Christopher Reeve to Open NPSF Conference on Integrity and Accountability in Clinical Research.

Business Editors/Health/Medical Writers

Integrity and Accountability in Clinical Research

CHICAGO & WASHINGTON--(BUSINESS WIRE)--Aug. 21, 2003

Experts to Share Techniques on Protecting Safety of Clinical Trial

Patients, Nov. 2-4, in Washington, D.C.

Acclaimed actor and director Christopher Reeve will open the Second Annual Conference on Integrity and Accountability in Clinical Research with a heartfelt address on the importance of human subject safety in clinical trials and other research. Presented by the National Patient Safety Foundation(R) (NPSF), the Conference opens Nov. 2, at the Renaissance Washington D.C. Hotel.

Reeve -- a clinical trial participant himself -- will join the Conference electronically as U.S. Congresswoman (Colo.) Diana DeGette (invited) and Conference Chair William R. Hendee, Ph.D., address the group in D.C. live. Hendee is senior associate dean and vice president of the Medical College of Wisconsin.

Designed to help researchers and their institutions meet the standards of integrity and accountability expected of research with human subjects, the meeting will address many of the issues and recommendations in the Institute of Medicine's 2002 report on "Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct" (http://www.iom.edu/report.asp?id=4438) as they relate to research using human subjects. An estimated 350 professionals and patients from a variety of disciplines are expected to participate as distinguished faculty share the latest approaches and techniques on keeping clinical trial patients safe.

FDA Commissioner Mark B. McClellan, M.D., Ph.D., will deliver the closing keynote Nov. 4, on the subject of "Respecting the Dignity of Human Subjects." He will focus on why human subject privacy, autonomy and safety are paramount in clinical research, and why integrity in research is essential to maintaining the public's trust.

"Research with human subjects must always be conducted with the welfare of the subjects foremost in mind," said Hendee. "As recent well-publicized events have demonstrated, this objective is not always achieved. This suggests that all stakeholders should strive for a higher level of integrity and accountability in clinical research. The challenge is to attain this higher level without creating a compliance burden on investigators and research sponsors that discourages research with human subjects.

"This Conference demonstrates NPSF's commitment to assist researchers and their institutions as they seek to ensure integrity and accountability in research with human subjects."

"Timely topics, outstanding speakers and plentiful opportunities for audience participation abound," noted NPSF Board Chair Carol Ley, M.D. "One thing that particularly sets these conferences apart is that we provide a forum where professionals can learn from research participants and patient advocacy groups."

Plenary session discussions will include such issues of concern as:

-- Informed Consent in Light of Genetics and Patient Privacy

-- Eliciting Informed Consent with Vulnerable Populations

-- Conflict and Confluence of Interests in Clinical Research

-- Bioterrorism Research and the Challenge of Preserving Patients

Rights

-- Accreditation and Certification: Creating an Ethical Climate

for Research.

Distinguished faculty include Robert Temple, M.D., associate director for medical policy at the FDA's Center for Drug Evaluation and Research, and nationally known ethicist Arthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics and director of its Center for Bioethics.

Attendees can earn Accreditation Council for Continuing Medical Education (ACCME) credits through the joint sponsorship of the Medical College of Wisconsin and the National Patient Safety Foundation.

The Conference is made possible through the generosity of such sponsors as Amgen (Nasdaq:AMGN), AstraZeneca (NYSE:AZN) and Wyeth (NYSE:WYE). A complete list of sponsors, and information on sponsorship opportunities is available at http://researchsafety.org/sponsors.html.

About NPSF

Founded in 1996 by the American Medical Association, CNA HealthPro, 3M and contributions from the Schering-Plough Corp., the National Patient Safety Foundation is an independent, nonprofit research and education organization that promotes patient and human research subject safety through educational offerings. The Foundation partners with healthcare providers and researchers, legal advisors, patient/consumer advocates, product and technology vendors, regulators and policymakers to achieve its objectives.

On the Net: NPSF site: http://www.npsf.org

On the Net: Conference site: http://www.researchsafety.org