
WASHINGTON — The National Institutes of Health is overhauling the leadership of its flagship hospital after an independent review concluded that patient safety had become ‘‘subservient to research demands’’ on the agency’s sprawling Bethesda campus.
The shake-up at the NIH Clinical Center, which was announced to staff Tuesday, represents the most significant restructuring at the nation’s premier biomedical research institution in over half a century.
NIH director Francis Collins said he will replace the hospital’s longtime leadership with a new management team with experience in oversight and patient safety, similar to the top structure of most hospitals. He is recruiting for three new positions: a chief executive, a chief operating officer, and a chief medical officer. Collins wants all three to be physicians, and he wants them in place by the end of the year.
John Gallin, a clinician-researcher who has headed the center since 1994, will stay on as director during the search.
‘‘We’re going to cast a wide net and see who we can reel in as swiftly as we can,’’ Collins said in an interview. ‘‘We’re looking outside for that CEO individual, whose focus is not on research but on managing all of the operations of the hospital to maintain the highest quality.’’
The Clinical Center, the largest hospital of its kind in the world, sees thousands of patients every year from across the United States and around the globe. Many are desperately ill with rare or intractable conditions, and the facility frequently represents their last and best hope. It provides free, state-of-the-art care as part of studies that have saved lives and led to medical breakthroughs.
But a task force appointed by Collins recently found that research interests and needs had taken priority over measures to ensure patients were protected. The panel’s bluntly worded review also found that unlike at many hospitals, the Clinical Center had no adequate system for individuals to anonymously report ‘‘near misses,’’ meaning errors in care or problems in treatment that could have caused serious injury. Moreover, it noted, supervisors failed to appropriately address situations that were identified.
The review, the first in decades, laid much of the blame on NIH’s organizational structure and fragmented authority — and on the Clinical Center’s lack of authority. Although identifying no cases of direct patient harm, it raised troubling questions about the agency’s internal clinical research, which makes up about 11 percent of the overall NIH budget.
‘‘We believe the time has come to recognize that the Clinical Center model needs to evolve and function the way other hospitals do,’’ Collins said in an interview. While applauding its ‘‘fabulous research’’ and long list of accomplishments, he said management needs to be reorganized and centralized ‘‘to more effectively focus on standards of patient safety, compliance, and oversight, which have been very difficult to achieve.’’
The Clinical Center, which opened in 1953, is where much of NIH’s own research takes place. It sees about 24,000 research volunteers of all ages each year. Only about 18 percent of participants are healthy individuals. About 25 percent have cancer.
During the 2014 Ebola epidemic in West Africa, the hospital cared for Nina Pham, one of two nurses who became sickened with the virus in the United States after an infected man from Liberia traveled to Dallas.
The majority of physicians and researchers conducting studies at the 200-bed hospital are employees of NIH’s 27 institutes and centers; they report to the heads of those other entities, not hospital leaders. Such diffuse authority ‘‘makes central decision-making and accountability nearly impossible,’’ the review said.
The Clinical Center itself has little authority, it added, and ‘‘there is no systematic way to monitor clinical practice’’ across all institutes.
Collins described the new leadership structure as an attempt to address those issues and not a ‘‘negative comment’’ about Gallin and his team. ‘‘It’s a vote of no-confidence in the structure that no longer fits the needs,’’ he said.
The task force was initially appointed last year to look into contamination problems in the hospital’s pharmacy unit, which manufactured drugs for research. A whistle-blower complaint had triggered a probe by the Food and Drug Administration; after deficiencies were found, NIH suspended some operations.
The safety lapses prompted Collins to ask for a broader look at hospital operations and all clinical research that takes place on the campus. The task force included outside hospital executives and was chaired by Norman Augustine, former CEO of Lockheed Martin.



