Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.
OBJECTIVE
Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country.


METHODS
Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group.


RESULTS
The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials.


CONCLUSIONS
Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.
Kodish
E
E
Department of Pediatrics, University of Chicago Pritzker School of Medicine, IL.
Stocking
C
C
Ratain
M J
MJ
Kohrman
A
A
Siegler
M
M
D000328:Adult; D000368:Aged; D002173:Cancer Care Facilities / Q000592:standards; D017321:Clinical Trials, Phase I as Topic / Q000592:standards*; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008495:Medical Oncology / Q000592:standards*; D008875:Middle Aged; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D011367:Professional Staff Committees; D012108:Research Personnel; D035842:Research Subjects; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D036302:Therapeutic Human Experimentation; D014481:United States