Ethical issues in non-intervention trials for thyroid cancer.
In recent years, the increasing numbers of small, apparently indolent thyroid cancers diagnosed in the world have encouraged investigators to consider non-intervention as an alternative to surgical management. In the following pages, the prospect of a non-intervention trial for thyroid cancer is considered with attention to the ethical issues that such a trial might raise. Such a non-intervention trial is analyzed relative to 7 ethical considerations: the social or scientific value of the research, the scientific validity of the trial, the necessity of fair selection of participants, a favorable risk-benefit ratio for trial participants, independent review of the trial, informed consent, and allowing the study participants to withdraw from the trial. A non-intervention trial for thyroid cancer is also considered relative to the central concept of equipoise.
University of Chicago, Chicago, USA. Electronic address: pangelos@surgery.bsd.uchicago.edu.
P
P
Angelos
Gustave Roussy, Paris, France.
D M
DM
Hartl
Memorial Sloan Kettering Cancer Center, New York, USA.
J P
JP
Shah
University of Edinburgh, Edinburgh, UK.
I J
IJ
Nixon
Mount Sinai Hospital, New York, USA.
R P
RP
Owen
University of Udine, Udine, Italy.
A
A
Rinaldo
University of Oviedo, Oviedo, Spain.
J P
JP
Rodrigo
Memorial Sloan Kettering Cancer Center, New York, USA.
A R
AR
Shaha
University of Arizona College of Medicine, Phoenix, USA.
C E
CE
Silver
University of Oviedo, Oviedo, Spain.
C
C
Suárez
International Head and Neck Scientific Group, Italy.
A
A
Ferlito
D002986:Clinical Trials as Topic / Q000941:ethics*; D018450:Disease Progression; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection / Q000941:ethics; D011379:Prognosis; D012107:Research Design; D018570:Risk Assessment; D013964:Thyroid Neoplasms / Q000473:pathology*; D057832:Watchful Waiting / Q000941:ethics*
Clinical trials; Equipoise; Ethics; Non-intervention; Research ethics; Thyroid cancer