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Upon completion of this activity, learners will be able to:
Identify relevant ethical historical events related to the practice of clinical research.
Summarize The Common Rule: Applications and Definitions.
Identify ethical research violations.
Topics covered:
Session 1: Reactive Regulation: 20th Century “Landmarks” (1 hour 3 minutes)
Session 2: Demonstrating Respect (48 minutes)
Session 2.1: Demonstrating Respect Part 2 (1 hour 41 minutes)
References
21 CFR, Subpart B, – 50.24
45 CFR §46.408(a) (2010).
45 CFR §46.402(b) (2010).
45 CFR 46.102d
45 CFR, Subpart D – 46.408a
The American Heritage Dictionary, 2nd College Edition
Appelbaum, et al. 1982/1987
Appelbaum, et al. 1987; 2002; 2004; Henderson et al. 2006; Daugherty, et al. 1995; Nurgat, et al. 2005
Beecher, HK, “Ethics and Clinical Research,” New England Journal of Medicine274 (1966): 1354-60.
Belmont; Reitsma & Moreno
Black’s Law Dictionary, 6th Edition
Canadian Network; cf. Gaston v. Hunter; Ahern v. VA
The Common Rule, Subparts B-D
de Melo-Martin/Ho 2008
DHEW Publication #77-0004. Washington, DC, US Government Printing Office, 1977.
DHHS/NIH/OHRP 45 CFR Part 46, 1991
Emmanuel et al. 2008
cf. Hellman and Hellman 1991
Henderson, et al 2007
Henry Beecher, MDHorng & Grady 2003
Hester 2013
Illustrations by Line Høj Høstrup, “A History of Human Guinea Pigs.”
Jansen et al. 2011
Joseph Gardella, MD (1962) Assistant Dean of Students, Harvard Medical School
Lidz, et al. 2003; 2004
Morreim
National Commission, Belmont Report (1979)
NBAC 2001
NewsTarget.com, by Dani Veracity, May 8, 2006
NYT, Nov. 28, 1999
Nuremburg Code (1949)
OHRP letter, Mar. 7, 2013; Lantos 2013
R. Steinbrook, N Engl J Med 354:18 (May 4, 2006
Randy Glasbergen. www.glasbergen.c0m
cf. Rothman and Michels 1994
Tuskegee Syphilis Study (1932-1973)
UAB consent 2004)
Weijer & Miller 2004
Weinfurt et al. 2008
Wendler 2012
Wired.com, by Randy Dotinga, April 6, 2004
http://www.foxnews.com/health/2014/03/10/drug-company-refuses-to-give-lifesaving-medication-to-7-year-old-boy
Speaker(s): Leah Eisenberg JD, MA
Speaker(s) bio
Leah Eisenberg is a clinical ethicist at University of Illinois Hospital. Her primary research interests relate to health literacy and improving patient understanding of medical and legal forms, including informed consent, assent, and HIPAA documents, recently through the use of comics. Another current research project involves the actual and perceived obligations of nurses towards pediatric patients in an active shooter event. She is co-editor of the Clinical Ethics case series in The American Journal of Bioethics. Another of her interests is graphic medicine. Prior to coming to UIC, she was Associate Professor of Medical Humanities and Bioethics at the University of Arkansas for Medical Sciences (UAMS). While there, she taught, served on two IRBs, directed the research ethics service, and was a clinical ethics consultant at both UAMS and Arkansas Children’s Hospital, the only children’s hospital in the state. Leah completed a fellowship in Bioethics Research at Mayo Clinic after earning a MA in Bioethics from Case Western Reserve University and a Juris Doctorate degree from the University of Wisconsin Law School.
