, after training is completed. All researchers must maintain a valid certification to receive approval for any new or continuing review IRB submission. A valid certification is successful completion of a HCA-HealthONE IRB-approved human subject protections course completed within the last three years.
Staff/Personnel Who Intervene/Interact with Research Subjects
Any individual listed as a principal investigator (PI) on a research protocol that involves any intervention or interaction with research subjects must complete the HCA-HealthONE IRB’s CITI training modules. A PI has ultimate responsibility for compliance with human subject protections and, therefore, must complete this training.
Any other individual (e.g. co-investigator, research nurse) listed on an HCA-HealthONE protocol who intervenes or interacts (including obtaining informed consent) with a research subject is also required to complete the HCA-HealthONE IRB’s CITI training modules.
If a research project has recognized subcontracts or collaborator arrangements, and the subcontractors or collaborators are involved with human subjects at an offsite location or another institution, personnel must complete one of the IRB-approved web-based programs or provide evidence of valid certification of human subject training from another institution.
Staff/Personnel Who Do Not Intervene/Interact with Research Subjects
Individuals whose work on human subject research protocols is limited to the following:
- Chart/medical record review
- Discarded biological specimens
- Database inquires
- Data analysis or statistical analysis
You must complete the modules listed below under the CITI Data or Specimens Only Research Learner Group:
- Belmont Report and CITI Course Introduction
- History and Ethical Principles
- Defining Research with Human Subjects
- Records-Based Research
- HIPAA & Human Subjects Research
If at any time the research role changes to include intervention or interaction with subjects, an individual will be required to complete additional biomedical or social/behavioral modules.
Staff/Personnel Who Are Involved in HUDs
Individuals whose work involves Humanitarian Use Devices (HUD)/Humanitarian Device Exemptions (HDE) are not required to complete a human subject protections certification program.
CITI:
The Collaborative Institutional Training Initiative (CITI) Program offers an on-line program for fulfilling the mandatory education requirement. For instructions on accessing CITI click here. This program is provided free of charge to all individuals obtaining certification to conduct research through HCA-HealthONE. Research staff are encouraged to complete the modules that best represent the type of research that they are conducting, i.e. Biomedical, Social and Behavioral Research, or Data and Specimens Research Only. When registering on-line, sign in using HCA-HealthONE as the institution.
NEW PI/Research Team Members:
All new research team members listed on a HCA-HealthONE IRB initial application are required to provide a valid human subject protections certification from CITI. Any individual that does not fulfill this requirement at the time of initial submission will not be approved to participate on the project until this requirement is completed.
Adding New Research Personnel: Any requests to add a new research team member (study coordinator, sub-PI, or individual who will intervene/interact with a subject) to a protocol during the life of the study will require a valid human subject protections certification before approval will be granted.
PIs/Research Team Members who have completed previous CITI modules:
Any Principal Investigator (PI), sub-PI, co-PI, study coordinator or any individual that has completed a Human Subject Protections certification program previously through CITI will be required to complete the CITI re-certification course every three years. Access the CITI re-certification program.
PIs/Research Team Members who have previously completed the NIH program:
As of July 1, 2014, certificates from the NIH human subject protection program will longer be accepted. Upon expiration of NIH certificates, all Principal Investigators and research staff will be required to complete the CITI modules to fulfill the human subject protection training requirement of the HCA-HealthONE IRB.