Ethical issues in phase I oncology research: A comparison of investigators and institutional review board chairpersons

E. Kodish*, C. Stocking, M. J. Ratain, A. Kohrman, M. Siegler

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

78 Scopus citations


Purpose: 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)1810-1816
Number of pages7
JournalJournal of Clinical Oncology
Issue number11
StatePublished - Jan 1 1992

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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