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Education of Principal Investigators Involved in Clinical Research
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Function, Project, Program, Organization, or Activity:

Education of Principal Investigators Involved in Clinical Research

Reason(s) Why Audit Is Needed:

The National Institutes of Health (NIH) released three notices on June 5, 2001, containing changes and clarifications of policies in the following areas: (1) education of investigators involved in clinical research; (2) data and safety monitoring in clinical trials; and (3) financial conflicts of interest for clinical investigators. In terms of immediate action, the first announcement is the most significant. After October 1, 2001, investigators submitting annual reports for research and development contracts that involve human subjects research or non-competing renewal applications for grants must include a description of the Principal Investigator's education on the protection of human research participants. Also, before funds are awarded for competing applications or contract proposals involving human subjects, investigators must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research. Obtaining additional research funds and the research resources that already exist are focuses of the President's Strategic Framework for Action II. Proactive policies and procedures that support this thrust must be put into place as soon as the external environment dictate their need.

Audit Objectives:

The objective of our work is to identify and assess the University's, specifically the Office of Research Administration's, strategy to prepare for NIH's new educational requirement.

Priority: Medium


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