Research Ethics and Informed Consent On the fac

28 Pages·2007·0.06 MB·English

1

[MUNSON; INTERVENTION AND REFLECTION, 8TH ED.]
NOTES AND REFERENCES
Chapter 1: Research Ethics and Informed Consent
On the face-transplant Case Presentation, information is drawn from the
following New York Times articles: Lawrence K. Altman, “French in First, Use
Transplant to Repair a Face” (1 December 2005) and “Patient Opted for
Transplant as Method to Mend Face” (2 December 2005), “Ethical Concerns on
Face Transplant Grow” (6 December 2005); Craig Smith, “Dire Wounds, a New
Face, a Glimpse in the Mirror” (2 December 2005). Information was also drawn
from Associated Press, “Face Transplant Woman Says She's Okay,” (7 December
2005) and Adam Sage, “Face Transplant Woman to Profit from Picture Sales,”
Times of London (8 December 2005).
The account of Nazi experiments is from the indictment in United States
vs. Karl Brandt, excerpted in Hastings Center Report, “Special Supplement:
Biomedical Ethics and the Shadow of Nazism” (6 August 1976): 5. The
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 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). The historical cases of
research on the poor are from M. H. Pappworth, Human Guinea Pigs (Boston:
Beacon Press, 1961), pp. 61–62. The Tuskegee case details are from the “Final
Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel,” U.S. Public
Health Service (Washington, D.C., 1973). HHS regulations on children as
research subjects were published in the Federal Register (8 March 1983).
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 tamoxifen trial, see, “Scientists
Cancel Tamoxifen Test,” Associated Press (7 April 1998). On foreign drug
2

testing, see Elisabeth Rosenthal, “For More Drugs, First Test Is Abroad,” New
York Times (7 August 1990) and Warren E. Leary, “U.S. Ethics Are Questioned by
Critics of Vaccine Test in Italy and Sweden,” New York Times (13 March 1994).
Facts in the Letrozole Case Presentation are drawn from the following
New York Times articles: Gina Kolata, “New Drug Regimen Greatly Cuts Risk of
Recurring Breast Cancer” (10 October 2003); Editorial, “Halting a Breast
Cancer Trial” (12 October 2003); Richard A. Friedman, “Long-Term Questions
Linger in Halted Breast Cancer Trial” (21 October 2003). The Jesse Gelsinger
Case Presentation draws heavily from 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 (28 November 1999).
The Social Context on radiation research is based on the New York Times
articles: Keith Schneider, “Nuclear Scientists Irradiated People in Secret
Research” (17 December 1993); “1950 Memo Shows Worry over Radiation Tests” (28
December 1993); “Signatures in Experiment Called Forgery” (12 April 1994); and
John H. Cushman, Jr., “Study Sought on All Testing on Humans” (10 January
1994). More recent developments are reported in the New York Times: Philip J.
Hilts, “Secret Radioactive Experiments to Bring Compensation by the U.S.” (20
November 1996), and Matthew L. Wald, “Rule Adopted to Prohibit Secret Tests on
Humans” (29 March 1997). See also the Associated Press story “Settlement is
Reached in Suit over Radioactive Oatmeal” (31 December 1997.) On The Social
Context on Phase Zero trials, see the account in Andrew Pollack, “In Drug
Research, the Guinea Pigs of Choice are Now, Well, Human,” New York Times (4
August 2004).
The Baby Fae Case Presentation is based on the following: New York Times
stories: L. K. Altman, “Learning from Baby Fae,” (18 November 1984); Philip M.
Boffey, “Medicine Under Scrutiny” (20 November 1984); Sandra Blakeslee,
“Baboon Implant in Baby Fae Assailed” (20 December 1985). For a detailed
discussion, see Ronald Munson, Raising the Dead: Organ Transplants, Ethics,
and Society (New York: Oxford University Press, 2002), Chapter 7.
3

Details of the experiments in the Willowbrook case are taken from Saul
Krugman and Joan P. Giles, “Viral Hepatitis: New Light on an Old Disease,”
JAMA, 212 (1970): 1019-1021. “Echoes of Willowbrook or Tuskegee?” is based on
Philip J. Hilts, “Ethics Officials to Investigate Drug Experiments on
Children,” New York Times (15 April 1998). On the Pernkopf anatomy, see
Nicholas Wade, “Doctors Question Use of Nazi's Medical Atlas,” New York Times
(26 November 1996).

Chapter 2: Physicians, Patients, and Others
The opening Case Presentation is based on the documentary film Dax's
Case, by Unicorn Medical (Dallas, Texas) for the Council for Dying (New York,
New York); produced by Donald Pasquella and Keith Burton: Directed by Donald
Pasquella.
On development of licensing procedures for physicians, see John Duffy,
The Healers: The Rise of the Medical Establishment (New York: McGraw-Hill,
1977). The multiple sclerosis study is reported in Hastings Center Report 13
(June 1983): 2-3. For a review of HIPPA, see Lynn Wagner, “Mapping the Way to
HIPPA Compliance,” Provider (March 2002), 20-34. On privacy and HIPPA, see
these New York Times articles: Abigail Zuger, “Sorry That Information Is Off
Limits” (3 June 2003); Robert Pear, “Health System Warily Prepares for Privacy
Rules” (5 April 2003) and “Ruling Limits Prosecution of People Who Violate Law
on Privacy of Medical Records” (5 June 2005). The Rand-Harvard study of
oncologists is summarized in Lawrence K. Altman, New York Times (15 May 2005).
Facts in the Vegan Baby Case are from the New York Times: Corey
Kilgannon, “Case of Vegetarian's Ailing Child Comes to Trial” (26 March 2003);
Greg Retsinas, “Couple Guilty of Assault in Vegan Case” (5 April 2003).
Material in the Case Big Brother vs. Big Mac is drawn from these New York
Times articles: N.R. Kleinfield, “Diabetes and Its Awful Toll Quietly Emerges
as a Crisis” (9 January 2006), “Living at an Epicenter of Diabetes, Defiance,
and Despair” (10 January 2006); Ian Urbina, “In the Treatment of Diabetes,
Success Often Does Not Pay” (11 January 2006); Daniel Williams, “Bent Out of
4

Shape,” Time (11 September 2006); Reuters, “Obesity Health Costs Exceed
Smoking, Drugs” (3 June 2005); Kate Walker, “Diabetes, Prevention, and Cause,”
UPI (26 October 2006).
The Social Context on pregnancy and prosecution is based on: Martha
Field, “Controlling the Woman to Protect the Fetus,” Law Medicine and Health
Care 2 (1989): 114-129 for the Monson and similar cases; New York Times (15
January 1986; 30 August 1988) for effects of alcohol and other drugs; (4 May
1989; 9 May 1989) for the Illinois cases; (2 February 1990) for a Wyoming
case; (28 October 1992) for the Gillespie case; (24 July 1992) for the Florida
Supreme Court decision; see Time (19 September 1988) for statistics about
crack babies. The Supreme Court decision is reported in Linda Greenhouse,
“Drug Tests Curbed During Pregnancy” New York Times (21 March 2001). The
Twitchell Case draws from David Margolic, “Death and Faith, Law and Christian
Science,” New York Times (6 August 1990) and “Convicted of Relying on Prayer,”
Time (16 July 1990). The reversal of the conviction was announced on CNN in
November 1994.

Chapter 3: HIV/AIDS
On the statistical picture of HIV/AIDS country by country, the use of
antiretroviral therapies, and steps toward a vaccine as presented in the
Social Context, see unaids.org. For a discussion of therapies in the
underdeveloped countries, see the World Health Organization at who.int/hiv. On
the history of AIDS in Africa and the efforts to deliver treatment, see New
York Times: Rachel L. Swarns, “AIDS Is Chief Cause of Death in South Africa,
Study Says” (16 October 2001) and “Newest Statistics Show AIDS Still Spreading
in Africa” (1 March 2001). On financing treatments, see Barbara Crossette,
“Annan in Washington to Seek AIDS Funds” (10 May 2001); David E. Sanger, “Bush
Says U.S. Will Give $200 Million to World AIDS Fund” (11 May 2001); Jane
Perlez, “U.N. Chief Calls on U.S. Companies to Donate to AIDS Fund” (1 June
2001). On current treatments of HIV in the third world, see “Infant Drugs for
HIV Put Mothers at Risk,” New York Times (24 February 2003) and Lawrence K.
5

Altman, “U.S. Speeding Up Approval Steps for AIDS Drugs,” New York Times (17
May 2004).
On the development of combination therapy, see Michael Waldhoz, “AIDS
Drug Cocktails in Use Since 1996 Cause Steep Drop in Deaths Study Finds,” Wall
Street Journal (26 March 1998); A.P.”AIDS Related Deaths Fall by 26 percent in
1996” (10 January 1998); L.K. Altman, “AIDS Deaths Drop 48% in New York,” New
York Times (2 February 1998); on emerging drug resistance, see L.K. Altman,
“Study Reports Drug Resistant Strains Have Increased to 14 Percent Among New
HIV Cases,” New York Times (7 February 2001). The Thompson Case is based on
accounts by a number of people with AIDS. On AIDS and suicide, see Seth
Mydans, “AIDS Patients' Silent Companion Is Often Suicide,” New York Times (25
February 1990).
The efforts to develop a vaccine are summarized at
gatesfoundaton.org/GlobalHealth; see also Andrew Pollack, “Large Trial Finds
AIDS Vaccine Fails to Stop Infection,” New York Times (24 February 2003), and
Reuters, “India's AIDS Vaccine Trials Enter Crucial Stage,” (9 February 2006).
Additional information is found at the Centers for Disease Control cdc.gov. On
microbicides, see Lawrence K. Altman, “Tests Begin on New Drugs to Protect
Women From Contracting HIV,” New York Times (13 July 2004).

Chapter 4: Race, Gender, and Medicine
The Tuskegee Case Presentation is based on the classic study, James H.
Jones, Bad Blood: The Tuskegee Syphilis Experiment, New and Expanded Edition
(New York: Free Press, 1993) and Alison Mitchell, “Survivors of Tuskegee Study
Get Apology From Clinton,” New York Times (17 May 1997).
The best guide to statistics in this area, one I have drawn from
heavily, is Health United States, 2006 (Washington, D.C.: Department of Health
and Human Services, Centers for Disease Control and National Center for Health
Statistics, 2006). The publication is available at cdc.gov/nchs/hus.htm. For a
survey of the range of ethnic health issues, see Thomas A. LaViest, ed., Race,
Ethnicity, and Health: A Public Health Reader (San Francisco: Jossey-Bass,
6

2002).
The section on African American health issues draws from the New York
Times articles: P.T. Kilborn, “Black Americans Trailing Whites in Health,
Studies Say” (26 January 1998); S.G. Stolberg, “Cultural Issues Pose Obstacles
in Cancer Fight” (14 March 1998); Richard Rothstein, “Linking Infant Mortality
to Schooling and Stress” (6 January 2002); editorial, “Subtle Racism in
Medicine” (22 March 2002); James Sterngold, “Los Angeles Inner City Beset by
Chronic Health Problems” (2 May 2002); S.G. Stolberg, “Racial Disparity Is
Found in AIDS Clinical Studies” (1 May 2002); Nicholas Wade, “Race Is Seen as
Real Guide to Track Roots of Disease” (30 July 2002). See also Office of
Minority Health Affairs, “Progress Report for Black Americans,” n.d. (issued
in 1998) and “Trends in the Health of African American Children,” n.d. (issued
in 1998). For an analysis of the roots of long-standing distrust of medicine
by blacks, see V.N. Gamble, “Under the Shadow of Tuskegee,” American Journal
of Public Health (November, 1997): 1773-1779. For studies on blacks and
cardiac catheterization and differential treatment, see Sheryl Gay Stolbert,
“Blacks Found on Short End of Heart Attack Procedure,” New York Times (10 May
2001) and Reuters, “Racial Gap in Cancer Survival is Not Biological, Study
Finds.” The CDC review of “health indicators” is reported by AP (24 January
2002). See also the following studies: Arnold M. Epstein, et al., “Racial
Disparities in Access to Renal Transplantation,” New England Journal of
Medicine, 343 (23 November 2000): 1537-1544; Peter B. Bach, et al., “Survival
of Blacks and Whites After a Cancer Diagnosis,” JAMA 287 (24 April 2002):
2106-2113. For an outstanding historical perspective, see Linda A. Clayton and
W. Michael Byrd, An American Health Dilemma: A Medical History of African
Americans and the Problems of Race: Beginnings to 1900 (New York: Routledge,
2000).
The discussion of the health problems of American Indians and Alaska
Natives is based on Office of Minority Health Affairs, “Progress Report for
American Indians and Alaska Natives,” n.d. (2005); Jo Ann Kauffman and Yvette
K. Joseph-Fox, “American Indian and Alaska Native Women,” in Marcia Bayne-
7

Smith, ed. Race, Gender, and Health, (Thousand Oaks, CA: Sage Publications,
1996): 121-171, and Indian Health Service, “Comprehensive Health Care Program
for American Indians and Alaska Native” (Indian Health Service website posted
16 February 1999; see updates 2005). On the problems of Asian Americans and
Pacific Islanders, see R.H. True and Tessi Guillerno, “Asian/Pacific Islander
American Women,” in Bayne-Smith, pp. 94-120 and Department of Health and Human
Services, “Progress Review: Asian Americans and Pacific Islanders” (13
September 1997). On the problems of Hispanics/Latinos, see A.L. Gichaello,
“Latino Women,” in Bayne-Smith, pp. 21-171, and Department of Health and Human
Services, “Progress Review: Hispanic Americans,” 29 April 1997.
On the costs of treating undocumented immigrants, see the following by
Robert Pear from New York Times: “U.S. Is Linking Status of Aliens to Hospital
Aid” (9 August 2004); “Payments to Help Hospitals Care for Illegal Immigrants”
(9 May 2005).
On bridging cultural gaps, see the following New York Times articles:
Gina Maranto, “Nurses Bridge Cultures to Give Better Care” (1 October 2002)
and Lynette Clemetson, “A Neighborhood Clinic Helps Fill the Gaps for Latinos
Without Health Care” (6 October 2002). The definitive book illustrating
medical cultures in conflict is Anne Fadiman, The Spirit Catches You and You
Fall Down: A Hmong Child, Her American Doctors, and the Collision of Two
Cultures (New York: Farrar, Straus, and Giroux, 1997).
Comparative figures for disease incidence and mortality for all ethnic
groups are from Health United States, 2006. I have also used information
supplied by the Office of Minority Health Resources Center of the Department
of Health and Human Services.
The National Institutes of Health's Office of Research on Women's Health
nih.gov/orwh serves as a focal point for women's health research conducted
under the auspices of NIH. Its web site contains information about the Women's
Health Initiative, research involving women, recruiting women as
investigators, and the “Strategic Plan to Address Health Disparities Among
Diverse Populations of Women.” The discussion of the lack of women as research
8

participants is based on Office Of Minority Health, “Including Women and
Minorities in Clinical Trials,” Closing the Gap (December/January, 1998): 11;
Michael Wines, “In Research, the Sincerest Form of Concern Is Money,” New York
Times (22 June 1997); the American Medical Association Council on Ethical and
Judicial Affairs' report and the Public Health Service's report of the Task
Force on Women's Health Issues are quoted in John M. Smith, Women and Doctors
(New York: Delta Books,1992). The GAO report charging failures of researchers
to enroll a sufficient number of women in studies is reported in Robert Pear,
“Studies Find Research on Women Lacking,” New York Times (29 April 2000). See
Nancy Wartik, “Hurting More, Helped Less,” New York Times (23 June 2002) on
whether women's complaints are taken seriously and dealt with appropriately.
On the Social Context on “ethnic” drugs like BiDil and DG031, see the
following articles form the New York Times: Andrew Pollack, “Big DNA Files to
Help Blacks Fight Diseases” (27 May 2003); Nicholas Wade, “Articles Highlight
Different Views on Genetic Basis of Race” (27 October 2004), and “Race-Based
Medicine” (14 November 2004); Stephanie Saul, ”U.S. to Review Drug Intended
for One Race” (13 June 2005), and “FDA Approves a Heath Drug for African-
Americans” (24 June 2005); editorial on BiDil, “The First Race-Based Medicine”
(19 June 2005); on DGO31, see Nicholas Wade “Genetic Find Stirs Debate on
Race-Based Medicine” (11 October 2005).
For the Hmong Case Presentation, see “Girl Flees After Clash of Cultures
on Illness,” New York Times (12 November 1994); for follow-ups on the case of
Lor Lee, see Fresno Bee (2 November 1996; 2 February 1995). Information in the
Social Context dealing with health and status: WorkHealth.org, Michael Marmot,
”The Whitehall Study (summary),” (2006); Patricia Cohen, “Forget Lonely, Life
Is Healthy at the Top,” New York Times (15 May 2004); Matthew Herper,
Forbes.com (19 June 2003).
On the Social Context dealing with men's health and the backlash,
statistics cited on causes of disease and death rates are from Centers for
Disease Control; life expectancy figures are from National Vital Statistics
Report, vol. 53, Deaths: Final Data for 2002, p.5; data about clinical trials
9

are cited from the “Fact Sheet” prepared by Men's Health America,
menshealthnetwork.org; information about NIH budget figures and the proposed
Office of Men's Health is from Dianna Thompson and Glenn Sacks, “When Men's
Health Doesn't Count,” which appeared first in Norfolk Virginian-Pilot (9
October 2002) and is posted on glennsacks.com.

Chapter 5: Genetic Control
The most recent information relevant to the Case Presentation on the
embryonic stem-cell debate is from the following New York Times articles: Gina
Kolata, “Embryonic Cells, No Embryo Needed,” (11 October 2005); Nicholas Wade,
“Harvard Scientists Report a Stem-Cell Advance” (23 August 2005), “Science
Academy Creating a Stem-Cell Panel” (16 February 2006), “Stem Cells May be Key
to Cancer” (21 February 2006); Sheryl Gay Stolberg, “G.O.P. Lawmakers Offer
Alternative Bill on Stem Cells” (12 July 2995), “Senate Leader Veers from Bush
Over Stem Cells” (29 July 2005),”Senate Leader Criticized and Praised for Stem
Cell Shift” (30 July 2005). On doubts about the effectiveness of somatic cells
in treatment, see Nicholas Wade, “Stem Cell Treatment for Heart Attack
Falters,” New York Times (1 March 2006). For basic information, see National
Institutes of Health, “Stem Cells: A Primer” (May, 2000),
nih.gov/news/stemcell/primer/htm. For the therapeutic possibilities of stem
cells, see Ronald Munson, Raising the Dead: Organ, Transplants, Ethics, and
Society (New York: Oxford University Press, 2002), Chapter 11, “Grow Your Own
Organs: Stem-Cell Engineering and Regenerative Medicine.”
The official Roman Catholic view of stem cells is found in Pontifical
Academy of Life, “Declaration on the Production and the Scientific and
Therapeutic Use of Human Embryonic Stem Cells,” issued at Vatican City: 25
August 2000. For accounts of the recent research and criticisms, I am indebted
to the magisterial series of articles by Nicholas Wade in the New York Times:
“Embryo Cell Research: A Clash of Values,” New York Times (2 July 1999);”Stem
Cells Yield Promising Results” (31 March 2001); “Findings Deepen Debate on
Using Embryonic Stem Cells” (3 April 2001); “Experiment Offers Hope for Tissue
10

Repair” (22 January 1999). The President's Council on Bioethics report, Human
Cloning and Human Dignity: An Ethical Inquiry (July, 2002), is available at
bioethics.gov.
The account of PKU screening in the Briefing Session draws from National
Academy of Sciences, Genetic Screening: Programs, Principles, and Research
(Washington, D.C.: National Academy of Sciences, 1975). For an account of
alpha-fetoprotein screening, see Barbara Gastel et al., eds., Maternal Serum
Alpha Fetoprotein: Issues in the Prenatal Screening and Diagnosis of Neural
Tube Defects (U.S. Department of Health and Human Services Publication HE
20.2: M41, 1981). For social problems caused by PKU laws and sickle-cell
screening, see Philip Reilly, “There's Another Side to Genetic Screening,”
Prism (January 1976): 55–57. Genetic screening and the problems it poses for
rights is considered by Susan West, “Genetic Testing on the Job,” Science 82
(September 1982): 16. On genetic testing, see Sandra Blakeslee, “Cause of
Brain Cells' Death in Seven Diseases Is Discovered,” New York Times(8 August
1997); Nicholas Wade, “Two Gene Discoveries Help Explain Misfires of Epilepsy
in the Brain,” New York Times (30 December 1997), “Newly Discovered Gene
Offers Clues on Deafness,” (14 November 1997), “Gene Mutation Tied to Colon
Cancers in Ashkenazi Jews” (26 August 1997), “Gene From a Mideast Ancestor May
Link 4 Disparate Peoples,” (22 August 1997) on familial Mediterranean fever
disease and “Genetic Cause Found for Some Cases of Human Obesity” (27 June
1997; Denise Grady, “Gene Link to Incurable Eye Disease is Found,” New York
Times (19 September 1997); Associated Press, “Blood Test Uncovers Inherited
Diseases in Fetuses,” (4 November 1996) and “Two Genes Found to be Causing
Some Diabetes” (5 December 1996); Natalie Angiers, “Scientists Zero In On Gene
Tied to Prostate Cancer” New York Times (22 November 1996). For an account of
how getting even good news about Huntington's disease can be stressful and
disorienting, see Patrick Cooke, “A Genetic Test for Huntington's Let Colin
MacAllister See His Future, And That's When His Free Fall Began,” Health
(July-August, 1993): 81-86. On recent breast cancer conclusions, see Jeffry
Kluger, Time (26 May 1997). Poll results are from a 1994 Time/CNNA survey