Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.
OBJECTIVE
To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients.


METHODS
After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed.


RESULTS
Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process.


CONCLUSIONS
To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.
Daugherty
C K
CK
Section of Hematology-Oncology and the MacLean Center for Clinical Medical Ethics, University of Chicago, IL 60637-1470, USA. kdaughe@mcis.bsd.uchicago.edu
D002986:Clinical Trials as Topic / Q000592:standards*; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D032882:Comprehension; D032962:Consent Forms; D030881:Disclosure; D036262:Empirical Research; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D035082:Federal Government; D005544:Forecasting; D033161:Government Regulation; D049673:History, 20th Century; D006801:Humans; D007258:Informed Consent / Q000266:history / Q000331:legislation & jurisprudence; D009369:Neoplasms / Q000628:therapy*; D033281:Nontherapeutic Human Experimentation; D009272:Persons; D011367:Professional Staff Committees; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012106:Research; D035842:Research Subjects; D035844:Researcher-Subject Relations; D036302:Therapeutic Human Experimentation; D035501:Uncertainty; D035862:Vulnerable Populations