Chapter 2: Research Ethics and Informed Consent
Case Presentation: The Afterlife of Henrietta Lacks draws extensively on Rebecca Skloot, The
Immortal Life of Henrietta Lacks (Kindle Edition: Crown/Archetype, 2010). Further sources include:
“Hairspray in Context: Race, Rock ’n Roll and Baltimore,” Thurgood Marshall Law Library; Antero Pietila,
“History of Baltimore’s Racial Segregation Includes a Hard Look at Newspapers’ Role,” Baltimore Brew,
March 15, 2010;; ACLU, “Crownsville: A Piece of Maryland History That Shouldn’t Be Forgotten” February
28, 2014; Tom Marquardt, “Tragic Chapter of Crownsville State Hospital’s Legacy,” Capital Gazette, June
5, 2013; Moore v. Regents of University of California (1990); Rebecca Skloot, “Taking the Least of You,”
The New York Times, April 16, 2006; John Bohannon, “Genealogy Databases Enable Naming of
Anonymous DNA Donors,” Science 339, no. 6117 (2013): 262; Paul Harris, “Final Twist to Tale of Henrietta
Lacks, the Woman Whose Cells Helped the Fight against Cancer,” The Guardian, March 30, 2013;
Rebecca Skloot, “The Immortal Life of Henrietta Lacks, the Sequel,” The New York Times, March 24, 2013;
and Carl Zimmer, “A Family Consents to a Medical Gift, 62 Years Later,” The New York Times, August 8,
2013.
Case Presentation: Jesse Gelsinger—The First Gene-Therapy Death draws extensively on
Paul Gelsinger’s statement to the National Human Research Protections Advisory Committee Meeting at
Bethesda, MD on 29 January 2002. Additional information is from Sheryl Gay Stolberg, “The Biotech Death
of Jesse Gelsinger,” New York Times Magazine, November 28, 1999; Deborah Nelson and Rick Weiss,
“Hasty Decisions in the Race to a Cure? Gene Therapy Study Proceeded Despite Safety, Ethics
Concerns,” The Washington Post, November 21, 1999, A01; Rick Weiss and Deborah Nelson, “Methods
Faulted in Fatal Gene Therapy: Teen Was Too Sick for Experimentation, Federal Probe Finds,” The
Washington Post, December 8, 1999, A01; Rick Weiss, “U.S., Researchers Reach Deal in ’99 Gene
Case Presentation: From Vioxx to the ASR Implant—Do Research Sponsors Suppress Bad
News? is based on Debra Pressey, “Patients Sue Maker of Recalled Hip Replacement Device,” The News-
Gazette, September 23, 2010; Barry Meier, “Remedy Is Elusive as Metallic Hips Fail at a Fast Rate,” The
New York Times, October 1, 2011; Deborah Cohen, “How Safe Are Metal–on–Metal Hip Implants?” BMJ
344 (2012): e1410; Quentin McDermott, “Joint Reaction,” Four Corners, May 16, 2011, transcript; Barry
Meier, “The Implants Loophole,” The New York Times, December 17, 2010; Pam Zekman, “Popular Hip
Replacement Made Patients Sick,” CBS Chicago, December 8, 2011; Barry Meier, “Frustration From a
Deal on Flawed Hip Implants,” The New York Times, November 26, 2013; Barry Meier, “Maker Aware of
40% Failure in Hip Implant,” The New York Times, January 23, 2013; D. J. Langton, S. S. Jameson,
A. V. F. Nargol, et al., “Accelerating Failure Rate of the ASR Total Hip Replacement,” J. Bone Joint Surg.
93-B (2011): 1011–1016; Barry Meier, “Implant at Own Risk,” The New York Times, April 3, 2010; Deborah
Cohen, “Revision Rates for Metal on Metal Hip Joints Are Double That of Other Materials,” BMJ 343
(2011): d5977; Jessica Dwyer and Octavia Peck Palmer, “Final Diagnosis—Elevated Blood Cobalt Levels
The discussion of Vioxx draws on the following sources: Steven Reinberg, “Vioxx’s Heart Risk
Lingered Long After Use Ended,” The Washington Post, October 14, 2008; David J. Graham, David
Campen, et al., “Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with
Cyclo-Oxygenase 2 Selective and Non-selective Non-steroidal Anti-inflammatory Drugs: Nested Case-
Control Study,” The Lancet 365, no. 9458 (2005): 475–481; Snigdha Prakash and Vikki Valentine,
“Timeline: The Rise and Fall of Vioxx,” NPR, November 10, 2007; Bruce M. Psaty and Richard A. Kronmal,
“Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case
Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others,” PLoS
Medicine 4, no. 6 (2007): 1001–1010; Justin E. Bekelman, Yan Li, and Cary P. Gross, “Scope and Impact
of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” JAMA 289, no. 4 (2003):
454–465; Joel Lexchin, Lisa A. Bero, Benjamin Djulbegovic, and Otavio Clark, “Pharmaceutical Industry
Sponsorship and Research Outcome and Quality: Systematic Review,” BMJ 326 (2003): 1167; “Rate of
Social Context: Prisoners as Test Subjects? makes use of information the following New York
Times articles: Ian Urbina, “Panel Suggests Using Inmates in Drug Trials,” August 7, 2006; and the editorial
“Safe Drug Testing in Prisons,” August 23, 2006. The Institute of Medicine’s “Ethical Considerations for
Research Involving Prisoners” (June 2006) reviews earlier recommendations, then discusses five
measures to protect prisoners as research subjects. An account of the malaria research conducted in
1944 is given in Alf S. Alving, et al. “Procedures Used at Stateville Penitentiary for the Testing of Potential
Antimalarial Agents,” Journal of Clinical Investigation, 27, no. 3, part 3 (May 1948): 2–5. Allen M.
Social Context: The Cold-War Radiation Experiments is based on Martha Stevens, The
Treatment: The Story of Those Who Died in the Cincinnati Radiation Tests (Durham, NC: Duke University
Press, 2002); “Settlement Reached in Suit Over Radioactive Oatmeal Experiment,” The New York Times,
January 1, 1998; The Crimson Staff, “MIT Named in Radiation Suit: Radioactive Material Fed to Children in
1950s Experiments,” The Harvard Crimson, December 7, 1995; Anna Snider, “A High Level of Criminal
Radioactivity,” Mother Jones, March/April 1994; and Hazel O’Leary, “Openness,” Gifts of Speech,
December 7, 1993.
Case Presentation: Baby Fae is based on the following New York Times stories: L. K. Altman,
“Learning from Baby Fae,” November 18, 1984; Philip M. Boffey, “Medicine under Scrutiny,” November 20,
1984; and Sandra Blakeslee, “Baboon Implant in Baby Fae Assailed,” December 20, 1985. For a detailed
discussion, see Ronald Munson, Raising the Dead: Organ Transplants, Ethics, and Society (New York:
Oxford University Press, 2002), Chapter 7.
In the Chapter 2 Briefing Session, the account of Nazi experiments is from the indictment in
United States vs. Karl Brandt, excerpted in Hastings Center Report, “Special Supplement: Biomedical
The classical paternalistic view of consent is expressed in Eugene G. Laforet, “The Fiction of
Informed Consent,” JAMA 235 (12 April 1976): 1579–1585. Placebos are discussed in Sissela Bok, “The
Ethics of Giving Placebos,” Scientific American 231 (November 1974): 17–23. The benefit of using
placebos in drug trials is discussed in Andrew C. Leon, “Placebo Protects Subjects from Nonresponse,”
Archives of General Psychiatry, Vol. 57 (April 2000). The discussion of research and children is indebted to
Jean D. Lockhart, “Pediatric Drug Testing,” Hastings Center Report 7 (June 1977): 8–10. Prisoners and
research is discussed in Jessica Mitford, Kind and Usual Punishment (New York: Knopf, 1973), as well as
Statistics about researchers and financial conflicts are from E.A. Boyd and L.A. Bero, “Assessing
Faculty Financial Relationships with Industry,” JAMA 284 (Nov. 1, 2000), 2209–2214. On the tamoxifin trial,
see, “Scientists Cancel Tamoxifen Test,” Associated Press, April 7, 1998. For the continuing debate over
conflict of interest, see these New York Times articles: Rony Caryn Rabin, “Researchers Square off on
Disclosure” April 1, 2009; and “Doctors Urge End to Corporate Ties” April 2, 2009; Gardiner Harris,
“Academic Researchers’ Conflicts of Interest Go Unreported” November 19, 2009; and “Medical Journal
Changes Its Policy After Criticism by Group” January 9, 2009.
Committee of the Physicians’ Health Study Research Group, “Final Report on the Aspirin Component of the
Ongoing Physicians’ Health Study,” The New England Journal of Medicine 321, no. 3 (1989): 129–135;
David A. Kessler, “Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation
of Drugs,” Department of Health and Human Services, Food and Drug Administration, July 19, 1993; Roni
Caryn Rabin, “The Drug–Dose Gender Gap,” The New York Times, January 28, 2013; and “CDC’s Abortion
Surveillance System FAQs,” Centers for Disease Control and Prevention, November 18, 2014.