This Article Full Text Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by SoRelle, R. Search for Related Content PubMed Articles by SoRelle, R.

(Circulation. 2001;103:e9038.)
© 2001 American Heart Association, Inc.

Cardiovascular News

Ruth SoRelle, MPH, Circulation Newswriter

New Food and Drug Administration Office and Director Named to Oversee Human Research Studies

A new office created by officials at the US Food and Drug Administration (FDA) will concentrate the agency’s activities in the area of human research subject protection under the direction of David Lepay, MD, PhD, who was appointed April 23, 2001, to head the Office for Human Research Trials.

Dr Lepay, who was previously a senior advisor of clinical science at the FDA, will coordinate the monitoring program for human clinical trials and oversee its good clinical practice policy. His office will also participate in such activities on an international level and coordinate with the Office of Human Research Protections in the US Department of Health and Human Services.

The move is only the latest in a series at the federal level to tighten the monitoring of medical research involving human beings.

Link Found Between Nurse Staffing and Patient Outcomes

The number of nurses in a hospital and the mix of their capabilities made a difference in the quality of care that patients receive, according to a study released April 20, 2001, by the US Department of Health and Human Services (HHS) Health Research and Services Administration (HRSA).

The study was based on data from records of 5 million hospital discharges from 799 hospitals in 11 states in 1997. The analysis of the data showed that there was a "strong and consistent relationship" between nurse staffing and 5 outcomes in patients: urinary tract infection, pneumonia, shock, upper gastrointestinal bleeding, and length of stay. In the study, more registered nurses in clinical positions at the hospital was associated with . . . [Full Text of this Article]