Human Subjects Protections Training
Training Requirements
All investigators and key personnel involved in human subjects research at UNI must complete training on the protection of human research participants before the research will be approved. No data collection or contact with human subjects may begin until written IRB approval is received.
ACCESS HUMAN SUBJECTS TRAINING
Key Personnel Required to obtain Human Participants Training
- Key personnel are those who have authority or responsibility for the design or management of the project, as well as those involved in recruitment or data collection activities. All key personnel must have training.
- Any person who explains the study for recruitment purposes or attempts to answer questions about the research must complete training.
- Advisors to student-led projects must have Human Subjects Training on file.
- Individuals who typically do not require training are staff involved in de-identified data entry, data analysis only, individuals providing video services, or individuals in the community who distribute written materials or make announcements about the study according to written script(s) provided by the research team.
- Non-UNI investigators and key personnel who are collaborating with UNI investigators on UNI approved research studies where UNI is the IRB of record.
Individuals not Required to obtain Human Participants Training
- Staff involved in de-identified data entry, data analysis only.
- Individuals providing video services.
- Technicians whose only role is performing a standard clinical procedure which is a part of the approved protocol.
- Individuals in the community who distribute written materials or make announcements about the study according to written scripts provided by the research team.
How to Obtain Required Human Training
- UNI IRB offers free training through UNI's subscription to the Collaborative Institutional Training Initiative Program (CITI).
- This program offers online courses that can be accessed by anyone affiliated with UNI. (See the CITI Training Program link below).
- Courses are tailored to specific areas of research and take an average of 2-4 hours to complete (although it may take longer for some depending on the course and number of elective modules you complete). Courses do not have to be completed in one sitting.
- Note: when selecting your training course, please be sure to complete the "Human Subjects Research Course." The course listing on Responsible Conduct of Research (RCR) does not meet the IRB training requirement in human subjects protections.
- Once completed, a training certificate will automatically be sent to the RSP office for recordkeeping. You do not need to send a copy of your certificate, but you should save a copy for your records.
- If you are not sure if we have your Human Subjects Training Certificate, you can inquire with the RSP office at irbsupport@uni.edu.
Important Information to know about Human Subjects Training
- Human subjects training is considered non-expiring - however some sponsors may require training is renewed at certain intervals.
- If you previously completed training at a former institution, please send your Training Completion Certificate to irbsupport@uni.edu.
- If you are working with research team members who have special situations whereby the CITI training program is not appropriate or feasible for staff, the IRB may approve an alternate human subjects training program. If approved, be advised that the Principal Investigator assumes all responsibility for training of support staff.
QUESTIONS?
If you are unsure about the status of your human subjects training or have further questions, please contact irbsupport@uni.edu.