The Ethics of Cancer Research. Laurie Lyckholm MD Virginia Commonwealth University Department of Internal Medicine Division of Hematology/Oncology. The Ethics of Cancer Research. Historical content Is there such a thing as informed consent?
Laurie Lyckholm MD
Virginia Commonwealth University
Department of Internal Medicine
Division of Hematology/Oncology
Muss, et al: Written informed consent in patients with breast cancer. Cancer 1979; 43:1549-1556.
Grossman, et al: Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994: 12:2211-2215.
Olver et al. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol 1995; 6:867-870.
The clinical investigator is seen as having an intrinsic conflict of interest or dual allegiance with regard to his/her role as physician for an individual patient and his/her role as scientific investigator.
Freedman, B: Equipoise and the ethics of clinical research. NEJM 1987; 317:141-5.
Adapted from Hellman, S: Of mice and men: problems of the randomized controlled clinical trial. NEJM 1991; 324:1585-1589.
Researchers test a new drug or treatment in a small group of people (20-80) for the first time to:
Daugherty, et al. in DeVita, ed. Principles and Practices of Cancer Treatment
The study drug or treatment is given to a larger group of people (100-300) to:
The study drug or treatment is given to large groups of people (1,000-3,000) to:
Taylor et al. Fundamental dilemmas of the randomized clinical trial process: Results of a survey of 1737 ECOG investigators. JCO 1994; 1796-1805.