Hidden Risks of Hospital Clinical Research

Dropper Into Vial

Dropper Into Vial
Hospitals can benefit from conducting clinical research in their facilities, but failure to identify and handle the risk exposures this research creates can cost millions of dollars.

RESEARCH AND DEVELOPMENT IN THE HOSPITAL SETTING (LifeLines, May 2012)

Read more about this topic in the May 2012 LifeLines newsletter

Hospital risk managers pay close attention to their clinical exposures but what about research activities?

Research activities that can create additional risk for hospitals include:

  • Conducting physician initiated trials at other hospitals – Patients participating in human clinical trials at a hospital’s own facilities are most likely covered by the hospital’s HPL policy, but what about patients recruited at other hospitals for a trial sponsored by the primary research hospital?
  • Conducting trials or studies in foreign countries – Many foreign jurisdictions require locally admitted policies to conduct certain activities within their boarders. Noncompliance with these regulations can result in financial penalties and, in some cases, criminal actions.
  • Offering services to outside third parties, for example lab services or assistance with trial data collection – HPL policies cover “bodily injury and property damage.” What coverage applies when the hospital is sued for financial damages (no bodily injury) that result from the hospital’s error or omission in providing these contracted services?
  • Manufacturing drugs or devices used in human clinical trials – HPL policies were never designed to cover manufacturing of novel drugs for human clinical trials. Some large research hospitals have cGMP manufacturing facilities or may do small-scale manufacturing for trials in their labs. These activities create additional risk.
  • Entering into technology transfer agreements – Hospitals routinely out-license their research technology to outside companies for further research and development. The “tech transfer agreement” should be carefully reviewed to assure no assumption of risk after the technology is released for commercial development.

Our recent LifeLines newsletter,  Research and Development in the Hospital Setting, sheds some light on these risks.

About David Shuey

David is an Executive Vice President & North America Practice Leader for Willis Life Sciences, based in Radnor,…
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