All individuals engaging in the conduct of research at DePaul with human subjects, including faculty sponsors supervising student researchers will be required to complete the CITI on-line Basic initial training program before they will be approved as personnel on a research protocol. Any individuals continuing to conduct human subjects research must then complete continuing education every 3 years.
In compliance with DePaul's Federal Wide Assurance (FWA), all individuals engaged in research on humans must complete an appropriate training program in the protection of human subjects. The FWA is an agreement between DePaul University and the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (DHHS). DePaul requires that all persons engaged in human subject research take the on-line CITI Basic initial training course. Additionally, DePaul will require that all individuals engaged in human subject research complete continuing education once every 3 years.
The educational requirements will help to ensure the safe and ethical conduct of research involving human subjects at DePaul University. Critical to ensuring the safe and ethical conduct of human subject research is ensuring that each person conducting the research have a solid foundation of knowledge and understanding of the historical reasons for IRB review, and the ethical and regulatory requirements to conduct human subject research. We expect all DePaul faculty, staff, and students who wish to participate in the conduct of research involving human subjects to be familiar with and to understand the underlying ethical principles, federal regulations and state laws, and policies and procedures that are incorporated into the DePaul University Human Research Protections Program (HRPP).
This policy applies to all faculty, staff, students (undergraduate or graduate), and other personnel who are engaged in the design, conduct, or data analysis of human subject research that is conducted under the authority of the DePaul University IRB. Faculty sponsors for student researchers must also complete the training, because they are ultimately considered the responsible parties for the legal and ethical conduct of student projects.
If there are questions regarding whether a particular activity constitutes human subjects research or if the activity is conducted under DePaul’s authority, researchers should consult with Office of Research Services- Research Protections staff. This education policy also applies to Institutional Review Board (IRB) members and Office of Research Services staff, and collaborating investigators from other institutions.
This policy applies to all research involving human subjects under the DePaul IRB’s purview regardless of whether or not it is funded, regardless of the source of funding or sponsorship, and regardless of the location where the research is conducted. It applies to both currently active and future research projects, and protocols granted an exemption determination.
The education completed under this policy will meet the training requirements for investigators and key research personnel involved in the conduct of research receiving funds from the Department of Health and Human Services (DHHS). For the purposes of federal funding, “key research personnel” include all individuals responsible for the design, conduct, and reporting of the research and who contribute in a substantive, measurable way (whether or not they receive payment under the grant). This may include consultants if they meet the definition of key personnel.
Individuals are considered to be conducting human subjects research or engaged in research with human subjects if:
- They conduct human subject research eligible for an exemption determination.
- They interact with human subjects for research purposes (for example, they have interpersonal contact with participants, they conduct research interviews, or administer research questionnaires).
- They obtain informed consent from subjects for research purposes.
- They directly receive a grant from a federal agency and the grant involves human subjects.
- They intervene with human subjects for research purposes by conducting invasive or non-invasive study procedures (such as blood drawing, collection of buccal smears, or administering individual or group psychotherapy) or by manipulating their environment (such as altering light, sound or temperature, or adjusting environmental events or social interactions).
- They obtain (from any source) privately identifiable information or biological samples (for example, observing and recording private behavior, obtaining the information from another researcher or institution, or using data previously collected for another use and already in their possession for a new research use).
The Principal Investigator (PI) must maintain in his/her research files a copy of educational certifications for all key research personnel involved in the conduct of the study. It is the responsibility of the PI to ensure that all personnel completes the initial training prior to submission of the project to the IRB for review (for new protocols) when new personnel joins the project after initial approval.
Additionally, it is the PI’s responsibility to ensure that all key research personnel complete the required continuing education and provide copies of documentation to the PI for the study files. In addition, if any continuing education courses are taken from sources other than DePaul’s required CITI refresher course, documentation should be submitted to the IRB if the individual wants to get credit (such as for attendance at a seminar, meeting, or conference with the primary focus on human subject research issues).
Persons taking the CITI training, either initial Basic or continuing (Refresher), under the DePaul affiliation do not need to supply Research Protections (RP) with copies of the CITI training as the RP will be notified directly through the CITI program of completion of training.