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PPT Slide

Strategic Priority # 1: New Services and Training

: Required Clinical Research Training Course

Leader: DeNedra McPherson

Collaborators: Ezekiel Emanuel, Chief, CC Bioethics Department

Alison Wichman, Deputy Director, Office of Human Subjects Research

Gregory Curt, Clinical Director, NCI

Jay Siegel, FDA

Anne Thomas, Associate Director, Office of Communications and Public Liaison, OD, NIH

Sara Byars, Deputy Chief, Office of Clinical Center Communications

Medical Arts and Photography Branch Representative

Advisor: John I. Gallin, Director, Clinical Center

Purpose/Goal: The goal of the course is to provide a standard knowledge base for all principal investigators to assure patient

safety and high quality in the NIH intramural research program. This course is designed to address one of the

essential Standards for Clinical Research Training and Education recently approved by the NIH for conducting clinical research in the intramural research program.

Scope: The four-hour course consists of the following modules:

• Ethical Issues in Human Subjects Research

• Roles and Responsibilities of the Investigator

• Roles and Responsibilities of the Institution

• Regulatory Issues

• Clinical Investigators and the Mass Media

The course will be presented in the traditional lecture format and ultimately transferred to the World Wide Web.

All principal investigators with a protocol approved through the CC are required to take the course and successfully complete a final exam.

Resources: 1 FTE will be required

Development of the web-based training course and on-line registration $90,000

Development of publicity materials, course binder and exam $17,000

Timeline: Initial course offered (234 students registered) September 12, 2000

Second course offering December 12, 2000

Target date for completion of web-based course January 31, 2001

Outcomes: All principal investigators will have a uniform understanding of their roles and responsibilities in order to

enhance the quality of research in the NIH intramural research program.

FY 2001 Key Initiative: Required Clinical Research Training Course

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