Required Training

FROM:              Jane E. Henney, MD Senior Vice President and Provost for Health Affairs

Anthony Perzigian, PhD Senior Vice President and Provost for Baccalaureate
and Graduate Education

Sandra J. Degen, PhD Vice President for Research

DATE:               December 7, 2005

SUBJECT:         New Policy: Demonstrating Knowledge of Human Research
Protection by Researchers

Adoption of New Policy

The University of Cincinnati is committed to following the highest standards of ethical conduct in human subject research.  The protection of human subjects participating in research is a shared responsibility of investigators, key research personnel¹, and the institution.  Together we have developed policies, procedures and standard operating procedures (SOPs) to ensure that we act responsibly, ethically, and in compliance with federal, state, and local regulations.

Central to the mission of fostering excellence in research is a commitment to ensuring that all individuals responsible for the design, conduct and reporting of a research study involving human subjects demonstrate an adequate level of knowledge in the protection of those human subjects. Today we are announcing the adoption of a new policy which defines the University of Cincinnati requirement for demonstrating such knowledge.

Compliance Dates

Effective January 1, 2006, individuals participating in the conduct of research that involves human subjects must demonstrate their knowledge prior to initiating any new research.  All individuals currently involved in approved research must demonstrate their knowledge no later than March 31, 2006.  Failure to comply with this policy will not affect the IRB review process but will impact the final approval status.  New research protocols or continuing review of on-going projects will not be approved until all key personnel have demonstrated their knowledge of human subject’s protection.

Demonstrating Knowledge

There are two approved methods for demonstrating your knowledge: 1) successfully completing the Collaborative IRB Training Initiative (CITI) web-based training course or 2) passing the Continuous Professional Development (CPD) on-line competency test.

CITI

The Collaborative IRB Training Initiative (CITI) web-based training course is accessed at www.citiprogram.org. Once you have accessed the site and logged in, select the Core training for the appropriate learner group. Learner groups are designated as either biomedical or social and behavioral. Completion of the Core training meets the requirement for demonstrating your knowledge.

CPD

The Continuous Professional Development (CPD) on-line competency test is accessed at cpd.uc.edu. Once you have accessed the site and logged in, select Competency Testing from either the Catalog or via the left-hand menu. Then select the appropriate test based on the type of research you conduct.

Training Records

The IRB staff will verify that you have demonstrated your knowledge by accessing the CITI or CPD records. It is NOT necessary for you to notify them.

Viewing the Policy

You may view the complete policy on-line at  HRP Policies or contact the Office of Research Compliance and Regulatory Affairs and request that a copy be sent to you.

¹ The definition of key research personnel is on line at Key Personnel.