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The Oxford Textbook of Clinical Research Ethics

Article in JAMA The Journal of the American Medical Association · September 2008
DOI: 10.1001/jama.300.12.1466-b

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 BOOK AND MEDIA REVIEWS
CURRENT DIAGNOSIS AND TREATMENT: EMERGENCY MEDICINE
Edited by C. Keith Stone and Roger L. Humphries
6th ed, 1043 pp, $69.95
New York, NY, McGraw-Hill, 2007
ISBN-13: 978-0-0714-4319-7
THE SIXTH EDITION OF CURRENT DIAGNOSIS AND TREATMENT:
Emergency Medicine achieves its stated goals. It is a concise
compendium for emergency medicine practitioners. The text
concentrates on practical aspects, with limited discussion
of the basic sciences.
This textbook comprises 48 chapters in 4 sections. The
first section, “Special Aspects of Emergency Medicine,” pro-
vides a general overview of the approach to the emergency
department (ED) patient; prehospital care; nuclear, biologi-
cal, and chemical weapons of mass destruction; disaster care;
and legal aspects proper to the specialty. Chapter 6 pre-
sents an extensive overview of emergency procedures. Al-
though this chapter describes detailed procedures such as
venous cutdown, it fails to address other contemporary pro-
cedures such as ultrasound-assisted venous access and the
value of end-tidal carbon dioxide concentration in expired-
air capnography. It must be noted that a valued strength of
this chapter is the clear delineation of indications and con-
traindications for every procedure.
The second section, “Management of Common Emer-
gency Problems,” comprises 13 chapters that review essen-
tial daily clinical problems. A highlight of this section is the
“essentials of diagnosis” bullet points, which present the es-
sential elements necessary for the diagnosis and manage-
ment of common problems in the ED. Many of the tables
clearly delineate distinguishing features necessary in the dif-
ferential diagnosis. The chapter that addresses the compro-
mised airway is succinct and provides a well-defined medi-
cation list that includes fundamental pharmacological
information. Indications, contraindications, and adverse ef-
fects of medications used in airway management are con-
cisely specified. In this section, the syncope and seizures
chapters address these daily ED presentations in a concise
yet inclusive format.
The third section addresses trauma emergencies. The high-
lights of this section are the chapters addressing vertebral
column and spinal cord trauma, orthopedic emergencies,
and hand trauma. The table and graphs in the chapter on
vertebral column trauma are valuable references. The es-
sentials of diagnosis in the orthopedic emergencies chap-
ter are explicit. The treatment and disposition sections in
these orthopedic chapters address daily ED problems and
serve as a useful rapid reference.
In the scope of 20 chapters, the last section addresses non-
traumatic emergencies. This section surveys all nontrau-
matic aspects of emergency medicine, including obstetrics
and gynecology as well as medical toxicology and pediat-
rics. The discussions related to toxicology and pediatrics are
somewhat oversimplified, considering that these special pa-
1466 JAMA, September 24, 2008—Vol 300, No. 12 (Reprinted)
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tient populations comprise a substantial percentage of ED
visits. The chapters addressing gastrointestinal tract and neu-
rological emergencies reflect the essence of this textbook—
concise, practical information for most emergency medi-
cine physicians.
Current Diagnosis and Treatment: Emergency Medicine is
certainly a worthwhile investment for the practicing emer-
gency medicine physician. This text provides a brief but com-
prehensive reference guide that should be close at hand in
the ED.
Alberto Perez, MD
Windham Community Memorial Hospital
Willimantic, Connecticut
aaperez@harthosp.org
Financial Disclosures: None reported.
THE OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS
Edited by E. Emanuel, C. Grady, R. Crouch, R. Lie, F. Miller,
and D. Wendler
827 pp, $150
New York, NY, Oxford University Press, 2008
ISBN-13: 978-0-1951-6865-5
IN THEIR INTRODUCTION, THE EDITORS OF THESE 73 CHAP-
ters state their primary ambition to create a text that can be
used to train researchers in developed as well as develop-
ing nations—a text that allows the foremost experts in clini-
cal research ethics to reflect critically on what has been a
scandal-driven and hence somewhat haphazard develop-
ment of standards. This distinguishes The Oxford Textbook
of Clinical Research Ethics from an elegantly written single-
author essay such as the well-received The Ethics of Bio-
medical Research: An International Perspective by Baruch Brody
(Oxford University Press, 1998).1
Section 1, “A Selected History of Research With Hu-
mans,” includes Paul Weindling’s discussion of the little at-
tention paid to identifying children experimented on by Nazi
physicians and Takashi Tsuchiya’s examination of the im-
munity from war crimes prosecution granted by the US mili-
tary to the biological warfare program of Imperial Japanese
unit 731 in World War II China. Walter Robinson and Bran-
don Unruh argue that Henry Beecher’s published criti-
cisms misunderstood Saul Krugman’s Willowbrook hepa-
titis experiments. James Jones concludes that a legacy of the
Tuskegee syphilis experiment was deep mistrust in black
communities of federal initiatives to restrict human immu-
nodeficiency virus infection. Interesting insights arise into
the origins of the randomized control trial (RCT) in a 1940s
UK streptomycin study (Alan Yoshioka) and the 1954 Salk
polio vaccine field trial (Marcia Meldrum). Sir Richard Doll,
the doyen of RCTs, is mentioned—but not that he ac-
cepted consultancies from corporations producing Agent Or-
ange and industrial chemicals while providing official evi-
©2008 American Medical Association. All rights reserved.

dence disputing these chemicals’ cancer-causing potential.
Robert Steinbrook considers the death of Jesse Gelsinger in
a gene therapy experiment in which a university and re-
searchers with substantial financial interests in the out-
come overlooked safety warnings. Some omissions include
chapters on unpublished clinical trials about pediatric an-
tidepressants or on cyclooxygenase 2 inhibitor research that
concealed toxic effects or lack of objectively demonstrated
therapeutic benefit.
Section 2, “Codes, Declarations, and Other Ethical Guid-
ance for Research with Humans,” pivotally begins with Ezek-
iel Emanuel, David Wendler, and Christine Grady discuss-
ing how guidance on research ethics is presented as sparse,
oracular statements that disguise disagreements about ap-
plication. These authors propose 8 ethical principles they
consider necessary, sufficient, and universal as a compre-
hensive and systematic framework. Subsequent chapters con-
sider the Nuremberg Code (George Annas and Michael Gro-
din), the Declaration of Helsinki (Richard Ashcroft), the
Belmont Report (Tom Beauchamp), and the Common Rule
(Joan Porter and Greg Koski). Other chapters analyze the
Council for International Organizations of Medical Sci-
ences guidelines, the Council of Europe, European Com-
munity directives on data protection and clinical trials, and
the national bioethics commissions. Notably absent is a chap-
ter on the Universal Declaration on Bioethics and Human
Rights from the United Nations Educational, Scientific and
Cultural Organization.
Section 3, “Context, Purpose and Value of Clinical
Research,” includes a terse critique by Alan Wertheimer
about emotive claims of exploitation in scientific research,
using as a case study a placebo-controlled trial of an anti-
meningitis antibiotic in Ecuador. Rebecca Dresser contrib-
utes a valuable piece on patient advocates and public repre-
sentatives, encouraging their role in research ethics
oversight through a principled alliance of such organiza-
tions. In section 4, “Scientific Design,” Franklin Miller and
Donald Rosenstein review challenge experiments involving
deliberate perturbation of human functioning, and David
Wendler and Franklin Miller argue that deception is per-
missible if scientifically necessary, social justifiable, mini-
mally risky, and eventually transparent. Other chapters
cover equipoise and randomization, research on emergency
medicine, biological samples, epidemiologic issues, behav-
ioral and social science, genetics, phase 1 oncology, and
surgery.
In section 5, “Participant Selection,” Neal Dickert and
Christine Grady consider incentives for participation on a
wage payment model, and Franklin Miller encourages in-
stitutional review boards (IRBs) to review recruiting adver-
tisements as setting the moral tone for subsequent re-
search. Other chapters focus on research involving women,
ethnic and minority populations, economically disadvan-
taged populations, individuals with impaired decision-
making capacity, children, healthy volunteers, fetuses, em-
©2008 American Medical Association. All rights reserved.
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BOOK AND MEDIA REVIEWS
bryos, and stem cells. Valarie Bonham and Jonathan Moreno
focus on research with prison or military populations. Sec-
tion 6, “Risk-Benefit Assessments,” includes a valuable chap-
ter by David Wendler and Franklin Miller on the advan-
tages of a net-risk test over a dual-track (therapeutic or
nontherapeutic) risk assessment. Section 7, “Independent
Review and Oversight,” includes a detailed chapter by Rob-
ert Temple and Sara Goldkind on the US Food and Drug
Administration, which could emphasize more the pres-
sures arising from industry cost-recovery and mention in-
fluential whistleblower David Graham.
In section 8, “Informed Consent,” Paul Appelbaum and
Charles Lidz interestingly review the therapeutic miscon-
ception (research participants’ mistaken belief that deci-
sions about treatment in a research project will be solely based
on their individual condition and needs). James Flory, David
Wendler, and Ezekiel Emanuel study empirical interven-
tions involving multimedia, enhanced consent forms, ex-
tended discussion, or test/feedback. David Wendler con-
siders whether children should be able to veto their
enrollment in research that offers them a direct benefit.
The subsequent section, “Respect for Human Research
Participants,” includes a valuable chapter by James
Hodge and Larry Gostin on how confidentiality accentu-
ates problems with group privacy and on distinguishing
research from public health activities. Wendy Mariner
contributes a core discussion on legal liability and com-
pensation, discussing how the Office for Protections from
Research Risks (now the Office for Human Research Pro-
tections) suspended federal funding at major US medical
centers and research institutes after a pattern of noncom-
pliance with regulations. Her list of recent tort claims
acutely highlights the fundamental problems plaguing
research: failing to seek IRB approval, letting IRB
approval lapse, negligently or fraudulently enrolling per-
sons in an RCT, using unapproved consent forms, admin-
istering an incorrect dosage contrary to trial protocol,
failing to stop a trial intervention that had been proven
harmful, failing to provide appropriate medical care to a
person having an adverse reaction to a trial intervention,
and failing to tell participants about risks discovered dur-
ing or after the trial. Mariner notes that federal regula-
tions forbid forcing research participants into waivers of
rights or releases from liability, that several recent law-
suits have targeted researchers who have not disclosed
their financial conflicts, and that compensation for
research injuries is not systematically available outside
the litigation system. James Lavery, in discussing how to
ensure participants’ subsequent access to beneficial treat-
ments, would also consider if insurance companies will
make RCT participation a condition of coverage. A sig-
nificant omission here is a chapter on whistleblowers,
unquestionably a potent force in ensuring research integ-
rity, as well as mention of ethical exemplars such as
Nancy Oliveri, unjust reprisals, public interest disclo-
(Reprinted) JAMA, September 24, 2008—Vol 300, No. 12 1467
 BOOK AND MEDIA REVIEWS
sures, or the virtue-based approach emphasizing that
learning ethical principles means little if there is little
support for them to be consistently applied in the face of
obstacles. Section 10, “Multinational Research,” includes
a valuable chapter by Ruth Macklin on issues such as
ethical imperialism and double standards. Soen Holm and
John Harris encourage a principle about the justice of
doing research when the risk to participants is small.
In section 11, “Clinical Investigator Behavior,” Trudo
Lemmens considers conflicts of interest created through
ghost writing, gag clauses, industry sponsor–friendly
design and publication bias, noncontributing authors,
industry-influenced expert committees, and peer review-
ers. He mentions uniform publication guidelines advo-
cated by medical editors, but these guidelines do not yet
include requirements for posting of consent forms, dis-
closure of refusal rates, or how informed consent was
otherwise tested or participant human rights protected.
Lemmens supports movement toward a system of manda-
tory registration of all clinical trials and academic
researchers being involved in clinical trials only through
an intermediate governmental structure. Ezekiel Emanuel
and Dennis Thompson mention how in 2006 JAMA
required authors who had not disclosed conflicts of inter-
est to publish apologies. Eric Campbell and David Blu-
menthal encourage the acquisition of more empirical data
on academia-industry relations in the wake of the Bayh-
Dole legislation. David Resnik highlights that research
misconduct in private industry can occur beneath the
cloak of trade secrecy. Drummond Rennie notes that in
1993 the Ig Nobel prize was awarded to the New England
Journal of Medicine for publishing a report from the
Global Use of Strategies to Open Coronary Arteries RCT
with 972 coauthors (2 words per author).
The editors, occupying authoritative positions in the Na-
tional Institutes of Health, can take pride in having created
a reference work that is well qualified to shape the ortho-
doxy of its discipline in an era of increasing corporate and
state control over medical research. A challenge for the sec-
ond edition will be that many topics, particularly informed
consent and the major research ethics instruments, are men-
tioned in multiple chapters, often with repetition and some-
times with apparent contradiction. However, praise is due
for how full authorial status is given to medical and law stu-
dents as well as to doctoral candidates.
Thomas A. Faunce, LLB, BMed, PhD
Medical School and College of Law
Australian National University
Canberra
thomas.faunce@anu.edu.au
Financial Disclosures: Dr Faunce reported serving as project director of an Aus-
tralian Research Council (ARC) grant investigating safety and cost-effectiveness
regulation of nanomedicine.
1. Kurth T, Gaziano JM, Cook NR, Logroscino G, Diener HC, Buring JE. Unre-
ported financial disclosures in a study of migraine and cardiovascular disease. JAMA.
2006;296(6):653-654.
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NURSE: A WORLD OF CARE
By Peter Jaret, Karen Kasmauski (photographer),
and Marla Salmon (senior editor)
240 pp, $29.95
Atlanta, GA, Emory University Press, 2008
ISBN-13: 978-0-9814-5650-8
INITIALLY, WHEN GAZING AT THIS BOOK’S COVER PHOTO-
graph, one’s eyes focus on a nurse who is reaching deli-
cately toward a mother feeding her newborn. Soon one’s eyes
are drawn toward the window in the background and into
the outdoor courtyard beyond which clothes are hanging
to dry, and one quickly realizes that if nothing else, Nurse:
A World of Care promises a vivid and artistic portrayal of
nurses around the world.
Opening the cover, 3 photographs practically jump off
the page to poignantly illustrate the book’s themes: “To Nur-
ture,” “To Care,” and “To Be a Nurse.” The dozens of im-
ages contributed by Karen Kasmauski (whose photo-
graphs have been featured in 30 articles for National
Geographic) capture nurses around the world doing what
they do best: interacting in meaningful relationships with
patients, families, and communities. To be sure, some of the
images of nurses are touching and reveal a tenderness and
compassion that may bring forth tears, particularly those
that remind readers of the deprivation and misery experi-
enced by the millions of persons living in impoverished na-
tions. But one also sees images of nurses in the developed
world—the nurse helping an expectant mother in her home
in Appalachia or nursing students tending to migrant work-
ers in fields in southern Georgia. Each photograph creates
a sense of intrigue that urges the viewer to hurry along, turn
the page, and see what is next. Indeed, this book provides a
rarely seen worldwide tour of images that communicates the
passions, successes, setbacks, and joys that are all part of
being a nurse, no matter where in the world nurses prac-
tice their art and science. When reaching the book’s final
photograph, which shows the eyes of an infant and a young
nurse fixed warmly on each other, readers will likely find
themselves thinking, “Thank God there are nurses.”
If that thought does not come through, then go back and
reread the forward provided by Jimmy Carter that elo-
quently describes the universal if invisible truth about nurses:
they hold the power to make a difference. The former presi-
dent tells readers that the significance of this book is that
It is about the kind of work nurses around the world do every day—
that my mother did in our small community in Georgia and in a
village in India. It serves to remind us that nurses embody what is
most precious in humankind. When the world at large comes to
value the contributions of nurses, it also will embrace its most vul-
nerable people, those whom nurses seek to serve. (p 7)
But this book offers far more than a “coffee-table book”
collection of quality photographs. Cleverly interspersed
among this photographic montage is an informative narra-
tive spread over 5 chapters that highlight the past and fu-
ture of the nursing profession. With clarity and economy,
©2008 American Medical Association. All rights reserved.