Managing risk in normal volunteers participating in metabolic studies.

Michael Dennis Jensen, Carol Siverling

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

BACKGROUND: Much emphasis has been placed on the risks volunteers face when participating in research studies, but little has been said about how to mitigate against such risks. METHODS: We review our experiences in over 15 years of managing risk in metabolic studies and the results of an intervention study designed to reduce the risk of femoral artery and femoral vein catheterization. RESULTS: Assessing the causes of adverse events and the context of a research study allowed us to design educational processes that reduced the incidence of adverse events. CONCLUSIONS: Although risk is inherent in any research study, approaching the risk issues in a manner designed to minimize the risk is possible. Ongoing efforts to further reduce risk in the context of research studies can benefit both the volunteers and the scientific community.

Original languageEnglish (US)
JournalJournal of investigative medicine : the official publication of the American Federation for Clinical Research
Volume51 Suppl 1
StatePublished - Feb 2003

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Healthy Volunteers
Research
Volunteers
Femoral Vein
Femoral Artery
Catheterization
Incidence

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

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title = "Managing risk in normal volunteers participating in metabolic studies.",
abstract = "BACKGROUND: Much emphasis has been placed on the risks volunteers face when participating in research studies, but little has been said about how to mitigate against such risks. METHODS: We review our experiences in over 15 years of managing risk in metabolic studies and the results of an intervention study designed to reduce the risk of femoral artery and femoral vein catheterization. RESULTS: Assessing the causes of adverse events and the context of a research study allowed us to design educational processes that reduced the incidence of adverse events. CONCLUSIONS: Although risk is inherent in any research study, approaching the risk issues in a manner designed to minimize the risk is possible. Ongoing efforts to further reduce risk in the context of research studies can benefit both the volunteers and the scientific community.",
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AB - BACKGROUND: Much emphasis has been placed on the risks volunteers face when participating in research studies, but little has been said about how to mitigate against such risks. METHODS: We review our experiences in over 15 years of managing risk in metabolic studies and the results of an intervention study designed to reduce the risk of femoral artery and femoral vein catheterization. RESULTS: Assessing the causes of adverse events and the context of a research study allowed us to design educational processes that reduced the incidence of adverse events. CONCLUSIONS: Although risk is inherent in any research study, approaching the risk issues in a manner designed to minimize the risk is possible. Ongoing efforts to further reduce risk in the context of research studies can benefit both the volunteers and the scientific community.

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