Letters
efforts to improve the MOC experience and to respond to 4. American Board of Internal Medicine. Updated exam blueprints: physicians
these valid concerns.2 For example, the American Board of
Internal Medicine (ABIM) recently reorganized its gover-
nance structure. 3 This effort was undertaken in part to
enhance program relevancy by increasing the number of
practicing nonacademic physicians participating at all levels
of governance. More than 70% of current ABIM governance
members spend more than half their time in clinical care.
Over the past 3 years, ABIM staff has changed examination
blueprints in all disciplines based on critical review by
thousands of physicians across the country.4 Earlier this
year, in response to diplomate feedback, ABIM announced
plans to roll out 2-year Knowledge Check-Ins taken at home
or in the office as an option to the traditional MOC exam-
ination.5 To ensure full transparency, comprehensive ABIM
financial information—including tax form 990 and the
audited financial statement—is freely available online, along
with a reader’s guide to help interested parties find the infor-
mation of interest.6 Of note, ABIM carries a platinum rating
for transparency from Guidestar, a designation attained by
less than 0.1% of all nonprofit organizations. I believe these
actions are indicative of the good faith efforts certifying
boards are pursuing to address the specific concerns out-
lined by Cardenas and Freeman.
Freeman suggests self-regulation is already weakened
due to a misalignment between medical licensure and spe-
cialty competence. He is correct that state medical boards
determine an individual’s legal ability to practice “medicine
and surgery,” but physicians, through their specialty boards,
define and curate the standards that define familiar disci-
plines (eg, ophthalmology or cardiology) and are widely
used to create public confidence that physicians are actually
trained to do what they do. In theory, without established
specialty standards, any licensed physician would be free to
perform a laser procedure or administer chemotherapy or
perform a heart transplant. Such was the state of affairs at
the beginning of the 20th century—at the very time when
physicians opted to create specialty boards to establish the
standards that defined the specialties practiced today. Laws
designed to weaken board certification do not advance the
medical profession.
David H. Johnson, MD
Author Affiliation: Department of Internal Medicine, University of Texas
Southwestern School of Medicine, Dallas.
Corresponding Author: David H. Johnson, MD, Department of Internal
Medicine, University of Texas Southwestern School of Medicine,
5323 Harry Hines Blvd, Room G5.210A, Dallas, TX 75390-9030
(david.johnson@utsouthwestern.edu).
Conflict of Interest Disclosures: The author has completed and submitted the
ICMJE Form for Disclosure of Potential Conflicts of Interest and reported
serving as a member of the American Board of Internal Medicine board of
directors from 2007 until 2015 and being board chair from 2013 until 2015.
1. American Board of Medical Specialties. Board certification and maintenance
of certification. http://www.abms.org/board-certification/. Accessed
October 17, 2017.
2. Berkowitz LR. The American Board of Internal Medicine maintenance of
certification program: cocreating the future. JAMA Surg. 2015;150(8):699-700.
3. American Board of Internal Medicine. The evolution of ABIM governance.
http://transforming.abim.org/infographic-governance/. Accessed October 17, 2017.
jama.com
© 2018 American Medical Association. All rights reserved.
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lead the way to more relevant assessments. http://transforming.abim.org
/updated-exam-blueprints-physicians-lead-the-way-to-more-relevant
-assessments/. Accessed October 17, 2017.
5. American Board of Internal Medicine. ABIM update: supporting you with
resources to navigate MOC. http://transforming.abim.org/abim-update-
supporting-you-with-resources-to-navigate-moc/. Accessed October 17, 2017.
6. American Board of Internal Medicine. Revenue and expenses. http://www.abim
.org/about/revenue-expenses.aspx. Accessed October 17, 2017.
The Nuremberg Code and Informed Consent
for Research
To the Editor The Viewpoint by Dr Moreno and colleagues1
understated the precedential value of the International Medi-
cal Tribunal's decision in the trial of Nazi doctors accused of
war crimes that established the Nuremberg Code and the
code’s influence on common law development of the legal
duty of researchers to secure informed consent from their
research participants. The refusal in 1987 of the US Supreme
Court, in the case of an army sergeant who had secretly been
dosed 4 times and claimed to have been injured in an lysergic
acid diethylamide (LSD) experiment, to adopt or apply the
code is noninformative because the majority on the Court
held that soldiers may not sue the government or military
leadership for monetary damages for injuries sustained while
serving. My review of case law identified 19 published opin-
ions from state and federal courts (applying federal law
as well as the laws of Arizona, Florida, California, Illinois,
Maryland, Massachusetts, Michigan, New York, and Pennsyl-
vania) that recognize the duty of researchers to secure an
informed consent from research participants. Four of those
courts favorably recited the International Medical Tribunal
decision or the code among other sources for establishing
the duty.2-5 Other sources cited include the Declaration of
Helsinki, other professional codes of ethics, federal regula-
tions, the special nature of the participant-researcher rela-
tionship, and perhaps most importantly, concerns about non-
consensual invasions of bodily integrity.
Without exception, every court in which the issue has been
presented on the merits has found that research participants
have the right to consent. The only courts that have not so con-
cluded are those that found plaintiffs' claims barred by stat-
utes of limitation or other policies limiting the civil liability of
the federal government. Although not binding and disposi-
tive, the International Medical Tribunal's decision and the
Nuremberg Code nonetheless are recognized authoritative
sources of law for courts throughout the United States.
Jon F. Merz, MBA, JD, PhD
Author Affiliation: Department of Medical Ethics and Health Policy, University
of Pennsylvania Perelman School of Medicine, Philadelphia.
Corresponding Author: Jon F. Merz, MBA, JD, PhD, Department of Medical
Ethics and Health Policy, University of Pennsylvania Perelman School of
Medicine, Blockley Hall Floor 14, 423 Guardian Dr, Philadelphia, PA 19104-4884
(merz@upenn.edu).
Conflict of Interest Disclosures: The author has completed and submitted the
ICMJE Form for Disclosure of Potential Conflicts of Interest and reported being
employed as an expert witness in 2 wrongful death civil lawsuits, both of which
alleged lack of informed consent for research for Rawle and Henderson
(representing defendant) and Becker Law Firm (representing plaintiff).
(Reprinted) JAMA January 2, 2018 Volume 319, Number 1 85
 Letters
1. Moreno JD, Schmidt U, Joffe S. The Nuremberg Code 70 years later. JAMA.
2017;318(9):795-796.
2. Kaimowitz v Department of Mental Health for the State of Michigan.
73 19434 AW (Mich Cir Ct 1973).
3. Whitlock v Duke University, 637 F Supp 1463 (MDNC 1986); affirmed,
829 F 2d 1340 (4th Cir 1987).
4. Cincinnati Radiation Litigation, 874 F Supp 796 (SD Ohio 1995).
5. Heinrich Ex Rel Heinrich v Sweet, 62 F Supp 2d 282 (D Mass 1999).
In Reply Dr Merz claims that we understated the “preceden-
tial value” of the Nuremberg Code on the common law
development of the “legal duty” of medical scientists to
secure informed consent. Our Viewpoint made clear that the
Code has been a “milestone in the history of biomedical
research ethics” and has served as an important “guideline”
for courts in the United States and possibly in other coun-
tries, but we also stated that the Code has not been adopted
by any government, “with the partial exception of the US
Department of Defense in 1953 regarding defensive experi-
ments concerning atomic, biological, and chemical agents.”
A systematic analysis of the code’s impact on US case law
would be valuable. However, the evidence Merz provides
does not undermine our argument. On the contrary, a close
reading of the evidence seems to strengthen it. Although 4
of the 19 published opinions he reviewed from state and fed-
eral courts refer specifically to the code, they do so not to
establish the “legal duty” of researchers to secure informed
consent, but rather as an important “guideline” and “law of
humanity” in the cases.
In Kaimowitz v Department of Mental Health, the
court noted that “in considering consent for experimenta-
tion,” the Nuremberg Code gives “guidance.”1 In Whitelock
v Duke University, the court stated that it was “not left with-
out persuasive guidance” on an appropriate standard of care
in the case.2 The judge then referred to the code, stating
that the “United States Military Tribunal at Nuremberg
adopted the Nuremberg Code as a proper statement of
the law of informed consent in connection with the trials
of German scientists for human experimentation after
World War II.” The opinion does not say that the US judicial
system “adopted the Nuremberg Code as a proper statement
of the law of informed consent.” Rather, the code and the
Declaration of Helsinki are both seen by the court as “persua-
sive guidance” in the case.
In Cincinnati Radiation Litigation, the court refers to
the directive by the Department of Defense, stating that
it “mirrored” the Nuremberg Code.3 Judge Beckwith then
refers to additional medical ethics “guidelines” such as the
1954 World Medical Association’s principles and the
National Institute of Health “guidelines” from the mid-
1950s. What is different in this case, however, is that the
Nuremberg Code is referred to as “part of the law of human-
ity” which “may [emphasis added] be applied in both civil
and criminal cases by the federal courts in the United
States”. The last case, Heinrich Ex Rel Heinrich v Sweet, sim-
ply refers back to Cincinnati Radiation Litigation, stating
that the Nuremberg Code “served as an explicit interna-
86 JAMA January 2, 2018 Volume 319, Number 1 (Reprinted)
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tional declaration” that had shocked the conscience of
humanity, which is why it should be seen to be “part of the
law of humanity.”4
The evidence provided by Merz does not conclusively
demonstrate that the Nuremberg Code has been uniformly
adopted by the US legal system or that the code has estab-
lished a “legal duty” for researchers to secure informed con-
sent, but shows that it has instead served as an ethical
“guideline” that informed legal opinions in 4 specific cases.
We agree, however, that this subject requires further study
in relation to the United States and internationally.
Jonathan D. Moreno, PhD
Ulf Schmidt, PhD
Steve Joffe, MD, MPH
Author Affiliations: Department of Medical Ethics and Health Policy, University
of Pennsylvania Perelman School of Medicine, Philadelphia (Moreno, Joffe);
School of History, University of Kent Canterbury, Kent, England (Schmidt).
Corresponding Author: Jonathan D. Moreno, PhD, Department of Medical
Ethics and Health Policy, University of Pennsylvania Perelman School of
Medicine, 423 Guardian Dr, BH1415, Philadelphia, PA 19104 (morenojd@mail
.med.upenn.edu).
Conflict of Interest Disclosures: The authors have completed and submitted
the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Moreno and
Schmidt reported receiving grants from the Wellcome Trust. Dr Joffe reported
that he was an expert witness in a clinical trial related lawsuit that involved a
number of issues, including informed consent.
1. Kaimowitz v Department of Mental Health for the State of Michigan. 73 19434
AW (Mich Cir Ct 1973).
2. Whitelock v Duke University, 637 F Supp 1463 (MDNC 1986); affirmed, 828
F2d 1340 (4th Cir 1987).
3. Cincinnati Radiation Litigation, 874 F Supp 796 (SD Ohio 1995).
4. Heinrich Ex Rel Heinrich v Sweet, 62 F Supp 2d 282 (D Mass 1999).
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