University of Indianapolis
Institutional Review Board
Researcher Training Requirements
Since October 1, 2000, the National Institutes of Health (NIH) has required education on the protection of human research participants for all investigators submitting NIH applications for grants, or proposals for contracts, or receiving new or non-competing awards for research involving human subjects. In accordance with this NIH requirement, the University of Indianapolis Institutional Review Board requires education on the protection of human research participants for all investigators submitting protocols for review (regardless of funding source). Before the board will review any proposed research involving human subjects, faculty, staff, student investigators, faculty sponsors of student investigators, and other key personnel involved in the proposed research must provide written evidence of education or training in the protection of human subjects. “Key personnel” are all individuals responsible for the design and conduct of the study – including, but not limited to principal investigators, faculty sponsors, and anyone (faculty, staff, students) who assist with data collection.
The University of Indianapolis provides this education by referring Principal Investigators and key personnel to the resource listed below. We have reviewed these materials and have determined that they provide satisfactory coverage of the ethical principals and procedures for conducting human subjects research. Researchers and key personnel must renew their education/training every two (2) years in order to be considered “current.”
To respond to this policy and provide a means for documentation of the required education/training, investigators submitting a protocol for IRB review (and faculty sponsors signing off on student protocols) must complete the following Internet-based training modules and submit the completed Certification of Training in Human Subject Protection form. Once the initial documentation has been filed with the IRB, that documentation will be kept on file and considered “current” until renewal is required two years after the initial filing.
Resource for Human Subjects Protection Education/Training:
Collaborative IRB Training Initiative (CITI) and the University of Miami
https://www.citiprogram.org/
University of Indianapolis Institutional Review Board
Certification of Training in Human Subjects Protection
Principal Investigator and Key Personnel Certification: Complete a separate Certification of Training in Human Subjects Protection form for each researcher or research team member who has completed the IRB Training AND submit this form with your IRB protocol documents. IRB approval for data collection cannot be given until all key research personnel have completed one of the training options identified below.
I, (insert Principal Investigator or Key Personnel Name)
______completed the training provided by:
______Collaborative IRB Training Initiative (CITI)
Please indicate the date you completed your training ______.
______
Signature Date
University of Indianapolis Authorizing Official Certification:
The University of Indianapolis approves the use of the above listed resources and the principal investigator or key personnel named above has attested that they have utilized the resources indicated above to receive education and training in the use of human subjects in research.
______
Signature Date
Donna B. Konradi, DNS, RN
Chair, University of Indianapolis Institutional Review Board
University of Indianapolis Institutional Review Board ·November 2007