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PERSPECTIVE
1011
The 20th Anniversary of the Hospitalist
n engl j med 375;11  nejm.org  September 15, 2016
mentation of quality- and systems-
related initiatives. Hospitalists
have been slow to pursue sub-
stantial inquiry into discovery re-
lated to the common inpatient
diseases they see or to lead multi-
center trials of new diagnostic or
therapeutic approaches. This defi-
ciency limits hospitalists’ credibil-
ity in academia and the advance-
ment of the field.
Although we continue to be-
lieve that the hospitalist model is
the best guarantor of high-quality,
efficient inpatient care, it’s clear
that today’s pressures require in-
novative approaches around this
core. In addition to following pa-
tients in post–acute care facili-
ties, another modified approach
is to have a subgroup of hospital-
ists function as “comprehensivist”
physicians who care for a small
panel of the highest-risk, most
frequently admitted outpatients
and remain involved when hospi-
talization is required. This model
aims to blend the advantages of
the hospitalist model for the vast
majority (>95%) of inpatients with
the potential advantages of conti-
nuity for a small group of patients
who are admitted repeatedly.
Hospitalist programs are inno-
vating in other ways as well. Many
are developing early-warning pro-
tocols in which electronic health
record data are used to identify
patients who are at risk for prob-
lems such as sepsis or falls. Others
are implementing bedside ultra-
sonography for procedures and
diagnosis, pioneering methods
of making rounds more patient-
and family-centric, implementing
unit-based leadership teams, or
applying process-improvement ap-
proaches such as the Toyota Pro-
duction System to inpatient care.
Many academic programs are
also experimenting with new ways
of reconnecting specialists and
scientists with trainees. Some have
begun offering focused basic-
science training to hospitalists,
others have developed molecular
medicine consult services, and
still others have instituted dual
attending programs, with a con-
sultative teaching specialist join-
ing a more hands-on teaching
hospitalist. Such innovations are
welcome and should be studied.
In fact, the field’s greatest risk
may well be complacency — fail-
ing to embrace the kinds of trans-
formation and disruption that
led to its birth, or being slow to
address the inevitable side effects
of even the best innovation.
When we described the hospi-
talist concept 20 years ago, we
argued that it would become an
important part of the health care
landscape. Yet we couldn’t have
predicted the growth and influ-
ence it has achieved. Today, hospi-
tal medicine is a respected field
whose greatest legacies may be
improvement of care and effi-
ciency, injection of systems think-
ing into physician practice, and
the vivid demonstration of our
health care system’s capacity for
massive change under the right
conditions.
Disclosure forms provided by the authors
are available at NEJM.org.
From the Department of Medicine, Univer-
sity of California, San Francisco, San Fran-
cisco (R.M.W.); and the College of Physi-
cians and Surgeons, Columbia University,
New York (L.G.).
This article was published on August 10, 2016,
at NEJM.org.
1.	 Wachter RM, Goldman L. The emerging
role of “hospitalists” in the American health
care system. N Engl J Med 1996;​335:​514-7.
2.	 Wachter RM, Katz P, Showstack J, Bind-
man AB, Goldman L. Reorganizing an aca-
demic medical service: impact on cost, qual-
ity, patient satisfaction, and education. JAMA
1998;​279:​1560-5.
3.	 Auerbach AD, Wachter RM, Katz P,
Showstack J, Baron RB, Goldman L. Imple-
mentation of a voluntary hospitalist service
at a community teaching hospital: improved
clinical efficiency and patient outcomes.
Ann Intern Med 2002;​137:​859-65.
4.	 The core competencies in hospital medi-
cine: a framework for curriculum develop-
ment by the Society of Hospital Medicine.
J Hosp Med 2006;​1:​Suppl 1:​2-95.
5.	 Auerbach AD, Wachter RM, Cheng HQ,
et al. Comanagement of surgical patients
between neurosurgeons and hospitalists.
Arch Intern Med 2010;​170:​2004-10.
DOI: 10.1056/NEJMp1607958
Copyright © 2016 Massachusetts Medical Society.The 20th Anniversary of the Hospitalist
Hospitalists and the Decline of Comprehensive Care
Hospitalists and the Decline of Comprehensive Care
Richard Gunderman, M.D., Ph.D.​​
Medical specialization dates
back at least to the time of
Galen. For most of medicine’s
history, however, the boundaries
of medical fields have been based
on factors such as patient age
(pediatrics and geriatrics), ana-
tomical and physiological systems
(ophthalmology and gastroenter-
ology), and the physician’s tool-
set (radiology and surgery). Hos-
pital medicine, by contrast, is
defined by the location in which
care is delivered. Whether such
delineation is a good or bad sign
for physicians, patients, hospitals,
and society hinges on how we
understand the interests and as-
pirations of each of these groups.
The hospitalist model has pro-
vided such putative benefits as
The New England Journal of Medicine
Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission.
Copyright © 2016 Massachusetts Medical Society. All rights reserved.
, Liercio Pinheiro de Araujo, Ph.D.
PERSPECTIVE
1012
Hospitalists and the Decline of Comprehensive Care
n engl j med 375;11  nejm.org  September 15, 2016
reductions in length of stay, cost
of hospitalization, and readmis-
sion rates — but these metrics
are all defined by the boundaries
of the hospital. What we don’t yet
know sufficiently well is the im-
pact of the rise of hospital medi-
cine on overall health status, total
costs, and the well-being of pa-
tients and physicians. The increas-
ing number of hospitalists cannot,
in and of itself, be taken as con-
clusive evidence of benefit. Such
increases can be driven by a vari-
ety of perverse incentives, such as
low payment rates for primary care
that place a premium on maximiz-
ing the number of patients a phy-
sician sees in a day and therefore
militate against taking the extra
time required to see inpatients.
In fact, increasing reliance on
hospitalists entails a number of
risks and costs for everyone in-
volved in the health care system
— most critically, for the patients
that system is meant to serve. As
the number of physicians caring
for a patient increases, the depth
of the relationship between patient
and physician tends to diminish
— a phenomenon of particular
concern to those who regard the
patient–physician relationship as
the core of good medical care.
Practically speaking, increasing
the number of physicians involved
in a patient’s care creates oppor-
tunities for miscommunication
and discoordination, particularly
at admission and discharge. Gaps
between community physicians
and hospitalists may result in
failures to follow up on test re-
sults and treatment recommen-
dations.1
Moreover, the acute care
focus of hospital medicine may
not match the need of many pa-
tients for effective disease pre-
vention and health promotion.
Studies are under way to see
whether these pitfalls can be miti-
gated, but I suspect the inherent
tensions will remain fundamen-
tally irresolvable.
From the patient’s point of
view, it can be highly disconcert-
ing to discover that the physician
who knows you best will not
even see you at your moment of
greatest need — when you are in
the hospital, facing serious illness
or injury.2
Who is better equipped
to abide by an incapacitated pa-
tient’s preferences or offer coun-
seling on end-of-life care: a phy-
sician with whom the patient is
well acquainted or one the patient
has only just met? The patient–
physician relationship is built
largely on trust, and levels of trust
are usually lower among strangers.
The hospitalist model also car-
ries risks and costs for physicians.
As community physicians, for their
part, participate less frequently in
the care of hospitalized patients,
their knowledge and skills in
hospital care may decline, and
they may play a shrinking role in
hospital-based education, as both
teachers and learners. Over time,
it’s likely to become increasingly
difficult for community physi-
cians to really mean it when they
promise patients to always be
there for them — a limitation
that may, in turn, erode the phy-
sician’s professional fulfillment.
Meanwhile, hospitalists face
a parallel narrowing of their
comfort range. As members of a
young field, many hospitalists
have relatively little experience
with outpatient medicine, a defi-
cit that’s exacerbated by hospital-
only practice. Physicians who
never see outpatients are at a dis-
advantage in understanding pa-
tients’ lives outside the hospital.
Over time, hospitalists may be-
come progressively less account-
able to nonhospitalized patients
and their communities, ultimately
becoming less effective advocates
for comprehensive medical care.
More broadly, the profession
of medicine stands to suffer. As
patient care becomes increasing-
ly fragmented, many physicians
find it more and more difficult
to provide truly integrated care.
Physicians whose practices rest
on a clear separation between in-
patient and outpatient care or
manifest a shift-work mentality
are more likely to respond to re-
quests from patients and col-
leagues with, “Sorry, but that’s
not in my job description.” Such
practice models may make physi-
cians’ lives easier, but they may
also reduce professional fulfill-
ment and promote burnout.
At the same time, the physi-
cian’s lounge, once an important
site of knowledge sharing and
professional collegiality, may be-
come depopulated. Exclusively in-
patient and outpatient physicians
see each other less frequently,
and medical students and resi-
dents have fewer role models who
provide comprehensive care. In
effect, the mounting walls of the
hospital constitute an increasingly
impermeable barrier between the
members of the profession.
The very term “hospitalist”
seems problematic. If we call some
physicians hospitalists, should we
call others “clinicists” or “offi-
cists”?3
Similarly, the move toward
shift work may open the door to
“matinists” and “nocturnists.” Us-
ing a misnomer such as “hospi-
talist” to mean acute care medi-
cine may seem harmless, but
calling things by the wrong
names is often the first step to-
ward becoming confused about
them — a particularly hazardous
state of affairs for a profession
facing an era of great flux.
A high percentage of hospital-
ists are employed by hospitals or
The New England Journal of Medicine
Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission.
Copyright © 2016 Massachusetts Medical Society. All rights reserved.
PERSPECTIVE
1013
Hospitalists and the Decline of Comprehensive Care
n engl j med 375;11  nejm.org  September 15, 2016
work at only a single hospital,
which can shift loyalty away from
patients and the profession and
toward the hospital. Some physi-
cians may be captured by the
hospital, whose incentives to in-
crease market share and profits
are not always well aligned with
the best interests of patients and
communities. For example, hos-
pital marketing may encourage
patients to suppose that their re-
lationship with the hospital is
more important than their rela-
tionship with any particular phy-
sician.
And yet even hospitals suffer
in some ways from the hospitalist
model. As community physicians
relinquish their hospital privileges,
the number of physicians on hos-
pital medical staffs tends to de-
cline. Fewer and fewer physicians
in the community ever set foot in
the hospital, let alone participate
in its decision making. As a re-
sult, hospital leaders can become
less informed and engaged with
the needs of their community. In
settings where community physi-
cians have functioned as effective
advocates, the loss of their voice
can widen the gap between hospi-
tal policies and community needs.
The reality is that medicine
can be practiced without hospi-
tals, but hospitals cannot func-
tion without physicians. In war-
torn parts of the world today, for
example, physicians are caring for
seriously ill and injured patients
and even performing complex
surgeries in outpatient settings.4
Although this state of affairs is
undesirable, it’s also a powerful
reminder of the real sine qua non
of medical care. A good hospital
is a great boon to patient care,
but the hospital itself is ultimate-
ly a tool — to be sure, a large,
complex, expensive tool — with-
out which patients can still be
given care.
To position the hospital at
medicine’s center is to create an
unbalanced system, one that will
continually jar both patients and
the health professionals who care
for them. The true core of good
medicine is not an institution but
a relationship — a relationship
between two human beings. And
the better those two human be-
ings know one another, the
greater the potential that their
relationship will prove effective
and fulfilling for both. Models of
medicine that ensconce physicians
more deeply in spatial and tem-
poral silos only make the pros-
pects for such relationships even
dimmer.
Disclosure forms provided by the author
are available at NEJM.org.
From Indiana University School of Medi-
cine, Indianapolis.
This article was published on August 10, 2016,
at NEJM.org.
1.	 Pham HH, Grossman JM, Cohen G,
Bodenheimer T. Hospitalists and care tran-
sitions: the divorce of inpatient and out­
patient care. Health Aff (Millwood) 2008;​27:​
1315-27.
2.	 Meltzer D. Hospitalists and the doctor-
patient relationship. J Legal Stud 2001;​30:​
589-606.
3.	 Bryant DC. Hospitalists and ‘officists’
preparing for the future of general internal
medicine. J Gen Intern Med 1999;​14:​182-5.
4.	 Taub B. The shadow doctors: the under-
ground race to spread medical knowledge as
the Syrian regime erases it. The New Yorker.
June 27, 2016 (http://www​.newyorker​.com/​
magazine/​2016/​06/​27/​syrias-war-on-doctors).
DOI: 10.1056/NEJMp1608289
Copyright © 2016 Massachusetts Medical Society.Hospitalists and the Decline of Comprehensive Care
Clinical Trials, Healthy Controls, and the IRB
HISTORY OF CLINICAL TRIALS
Clinical Trials, Healthy Controls, and the Birth of the IRB
Laura Stark, Ph.D., and Jeremy A. Greene, M.D., Ph.D.​​
The U.S. Office for Human
Research Protections (OHRP)
is revising the Common Rule that
guides research involving human
subjects — the first substantial
overhaul of clinical research regu-
lation in 40 years. In 2011, when
the OHRP announced its plan to
revise the regulations, it described
the current system of review by
local institutional review boards
(IRBs) as burdensome for multi-
site studies, such as collaborative
clinical trials, and as a force that
“can significantly delay the initi-
ation of research projects.” The
revisions will have global reper-
cussions. In determining how best
to fix the Common Rule, it is im-
portant to understand how our
current local review system was
designed to address specific prob-
lems in the 1950s, when random-
ized clinical trials were first
emerging.
The local IRB review model
stems from the practices that the
National Institutes of Health (NIH)
created for its research hospital,
known as the Clinical Center, in
Bethesda, Maryland. NIH scien-
tists and lawyers created the sys-
tem to manage a new kind of
human subject — the “normal
control” — for clinical studies
that were far smaller than today’s
randomized, controlled trials
(RCTs). Efforts to recruit healthy
volunteers for medical research
The New England Journal of Medicine
Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission.
Copyright © 2016 Massachusetts Medical Society. All rights reserved.

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Hospitalists and the_decline_of_comprehensive_care-3

  • 1. PERSPECTIVE 1011 The 20th Anniversary of the Hospitalist n engl j med 375;11  nejm.org  September 15, 2016 mentation of quality- and systems- related initiatives. Hospitalists have been slow to pursue sub- stantial inquiry into discovery re- lated to the common inpatient diseases they see or to lead multi- center trials of new diagnostic or therapeutic approaches. This defi- ciency limits hospitalists’ credibil- ity in academia and the advance- ment of the field. Although we continue to be- lieve that the hospitalist model is the best guarantor of high-quality, efficient inpatient care, it’s clear that today’s pressures require in- novative approaches around this core. In addition to following pa- tients in post–acute care facili- ties, another modified approach is to have a subgroup of hospital- ists function as “comprehensivist” physicians who care for a small panel of the highest-risk, most frequently admitted outpatients and remain involved when hospi- talization is required. This model aims to blend the advantages of the hospitalist model for the vast majority (>95%) of inpatients with the potential advantages of conti- nuity for a small group of patients who are admitted repeatedly. Hospitalist programs are inno- vating in other ways as well. Many are developing early-warning pro- tocols in which electronic health record data are used to identify patients who are at risk for prob- lems such as sepsis or falls. Others are implementing bedside ultra- sonography for procedures and diagnosis, pioneering methods of making rounds more patient- and family-centric, implementing unit-based leadership teams, or applying process-improvement ap- proaches such as the Toyota Pro- duction System to inpatient care. Many academic programs are also experimenting with new ways of reconnecting specialists and scientists with trainees. Some have begun offering focused basic- science training to hospitalists, others have developed molecular medicine consult services, and still others have instituted dual attending programs, with a con- sultative teaching specialist join- ing a more hands-on teaching hospitalist. Such innovations are welcome and should be studied. In fact, the field’s greatest risk may well be complacency — fail- ing to embrace the kinds of trans- formation and disruption that led to its birth, or being slow to address the inevitable side effects of even the best innovation. When we described the hospi- talist concept 20 years ago, we argued that it would become an important part of the health care landscape. Yet we couldn’t have predicted the growth and influ- ence it has achieved. Today, hospi- tal medicine is a respected field whose greatest legacies may be improvement of care and effi- ciency, injection of systems think- ing into physician practice, and the vivid demonstration of our health care system’s capacity for massive change under the right conditions. Disclosure forms provided by the authors are available at NEJM.org. From the Department of Medicine, Univer- sity of California, San Francisco, San Fran- cisco (R.M.W.); and the College of Physi- cians and Surgeons, Columbia University, New York (L.G.). This article was published on August 10, 2016, at NEJM.org. 1. Wachter RM, Goldman L. The emerging role of “hospitalists” in the American health care system. N Engl J Med 1996;​335:​514-7. 2. Wachter RM, Katz P, Showstack J, Bind- man AB, Goldman L. Reorganizing an aca- demic medical service: impact on cost, qual- ity, patient satisfaction, and education. JAMA 1998;​279:​1560-5. 3. Auerbach AD, Wachter RM, Katz P, Showstack J, Baron RB, Goldman L. Imple- mentation of a voluntary hospitalist service at a community teaching hospital: improved clinical efficiency and patient outcomes. Ann Intern Med 2002;​137:​859-65. 4. The core competencies in hospital medi- cine: a framework for curriculum develop- ment by the Society of Hospital Medicine. J Hosp Med 2006;​1:​Suppl 1:​2-95. 5. Auerbach AD, Wachter RM, Cheng HQ, et al. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med 2010;​170:​2004-10. DOI: 10.1056/NEJMp1607958 Copyright © 2016 Massachusetts Medical Society.The 20th Anniversary of the Hospitalist Hospitalists and the Decline of Comprehensive Care Hospitalists and the Decline of Comprehensive Care Richard Gunderman, M.D., Ph.D.​​ Medical specialization dates back at least to the time of Galen. For most of medicine’s history, however, the boundaries of medical fields have been based on factors such as patient age (pediatrics and geriatrics), ana- tomical and physiological systems (ophthalmology and gastroenter- ology), and the physician’s tool- set (radiology and surgery). Hos- pital medicine, by contrast, is defined by the location in which care is delivered. Whether such delineation is a good or bad sign for physicians, patients, hospitals, and society hinges on how we understand the interests and as- pirations of each of these groups. The hospitalist model has pro- vided such putative benefits as The New England Journal of Medicine Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission. Copyright © 2016 Massachusetts Medical Society. All rights reserved. , Liercio Pinheiro de Araujo, Ph.D.
  • 2. PERSPECTIVE 1012 Hospitalists and the Decline of Comprehensive Care n engl j med 375;11  nejm.org  September 15, 2016 reductions in length of stay, cost of hospitalization, and readmis- sion rates — but these metrics are all defined by the boundaries of the hospital. What we don’t yet know sufficiently well is the im- pact of the rise of hospital medi- cine on overall health status, total costs, and the well-being of pa- tients and physicians. The increas- ing number of hospitalists cannot, in and of itself, be taken as con- clusive evidence of benefit. Such increases can be driven by a vari- ety of perverse incentives, such as low payment rates for primary care that place a premium on maximiz- ing the number of patients a phy- sician sees in a day and therefore militate against taking the extra time required to see inpatients. In fact, increasing reliance on hospitalists entails a number of risks and costs for everyone in- volved in the health care system — most critically, for the patients that system is meant to serve. As the number of physicians caring for a patient increases, the depth of the relationship between patient and physician tends to diminish — a phenomenon of particular concern to those who regard the patient–physician relationship as the core of good medical care. Practically speaking, increasing the number of physicians involved in a patient’s care creates oppor- tunities for miscommunication and discoordination, particularly at admission and discharge. Gaps between community physicians and hospitalists may result in failures to follow up on test re- sults and treatment recommen- dations.1 Moreover, the acute care focus of hospital medicine may not match the need of many pa- tients for effective disease pre- vention and health promotion. Studies are under way to see whether these pitfalls can be miti- gated, but I suspect the inherent tensions will remain fundamen- tally irresolvable. From the patient’s point of view, it can be highly disconcert- ing to discover that the physician who knows you best will not even see you at your moment of greatest need — when you are in the hospital, facing serious illness or injury.2 Who is better equipped to abide by an incapacitated pa- tient’s preferences or offer coun- seling on end-of-life care: a phy- sician with whom the patient is well acquainted or one the patient has only just met? The patient– physician relationship is built largely on trust, and levels of trust are usually lower among strangers. The hospitalist model also car- ries risks and costs for physicians. As community physicians, for their part, participate less frequently in the care of hospitalized patients, their knowledge and skills in hospital care may decline, and they may play a shrinking role in hospital-based education, as both teachers and learners. Over time, it’s likely to become increasingly difficult for community physi- cians to really mean it when they promise patients to always be there for them — a limitation that may, in turn, erode the phy- sician’s professional fulfillment. Meanwhile, hospitalists face a parallel narrowing of their comfort range. As members of a young field, many hospitalists have relatively little experience with outpatient medicine, a defi- cit that’s exacerbated by hospital- only practice. Physicians who never see outpatients are at a dis- advantage in understanding pa- tients’ lives outside the hospital. Over time, hospitalists may be- come progressively less account- able to nonhospitalized patients and their communities, ultimately becoming less effective advocates for comprehensive medical care. More broadly, the profession of medicine stands to suffer. As patient care becomes increasing- ly fragmented, many physicians find it more and more difficult to provide truly integrated care. Physicians whose practices rest on a clear separation between in- patient and outpatient care or manifest a shift-work mentality are more likely to respond to re- quests from patients and col- leagues with, “Sorry, but that’s not in my job description.” Such practice models may make physi- cians’ lives easier, but they may also reduce professional fulfill- ment and promote burnout. At the same time, the physi- cian’s lounge, once an important site of knowledge sharing and professional collegiality, may be- come depopulated. Exclusively in- patient and outpatient physicians see each other less frequently, and medical students and resi- dents have fewer role models who provide comprehensive care. In effect, the mounting walls of the hospital constitute an increasingly impermeable barrier between the members of the profession. The very term “hospitalist” seems problematic. If we call some physicians hospitalists, should we call others “clinicists” or “offi- cists”?3 Similarly, the move toward shift work may open the door to “matinists” and “nocturnists.” Us- ing a misnomer such as “hospi- talist” to mean acute care medi- cine may seem harmless, but calling things by the wrong names is often the first step to- ward becoming confused about them — a particularly hazardous state of affairs for a profession facing an era of great flux. A high percentage of hospital- ists are employed by hospitals or The New England Journal of Medicine Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission. Copyright © 2016 Massachusetts Medical Society. All rights reserved.
  • 3. PERSPECTIVE 1013 Hospitalists and the Decline of Comprehensive Care n engl j med 375;11  nejm.org  September 15, 2016 work at only a single hospital, which can shift loyalty away from patients and the profession and toward the hospital. Some physi- cians may be captured by the hospital, whose incentives to in- crease market share and profits are not always well aligned with the best interests of patients and communities. For example, hos- pital marketing may encourage patients to suppose that their re- lationship with the hospital is more important than their rela- tionship with any particular phy- sician. And yet even hospitals suffer in some ways from the hospitalist model. As community physicians relinquish their hospital privileges, the number of physicians on hos- pital medical staffs tends to de- cline. Fewer and fewer physicians in the community ever set foot in the hospital, let alone participate in its decision making. As a re- sult, hospital leaders can become less informed and engaged with the needs of their community. In settings where community physi- cians have functioned as effective advocates, the loss of their voice can widen the gap between hospi- tal policies and community needs. The reality is that medicine can be practiced without hospi- tals, but hospitals cannot func- tion without physicians. In war- torn parts of the world today, for example, physicians are caring for seriously ill and injured patients and even performing complex surgeries in outpatient settings.4 Although this state of affairs is undesirable, it’s also a powerful reminder of the real sine qua non of medical care. A good hospital is a great boon to patient care, but the hospital itself is ultimate- ly a tool — to be sure, a large, complex, expensive tool — with- out which patients can still be given care. To position the hospital at medicine’s center is to create an unbalanced system, one that will continually jar both patients and the health professionals who care for them. The true core of good medicine is not an institution but a relationship — a relationship between two human beings. And the better those two human be- ings know one another, the greater the potential that their relationship will prove effective and fulfilling for both. Models of medicine that ensconce physicians more deeply in spatial and tem- poral silos only make the pros- pects for such relationships even dimmer. Disclosure forms provided by the author are available at NEJM.org. From Indiana University School of Medi- cine, Indianapolis. This article was published on August 10, 2016, at NEJM.org. 1. Pham HH, Grossman JM, Cohen G, Bodenheimer T. Hospitalists and care tran- sitions: the divorce of inpatient and out­ patient care. Health Aff (Millwood) 2008;​27:​ 1315-27. 2. Meltzer D. Hospitalists and the doctor- patient relationship. J Legal Stud 2001;​30:​ 589-606. 3. Bryant DC. Hospitalists and ‘officists’ preparing for the future of general internal medicine. J Gen Intern Med 1999;​14:​182-5. 4. Taub B. The shadow doctors: the under- ground race to spread medical knowledge as the Syrian regime erases it. The New Yorker. June 27, 2016 (http://www​.newyorker​.com/​ magazine/​2016/​06/​27/​syrias-war-on-doctors). DOI: 10.1056/NEJMp1608289 Copyright © 2016 Massachusetts Medical Society.Hospitalists and the Decline of Comprehensive Care Clinical Trials, Healthy Controls, and the IRB HISTORY OF CLINICAL TRIALS Clinical Trials, Healthy Controls, and the Birth of the IRB Laura Stark, Ph.D., and Jeremy A. Greene, M.D., Ph.D.​​ The U.S. Office for Human Research Protections (OHRP) is revising the Common Rule that guides research involving human subjects — the first substantial overhaul of clinical research regu- lation in 40 years. In 2011, when the OHRP announced its plan to revise the regulations, it described the current system of review by local institutional review boards (IRBs) as burdensome for multi- site studies, such as collaborative clinical trials, and as a force that “can significantly delay the initi- ation of research projects.” The revisions will have global reper- cussions. In determining how best to fix the Common Rule, it is im- portant to understand how our current local review system was designed to address specific prob- lems in the 1950s, when random- ized clinical trials were first emerging. The local IRB review model stems from the practices that the National Institutes of Health (NIH) created for its research hospital, known as the Clinical Center, in Bethesda, Maryland. NIH scien- tists and lawyers created the sys- tem to manage a new kind of human subject — the “normal control” — for clinical studies that were far smaller than today’s randomized, controlled trials (RCTs). Efforts to recruit healthy volunteers for medical research The New England Journal of Medicine Downloaded from nejm.org on September 15, 2016. For personal use only. No other uses without permission. Copyright © 2016 Massachusetts Medical Society. All rights reserved.