The n e w e ng l a n d j o u r na l of m e dic i n e

Medicine a nd So cie t y

“Ethics and Clinical Research” — The 50th Anniversary

of Beecher’s Bombshell
David S. Jones, M.D., Ph.D., Christine Grady, M.S.N., Ph.D., and Susan E. Lederer, Ph.D.

Human-subjects research receives intense scru- “full consent.” Otherwise “the sacred cord which
tiny today. Researchers, institutions, funders, and binds physician and patient snaps instantly.”11
journals pay serious attention to ethical conduct. Some researchers heeded these tenets. Walter
Yet controversies continue, whether about experi- Reed solicited volunteers from American soldiers
menting with oxygen levels in neonatal intensive and recent Spanish immigrants in Cuba, offered
care or with the duty hours of surgical resi- them payment, and had them sign contracts
dents.1,2 Some commentators have even argued certifying their awareness of the risks before
that anxiety over the ethics of Ebola research exposing them to yellow fever. Other researchers
created delays that resulted in lost opportunities.3 triggered scandals by infecting patients, orphans,
Many researchers and bioethicists believe that or asylum inmates with pathogens without their
serious discussions of research ethics began after knowledge.8,9 In 1916, Walter Cannon pushed
World War II.4-6 The actual history is longer and the American Medical Association (AMA) to
more complex. Nonetheless, Henry Beecher’s mandate informed consent for research.12 The
“Ethics and Clinical Research,” published 50 years organization refused, arguing that misconduct
ago, played an important role. Beecher warned was a problem of rogue researchers, not re-
researchers and the public about serious prob- search itself. The AMA believed that trust, not
lems with research in the United States and regulation, would foster better research and
exhorted researchers to reform.7 Research regu- clinical care.9
lations proliferated in the ensuing decades. How- World War II prompted extensive human ex-
ever, as Beecher surely anticipated, new policies perimentation. American researchers were often
and procedures have not resolved every dilemma. scrupulous in their use of informed, consenting
Now, as in 1966, reasonable people disagree volunteers but sometimes pressured soldiers to
about research ethics. volunteer without full knowledge of the risks
and sometimes used institutionalized popula-
tions.8,13-15 German and Japanese researchers went
Re se ar ch E thic s before 19 6 6:
Regul ate or Rely on Vir t ue further, committing atrocities in the name of
scientific research.16,17 When allied authorities
Humans have experimented on humans for mil- prosecuted Nazi physicians at the War Crimes
lennia, and they have long been aware of ethical Tribunal (Fig. 1), they issued the Nuremberg
risks.8 Human research expanded in the late Code, specifying that researchers should always
19th century, as physicians tested new theories recruit competent research subjects who under-
and technologies.9 Ethical concerns remained stood the nature of the research and voluntarily
paramount. Claude Bernard set a high bar in consented to participate.18,19
1865: “The principle of medical and surgical The Code, however, had no binding legal au-
morality consists in never performing on man thority, and American researchers responded in
an experiment which might be harmful to him complex ways. Some government agencies is-
to any extent, even though the result might be sued new guidelines — in 1953, for instance, the
highly advantageous to science.”10 William Osler secretary of defense mandated written consent
insisted that researchers experiment on patients in military research on atomic, biologic, and
only if “direct benefit is likely” and only with chemical weapons (though this policy was kept

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 The n e w e ng l a n d j o u r na l of m e dic i n e

Figure 1. The Defendants Dock during the Medical Case (Doctors’) Trial
at the Military Tribunal at Nuremberg, 1946 to 1947.
U.S. Holocaust Memorial Museum; courtesy of Hedwig Wachenheimer
­Epstein.

“top secret”).20 The same year, the National

Institutes of Health (NIH) Clinical Center im-
Figure 2. Henry Beecher.
plemented peer review and informed consent
Courtesy of Massachusetts General Hospital, Archives
for research on healthy volunteers. In other and Special Collections.
venues, however, much was left to researchers’
discretion.8,21
Many U.S. scientists believed that the Code, ried that the provision would cripple the coun-
a response to the work of experiments by Nazi try’s lead in drug research, in part by preventing
researchers, did not apply to them.22 Others research on children and the mentally ill.24,25
understood the need for guidelines but sought Scandals, however, raised questions about
to moderate the Code’s strict language. For in- whether to trust U.S. researchers. In 1964, news
stance, as the World Medical Association drafted broke that 22 patients at the Jewish Chronic
its 1964 Declaration of Helsinki, U.S. represen- Disease Hospital in Brooklyn had been injected
tatives, with funding from the pharmaceutical with cancer cells without their knowledge. The
industry, blocked the requirement for informed media firestorm, hearings, and lawsuits raised
consent in all cases, believing it would threaten fundamental questions about medical research.
placebo-controlled drug trials. They also blocked However, the researchers from Memorial Sloan
a ban on research on institutionalized children Kettering who conducted the study received no
and prison inmates, who were widely used to serious sanction.26
test vaccines and drugs.23 Similarly, when the
Senate debated a 1962 amendment that would “E thic s and Clinic al Re se ar ch”
have mandated informed consent for research
with experimental drugs, dozens of leading re- By 1950, Henry Beecher (Fig. 2), an anesthesiolo-
searchers protested. One described informed gist at Massachusetts General Hospital, had
consent as “a snare and delusion”: “it is for the emerged as a respected researcher, having exam-
most part impossible to achieve and is certain to ined battlefield trauma, the safety of anesthesia,
do more harm than good.” Henry Beecher wor- subjective experiences (e.g., pain, thirst, and nau-

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 medicine and society

sea), and placebo responses.4,8,22,27,28 He advocat- to accuse Beecher of “gross and irresponsible
ed careful research methods, including the use exaggeration.”34 Beecher condemned their kan-
of placebo controls. He had also consulted for garoo court and accused them of defamation
the military about the use of mescaline and LSD of character.30 The exchange received extensive
as “truth serums,” research that involved discus- media coverage.
sions with Central Intelligence Agency interro- After an inquiry to Science, Beecher submitted
gators and former Gestapo officials.29 This his manuscript to JAMA in August. The editor
work got Beecher interested in “certain problems rejected it, citing its excessive length (it described
of human experimentation”30 (for the specific 50 research studies) and poor organization.
Beecher papers cited here, see the Supplemen- Beecher submitted a revised manuscript to the
tary Appendix, available with the full text of this Journal in November. Garland sent it “to some
article at NEJM.org). In 1952, he asked Pentagon picked reviewers,” expecting no serious prob-
officials for their new policy on human research. lems. Six of the seven recommended against
In 1955, he wrote to an English colleague to publication: there were too many cases; Beecher
learn about the Medical Research Council in- did not allow the investigators to tell their side
structions for investigators and editors.30 of the story; many readers would recognize the
In 1959 and 1963, Beecher published articles “anonymous” cases; and his critiques had al-
in JAMA about the role conflict faced by physi- ready received extensive media coverage. One
cian-investigators.31,32 Neither generated much reviewer supported publication, but only if the
response. He then collected examples of trou- Journal obtained a legal opinion “regarding any
bling behavior by U.S., Canadian, and European possible problems.”30
researchers. For instance, he examined 100 con- The editorial board voted to reject the sub-
secutive articles in the Journal of Clinical Investiga- mission, but Garland overruled them.35 Blurring
tion (JCI) and concluded that 12 were “unethical the line between editor and coauthor, he helped
or questionably ethical.” He compiled a set of Beecher revise the manuscript. Beecher reduced
50 articles on studies funded by government the examples to 25 and provided Garland with
agencies, conducted at leading institutions, and their citations. Garland convened a “brain cabi-
published in leading journals. He took care to net” (two colleagues) to assess Beecher’s accusa-
ensure that his critiques were fair. For instance, tions; they settled on a final list of 22 cases.
he queried New England Journal of Medicine editor Garland also moderated Beecher’s language: “I
Joseph Garland about the Journal’s decision to have tried to omit anything accusatory or espe-
publish a study of thymectomy in children; cially critical, since what we want is not an indict-
Garland admitted that the ethical review had ment but a sober and undramatic presentation of
been inadequate.30 Beecher also recognized his what has been done and is being done in viola-
own mistakes. He regretted a 1948 study in tion of basic ethics.”30 The Journal published the
which researchers in his laboratory, without ad- article in June with an editorial by Garland.7,36
equate consent, prolonged anesthesia “beyond The cases made for shocking reading. Beecher
that necessary” to study the effects on kidney focused on human experiments in which patients
function.30,33 were used not for their benefit, “but for that, at
Beecher then accepted an invitation to speak least in theory, of patients in general.”7 Research-
at a conference in March 1965. He delivered a ers sometimes withheld known treatments. In
“bombshell.” After reviewing the Jewish Chronic the case Beecher considered most egregious,
Disease Hospital controversy, he proceeded, with- penicillin was withheld from 109 soldiers with
out naming names, to describe 17 additional streptococcal infections; acute rheumatic fever
cases in which researchers had failed to obtain developed in 2 and acute nephritis in 1. In some
consent or had harmed their research subjects: cases, patients experienced harm or risk of harm
“what seem to be breaches of ethical conduct in without benefit. In others, researchers had not
experimentation are by no means rare, but are obtained consent. The examples were not from a
almost, one fears, universal.”30 Reaction from lunatic fringe.4 Four came from Harvard Medical
his colleagues was immediate. Thomas Chalm- School, three from the NIH Clinical Center, and
ers and David Rutstein called a press conference the rest from other prominent institutions. The

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 The n e w e ng l a n d j o u r na l of m e dic i n e

cases had passed peer and editorial review at the justifications. Geoffrey Edsall, from the Massa-
Journal (five articles), JCI (five), JAMA (two), and chusetts Department of Public Health, told
Circulation (two). Beecher that “If I had a child in Willowbrook,
Beecher insisted that the researchers not be and if I had had it clearly explained to me — as
named: “I have no wish to point a finger at in- Krugman et al. did with the parents of his chil-
dividuals. I was pointing to an all-too-general dren — that my child was bound to come down
practice.”30,37 Garland accepted Beecher’s request with hepatitis sooner or later, as all the children
and asked readers to trust the Journal’s assess- do in Willowbrook; if I was then asked to permit
ment of the veracity of Beecher’s accusations. my child to be part of an experiment which
Beecher was besieged by requests to identify his hopefully would be of benefit to man, I would
sources but steadfastly refused. As he explained be delighted to have that opportunity to allow
to Arnold Relman, then editor of JCI, “I am as- the child to contribute.” If ethical barriers were
sured by a professor in the Harvard Law School set too high, Edsall argued, they would disrupt
that the individuals involved could be subjected “the trend of progress that all human beings
to criminal prosecution, and I have no wish to want, and that the vast majority are willing to
invite such action.”30 Beecher had divided loyal- contribute to.”30
ties. Even as he drew attention to misconduct, he
did not want researchers to suffer legal conse- The Af termath
quences.4 Since he expected that many cases
would be recognized by the research commu- Despite Beecher’s fervor, his goals were modest.
nity, he might have hoped that the researchers He qualified his “troubling charges” with the
would be shamed among their peers, if not affirmation that “American medicine is sound,
publicly. Remarkably, when the researchers were and most progress in it is soundly attained.”7 He
unmasked in 1991, they received little atten- hoped that simply revealing problems would be
tion.8,38,39 sufficient to address them. As he told Garland,
Reactions in 1966 varied widely. Medical re- “most of the ethics errors are owing to thought-
searchers were often angry and defensive, clini- lessness or carelessness, not a vicious disregard
cians were outraged by researchers’ conduct, for the patients’ rights. I am utterly convinced
and the public piled on with their own accounts that calling attention to the ethical problems
of physician misconduct.28 The researchers re- involved will lead to elimination of the vast ma-
sponsible for one of Beecher’s cases published a jority of mistakes.”30 He did not recommend new
letter to the Editor: “Dr. Beecher quotes out of regulations or formal oversight, instead empha-
context, oversimplifies and otherwise distorts sizing the importance of informed consent and
the purpose and findings of our investigation.”40 “the more reliable safeguard provided by the
Beecher dismissed them: “I do not believe this is presence of an intelligent, informed, conscien-
so, and obviously neither did the 3 editors who tious, compassionate, responsible investigator.”7
checked my cases.”37 Eugene Braunwald, involved Beecher’s exposé had immediate impact.
in three of Beecher’s cases at the NIH Clinical Members of Congress wrote to the NIH inquir-
Center, prepared a point-by-point critique, argu- ing about possible corrective actions.8 Beecher’s
ing that Beecher misunderstood the role of pa- article provided support for a 1965 proposal by
tients and healthy volunteers and the role of NIH director James Shannon to require peer re-
consent at the Clinical Center. But recognizing view of research, protect the rights and welfare
the value of some of Beecher’s critiques, Braunwald of participants, and ensure appropriate informed
decided not to respond.41 consent.43 Historian David Rothman highlights
It was clear that thoughtful researchers could 1966 as the start of a broad transformation of
disagree. Beecher’s list included studies at the bioethics and the patient–doctor relationship, as
Willowbrook State School, in which researchers patients, lawyers, and ethicists shaped medi-
had infected disabled children with hepatitis.7,42 cine’s moral code. Beecher, according to Roth-
As he explained to one critic, “The thought that man, had joined the ranks of Harriet Beecher
some would have agreed that deliberate infec- Stowe, Upton Sinclair, and Rachel Carson.8
tion was all right since the subjects were mental These changes, however, were not a response
defectives gives me the Nazi shudders.”30 The to a single article. Beecher had published repeat-
study’s defenders, however, appealed to other edly about research ethics. Maurice Pappworth

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 medicine and society

worked in parallel in England to expose unethi- or who can be appropriate research subjects:
cal research.22 In February 1966, between Beech- thoughtful people often disagree. Articles like
er’s conference presentation and publication of Beecher’s play a crucial role in fostering debate
the article, the U.S. Surgeon General requested that can lead to consensus about ethical values.
that hospitals and universities establish review Third, many interests — medical, personal, po-
boards.21 Many scholars joined the discussion litical, military, and commercial — have led re-
after Beecher.44 And scandals continued to searchers to conduct studies they knew to be
emerge. The Tuskegee syphilis study, which transgressive. It would be hubris to think that
seized public attention in 1972, was the most such lapses could not happen again.
famous.45 In response, Senator Edward Kennedy Disclosure forms provided by the authors are available with
(D-MA) held hearings on human experimenta- the full text of this article at NEJM.org.

tion that led to the National Research Act in From the Department of Global Health and Social Medicine,
1974 and the National Commission for the Pro- Harvard Medical School, Boston (D.S.J); the Department of the
tection of Human Subjects. The Commission’s History of Science, Harvard University, Cambridge, MA (D.S.J.);
the Department of Bioethics, National Institutes of Health
1979 Belmont Report guided the systems that Clinical Center, Bethesda, MD (C.G.); and the Department of
continue to regulate human research in the Medical History and Bioethics, University of Wisconsin Madi-
United States.8,9 son School of Medicine and Public Health, Madison (S.E.L.).
Would Beecher be satisfied with current ar-
1. Drazen JM, Solomon CG, Greene MF. Informed consent and
rangements? He put his trust in two safeguards: SUPPORT. N Engl J Med 2013;​368:​1929-31.
informed consent and virtuous researchers. In- 2. Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-
formed consent is almost always obtained today, randomized trial of duty-hour flexibility in surgical training.
N Engl J Med 2016;​374:​713-27.
though it remains imperfect.46 Investigator vir- 3. Gericke CA. Ebola and ethics: autopsy of a failure. BMJ 2015;​
tue is highly valued, yet ironically, the compli- 350:​h2105.
ance culture of modern human-subjects protec- 4. Rothman DJ. Ethics and human experimentation. N Engl J
Med 1987;​317:​1195-9.
tion assumes that investigators cannot be relied 5. Faden RR, Beauchamp TL. A history and theory of informed
on.47 Discussions of ethics have become ubiqui- consent. New York:​Oxford University Press, 1986.
tous in the research community, something 6. Truog RD. Patients and doctors — evolution of a relation-
ship. N Engl J Med 2012;​366:​581-5.
Beecher would have applauded. However, re- 7. Beecher HK. Ethics and clinical research. N Engl J Med
searchers complain that institutional review 1966;​274:​1354-60.
boards have lost sight of their original purpose 8. Rothman DJ. Strangers at the bedside: a history of how law
and bioethics transformed medical decision making. New York:​
of protecting human subjects, focusing instead Basic Books, 1991.
on bureaucratic minutiae.48 And researchers still 9. Lederer SE. Subjected to science: human experimentation in
worry that excessive attention to ethics can hin- America before the Second World War. Baltimore:​Johns Hop-
kins University Press, 1995.
der the research enterprise. 10. Bernard C. An introduction to the study of experimental
Are we — 50 years after Beecher — better medicine (1865). New York:​Dover, 1957.
than our predecessors at recognizing and pre- 11. Osler W. The evolution of the idea of experiment in medi-
cine. Trans Cong Am Phys Surg 1907;​7:​7-8.
venting unethical research? All Beecher’s exam- 12. Cannon WB. The right and wrong of making experiments on
ples had been published in prominent journals, human beings. JAMA 1916;​67:​1372-3.
yet few had inspired an outcry. We assume that 13. “Ethically impossible”: STD research in Guatemala from
1946 to 1948. Washington, DC:​Presidential Commission for the
we are now more sensitive to ethical concerns Study of Bioethical Issues, 2011.
than past researchers, and we may well be. We 14. Smith SL. Mustard gas and American race-based human ex-
have well-established guidelines that did not perimentation in World War II. J Law Med Ethics 2008;​36:​517-
21.
previously exist.49 But sensitivity to research eth- 15. Smith SL. Toxic exposures: mustard gas and the health con-
ics did exist, even if past researchers resisted sequences of World War II in the United States. New Brunswick,
formal regulation: many understood how they NJ:​Rutgers University Press (in press).
16. Weindling P. Nazi medicine and the Nuremberg Trials: from
ought to behave toward research subjects and medical war crimes to informed consent. New York:​Palgrave
worried about their failures to do so. Neverthe- Macmillan, 2004.
less, ethical failures occurred throughout the 17. Harris SH. Factories of death: Japanese biological warfare,
1932-1945, and the American cover-up. New York:​Psychology
20th century and continue in the 21st. Press, 2002.
Three lessons are clear. First, ethical values 18. Weindling P. “No mere murder trial”: the discourse on hu-
change over time, and it is important to under- man experiments at the Nuremberg medical trial. In:​Roelcke V,
Maio G, eds. Twentieth century ethics of human subjects re-
stand how and why. Second, there is not always search: historical perspectives on values, practices, and regula-
consensus on what counts as ethical research, tions. Stuttgart, Germany:​Franz Steiner Verlag, 2004:​167-80.

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 medicine and society

19. Annas GJ, Grodin MA, eds. The Nazi doctors and the esthesia on the renal function of man. J Pharmacol Exp Ther
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Declaration of Helsinki. In:​Roelcke V, Maio G, eds. Twentieth perimentation. N Engl J Med 1966;​275:​790-1.
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24. Podolsky SH. The antibiotic era: reform, resistance, and the Willowbrook State School. In:​Emanuel EJ, Grady C, Crouch RA,
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33. Burnett CH, Bloomberg EL, Shortz G, Compton DW, Beecher DOI: 10.1056/NEJMms1603756
HK. A comparison of the effects of ether and cyclopropane an- Copyright © 2016 Massachusetts Medical Society.

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