Managing risk in normal volunteers participating in metabolic studies.
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.
Jensen
Michael D
MD
Endocrine Research Unit, Mayo Clinic & Foundation, Joseph 5-194, 200 First Street SW, Rochester, MN 55905, USA. jensen.michael@mayo.edu
Siverling
Carol
C
D000273:Adipose Tissue / Q000378:metabolism*; D002404:Catheterization; D005230:Fatty Acids, Nonesterified / Q000378:metabolism*; D006801:Humans; D018482:Muscle, Skeletal / Q000378:metabolism*; D033281:Nontherapeutic Human Experimentation / Q000941:ethics*; D012308:Risk Management; D015430:Weight Gain
D005230:Fatty Acids, Nonesterified