June 2005

As a research institution committed to upholding the highest standards of scholarship and creative activity, we sought and received full accreditation by The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) last Fall. This distinction means that we have committed to protecting the rights and welfare of research participants by promoting scientifically meritorious and ethically sound research and to fostering and advancing the ethical and professional conduct of persons that engage in research with human participants.

The University of Arizona has an assurance of compliance with the Department of Health and Human Services (DHHS). The assurance of compliance is a written document submitted by an institution (not the Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by DHHS. Through the assurance, the institution commits to DHHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46. The University of Arizona currently has on file a Federalwide Assurance. The Federalwide Assurance is the only type of assurance currently accepted and approved by the Office for Human Research Protections (OHRP) of DHHS.

When the Signatory Official (the Vice President for Research, Graduate Studies, and Economic Development) signs the document he/she attests to the following statement:

"I recognize that providing all research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education about human subject protections will help ensure that the requirements of this Assurance are satisfied."

Additionally, in section 12 of the Federalwide Assurance OHRP states the following:

"OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following: relevant ethical principles, relevant Federal Regulations, written IRB procedures; OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subject research; and b) research investigators complete appropriate institutional educational training before conducting human subjects research."

In order to meet federal requirements, the University of Arizona must offer a continuing education program to all research personnel conducting human subjects research. The previous training model (Rochester Manual) used by the University did not afford the institution a method for revising and updating the information studied in preparation for passing the human subjects training test. It also required local resources for administering and maintaining the test module and certificates. Therefore, the adoption of a new module, the Collaborative Institutional Training Initiative (CITI) Program, offers several advantages for the University including its immediate availability, its maintenance and administration by a third party, and most importantly, its widespread use nationally by many respected research institutions. By adopting CITI the University of Arizona is now able to fulfill its obligation to provide investigators with initial and continuing education in the area of human subjects protection and concentrate other limited resources to the areas of protocol review and IRB support and administration.

CITI is a modular-based, on-line system that is customized to meet the needs of both Behavioral and Biomedical researchers. To access the program log onto the system at www.citiprogram.org, and register with the user name and the password you choose. You can then log on as often as needed to review all of the required modules and take the quizzes. You can complete the training a little at a time, or all at once. This program also allows for collaborators, not affiliated with the University of Arizona, to take the training on-line so they can be part of your research team.

Updated Phase-In Dates for Training and Continuing Training of All Research Personnel (Supersedes All Previous Communications Related to CITI)

• All new researchers (those taking the test for the first time) will be required to use CITI for completion of their human subjects training, effective May 15, 2006
• All other researchers and study staff whose training date is older than 2 years as of January 1, 2007, are required to update their training by completing the CITI Program modules prior to January 1, 2007.
• Research personnel will be required to update their training every two years in order to meet continuing education requirements.
• Effective January 1, 2007, Verification of Human Subjects Training Forms submitted for new projects, continuing review of existing projects, or personnel changes, may not contain training dates more than two years old.

Should you have any questions related to the adoption of the CITI program or the timeline for its implementation, please contact Rebecca Dahl, Director, Human Subjects Protection Program, at 626-5925 or rdahl@email.arizona.edu.