Ensuring the Safety and Privacy of Human Research Subjects

Venue: Princeton

Location: Princeton, New Jersey, United States

Event Date/Time: Sep 26, 2002 End Date/Time: Sep 27, 2002
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Clinical Trials professionals have a responsibility first and foremost to protect the safety and privacy of human research subjects. There is a perception that the research environment is more commercialized and competitive and industry-sponsored trials have come under the scrutiny of regulatory agencies. Research professionals must balance the multiple projects involved in bringing drugs to market as quickly as possible without sacrificing the safety of human subjects. The future success of clinical research is dependent upon the confidence of human subjects that their safety is being adequately protected.

Protecting human subjects is a collaborative effort for all research professionals involved in the conduct of clinical trials. At the Ensuring the Safety and Privacy of Human Research Subjects conference, the Institute for International Research provides a neutral forum for sponsors, investigative sites, CROs and IRBs to come together and discuss their various roles and responsibilities in protecting human research subjects. Hear from experienced industry professionals as they advise on what should and must be done to ensure that patient safety and privacy is protected.

On day one of the conference we offer a morning workshop: Training a Research Team on Responsibilities for Human Subject Protection. This workshop is designed for those directly responsible for managing monitors and site-related projects. Attendees will benefit from attending this workshop as we explore the essential skills and procedures that must be taught to those responsible for monitoring a site’s protection of human subjects.

The main conference begins in the afternoon of day one. The first presentation clarifies the ambiguity surrounding HIPAA and how it applies to industry-sponsored clinical research. Following the HIPAA presentation, a representative from OHRP explains how their role in international studies impacts the review process and provides an update on their current activities. As the afternoon continues we explore some of the regulatory issues surrounding human subjects protection. Hear from a Washington attorney on how to prevent legal litigation and explore the complexity of issues currently faced by IRBs. We wrap up day one by examining the evolution of the informed consent and how history has affected current legislation.

The morning presentations on day two are dedicated to understanding the roles and responsibilities of investigative sites, sponsors and IRBs in protecting. Speakers discuss how to select a responsible site and examine the implications of a site that is certified. Learn what authority falls within the IRB’s jurisdiction and what furthermore sponsors cans do to ensure that human subjects are fully informed and protected. The afternoon sessions continue to focus on the responsibilities of sponsors and specifically the role of the internal quality assurance department and how it ties in with a company’s structure in ensuring patient protection. The final conference session discusses relevant issues concerning monitoring global trials.

Our distinguished speaking faculty includes representation from:

The Ardent Health Services, Association for the Accreditation of Human Research Protections Programs (AAHRPP), Bio-Technology General, Inc., Chiron Corporation, Daiichi Corporation, Inc., Epstein Becker & Green, Office of Human Research Protections (OHRP), MCP Hahnemann University/Drexel University, Merck & Co., Inc., Pricewaterhouse Coopers, Rx Trials, Inc., Sanofi-Synthelabo Research, Schulman Associates IRB, and Viventia Biotech Inc.

In attending this conference you will learn:

What must be done to ensure the privacy of human subjects and comply with HIPAA regulations
OHRPs perspective on monitoring global clinical trials
What legal liability should you be aware of pertaining to the protection of human subjects
Characteristics of a well-trained site and warning signs for those that are not
Methods for ensuring that patients are fully informed and how to check for comprehension of risks and procedures
Necessary reporting of adverse events and updating of safety risks in global studies
How to integrate QA activities into the companies overall capabilities for protecting human subjects
To what extent the evolution of the informed consent has impacted current legislative requirements
What falls within the IRBs jurisdiction to ensure the safety and privacy of human subjects is protected
Don’t miss the opportunity to participate in this timely and important conference. Join us in discussing what steps must be taken to ensure the protection of human subjects and ultimately the future success of clinical research.