Research Practitioner articles from September 2005

Research Practitioner archives from September 2005

From the editors.
September 1, 2005... It is a characteristic of scientific inquiry that areas of interest and eventual importance will be studied and advances made. Unless specifically forbidden by law, scientists will manage to study many problems using public funds if available...

Vioxx verdict.(In the News)
September 1, 2005... The first of many Vioxx lawsuits underway has come to a close with a victory for the plaintiff, Carol Ernst, who claimed that the drug caused her husband's death. The jury awarded Mrs. Ernst $253.5 million, which included $24.5 million for...

The search for an effective bird flu vaccine.(In the News)
September 1, 2005... The discovery of a lethal strain of bird flu in Siberia has created a sense of alarm throughout Europe in recent weeks. European leaders already have taken preventive actions, fearful that the flu could travel across the Ural mountains and...

The National Academies' guidelines for human embryonic stem cell research.
September 1, 2005... The U.S. government has not supported research involving human embryos or human embryonic stem cells (hES cells), except in the most limited way. Congressional legislation forbids the use of federal funds for any research that destroys an...

Maximizing opportunities in investigator-initiated clinical research.(ISSUES IN RESEARCH MANAGEMENT)
September 1, 2005... Investigator-initiated research offers health care professionals the opportunity to create and design their own clinical research studies. Investigators need to understand the responsibilities that come with it, which include personal legal...

SACHRP nominations sought.(Regulatory Update)(Secretary's Advisory Committee on Human Research Protections )
September 1, 2005... In the August 22, 2005, Federal Register, the Department of Health and Human Services (HHS) published a notice soliciting nominations for membership on the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides...

FDA draft guidance on emergency uses.(Regulatory Update)(Brief Article)
September 1, 2005... In the July 5, 2005, Federal Register, the Food and Drug Administration (FDA) announced the availability of a draft guidance document titled Emergency Use Authorization of Medical Products. The draft document explains FDA's policies for...

FDA draft guidance on gene therapy adverse events.(Regulatory Update)
September 1, 2005... In the August 23, 2005, Federal Register, FDA announced the availability of a draft guidance document titled Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed Adverse Events. The draft provides sponsors...

FDA warning letters.(Regulatory Update)(Utah Valley Institute of Cystic Fibrosis in Provo)
September 1, 2005... Several FDA warning letters of interest are excerpted below. Dr. Clark Bishop, Sponsor-Investigator Following an inspection conducted between January 27-30, 2004, and February 2-5, 2004, FDA's Center for Drug Evaluation and Research...