Inside information: Financial conflicts of interest for research subjects in early phase clinical trials.
In recent years, several research subjects have told us that they had bought or intended to buy stock in the companies sponsoring the clinical trials in which they were enrolled. This situation has led us to ask what, if any, are physician-investigators' scientific, ethical, and legal responsibilities concerning research subjects who choose to buy stock in the companies sponsoring the clinical trials in which they are participating. Although the scope of this problem is unknown and is likely to be small, this commentary examines the scientific, ethical, and legal concerns raised by such activities on the part of research subjects enrolled in early phase clinical trials. In addition, this commentary also outlines the basis for our opinion that research subjects involved in an early phase clinical trial should avoid the financial conflicts of interest created by trading stock in the company sponsoring the clinical trial.
Helft
Paul R
PR
Department of Medicine, Indiana University School of Medicine, the Regenstrief Institute for Health Care Research, and the Indiana University Center for Bioethics, Indianapolis, IN, USA. phelft@iupui.edu
Ratain
Mark J
MJ
Epstein
Richard A
RA
Siegler
Mark
M
D017321:Clinical Trials, Phase I as Topic / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D016265:Conflict of Interest; D004345:Drug Industry / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000009:adverse effects / Q000191:economics / Q000592:standards; D032984:Ethics, Research; D006801:Humans; D033181:Information Dissemination / Q000941:ethics / Q000331:legislation & jurisprudence; D007258:Informed Consent; D010817:Physician-Patient Relations; D035842:Research Subjects / Q000191:economics / Q000331:legislation & jurisprudence; D012109:Research Support as Topic; D014481:United States
D015507:Drugs, Investigational