Contact: David Rosenthal

Health Care Compliance Strategies, Inc.

877-933-4227 phone

(516) 478-4100 phone

dmr@hccs.com

HCCS RELEASES ONLINE COURSE IN HUMAN SUBJECTS PROTECTION

- meets the NIH training requirements on human subjects protection

JERICHO NY USA -- HCCS NEWS SERVICE(TM) -- MARCH 03 2004 -- Health Care Compliance Strategies, Inc. (HCCS), the leading provider of online multimedia compliance education for hospitals and other healthcare facilities, announced today the release of "Research Compliance: Human Subjects." It is the second in a series of multimedia courses in the new HCCS Research Compliance Suite.

The course is designed to meet the NIH training requirements on human subjects protection for all staff members. It is available now for Intranet, Internet or CD-ROM rollout for any size organization.

Developed in collaboration with Children's Hospital of Philadelphia, City of Hope National Medical Center, and the State University of New York (SUNY), the course provides an overview of key compliance issues that are related to human subject protection.

http://www.hccs.com

CONTENT FOCUS:

The course covers the regulatory framework, HIPAA, the roles and responsibilities of various individuals and committees involved in clinical research, informed consent, vulnerable subjects, IRB responsibilities, conducting clinical research trials and other considerations.

RESPONSIBLE CONDUCT OF RESEARCH:

"Healthcare organizations that conduct research have a responsibility to assure that research conducted on their premises are conducted in an ethical manner, in compliance with all applicable federal, state and local regulations," says Bill Sacks VP of HCCS. "The HCCS 'Research Compliance Suite' provides engaging, accurate and updated information to prepare clinical researchers, support staff, IRBs and institutional officials to meet their regulatory obligations."

REGULATORY ENVIRONMENT:

In its 2004 Workplan, the DHHS Office of the Inspector General described its auditing and enforcement plans related to clinical research. It is critically important that organizations conducting sponsored research are prepared to respond to internal and external inquiries seeking to evaluate compliance with applicable government rules and regulations.

"Regulatory agencies are continually looking to strengthen the protections afforded to subjects participating in research," says Mr. Sacks. "Over the past several years, the number of audits of researchers has increased dramatically. All persons involved in conducting such research are scrambling to comply with numerous policies and regulations. Failure to satisfy auditors could result in the loss of critical federal and other funding, as well as an inability to sustain operations."

RESEARCH COMPLIANCE SUITE:

"Human Subjects" is the latest in a series of online training courses in the Research Compliance Suite from HCCS. The first multimedia course in the series, "Grants & Contracts" was released in Nov. 2003. The next course, "Conflicts of Interest" will be released in April, 2004.

TRAIN ALL RESEARCH STAFF IN ALL RESEARCH ORGANIZATIONS:

Like all HCCS courses, this new course provides for job-function specific learning. Individuals in research organizations that would benefit from the HCCS "Human Subjects" training course include anyone conducting, monitoring or auditing clinical research involving human subjects. Institutions that would benefit from the HCCS human subjects training course include universities and medical schools, hospitals, physician offices and other health care facilities conducting human subjects research.

HCCS COURSEWARE:

HCCS' software uses video scenarios, audio, text and interactive exercises to create an engaging and cost effective method of educating healthcare employees. Each employee can select a viewing mode that will match the capabilities of their computer and Internet/intranet connection. Curriculum content can easily be tailored to meet the needs of different job functions. Courses can be customized to include internal policies and procedures and to meet the specific needs of an organization.

Created by leading research compliance specialists and experts in interactive education, the HCCS Research Compliance Suite explains regulations and procedures through a series of entertaining, concise and easy to follow modules. The courses are automatically updated as regulations and requirements change. The combination of authoritative content, multimedia presentation, detailed management reporting and ease of delivery provides for a highly effective solution to the difficult training task required of administrators that need to train large staffs.

HCCS courseware is currently in use at hundreds of hospitals and health care facilities with over 600,000 registered users. Other HCCS courseware titles include "Fraud Awareness: Professional Compliance", "Fraud Awareness: Corporate Compliance", "HIPAA Compliance" and the new "Joint Commission Compliance Suite."

FOR FURTHER INFORMATION OR TO REQUEST A DEMONSTRATION:

David M. Rosenthal

Health Care Compliance Strategies, Inc.

30 Executive Plaza, Suite 400C

Jericho NY USA 11753

877-933-4227 phone

dmr@hccs.com

http://www.hccs.com