Retroactive Ethical Judgments
and Human Subjects Research:
The 1939 Tudor Study in Context1
A paper prepared for delivery at the
Symposium on Ethics and The
Implications for Research in Stuttering
Ph.D. Program in Speech and Hearing Sciences
The City University of New York
New York City
December 13, 2002
[Draft 20021207 0800]
|Introduction and Summary III. Complacency and Opposition to Reform||IV.
Ethical Analysis of the Tudor Study: Indictment or Itemization?
Measured by Today's Standards
Measured by the Standards of its Time
Speech pathologists will remember the summer of 2001 for something other than its weather and World Series.
However significant speech pathology research may be, seldom is its publication the focus of national media attention.
And yet for couple weeks that summer stuttering research was at the center of a national media blitz. The subject was not a new discovery, such as one the New England Journal of Medicine contributes to the evening television news from time to time. The media's powerful spotlight was focused on an obscure and dusty, then 62-year-old little master's thesis about speech disfluency.3
That fact alone ought to have made university and association administrators, speech pathologists and journalists a little suspicious. Some were. Others took the bait hook, line and sinker and felt obliged to join in the rock throwing before complying with the wall sign's admonition to "Engage brain before starting mouth."
The barrage of ethical and moral accusations hurled at the 36-years-dead supervisor, Dr. Wendell Johnson, and the surviving researcher, Mary Tudor, were driven by a couple of emotionally charged, supermarket tabloid-style articles by Jim Dyer in the San Jose Mercury News.4 The articles were treated as a major expose, widely distributed by the Mercury News, and reprinted all across the country. It is noteworthy that the nation's newspaper of record, the New York Times, chose not to mention the stories.5
The reporter resigned shortly thereafter, when his own ethical lapses were revealed.6 Meanwhile, the damage had been done.
The advice attributed to Mark Twain, "never pick a fight with someone who buys printer's ink by the barrel," is still applicable. Media damage, once done, can almost never be repaired; truth is a notoriously slow runner in its race with defamation.
No, the damage cannot be undone. However, this Symposium's assemblage of professional research scientists are entitled to, and can certainly handle in responsible fashion, an analysis of the ethical charges regarding the Tudor study.
Rather than detail those charges now, for any who are not already familiar with them, the nature of the study, and charges, will be treated throughout this paper's analysis of responses.
In summary, the responses explored below are:
1. No harm; no intention to do harm. If some of the critics of the substance (i.e., analysis of data and conclusions) from the Tudor study are correct, the researcher not only could not, and did not, "cause stuttering" in any of the subjects, neither did she do them any other harm. Nor is there any evidence that she or her supervisor intended to do any permanent harm. Thus, as human subjects researcher Dr. Michael Flaum has written in response to a Tudor-critical editorial in his university's college paper, "That really ought to be the end of the matter. If harm was neither intended nor done, what's the problem? Where's the 'lack of ethics' your editorial headlined?"7
2. Compared to what? Assume for the moment that harm was done - even though the best evidence now suggests that it was not. That "everybody's doing it" is never a defense, regardless of what the "it" is. But scholarly thoroughness - not to mention basic fairness - require that the procedures used in the Tudor study be evaluated in the context of the standards used in other human subjects research during the past 63 years. That historical context leaves the Tudor study looking very good indeed.
3. Complacency and opposition to reform. The human subjects research abuses during the post-World War II years, years following the creation of ethical standards not in place at the time of the Tudor study, are relevant for another reason. Not only were those more recent studies seemingly objected to by no one, and conducted by well-regarded professionals. Once abuses were noted, the most common response of administrators and researchers in industry, research institutions and the academy was one of defensiveness rather than apologies and calls for reform.8 There was seemingly greater concern about the possible effect of adverse public relations on legislative and financial support of the research than the harm done to the human subjects. Regrettably, administrative preference for that response seems to have continued to the present day.
4. Indictment or itemization? Given this history, and modern day abuses, if one is interested in exploring and improving the ethical standards applicable to human subjects research the Tudor study seems a most trivial and unproductive example to choose. If one wishes to do so anyway, the only responsible approach is to itemize the qualities and procedures of that study one at a time. What specifically is it about the Tudor study that is thought to be unethical? When the analysis is approached in that way there are few, if any, aspects of the study one could fairly criticize.
5. Measured by today's standards. Assume two false assumptions: that harm was done, and that the most appropriate baseline for evaluating the Tudor study's ethics are the human subjects research standards in place today. At a minimum, the procedures used by Tudor compare very favorably with those used by some researchers in prestigious U.S. institutions since 1939 - even including studies during the past five years.
6. Measured by the standards of its time. From virtually any perspective, and measured by even the most stringent ethical standards, the Tudor study's ethics compare very well. But why would one want to measure the human subjects research ethics of a study done 63 years ago by the standards of today? That is as unfair and inappropriate as it would be to measure the ethical behavior of each of us today by the standards of the year 2065 - 63 years from now. Clearly, the procedures used by Tudor were, as a former university vice president for research has concluded, "well within the norms of the time."9
7. Scholarship and scandals. This paper does not address the arguments of those who criticize the conclusions drawn from the Tudor study data by the researcher - but would take no issue with those critics if it did. Science is science. If the Tudor study's data is subject to a more accurate analysis today than when it was first gathered, that analysis should be done, reported, and published - as it has been.10
Similarly, the ethical issues surrounding the study also can be explored in a dispassionate, analytical and scholarly way.
The author's primary objection to criticism of the study's ethics relates to criticisms that have been as full of emotionalism as they have been empty of factual analysis and serious reflection. Such criticisms are similar to the thoughtless repetition of harmful, inaccurate and uncorroborated gossip in daily life. In this case some critics are quite willing to trash the reputations of others - and to do so with the language of moral outrage - notwithstanding the fact that their positions often reek of hypocrisy and are put forward for less than savory reasons. There should be, in short, an ethics of ethical criticism. There is an ethics of journalism - and it was grossly violated in this case.11
I. No Harm; No Intention to Do Harm
Nicoline Grinager Ambrose and Ehud Yairi are critical of the conclusions that Mary Tudor drew from her data.12 Nor do they believe the study is ethically pure by today's standards.
Given that they are severe critics of, not apologists for, the study it is the more credible (and commendable) that they are able to bring such scholarly balance and dispassion to their analysis of Tudor's ethics. They report their belief that no harm was done to the subjects, in the sense of "instilling chronic stuttering," and that there was no intention to do harm.13 As they put it,
"As it stands, the study failed to provided any credible scientific support that stuttering was produced 'in the laboratory' or to lend other support to the diagnosogenic theory of stuttering. . . . Our assessment of the ethical issues suggests that the study should be viewed within the common standards of the period, that there is no evidence of intent to harm, and that the objective of increasing disfluent speech should not be confused with instilling chronic stuttering in normally fluent children."14As Dr. Michael Flaum, quoted above, concluded, "That really ought to be the end of the matter."15
II. Compared to What?
A. What is Human Subjects Research?
"Human subject research," as the phrase suggests, is research that has gone beyond the laboratory test tube and animal studies and must involve humans if it is to be continued at all.
A common example would be the testing of a new pharmaceutical product. Under current law, before a new drug can be sold to the public the manufacturer must demonstrate that it won't do serious harm, that it will actually alleviate whatever condition it's designed to cure, and that its side effects are known and communicated.16 This usually requires that the drug be tested on humans.
Those who take the drug as a part of that test are called human subjects.
B. The Evolution of Human Subjects Research Ethics
Over time, thinking shifts regarding ethics in human subjects research. It is different today from what it was 63 years ago - and will be 63 years from now. Here are two examples.
As for the past, there is now greater sensitivity regarding the use of prisoners and institutionalized children as subjects than there was during the Nineteenth and early Twentieth Centuries.
Similarly, for the future, disparities today in the ethical standards applied by U.S. researchers to human subjects in North America and those living in developing countries may someday come to be seen as highly unethical.17
There has been much progress over the last 45 years in thinking about the ethics of human subjects research. Many more regulations and opportunities for review are in place.
It is still possible for harm to occur. It is still probable that future ethicists will look back and condemn practices widely accepted today. But either is much less likely than a century, half-century, or even decade ago.
The research community can be rightfully proud of that progress.
At the same time, two things must be said.
(1) As with any increased consciousness and sophistication, such as "political correctness," pendulums have a tendency to swing beyond the mid-point. This may be happening with human subject research ethical standards - that is, some of today's standards may be inhibiting needed research while producing little benefit.18
(2) Ethical violations, and resulting harm to human subjects, still occur, whether measured by the articulated standards of today or the standards that may evolve in the future.19
C. The Four Phases of Ethical Evolution
In evaluating the evolution of human subjects research ethics it is useful to identify four rather arbitrary historic periods.
The first includes roughly the Nineteenth and first half of the Twentieth Centuries. During this phase there were "ethics" in general, but few if any articulated, published or even agreed-upon human subjects research ethical standards. The ethical standards and issues, like the research designs, were left almost entirely to individual researchers.
The second, and primary focus of this historical section of the paper, is the period from World War II through the 1970s. This is the time when abuses began coming to public attention, consciousness was raised, and published international ethical standards evolved.
The third might be the 1980s, when new standards were finally in place and applied.
That would leave the fourth and final phase as the last five years, a period when concerns and procedures have been at their most intricate and intense - and some would say self-defeating20 - stage so far.
Phases I, III and IV are dealt with only in passing.
The illustrations selected from Phase II, described below, will be referred to throughout the remainder of the paper.
D. From World War II Through the 1970s21
Following World War II a review of experiments conducted by German researchers resulted in what came to be called the Nuremberg Code of 1948.22 It provided that human subjects research should only involve subjects who give informed consent and volunteer to participate.
The code is significant because it marks the beginning of Phase II. The first time such standards were ever set forth in an international agreement was 1948 - a full nine years after the 1939 Tudor study.
This was followed by the World Medical Association's Declaration of Helsinki, adopted a full quarter century after Tudor, and most recently revised in 2000.23 It spells out some additional requirements, such as the suggestion that laboratory and animal research should precede human subject research.
It is worth noting, however, that even today these most rigorous standards do not forbid the taking of risks in human subject research. The necessary finding is simply that "risks to subjects are reasonable relative to anticipated benefits . . . and the importance of the knowledge that may reasonably be expected to result."24
Bear in mind that none of the experiments described below were done by some crazed Frankenstein. None were done by a lone researcher in a secret laboratory outside the control of respectable research institutions and other controls. These are studies done by well-educated, accomplished and respected professionals. Most were reviewed and funded by even more professionals and institutions. They were often published in peer reviewed academic journals.
Few or no questions of their propriety were raised by anyone along the way.
Note also that, with the exception of the 1939 study, all were done after ethical standards and regulations were in place that would seem to have been violated by one or more aspects of the study.
1. The Tuskegee Syphilis Study
The classic illustration of the ethical problems in human subject research is what has come to be known as the Tuskegee syphilis study, designed and conducted by highly educated, professional physicians of the U.S. Public Health Service.
Over 400 African-Americans with syphilis were recruited. Not only was there no informed consent by them, they were affirmatively misinformed that they would receive "special free treatment." They were not informed of the nature of their disease or that the research would offer them no therapeutic benefit.
Their complications got worse. Their death rate became twice that of the control subjects. Yet the study continued.
Even after penicillin became available, and was known to be effective in the treatment of syphilis, the men were neither informed of this nor treated.
When outside doctors diagnosed a subject as having the disease researchers intervened to prevent treatment.
The existence of this study is well known by public and research professionals alike. What is not so widely known is that the Tuskegee study continued from 1932 until 1973 - long after the Nuremberg Code and Helsinki Declaration were known and widely discussed!
How could this be?
Was it because the study was unknown to the research community?
No, that can't be the explanation. There was nothing secret about it. It was widely reported in medical journals over a period of 40 years.
One of today's administrative protections of subjects' rights is the institutional review board, or IRB. A researcher's colleagues must review and approve a human subjects study and find that it complies with current administrative regulations, institutional procedures and ethical standards.
Perhaps that was the problem. There were no IRBs at that time.
No, that can't be the answer either. Earlier versions of an IRB were in place. The Tuskegee study was periodically reviewed and approved by Public Health Service officials and medical societies. And since the PHS was a federal agency, presumably there was Congressional oversight and acquiescence as well.
Today such agencies and institutions would have detailed regulations in place. Maybe the PHS didn't have any at that time.
No, that can't be it either. The Public Health Service Policy for the Protection of Human Subjects became effective six or more years before the study was stopped.
Is the Tuskegee story merely one unfortunate aberration in an otherwise stellar record of substantial and ethical accomplishment by research institutions? Unfortunately not.
2. Radiation at the "Science Club"
From 1946 to 1956 19 boys who thought they were part of a science club were, without their consent or knowledge, drinking radioactive milk provided them by researchers from Harvard and MIT.
3. The Calculated Risk of Atomic Bomb Radiation Exposure
Radiated milk is one thing. But in 1949 the Atomic Energy Commission studied the question of whether the fallout from its atomic bomb tests could threaten the viability of life on earth. Apparently it concluded the risk was worth it, because the tests continued - including those that involved what it conceded was a "calculated risk" of radiation exposure to populations living downwind from the tests.
4. Doctors' Patients as Human Research Subjects
Until the 1960s pharmaceutical companies paid doctors who were willing to use their uninformed patients for human subject research. Participating doctors were provided free samples by the drug companies, required to keep records of patients' reactions, and provide those results to the companies. The practice was so accepted and widespread that, even today, few think it worthy of comment.
In fact, it's still with us. Today's testing takes the form of so-called "clinical trials" in academic medical centers. Most subjects have provided some form of informed consent, thereby relieving the institutions of potential legal liability. But the medicines are still free, the doctors are still compensated by the pharmaceutical houses in a variety of ways, and the risks still fall on the patients.
In the 1960s there was no law that required drugs be tested before marketing. Companies didn't have to show their products were even safe, let alone useful for the conditions for which prescribed.
At that point in the ethics of human subjects research America was an entire nation of uninformed, non-consenting human subjects - all for the profit of drug companies and doctors.
Injury, disease and death were the occasional result. They still are - even after the required testing. In August 2001 it was reported that some 81 persons using cholesterol-lowering drugs had died from muscle cell degeneration. Philip J. Hilts reports doctors often ignore warnings regarding usage and side effects. As few as 5 percent were found to be conducting the essential monthly liver tests of their patients.25
And there is one sense in which every doctor's patient is a kind of "human subject" - even if not part of a clinical trial. There are changes in procedures as well as pharmaceuticals. Good doctors want to keep up with both. But that means there are increased risks necessarily involved while the doctor is perfecting the new techniques. This is especially true for specialists practicing outside of major research hospitals, for whom there may be relatively few cases on which to hone their skills.
5. The Thalidomide Babies
Why did the lucrative practice of paying doctors to test drugs on patients stop?
One of the 1950s tests involved a sedative from Germany called thalidomide. It was given to pregnant women to control sleep and nausea.
Unfortunately, however useful as a sedative, one of thalidomide's nasty side effects is that it causes missing or deformed limbs and other severe deformities in fetuses. As a result, the human subjects in this research project, almost all of whom were in Europe, gave birth to some 12,000 so-called thalidomide babies who provided dramatic "visuals" for national television.
6. The Army's Exclusion
In 1962, the U.S. Army addressed human subject research issues with regard to its atomic, chemical and biological warfare experiments on soldiers and others. But with the urging of non-military consultants it expressly excluded "clinical research" involving military personnel from its standards.
By 2002 the Defense Department released more than two dozen reports of previously classified exercises from 1962 through 1973 involving the deliberate exposure of U.S. troops to chemical and biological weapons - without the consent, or even knowledge, of the subjects. The agents used, "some of the most poisonous in the arsenal," included VX, sarin, soman, tabun, and Bacillus globigii (related to anthrax). As of 2002 the Department was trying to track down some 5500 known subjects.26
7. Injecting Cancer
As late as 1963, doctors in a New York hospital were deliberately injecting live cancer cells into subjects. The chief investigator was a physician from the Sloan-Kettering Cancer Research Institute. The study was reviewed and approved by the hospital's medical director. There was no documentation of the subjects' consent, nor were they informed what was being done to them.
After the study was revealed there were no immediate repercussions for the hospital, Sloan-Kettering, the university involved, or the U.S. Public Health Service.
8. The Chimpanzee's Kidney Experiment
The same year a Tulane University doctor performed an unsuccessful transplant of a kidney from a chimpanzee into a human being. The procedure promised no benefit to the recipient or new scientific knowledge. It was funded by the National Institutes of Health after layers of bureaucratic evaluation and approval.
9. Giving Hepatitis to the Mentally Retarded
From 1956 to 1972 a New York University doctor led a study team at the Willowbrook State School for the Retarded in New York. The team wished to study hepatitis.
The child subjects were fed extracts of stools from individuals infected with hepatitis.
Did their parents consent? In theory yes, in reality no.
The consent form seemed to suggest that the children were going to receive a vaccine to protect against the virus rather than be deliberately infected with the disease.
Moreover, Willowbrook told parents it was overcrowded and unable to take more residents - unless parents would consent to their children becoming a part of the study, in which case there was plenty of room.
Note that the study could have as easily been done with children who already had the disease rather than infecting those who did not.
Was the doctor on a frolic of his own? No. The study was reviewed, approved and funded by the Armed Forces Epidemiological Board. It was further reviewed and approved by the executive faculty of the NYU School of Medicine.
10. NASA's Exception
It was 1968 before NASA came up with an informed consent policy. However, even then the policy provides that the requirement can be waived in a number of circumstances, including when the research "would be seriously hampered" if consent had to be obtained.
11. LSD From the CIA
It was not until 1975 that Congressional hearings brought to public attention the human subject research projects of the CIA and Defense Department.
The agencies wanted to know the extent to which it was possible to control human behavior through the use of psychoactive drugs, such as LSD, mescaline, and other chemical, biological and psychological means including radiation. The subjects used in these experiments had not given informed consent, and some died.
The project's code name was MKULTRA, and involved at least 150 individually reviewed, approved and funded projects conducted by presumably reputable research scientists.
The CIA director ordered all records of the studies deliberately destroyed in 1973.
III. Complacency and Opposition to Reform
As note earlier, these 11 illustrations, from the dozens more that could be cited, are relevant both for what has been thought to be acceptable in human subjects research and for the reactions of professionals once abuses were publicized.
A. The Tuskegee Syphilis Study
What finally stopped the Tuskegee study? Obviously it was not the ethical concerns of a research community clearly willing to continue operations in violation of known standards.
No, it was public outrage that finally prodded Congress into holding hearings on human subject research ethical and legal standards.
Even then, after all the revelations, Senator Ted Kennedy's bill to create a National Human Experimentation Board - as recommended by the Tuskegee Syphilis Study Ad Hoc Panel - was defeated. The hope for oversight of all federally funded research was shattered.
The compromise, the National Research Act of 1974, required regulations governing only the Department of Health, Education and Welfare. And even those regulations were watered down, leaving the grantee institutions free to regulate themselves through their self-appointed institutional review boards.
The subsequent Belmont Report, spelling out more ethical standards ("respect, beneficence and justice"), did not appear until 1979.27 The Department of Health and Human Services (DHHS) regulations based upon that report became available in 1981.
Other governmental agencies did not sign on until 10 years later. The DHHS regulations were formally adopted by over a dozen agencies in 1991 and are now referred to as the "Common Rule." And even this set of rules provides for six categories of exemptions.
B. The Thalidomide Babies
The deformities in 12,000 thalidomide babies was a dramatic human subjects failure. However, only after those deaths had attracted a good deal of media attention were Congressional hearings scheduled and held.
Notwithstanding the dramatic events, however, the industry and research community were successful in weakening the legislation. Informed consent would be required, but "the best judgment of the doctors involved" would control whether consent was "feasible" or "in the best interests of the patient."
With little or no thanks to the pharmaceutical industry or medical profession the law now authorizes the Food and Drug Administration (FDA) to insist on the safety and efficacy of new drugs.
Even today, this law is still being attacked by industry on the grounds it is delaying the time it takes to get drugs to patients - and experiments with thalidomide continue, though hopefully not on pregnant women.
C. Injecting Cancer
As noted above, even after it was revealed that the Sloan-Kettering researchers had been deliberately injecting cancer into human subjects there were no immediate repercussions for the hospital, Sloan-Kettering, the university involved, or the U.S. Public Health Service. Such professional concern as did exist focused not so much on the ethics of the project, and harm to the subjects, as on the possible adverse impact of public knowledge on the continued funding of such research and the possibilities of legal liability.28
D. The Chimpanzee's Kidney Experiment
Following the revelations of this experiment, there was a thorough NIH review of "research protocols and procedures." However, the ultimate recommendation was for no changes whatsoever. The agency was concerned that, if it had standards they might "inhibit, delay or distort the carrying out of clinical research." It was simply, "not in a position to shape the educational foundations of medical ethics."
E. Deaths in Developing Countries
The dual ethical standards in human subject research applied to subjects living in developing countries are illustrated in note 17, above. For example, in the Uganda AIDS study, partners of AIDS-infected subjects were not informed and 90 of them (22 percent) subsequently died.
What was the response of today's ethical professionals? AllAfrica Global Media reports that "The Rakai study was approved by scientific and ethics boards in Uganda and the U.S. After the controversy broke out, UNAIDS, the United Nations office that coordinates the international response to the epidemic, found no ethical violations."29
F. The Beecher Report
Someone who did try to bring attention to some of the earlier questionable studies was a researcher named Henry Beecher. He spoke at a convention of science journalists in 1965. He cited 22 examples of research with potentially serious ethical violations that he had found in published reports in medical journals.
In other words, apparently the authors and editors of these 22 papers were either oblivious to the ethical standards they had violated or they simply didn't care.
Rather than distance himself from such abuses, however, Beecher was candid enough to acknowledge that "in years gone by work in my laboratory could have been criticized."
His paper was rejected for publication by the Journal of the American Medical Association Journal (JAMA).
IV. Ethical Analysis of the Tudor Study: Indictment or Itemization?
To phrase an ethical inquiry into the Tudor study as a question of "whether 'it' was ethical or unethical" is to reveal one's lack of analysis before the inquiry even begins.
The question must be phrased, not in terms of a gestalt reaction to the study as a whole, but in terms of each of the specific aspects of the study that might be subject to criticism. Some of those aspects are listed below. As will be seen, when examined in this fashion the Tudor study - conducted at a time when there were no ethical standards in existence - compares very favorably indeed with those that followed, when there were standards.
A. Was there anything unethical about the involvement of children as human subjects?
Although today's standards for child research subjects are quite strict, their participation is still possible at the present time. Indeed, as many as 95 percent of children with cancer are today involved in clinical trials.30
Clearly children continued to be a part of many studies during Phase II. Consider, for example, the boys served radioactive milk, or the children infected with hepatitis.
Indeed, since the study involved a test of an hypothesis about the onset of stuttering in children it was necessary that they be involved if the study was to be done at all.
This would not appear to have been the case with the later Phase II experiments, approved as appropriate at the time, such as those involving children's reaction to radioactive foods or hepatitis. Those studies presumably could have used adults.
So the mere fact that children were involved in the study is not, alone, basis for adverse ethical or moral judgment.
B. Was there anything unethical about the use of residents of an institution?
Participation by institutionalized individuals, including children, was approved even after standards were in place during Phase II.
For example, the Willowbrook hepatitis study was proposed by a qualified research scientist and approved by the faculty of the NYU School of Medicine, among others. It involved institutionalized children who were mentally retarded. At least the children used in the Tudor study were of normal intelligence.
The study involving the injection of cancer cells used institutionalized adults.
Moreover, in 1939 it was both common and thought by all to be totally acceptable to use the very institution used in the Tudor study: the Iowa Soldiers' Orphans' Home. Many other University of Iowa professors and graduate students used the facility in this way. In fact, one of the stuttering study participants is quoted as saying, referring to other studies, "Every week somebody else from the university would come and start testing us for God knows what."31
The Iowa State Board of Control, which oversaw the orphanage, encouraged this research, as did, presumably, the university. Permission from the orphanage was required, and was obtained.32
No, it's hard to fault the study even under today's standards, let alone the standards of its time, because it involved institutionalized subjects.
C. Was informed consent not provided?
After standards were in place the Atomic Energy Commission didn't get informed consent before risking radiation for large populations.
Doctors didn't get the consent of their unwitting patients testing new drugs.
The Sloan-Kettering doctor didn't get the consent of those he injected with cancer.
The 1968 NASA standards expressly permit the waiver of subjects' informed consent when obtaining it would interfere with the research.33
Indeed, if "informed consent" were always required much of the research in social psychology could not have been done. It often requires some measure of deception of the one human subject being studied in the group of those otherwise informed.34 Indeed, one can question the extent to which college students in psychology classes, even today, have provided anything fairly considered "informed consent" when participation in such experiments is a requirement of the course.
Of course, the 1939 experiment was not a NASA study. But it may very well have met NASA's 1968 standard. That is, it would have been a very different if not impossible experiment if the subjects were first told of its nature.
So it's not clear that the Phase I Tudor study, even if judged by the standards of Phase II, would necessarily have been unethical if no consent had been obtained.
But, in fact, it can be fairly argued that there was informed consent in this case.
Obviously, by definition no researcher could obtain the consent of the parents of orphans. Thus, the only person who could legally give consent on their behalf was the administrator of the orphanage. And all indications are that he did consent.35
So, for this variety of reasons, it seems inappropriate to criticize the study on grounds that consent was not obtained.
D. Did the researcher knowingly and deliberately do permanent harm to the subjects?
Two independent scientists, Ambrose and Yairi, who are otherwise critical of the conclusions drawn from the Tudor study data by the researcher, have concluded that Dr. Wendell Johnson and Mary Tudor neither did any lasting harm to the subjects nor intended to do anything that might cause harm.36 Indeed, they conclude that the procedures used in the Tudor study did not, and could not have, caused "stuttering."
Even if Ambrose and Yairi's conclusions were not sustained by their review of the Tudor data - and there is every reason to think they are - there is little basis for drawing contrary conclusions.
Injecting cancer or hepatitis into subjects is deliberately doing known harm.
Using LSD on unsuspecting subjects to test its possible utility as a military or intelligence weapon is deliberately doing harm.
Even today, testing the efficacy of new drugs on diseased human subjects by deliberately withholding the remedy from the proportion of them getting placebos risks a measure of harm - in the case of young children in Thailand the harm we call AIDS.37
If we could know that Mary Tudor and Dr. Wendell Johnson knew to a certainty that the result of the experiment would be to turn normal speakers into life-long stutterers an ethical judgment might be warranted. But we don't know that. And every available scrap of evidence suggests exactly the opposite.
The 1939 Tudor study involved speaking to children in a manner and with words still used today by millions of well-meaning parents who want nothing more than to "improve" their child's disfluent speech.
The hypothesis being tested was that this would increase the child's disfluency. But what might be expected to result from four months of intermittent contact could reasonably be presumed to be only temporary, or at worst something that would promptly respond to therapy.
Dr. Wendell Johnson suffered from his own severe stuttering in 1939, and had a reputation among those who knew him for extreme kindness and sensitivity - especially with children.38 It is simply inconceivable that there was, before the study, even a known risk, let alone a probability, of certain and permanent harm from this experimental design.
Compare this experiment with those Dr. Wendell Johnson, who described himself as "a professional white rat," was subjected to by his professors. As one journalist describes it, he "was hypnotized, psychoanalyzed, prodded with electrodes, and told to sit in cold water to have his tremors recorded. Like Demosthenes, the ancient Greek stutterer, he placed pebbles in his mouth [and] had his dominant arm, the right, placed in a cast to help prove his professor's controversial 'cerebral dominance' theory . . .."39
The passage makes three points. It provides a perspective as to the acceptable range of human subject experimentation in Phase I. It shows Dr. Wendell Johnson's commitment to science and the passion he brought to a lifetime of stuttering research. It also demonstrates the rather dramatic contrast between what he was quite willing to endure himself and what was being tested with Mary Tudor's master's thesis.
Most important, this 1939 study involved none of the approved physical contact, nuclear radiation, drug-induced behavior modification, exposure to disease, untested pharmaceuticals or other invasive techniques sometimes used in human subject research after standards were in place.
E. How much permanent harm came from this brief experiment?
All that is now available are a sensationalist journalist's repetition of quotes from the subjects - at least one of whom is trying to build a lawsuit, even though she is quoted as acknowledging that she did not stutter during the 45 years of her marriage.
And, of course, "a correlation is not a cause."
The subjects undoubtedly had many adverse conditions to deal with before, during and after their stay in the orphanage. Some had become stutterers before the study began. Thus, even if a subject suffered a speech-related problem as an adult, that alone would not indicate that the problem could be traced in a causal way to the study.
Moreover, and perhaps one of the more serious indictments of the journalist's professional ethics and abilities, the very human subject he selected to highlight was one whose fluency actually improved during the course of the study!40 Whatever this may indicate regarding the validity of the theory drawn from the data by the researcher, it certainly seriously undercuts the journalist's efforts to trash the reputation of the supervisor because of the harm he did to the subjects.
But let's assume for the sake of argument that (a) there was harm, and (b) a causal relation could be shown between the study's procedures and that harm - both of which seem most unlikely.
Even if they were both found to be true, if we are to pass moral judgment on the researcher there then remains the additional and considerable question, which the passage of time prevents answering, as to how deliberate or predictable any of this harm was.
This was original research. No one had ever done it before. As discussed above, there was a substantial probability there would be no effect whatsoever on the subjects. The hypothesis, however interesting, might have proven to be totally invalid - like so many research scientists' hypotheses before and since.
There is reason to know that the injection of cancer or hepatitis is going to cause temporary or permanent harm.
There was no reason to believe that even troublesome temporary, let alone permanent, harm would result from speaking to children in the ways parents do.
It would have been quite reasonable for the researchers to believe, knowing what was then known, that any disfluencies created in the six subjects' speech during this brief, four-month experiment would quickly disappear.
If in fact they did not disappear in all subjects it is certainly regrettable. But it does not automatically follow that it represents a reprehensible moral and ethical lapse. This is true regardless of whether one evaluates it by the norms of Phase I, when it occurred, or by comparing it with numerous studies done after those standards were in place during Phase II.
Recall as well today's standard with regard to risk. It is not that no risks may be taken. It is that "risks to subjects are reasonable relative to . . . the importance of the knowledge that may reasonably be expected to result."41
Given the millions of stutterers who have benefited from stuttering research, and the millions of children who have not become stutterers because the findings have been communicated to parents, even if harm could be shown one could still argue that today's standard of permissible risk was met.42
F. Was there a way of testing the Tudor study's hypothesis without involving children?
There were undoubtedly some times during Phase II when an animal study might have been a preferable alternative to the use of human subjects.
This was not the case with the Tudor study. Obviously, animal studies are of no use when studying human communication.
And if the focus of a study is on the onset of stuttering in young children, as it was, the participation of young children is required.
The conclusion may be that human subjects research ethics preclude humankind ever finding out what the Tudor study sought to explore. If so, that is a very heavy price to pay.
But even that conclusion, if sound, makes the point. Whatever else may be said of the Tudor study by way of criticism, it cannot be faulted on grounds it failed to use an obvious alternative methodology. There simply was no obvious alternative.
G. Were a large number of subjects affected?
It is regrettable if even one human subject is harmed by a research project.
But the fact is that very few were involved in the 1939 Tudor study - especially when compared with the numbers in the Phase II studies.
Tens of thousands were potentially involved in the atomic bomb tests.
Twelve thousand babies were affected by thalidomide.
Only two or three of the stuttering research subjects are even now alleged to have been adversely affected. (And, of course, there are the more recent conclusions from the data that no subjects were, nor could they have been, harmed.)
H. Did the experiment continue after the results were known?
The stuttering experiment was a short-lived four-month experiment. Once the hypothesis was tested and thought to have been proven the study ceased.
Compare this ethical response to what was done in the Tuskegee study over the course of, not four months but forty years.
Clearly the study cannot be faulted on grounds there was a purposeful, continuing, callous abuse of anyone.
I. Was there any after-study concern for the subjects?
An effort was made to provide recuperative therapy for any Tudor subject whose speech was thought at the time to potentially benefit from it.43 Judging by the number of subjects who have told the media they suffered no long-term consequences the therapy may well have been helpful.
But this was the dawn of
human understanding of stuttering. Therapies that would be routine today
were simply unknown at the time. It is not clear that
there was, then, anything more that could have been done than what was done.
In hindsight, a critic could argue that additional recuperative therapy should have been provided anyway - if for no other reason than to remove any possible question regarding the researcher's desire to be helpful.
The very least that must be credited, however, is that there was far more after-study concern and care of the Tudor subjects than has been provided in many human subject experiments since.
J. Were the results not published and the data destroyed?
Some media reported that the results of the Tudor study were never published.44 Standing alone this is so misleading as to be false.
As with all master's theses at the University of Iowa at the time, the Tudor thesis was bound, given to the University's library, cataloged, and made available to the public. There was no effort to suppress it.
Few masters' theses are commercially published or reprinted in academic journals.45 They are simply put in academic libraries. That is what was done with this one. It is apparently true that the study was not referred to very much if at all in subsequent academic articles. But that is also the fate of much scholarship.
It is not customary to save all the research data from a master's thesis. But it is certainly inaccurate to suggest that the data in this study was "destroyed." Indeed, some media reports indicate that much if not all of it was saved in this instance by the student who did the study.
This behavior - making the study available and saving the research data - especially after any concerns the researcher and supervisor may have had over the results, compares very well with, say, the actions of the CIA director. As mentioned above, he maintained secrecy regarding the agency's human subject research and then deliberately ordered destroyed the records of the agency's 150 LSD studies.
Thus, if one engages in analysis of the elements of human subject research ethics - rather than sensationalist broadside accusations - the Tudor study is seen to compare very favorably with an element-by-element analysis of other, later, Phase II studies.
V. Measured by Today's Standards
As mentioned above, it seems no more appropriate to judge the ethics of actions in 1939 by the standards of 2002 than to later pass judgment on our ethics today from the vantage point of the ethical standards of 2065.46
Many of the Tudor study's critics have fallen into this trap known so well to general semanticists.47 These critics think and speak as if "ethics is ethics." General semanticists use what they call "dates and indexes." They are never surprised to find, indeed they rather expect, that "ethics1939 is not at all like ethics2002."
As the previous section has demonstrated, however, even if one uses the totally inappropriate standards of 2002 the Tudor study still comes out looking a good deal more ethical even than many of the studies going on in Phase IV.
It may turn out that no one has yet earned the right to cast moral aspersions on those who have gone 63 years before us, even in this Phase IV period of heightened awareness. For after all the pious proclamations from the Tudor study's critics that we have evolved into creatures with a heightened ethical and moral sense, there is substantial evidence that things still are far from perfect in research land.
Indeed, the evolution of human morality with regard to any aspect of human behavior is usually a very slow process.48 And as often proves to be the case, the mere existence of institutions, regulations and ethical standards are not enough to protect the rights of human subjects, as the following examples demonstrate.
A 1994 Department of Energy advisory committee report contains an historical account of Public Health Service employees' site visits to research institutions some years ago. Those visits "revealed a wide range of compliance . . . confusion about how to assess risks and benefits, refusal by some researchers to cooperate with the [PHS] policy, and in many cases, indifference by those charged with administering research and its rules at local institutions."
As late as the post-1998 period the NIH has shut down research programs at eight prestigious institutions for a variety of ethical violations - including the September 1999 death of a human subject in a gene therapy study who, it is alleged, was not adequately informed of the risks.
Consider the April 2000 report of the DHHS Office of Inspector General, "Protecting Human Research Subjects." The report notes the office's concerns two years earlier: a "call for widespread reform," "a sense of urgency," "disturbing inadequacies in IRB oversight of clinical trials," up to and including "the death of a teenager participating in a gene transfer clinical trial funded by NIH."
Presumably death could be considered a kind of "permanent harm" at least the equivalent of stuttering.
Notwithstanding these concerns, "few of [the office's] recommended reforms have been enacted."
Some of the ethical practices used by U.S. institutions today with their research in developing countries will soon come in for serious criticism. One example may be enough to make the point.
A major academic journal reported in March 2000 a study reminiscent of that in Tuskegee. It was done by researchers from no less prestigious a research institution than Johns Hopkins. In the Rakai region of Uganda they monitored 415 couples, of which only one partner was infected with HIV. The researchers did not inform the AIDS-free partners. Thirty months later 90 of the formerly healthy spouses had become infected. The journal's editor noted that the study was unethical by U.S. standards.51
In July 2001 there were news reports that the federal Office for Human Research Protections had shut down human subjects research at Johns Hopkins. This was huge; all Hopkins medical institutions received $419 million in research funds from the NIH alone in 2000, the most of any such institution. The cited reason? "This is about protecting people's lives." The precipitating cause? The death of yet another human subject.52
Indeed, the contrast between the media's coverage of this 2001 death at one of the nation's largest research institutions and the coverage of the little 1939 Tudor study is striking. The word "hypocrisy" may or may not be misplaced, but "disparity" certainly is not.
There were no editorials passing moral judgment on the Hopkins researchers and their institution. No characterization of their work as a "monster study." No calls for punishment, or for removing names from buildings. Indeed, there was not even an editorial demand for apologies to the family members of the dead subject, let alone proposals that they be paid damages - all of which editors thought appropriate for the 1939 study. There were no known media mentions of expressions of sympathy or sorrow for the deceased's survivors - though surely there must have been.
Comparison of the 1939 and 2001 Studies
|The 1939 Tudor Masters Thesis||The 2001 Johns Hopkins Study|
|The 1939 study was conducted before any ethical standards were in place; before even the Nuremberg and Helsinki statements. All possible approvals were obtained. No standards were violated.||The 2001 study was conducted after decades of evolution of written and detailed standards and the existence of institutional review boards - the relevant board having approved the study. Standards were violated.|
|The 1939 study involved a young master's degree student with little or no funding.||The Johns Hopkins study involved respected professionals in the largest medical research institution in the country; the recipient of $419 million for taxpayer-supported research.|
|The 1939 study was conducted before there was any way of knowing what impact it would have upon the subjects, and every reason to believe any adverse effects easily could be reversed. It was original research; by definition there was no prior literature.||The Hopkins study involved the use of hexamethonium, a chemical about which a great deal is known and published in the literature. It was known to cause lung damage; indeed, that was the point of using it. It was given in amounts some doctors characterized as "extraordinarily large"; amounts the FDA would not have approved if they been asked.|
|The 1939 study involved the maximum informed consent possible under the circumstances (that of the adult administrator of the institution where the subjects lived). No objections were raised to the study from any quarter - not the university, not the institution, and not the state agency with oversight responsibility for the institution. The least that can be said is that the researcher complied fully with all the informed consent required by any ethical standards at the time.||The 2001 study's subjects provided a measure of consent, but it was not fully informed, as required. They were unaware of the full extent of the risks to which they were being subjected - such as death from the total destruction of their lungs. What they were told was a "medication" was in fact a lung irritant, not an asthma remedy. It was a chemical that lost FDA approval for its original intended purpose in 1972, was not approved by the FDA for this study, was being used experimentally, in excessive amounts, and at no time in its history had ever been approved in an inhaled form.|
|The 1939 study is criticized because what was done to the subjects (speaking to them in ways millions of parents still do every day) did not involve the evaluation of a cure, something that could potentially benefit the subjects (whether or not they already stuttered). It was, rather, a practice that might create the condition called stuttering.||But that is precisely what the 2001 study did. In researching asthma the Hopkins researchers deliberately used a chemical they knew would worsen the subjects' lung condition. It was in no sense a "cure for asthma."|
|The 1939 study is criticized because it resulted in permanent harm (an assertion seriously challenged by current reviews of the Tudor data). But assume for the sake of argument the study did cause stuttering.||The 2001 study caused a death. Shouldn't death be considered a kind of permanent harm that ranks right up there alongside stuttering? Apparently not in the minds of many journalists and editorial writers.|
|The very least that can
be said is that the 1939 researcher did not knowingly and deliberately
do permanent harm to the subjects.
|The 2001 researcher either knew, or ought to have known (based on the required literature search), that his deliberate actions risked permanent harm, including death, to his subjects. Indeed, his own description of the study said that its purpose "is to find out how the tubes that carry air into the lungs can stay open even when we breathe all types of irritating chemicals." This was, by any definition, knowingly and deliberately doing harm.|
Whatever may be said by way of criticism of the ethics of the Tudor study, any fair critic would have to concede that, even applying the ethical standards of today, it compares very favorably to the ethical lapses in the current studies to which those ethical standards clearly do apply.
VI. Measured by the Standards of its Time
Given that the Nuremberg Code did not come into existence until 1948, the fact is that there were no internationally agreed upon standards, national laws or regulations that would have been applicable to the Tudor study in 1939.
As a former university vice president for research put it, the ethical standards applied by Dr. Wendell Johnson and Mary Tudor were "well within the norms of the time."53
Thus, if one is to do the fair thing, the ethics of the study will be judged by the research standards of the time - nationally, in Iowa, at the University of Iowa, and at the institution involved. By those standards it seems somewhere between very difficult and impossible to come to any critical ethical judgment of the Tudor study.
Indeed, what is particularly striking, given the absence of standards, is the sensitivity both the researcher and supervisor brought to the subjects of the study - self-imposed standards that compare very favorably with those of today.
VII. Scholarship and Scandals
A. Why Select the Tudor Study for Ethical Analysis?
Human subjects research ethics, and the evolution of the standards reflecting those ethical principles and practices, are clearly important subjects worthy of academic, and even journalistic, attention.
But if one is going to pursue such an inquiry, there is a very large, and as yet unanswered, question as to why the Tudor study would play any role in that inquiry. Singling it out as the case study in a review of the history and standards for human subjects research ethics is, at best, a little bizarre.
Reflect upon the hundreds or thousands of studies that have been conceived, reviewed, approved, funded and carried out by academic research institutions during the last half of the 20th Century - up until today - some of which are detailed in Part II. D., above. Obviously, many prominent and reputable academic researchers, institutions, and granting agencies believed that those studies were defensible after ethical standards were in place.
By what logic would one ignore those studies, after ethical standards were in place? Why would one stretch to single out for moral judgment a little 1939 master's thesis, conceived and carried out long before any such standards existed - a study that "was fully within the norms of the time"?
B. Why Would University and Association Officers Join in the Critical Chorus?
Why would an officer of a professional association that includes speech pathologists want to say - not incidentally of one of the persons most responsible for the creation of that association - that the research "cannot be justified on theoretical, moral or ethical grounds and represented a serious error of judgment"54?
Why would a current university administrator at Dr. Wendell Johnson's institution want to be quoted as saying, "This is not a study that should ever be considered defensible in any era. In no way would I ever think of defending this study. In no way. It's more than unfortunate."55
It may be "more than unfortunate" that the mass media brought the Tudor study to national attention. But if it was so indefensible, if apologies are so ethically necessary, why was none of this said and done when the study was spread across a local newspaper in that university's town years ago? Or described in an academic journal years before that? Or in a novel two years ago?56
The university administrator and association officer quoted above were unwavering in their rectitude. "The University of Iowa today has in place a strict policy and procedures [so that] experiments of this nature [the 1939 stuttering study] cannot happen again," says one.57 "Such research is strictly prohibited under [the association's] Code of Ethics," says the other.
They thereby built themselves a very high pulpit from which to cast moral judgments on their predecessors below. Unfortunately, it sat atop a shaky scaffolding from which their fall from grace proved to be as painful as it was prompt. Not only are there the numerous examples of unethical practices throughout the research community today,58 detailed in Part V., above, but the University of Iowa in particular was soon to be criticized for its violations.59
Is this but one more example of a professional association and research institution responding more to the public relations demands60 of a negative national media blitz than to genuine concerns about the ethical issues of human subject research - including issues about what's going on today, but unknown to the public?
C. The Ethical Failures of the Ethical Criticism
Such moral castigation, and the tabloid-style journalism that preceded and provoked it, are deliberate efforts that have the effect of removing the study from meaningful perspective.
But these comments and articles will have zero impact on today's human subjects research ethical standards and administration.62 Indeed, it truly would be shocking if this 63-year-old, Phase I master's thesis were to raise ethical issues that have still not been addressed in the detailed Phase IV regulations of today.
It also might be worth harming a reputation if the revelations would help millions, thousands, hundreds, or even dozens of people. There are numerous examples in which that is the case involving everything from information about tobacco, asbestos, pharmaceuticals' side effects, and lead to silicone breast implants, Ford vehicles and Firestone tires.
Today, it is not clear whether any of the Tudor subjects were harmed by the study in any way. Worst case - which requires that the assertions of litigants' and their lawyers be treated as fact, rather than merely negotiating gambits - there were one or two individuals whose disfluency increased.
The question is not whether a mere two people matter. Of course they do.
The question is whether, even as to them, the publication of these articles and administrators' comments, at this time, do not do even them more harm than good.
D. Journalist Heal Thyself
It's pointless to speculate as to a journalist's motives. It does appear that there was a deliberate effort to dramatize, and emotionalize, a 63-year-old master's thesis into a national story discrediting the reputation of a man 37 years dead.
This is the stuff for which the law provides remedies - such as defamation or false light. It involves the use of a fact here and there to present a damaging and false overall impression of someone.
The author of the stories in question was quick to formulate and cast moral opprobrium on the researcher and supervisor. He was considerably slower in coming to an examination of his own ethical lapses. In fact, it appears he never bothered to consider them at all.
Journalistic ethics is not the oxymoron many believe it to be. There is a Society of Professional Journalists which has a "Code of Ethics,"63 the most recent version of which was adopted in September 1996. There are a number of provisions in this Code that raise issues with regard to the ethics of the reporter's and newspaper's handling and promotion of the story about the 1939 Tudor thesis.
The Code speaks of goals such as "public enlightenment" from journalism. Journalists have a "duty" to "further those ends by . . . providing a fair and comprehensive account of . . . issues. . . . [and] to serve the public with thoroughness and honesty."
"Journalists should . . . examine their own cultural values and avoid imposing those values on others."
They should "show compassion to those who may be affected adversely by news coverage. Recognize that gathering and reporting information may cause harm or discomfort . . . [and] that private people have a greater right to control information about themselves than do public officials . . .. Only an overriding public need can justify intrusion into anyone's privacy."
Finally, a standard perhaps more applicable to the editors responsible for a newspaper's promotion, or hype, "Journalists should . . . Make certain that headlines, news teases and promotional material, photos, video, audio, graphics, sound bites and quotations do not misrepresent. They should not oversimplify or highlight incidents out of context."
Consider these admonitions in turn.
The stories detracted from, rather than added to, "public enlightenment" about ethics in human subjects research. Their account of the issues was not fair, comprehensive, thorough, nor honest.
One of the more serious indictments of the journalist's professional ethics and abilities is that the very human subject he selected to highlight was one whose fluency actually improved during the course of the study!64 Whatever this may indicate regarding the validity of the theory drawn from the data by the researcher, it certainly seriously undercuts the journalist's efforts to trash the reputation of Dr. Wendell Johnson because of the harm he did to the subjects. One would think that a "fair" account, presented with "honesty" would have to have, at a minimum, a measure of factual accuracy.
The stories involved the imposition of the cultural values of the journalist on others - moreover, others who lived and acted in a different time and place, 62 years before the story was written.
There was no demonstration of compassion, and total indifference to the harm or discomfort the stories would cause to the named subjects, the researcher, and the family survivors of the supervisor of the study.
There was no overriding public need that justified this intrusion into the privacy of those individuals.
In order to avoid "intrusion into anyone's privacy" at least the researcher and supervisor had enough sensitivity to refer to the subjects by number rather than by name. Unfortunately, the journalist chose to ignore both their ethical sense of decency and his own ethical standards in this regard.
The journalists' Code of Ethics also provides that,
"Journalists should . . . Avoid undercover or other surreptitious methods of gathering information except when traditional open methods will not yield information vital to the public. Use of such methods should be explained as part of the story."
On July 25, 2001, the journalist's executive editor felt obliged to run an editorial revealing that the journalist had violated the paper's own ethical standards (a provision equivalent to that quoted above).65 The journalist had gained entry to a State of Iowa archive that is closed to journalists. He had misrepresented that his role was that of an academic researcher. The editor failed to mention any of the other ethical violations, including the violation of the privacy rights of the subjects - the protection of which was one of the purposes of excluding journalists from the archives.
As for the ethics of the promotional material, consider this promo in the journalist's paper a couple days before the series was scheduled to run. The headline blared:
"San Jose Mercury News Uncovers Secret Experiment to Make Orphans Stutter;The promo began,
Traces Living Legacy of Tormented Children and Haunted Researcher"
"In a chilling investigative series beginning Sunday, the Mercury News reveals for the first time the complete story of a secret experiment conducted 60 years ago to induce a group of orphans to stutter. The study [was] designed and concealed by Wendell Johnson . . .."66Consider the errors and exaggerations. There was nothing to "uncover." The study was not "revealed for the first time."67 It had never been secret. It was not concealed. The researcher did not "torment" the subjects. "Chilling"? "Haunted"?
As explained above, the study was published and available in the University of Iowa library just like any other master's thesis. It has been described in the professional literature and by prior newspapers.
Compare this promotion with the ethical standard. Are these "headlines, news teases and promotional material [that] do not misrepresent; [that do] not oversimplify or highlight incidents out of context"? Or do they (and the series itself) have more in common with sensationalist, tabloid, supermarket scandal sheets?
The journalist's ethical violations ultimately led to his "resignation."68 It is not within the scope of this paper to pursue whether he may also have violated legal rights referred to as defamation or false light.
It is enough to note that he is in a very weak position indeed when it comes to questioning the ethics of others - especially in the emotionally laden vocabulary of tabloid slander. After all, those he criticized acted before the existence of relevant ethical standards for human subjects research. He has violated the ethical standards that were applicable to journalism at the time he wrote.
We are not looking back on his actions with the benefit of hindsight. We are not judging him with the standards of journalistic ethics at the end of their evolutionary process 63 years from now, in the year 2065. We are using the standards in place at the time he wrote, standards that presumably were well known to him.
Whether judged by the ethical standards of its time, or even by those of today, the ethics of the Tudor study of the onset of stuttering - whatever the study's substantive faults - compare very favorably with those of other human subjects research.
If its substantive critics are right, no harm was done or intended, either by Dr. Wendell Johnson or by Mary Tudor. The study could not, and did not, "cause stuttering."
Even if those critics are wrong, and the subjects did suffer harm, there is at this point no proof that it was caused by anything done by Mary Tudor - as distinguished from subjects' experiences before, during, or after their stay in the institution.
Assume the critics are wrong, the subjects did suffer harm, and there is a finding that the harm came from the study. There were no international or other statements of ethical standards for human subjects research at the time of the study in 1939 - and, therefore, none that could have been violated.
Even if all of the above were true, and it were to be irrationally and unfairly decided that the study's ethics should be judged by the standards of today, it would still be difficult to find any ethical violations.
Even using today's standards, one cannot judge the ethics of "the study" - only the specific ethical standards that are alleged to have been violated. Few, if any, can be found.
Finally, insofar as there might be found to be any specific violations, there are many more, of much greater seriousness, going on today that have not brought forth anything like the moral castigation hurled at Dr. Wendell Johnson and Mary Tudor.
Thus, we conclude this review of the human subjects research ethics of the Tudor study more perplexed than we began.
Why were the ethics of the Tudor study attacked? We can only speculate as to the motives of others - a task even less rewarding than looking for ethical needles in a 63-year-old haystack.
2 Nicholas Johnson teaches at the University of Iowa College of Law, and formerly served as co-director of that university's Institute for Health, Behavior and Environmental Policy. He is perhaps best known as a dissenting FCC Commissioner and author of How to Talk Back to Your Television Set. A Web site with his writings and additional information is www.nicholasjohnson.org. He is the son of the Tudor study's supervisor, Dr. Wendell Johnson.
3 Mary Tudor, An Experimental Study of the Effect of Evaluative Labeling on Speech Fluency (master's thesis, University of Iowa, Aug. 1939).
4 Jim Dyer, "Ethics and Orphans: The Monster Study," Part One of a Mercury News Special Report, San Jose [CA] Mercury News, June 10, 2001, p. 1A. The accompanying promotion said, "The 'Monster Study' in 1939, an ambitious professor conducted a secret experiment on a group of orphans to test a new theory on stuttering. The results helped gain renown for the professor, but many of the children were psychologically harmed for life. The study was covered up, even from the orphans - until now." Aside from the usual difficulties one would confront in an effort to "gain renown" from a "secret experiment" that was "covered up . . . until now" - even one known to be a "monster study" - the numerous violations of journalistic ethics represented by the newspaper's promotional announcements are detailed in Part VII. D., below. There is no evidence for the assertion that "many of the children were psychologically harmed for life."
Part Two was published by the same newspaper June 11, 2001, also on page 1A. It's promotional material included: "An experiment leaves a lifetime of anguish the study's young victims were left in ignorance, to cope alone. Experts debate whether the benefits justified the harm."
5 Equally noteworthy is the contrast between the coverage of the 1939 Tudor study by the Mercury News, and the coverage by the Baltimore Sun of a death during Johns Hopkins' human subjects research in 2001. The Sun's stories included an upbeat profile of the researcher, an explanation both of the need for oversight and the harm that can come from governmental over-reaction (see note 18, below), an exploration of the most appropriate public relations reaction for an institution in this position, and some of the conflict of interest issues that arise when the academy gets in bed with business. In short, it put the story in context. It used the story to explore some of the broader issues for its readers. It used its editorial page responsibly. For cites to Sun articles see note 43, below.
6 See the discussion in Part VII. D., below.
7 Michael Flaum, M.D., "Research Did Not Cause Stuttering," Guest Opinion, The Daily Iowan, September 4, 2002, p. 8A.
8 That this is not always the case, that there are mature adult responses occasionally, is illustrated by the Baltimore Sun's noting the contrast between the responses of Johns Hopkins and Rochester researchers after the death of a human subject. "In Rochester in 1996 [following the death of a human subject], doctors disclosed as many details as they could, at the risk of embarrassing themselves and complicating their legal position. . . . In Baltimore in the past few weeks, Hopkins leaders initially chose to reveal little, at the risk of appearing to have something to hide." Eric Siegel and Diana K. Sugg, "Management of Crisis Key to Public Trust," The Baltiimore Sun, June 24, 2001.
9 "For [former University of Iowa Vice President for Research] Duane Spriestersbach . . . [the] experiment was both justified and ethical. 'It was a different time and the values were different . . .. Today we might disagree with what he did, but in those days it was fully within the norms of the time.''' Jim Dyer, "Ethics and Orphans: The Monster Study," Part Two of a Mercury News Special Report, San Jose [CA] Mercury News, June 11, 2001, p. 1A. Others agree. "The University of Iowa's stuttering experiment six decades ago . . . wouldn't have been considered so unusual at the time, according to experts." Colleen Krantz, "Orphans Targteted for Tests," Des Moines Register, July 9, 2001, p. 1. As University of Iowa President Mary Sue Coleman put it, "It was a different time and place." Jim Jacobson, "UI Denounces Experiment," Iowa City Gazette, June 13, 2001, p. 1A. The University's Human Subjects Office director, Trish Wasek, said, "It was a different time and a different set of mores in existence at the time." Colleen Krantz, et al., "U of I Rues Experiment on Stutterers," Des Moines Register, June 14, 2001, p. 1.
10 See, e.g., Nicoline Grinager Ambrose and Ehud Yairi, "The Tudor Study: Data and Ethics," American Journal of Speech-Language Pathology, vol. 11, 190, 199-200, May 2002.
11 See the discussion in Part VII. D., below.
12 "Our reanalysis of the original data from the Tudor study failed to confirm the hypotheses of the investigator and her advisor. . . . For the disfluencies counted in this study, there were no observable or significant increases or decreases in any disfluency type for any of the four groups. The only larger change was for the normally fluent group labeled stutterers (Group ILA) who increased interjections in their speech, a disfluency type that is typically regarded as normal. Some individuals in this group had considerable change in one or two types, but none that provided direct evidence of stuttering." Nicoline Grinager Ambrose and Ehud Yairi, "The Tudor Study: Data and Ethics," American Journal of Speech-Language Pathology, vol. 11, 190, 199-200, May 2002. See also, Ehud Yairi and Nicoline Ambrose, "The Tudor Experiment and Wendell Johnson: Science and Ethics Reexamined," and Mary M. Annett, "Article Alleges 1939 Study Taught Children to Stutter," both in the ASHA leader, vol. 6, no. 13, July 24, 2001. The president of the Stuttering Foundation of America has noted, "In the 60 intervening years, no other researcher [than Mary Tudor] has demonstrated that labeling someone a stutterer or criticizing his speech alone leades to the development of stuttering." Jane Fraser, The Fresno Bee, July 10, 2001, p. B6.
13 "Inasmuch as there is willingness to recognize differences in standards that existed 60 years ago, the remaining major concern in the case of the Tudor study is whether or not the experimenter and her mentor intended to cause harm by turning normally speaking children into children who stutter. Our review of the study reveals no such apparent intent. The study investigated whether the level of disfluency could be changed as a result of labeling. It was not to create stutterers. Even if there was an unstated goal to increase disfluency to a level perceived as stuttered speech, there is no indication that Tudor or Johnson believed that, if successful, this would make the children chronic stutterers. This, in our opinion is a critical point in judging the ethics of those involved in the conduct of the study." Ambrose and Yairi, above note 10, p. 200.
14 Ambrose and Yairi, note 10, above, p. 201.
15 See note 7, above.
16 See, e.g., FDA Backgrounder, " Milestones in U.S. Food and Drug Law History," especially the Kefauver-Harris Drug Amendments of 1962, http://www.cfsan.fda.gov/mileston.html.
17 The World Health Organization (WHO) is involved in evaluating the ethics of a number of aspects of medical care in developing countries. Among its concerns are ethical issues surrounding the use of human subjects in developing countries by researchers and corporations in the developed world. As with U.S. manufacturers' exploitation of developing countries' prison, slave and child labor in sweatshops at poverty wages, so have U.S. pharmaceutical companies sometimes dumped drugs in developing countries that have been rejected by the FDA for sale in the U.S. Similarly, the concern for human subjects research ethics when Americans are involved in studies tends to evaporate beyond our borders. As one author has put it, researchers are "changing their ethics ' at the customs desk.'" Paul M. McNeill, "Should Research Ethics Change at the Border?" The Medical Journal of Australia, 1998; 169: 509-510. http://www.mja.com.au/public/issues/nov16/mcneill/mcneill.html
The WHO has an ethics page on the Web. http://www.who.int/aboutwho/en/ensuring/ethics.htm It also has a page listing its ethics publications, "World Health Organization Publications: 1991-2001." http://www.who.int/dsa/cat98/ethic8.htm One of those publications refers to "current ethical controversies as experienced in Argentina, Brazil, Canada, Colombia, Chile, Spain, the United States, Mexico and Peru."
The Centers for Disease Control and Prevention has a "Human Subjects Research" page, http://www.cdc.gov/od/ads/hsr2.htm, and provides the text of the Council for International Organizations of Medical Sciences (CIOMS), "International Guidelines for Ethical Review of Epidemiological Studies" (Geneva, 1991). http://www.cdc.gov/od/ads/intlgui3.htm
As recently as March 2000 the New England Journal of Medicine reported a study reminiscent of Tuskegee (discussed in Part II. D. 1., below) done by researchers from no less prestigious a research institution than Johns Hopkins. In the Rakai region of Uganda they monitored 415 couples of which only one partner was infected with HIV. The researchers did not inform the AIDS-free partners. Thirty months later 90 of the formerly healthy spouses had become infected. The journal's editor charged that the study was unethical by U.S. standards. "Ethics of Medical Research in the Third World," AllAfrica Global Media, Feb. 2, 2001. http://allafrica.com/stories/200102020128.html Five people died in a South African clinical trial of anti-AIDS drugs at the Kalafong hospital where participants "claimed they were ill-informed about their rights when they signed consent forms." Ibid.
Paul M. McNeill, cited above, reports that as a result of providing HIV-infected mothers with placebos as a part of studies in Thailand, Africa and the Caribbean, their children were unnecessarily, and deliberately, permitted to develop AIDS.
18 The idea that today's super-sensitivity about human subject research ethics is both preventing research that needs to be done, and producing unfair moral judgments about that which has gone before, is supported by a couple of articles: Christopher Shea, "Don't Talk to the Humans," Linquafranca, vol. 10, no. 6, September 2000, http://www.linguafranca.com/print/0009/humans.html, and John R. Stanley's "Ethical Accusations: The Loss of Common Sense," Archives of Dermatology, vol. 136, no. 2, February 2000, http://archderm.ama-assn.org/issues/v136n2/ffull/dlt0200-4.html.
Shea discusses examples of IRBs interfering with research in anthropology, history, journalism, public policy (researchers' interviews with government officials) and urban ethnography.
He cites the case of a history Ph.D. candidate who also works as a newspaper editor. "So during the day, when he's working on his dissertation, he is supposed to get permission from an IRB before he talks to a retired governor or columnist. . . . At night, he can call up anyone he wants and grill them."
Shea makes the distinction between what he characterizes as the ethical equivalent of "run[ning] a red light on a deserted street at 3:00 a.m." (by someone who was very nearly denied tenure for his offense) and some of the ongoing ethical violations:
"You would not get the impression that human-subject committees are overly aggressive from reading the newspapers. In September 1999 a young man died while undergoing experimental gene therapy at the University of Pennsylvania, and his father subsequently claimed that no one had fully explained the risks involved in the treatment. Since the fall of 1998 the National Institutes of Health (NIH) have shut down research programs at eight institutions, including Duke University Medical Center, the University of Illinois at Chicago, and Virginia Commonwealth University. The NIH cited violations that ranged from inadequate record-keeping to a failure to review projects that should have been vetted."
One of the WHO ethics publications asserts that there is "a growing perception that research involving human subjects is beneficial rather than threatening and that vulnerable groups, such as women, children, the elderly, and prisoners, should not be deprived arbitrarily of the opportunity to benefit from investigational drugs, vaccines or devices." "World Health Organization Publications: 1991-2001." http://www.who.int/dsa/cat98/ethic8.htm.
19 See discussion in Part V., below.
20 See note 18, above.
21 Many of the studies listed in this section came from the Department of Energy's Advisory Committee on Human Radiation Experiments Report, DOE Openness: Human Radiation Experiments. http://tis.eh.doe.gov/ohre/roadmap/achre/ The Committee was established by the President in 1994. See especially "Part I. Ethics of Human Subjects Research: A Historical Perspective." http://tis.eh.doe.gov/ohre/roadmap/achre/overpt1.html.
The U.S. Department of Health and Human Services' Office for Human Research Protections is a prime site for links to many of the basic documents both historical and current. http://ohrp.osophs.dhhs.gov/polasur.htm. One of its pages provides links to educational material for researchers about human subjects ethics. http://ohrp.osophs.dhhs.gov/educmat.htm.
A "Research Ethics" collection of links to human subjects research ethical standards of international and U.S. bodies is maintained at Swinburne University of Technology in Melbourne, Australia. http://ecco.bsee.swin.edu.au/studes/ethics/. And see the bibliography of 464 hard copy publications, "Teaching Research Ethics: Annotated Bibliography." http://ecco.bsee.swin.edu.au/studes/ethics/ethics-biblio.html.
The Virginia Commonwealth University's site, "Ethics of Research Involving Human Participation," contains useful links. http://www.vcu.edu/hasweb/psy/faculty/fors/ethics.htm. Professor Lawrence M. Hinman at the University of San Diego maintains an "Ethics Update" site. http://ethics.acusd.edu/.
The National Library of Medicine's "Current Bibliographies in Medicine" series includes 5000 references in "Ethical Issues in Research Involving Human Participants," Current Bibliographies in Medicine 99-3, http://www.nlm.nih.gov/pubs/cbm/hum_exp.html. The Introduction notes the significance of the President's 1997 apology to the survivors of the Tuskegee Syphilis study and the reforms that followed. It says, "Contemporary safeguards such as [IRBs] are important, but by themselves are insufficient. Educating researchers and the public about research ethics is critical for the full protection of research participants." This bibliography is itself a consequence of that finding, and the work of the Bioethics Education Materials and Resources Subcommittee of the National Bioethics Advisory Commission.
22 The Nuremberg Code (1948) is a basic document available from numerous sources and Web sites. One is, "Nuremberg Code: Directives for Human Experimentation," Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949, http://ohsr.od.nih.gov/nuremberg.php3.
23 World Medical Association, "Declaration of Helsinki" (Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, as amended by the 29th World Medical Assembly, Tokyo, Japan, October, 1975, 35th World Medical Assembly, Venice, Italy, October 1983, and the 41st World Medical Assembly, Hong Kong, September 1989), http://ohsr.od.nih.gov/helsinki.php3. And see Glen Drew, "Side-by-Side Comparison of 1996 and 2000 Declaration of Helsinki," http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/h1996-2000.pdf.
24 See, e.g., NIH, Office of Human Subjects Research, "Criteria for Institutional Review Board (IRB) Approval of Research Involving Human Subjects," http://22.214.171.124/ohsrsite/info/sheet3.html. Criterion 2 provides, "An IRB may approve research only after it has determined that all of the following requirements are satisfied: (b) Risks to subjects are reasonable relative to (1) anticipated benefits, if any, to subjects, and (2) the importance of the knowledge that may reasonably be expected to result."
25 Philip J. Hilts, "Drug's Problems Raise Questions on Warnings," New York Times, Aug. 21, 2001.
26 . "Defense Dept. Offers Details of Toxic Tests Done in Secret," New York Times, Oct. 10, 2002.
27 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research ("The Belmont Report"), April 18, 1979, http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm.
28 This common knee-jerk, defensive reaction continues to this day. Following the death of a subject during a 2001 Johns Hopkins study discussed in Part V., below, there was an expression of considerable outrage by Johns Hopkins' doctors over the government's closing down their research ("unwarranted, unnecessary, paralyzing and precipitous"). There was after all, they pointed out, only one dead subject. You would think it was they who were the victims rather than their dead human subject and her family members. For Baltimore Sun coverage see note 43, below.
Nor was concern about loss of funding limited to Hopkins. The University of Iowa contributed to a local news story by Jim Jacobson, headlined "UI Funding Unaffected by Halt in Johns Hopkins Cancer Study," Iowa City Gazette, July 21, 2001, p. 1. Apparently Hopkins, rather than the government, pays the university $700,000 a year for one study and $11,000 for the other. Local citizens were no doubt reassured to learn that the local research "likely will not be affected." There was no mention of the death.
29 "Ethics of Medical Research in the Third World," AllAfrica Global Media, Feb. 2, 2001. http://allafrica.com/stories/200102020128.html
30 Dr. Timothy J. Eberlein, "Medical Insurers Should Pay for Clinical Trials of Experimental Cancer Treatments," Washington University St. Louis Record, Feb. 17, 2000, http://wupa.wustl.edu/record/archive/2000/02-17-00/articles/eberlein.html.
31 Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 11, 2001.
32 Even Mercury News reporter Jim Dyer later acknowledged, during an NPR interview, that "[Johnson] went to the . . . place that the University of Iowa . . . had used for several studies and research projects, and received permission . . . for this particular project." NPR, "Weekly Edition," June 23, 2001. He wrote, "In fact, in its 1936 biennial report, the Iowa State Board of Control, which oversaw all state institutions, openly encouraged and reported on cooperation with the University of Iowa in conducting research using children in various institutions." Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 11, 2001. And see Colleen Krantz, "Orphans Targeted for Tests," Des Moines Register, July 9, 2001, p. 1. James Holmes, superintendent of the institution during the 1950s and 1960s has said of the Tudor study, "The state much have known about it." Dyer, above.
33 References to the full text of the NASA standards, and their historical evolution, are a part of the Advisory Committee on Human Radiation Experiments Report, note 21, above; see Part I, Chapter 3, NASA Policy at, http://tis.eh.ddoe.gov/ohre/roadmap/achre/chap3.html.
34 "The history of psychology . . . is studded with experiments whose designers gave too little thought to the well-being of their subjects. . . .[I]n the early 1960s the young Theodore Kaczynski - the future Unabomber - was among a group of Harvard students garlanded with electrodes and confronted by skilled lawyers who ridiculed and demolished what the students avowed were their most deeply held beliefs. No one explained the experiment in advance, the psychologists wanted to see how the students would handle the stress." Christopher Shea, "Don't Talk to the Humans: The Crackdown on Social Science Research," Linguafranca, vol. 10, no. 6, Sep. 2000. For additional references see, Nicholas Johnson, "Psychology's Special Problems," in "Cites, Sites, Sources and Notes," http://www.uiowa.edu/~cyberlaw/hsr/hsrsites.html.
35 Even Tudor ethics critic Jim Dyer expressly acknowledges, "In the autumn of 1938, Johnson received permission from orphanage officials to begin his experiment." Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 10, 2001. He continues, "The university had already conducted numerous research projects . . . there, among them a decades-long study to see if developmental retardation would be more common among children who remained in the overcrowded and unstimulating orphanage than among children placed in a special new preschool."
36 See notes 12, 13, and 14, above. Retired Marquette speech pathology professor Bill Trotter agrees: "I know Wendell Johnson was an extremely ethical and moral person, and if something happened to those children it was because of something he did not foresee." Jim Dyer, "Ethics and Orphans: the 'Monster Study,'" San Jose Mercury News, June 11, 2001.
37 See note 17, above.
38 For any readers totally unaware of the reputation of Dr. Wendell Johnson for ethical, kindly and thoughtful behavior toward others, a few quotes and a Web site link may provide at least some insight.
Shortly after the Mercury News articles the former director of the Indiana University Speech, Language and Hearing Clinics wrote, "Johnson . . . completed a formidable body of scientific research that gave hope to millions. Johnson was a remarkable personality who got along well with everyone. His stuttering clients, their families, university students, etc. all loved him. He was such a kind man. There was nothing that he would ever have done intentionally to harm anyone." Robert L. Milisen, "Johnson Was a Great Man," Iowa City Press-Citizen, June 27, 2001, p. 11A.
Former colleague Dr. D.C. Spriestersbach told Jim Dyer, "Wendell Johnson was a most revered and universally loved man." Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 11, 2001.
Four speech pathologists wrote, "Recently have come comparisons of Dr. Wendell Johnson to Timothy McVeigh and Adolf Hitler. This has made us so angry. Johnson has no similarities to such individuals. He was a fine man, dedicated to helping solve the problems of stuttering, not only in the United States but also in the world. All that has been accomplished in this emotion-laden journalism is the trashing of a well-earned reputation of one of the most decent men who ever lived." Judith Knabe, Peggy Gingerich, Nancy Fesenmeyer, Jill Lorack and Becky Hubbard, "Wendell Johnson was a Fine Man: Judge Him in Light of the Times," Iowa City Gazette, July 5, 2001, p. 7A.
Even while issuing the University's apology to surviving subjects of the Tudor study, the University's Vice President for Research, David Skorton, who was very critical of the study's ethics, added, "In no way does this statement denigrate Wendell Johnson's very important and contributory career. He was a huge, positive factor in the field of speech pathology and in the lives of many, many patients with speech disorders." Kathryn Ratliff, "UI Apologizes for Research on Stuttering," Iowa City Press-Citizen, June 14, 2001, p. 1A.
A former student and colleague wrote of him after his death, "He was much beloved, even by those in Iowa City who knew little of his international recognition and awards. To them he was a neighbor, a great public speaker, teller of stories, composer of songs and limericks, personal counselor and active member of civic organizations. When he died, in addition to the stories in national news magazines and newspapers, the family was flooded with thousands of letters from individuals around the world, formerly unknown to them, who had been touched in some way by his life and love of humankind." Dean Williams, "Remembering Wendell Johnson," Et cetera, Winter 1992-93, p. 433, reprinted from the Daily Iowan, May 4, 1992.
"The man I knew seemed exceedingly gentle and incapable of angering. His disposition had a very calming effect in otherwise trying times. . . . A few days before he died in August 1965, I received a very long letter with remarks on his health status, general philosophizing, and the wish that he could be 50 white rats so his physicians could do the kind of research on his condition that could provide some answers, a typically Johnsonian approach to life. . . . To sum up the Johnson I knew, my best memories are of a pleasant, jovial, dedicated man whose love of life and of people was evidenced in his every act." Joseph L. Stewart, "Wendell Johnson: A Memoir," Et cetera, Winter 1992-93, p. 424.
See generally, "Wendell A. L. Johnson Memorial Home Page," http://www.uiowa.edu/~cyberlaw/oldinav/wjhome.html.
39 Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 10, 2001.
40 "As you can see, the woman 'featured' in Dyer's articles actually got more fluent over the four months." Dr. Robert W. Quesal, e-mail to author, June 21, 2001, with accompanying supporting analysis of the Tudor study data.
41 See note 24, above.
42 As one stutterer puts the question, and then answers it: "Were the experiments justified? Was their potential benefit to society greater than the potential harm to the subjects? Speaking as a stutterer myself, I think 'yes.' Johnson's results showed that stuttering is learned behavior that can be modified, not a congenital curse that has to be accepted as given. Johnson gave hope and opportunity to the thousands of us who are afflicted with stuttering." James Hedges, "A New Perspective on Stuttering Research," The Daily Iowan, June 25, 2001, p. 4.
43 Even Tudor ethics critic Jim Dyer acknowledges that "Johnson asked Tudor to evaluate the children and try to reverse the effects of the experiment using positive therapy." Jim Dyer, "Ethics and Orphans: The 'Monster Study,'" San Jose Mercury News, June 11, 2001.
44 See discussion of these charges in Part VII. D., below.
45 Dr. Wendell Johnson's master's thesis, Because I Stutter, was one of the very few master's theses to be commercially published (by Appleton in 1930). Although out of print, it is available on the Web at http://www.uiowa.edu/~cyberlaw/wj/bis/wjbis.html.
46 Standards change over time with regard to many aspects of human behavior.
Language widely used without objection at one time, say, the way some men talked about women during the 1950s, may become the basis for everything from social shunning to law suits for sexual harassment decades later.
There are undoubtedly dozens of examples of practices raising ethical issues that have not yet been addressed in today's standards. By way of illustration, the author was a human subject in a University of Iowa clinical trial of a new drug. It is apparently standard practice to require human subjects - who are taking at least some risk for no pay in a project from which everyone else is profiting - to sign a couple of waivers. One absolves the institution not only from any liability for harm, but even liability for negligence! The other seems especially uncaring. The testing institution, a major research hospital, expressly leaves human subjects harmed by the study entirely on their own in their search for restorative medical care. Is this ethical? Under today's standards apparently it is. Will we take another view of the matter in the future? One would hope so. And, if so, will moral outrage then be voiced about those who utilized such overreaching waiver language today? One would hope not.
Fifty years from now a majority of the world's population may conclude that today's animal rights activists were right all along. Those of us who are, today, not vegetarians may then be described as barbarians for our willingness to slaughter animals and eat their flesh. We may even become named defendants in mock trials for our participation in this animal genocide. PETA (People for the Ethical Treatment of Animals) has for years objected to the use of animals in research. http://www.peta.org See especially "Cruel Science," http://www.peta.org/cmp/sci.html, and "Stop Animal Tests," http://www.stopanimaltests.com.
The citizens of many countries already regard us as barbarians because we continue the death penalty, a practice they believe violates the U.N.'s Universal Declaration of Human Rights - as President George W. Bush discovered during his 2001 European trip.
Those who are insistent on applying today's standards to the human subject research of others in the 1920s and 1930s might at least first consider the consequences. To apply today's standards to yesterday's research will mean that, for the next few years professional societies, research universities and other institutions will be doing little other than issuing apologies to the thousands of experimental subjects of that time - if not writing checks for billions of dollars. Indeed, one journalist has already seriously suggested they should be doing just that. John Carlson, "U of I, State Owe Yesteryear's Orphans the Whole Truth," Des Moines Register, June 17, 2001, p. 1B.
47 Although best known as a speech pathologist, Dr. Wendell Johnson was also one of the founders of the International Society for General Semantics. His book, People in Quandaries, first published in 1946, is still available.
48 For example, it was as late as December 2002 before the State of Oregon first acknowledged that its program of forced sterilization was no longer acceptable. From 1917 through 1983, over 2500 Oregonians - "girls in reform school, people in mental institutions and poor women selected by welfare workers" - were sterilized. AP, "Ore. Gov. Apologizes for Sterilization," filed at 10:15 p.m. ET, Dec. 2, 2002.
49 As noted below, a small step in this direction was finally taken by NIH in October 2000.
50 These sources are referenced in note 21, above.
51 See note 17, above.
52 The most detailed reporting about the Johns Hopkins controversy has been, not surprisingly, in the Baltimore Sun. For a relatively complete list see, Nicholas Johnson, "Epilogue," http://www.uiowa.edu/~cyberlaw/hsr/hsrepilo.html. See also, e.g., Gina Kolata, "U.S. Suspends Human Research at Johns Hopkins After a Death," The New York Times, July 20, 2001.
53 Note 9, above.
54 John Bernthal, President, American Speech-Language-Hearing Association, "U of I Speech Study was Unethical," Des Moines Register, June 19, 2001, p. 8. The article was nationally distributed and printed in a number of papers.
55 "UI Apologizes for Stuttering Study," San Jose Mercury News, June 14, 2001. And see, "University Apologizes for '39 Experiment," Chicago Tribune, June 14, 2001, p. 19. University of Iowa President Mary Sue Coleman was quoted as saying, "There's no way I can condone that kind of research." Jim Jacobson, "UI Denounces Experiment," Iowa City Gazette, June 13, 2001, p. 1A. Richard Hurtig, Chair of the UI Department of Speech Pathology and Audiology was quoted as saying that "this is not the kind of study anyone today would even think of proposing or would an institutional review board authorize." Kathryn A. Ratliff, "UI Stuttering Study Doubted," Iowa City Press-Citizen, June 12, 2001, pp. 1, 7.
56 See note 58, below.
57 University of Iowa Vice President for Research David Skorton's statement was widely reported in June 2001, e.g., Jim Jacobson, "UI Regrets Stuttering Experiments," Iowa City Gazette, June 14, 2001, p. A1.
58 The suggestion that today's research institutions and individuals possess a moral superiority to their predecessors, that there are standards in place today to prevent any possibility of the problems of earlier times, is a triumph of arrogance over experience. The abuses detailed in the DHHS Office of Inspector General's report, "Protecting Human Research Subjects," were published as recently as April 2000. It is available online in pdf format. http://www.os.dhhs.gov/progorg/pei/reports/447.pdf.
The NIH requirement of "education on the protection of human research participants for all investigations" was established even later, in October 2000. One institutional response has been a simple online summary presentation of some highlights that researchers are required to scan. An example is the University of Michigan's "Protection of Human Research Subjects Computer-Based Training for Researchers." http://www.umich.edu/~drda/training. Stanford University offers a similar "Use of Human Subjects in Research: History" tutorial module. http://www.stanford.edu/dept/DoR/hs/History/his01.html.
59 Regarding institutional response the Sun noted, "In Rochester in 1996 [following the death of a human subject], doctors disclosed as many details as they could, at the risk of embarrassing themselves and complicating their legal position. . . . In Baltimore in the past few weeks, Hopkins leaders initially chose to reveal little, at the risk of appearing to have something to hide." Eric Siegel and Diana K. Sugg, "Management of Crisis Key to Public Trust," The Baltiimore Sun, June 24, 2001.
Less than one week after the Johns Hopkins revelations the Des Moines [Iowa] Register headlined on page one: "U of I Faces Probe Over Research." The story noted that, among other things, "the issues raised . . . focus on internal review boards that sometimes rushed approval of changes in experiment guidelines and did not document procedures in enough detail." Colleen Krantz, "U of I Faces Probe Over Research," Des Moines Sunday Register, July 22, 2001, p. 1.
A letter to the university in 1999 from the Food and Drug Administration referred to its reviews at the university in 1992, 1995 and 1998. Each of those reviews involved violations that "are of particular importance because many of them have been observed during past inspections where corrections were promised by your institution but not implemented."
According to the news story, an FDA spokesperson said it is "fairly rare to see issues remain unresolved after several visits, as inspectors suggested was the case at the University of Iowa."
A spokesperson for the university tried to minimize, even trivialize, the violations as "minor administrative details." Said another, "the more complex the research the greater the likelihood there are some failures because we are, after all, all human."
Apparently the standard of at least some educational administrators is to be human and forgiving of our own ethical and legal errors, but morally outraged by those of our predecessors.
The same University spokesperson who joined in the chorus of moral outrage, saying that the Tudor study was "unfortunate and indefensible," was later quoted in a local paper's follow-up on the Register expose of the University's own failings. It reported that, "The university calls into question both the headline and its placement as Sunday's leading story" - while acknowledging that the story itself was "mostly accurate if read in its entirety. The headline and the story's placement? Is this an academic or a publicist who's speaking?
The University of Iowa's continuing tenacious campaign against the Des Moines Register's headline and placement was represented in a letter to the editor with, presumably, a headline finally thought acceptable, David Skorton, "No Action Pending Regarding U of I Research," Opinion, Des Moines Register, August 5, 2001, p. 9A.
The contrast between this protest - of a story it concedes was "balanced and mostly accurate" - and its response to the media's unethical and broadside attacks on the 1939 study are striking. In the latter case it not only failed to protest anything about the stories - whether their content or headlines and placement - it actually joined in the moral castigation of its own former faculty member!
There was, of course, no reference to how "unfortunate and indefensible" it is that today's clear governmental standards have not been complied with in spite of repeated government investigations and university assurances of correction.
See generally, George Pappas, "Gov't Probe of UI Research 'Minor,'" The Daily Iowan, July 23, 2001, p. 1; George Pappas, "UI Fires Back at Register's Headline," The Daily Iowan, July 24, 2001, p. 1; Ryan Foley, "'Monster Study' Reporter Under Fire," The Daily Iowan, July 26, 2001, p. 1.
60 One of many possible consequences of such a hurried rush to public relations offensive is its impact on litigation. With potential plaintiffs waiting in the wings, to launch a gratuitous assault on a former faculty member as someone who supervised "a study that should [n]ever be considered defensible in any era" - however erroneous and unjustified, and potentially useful in the public relations short run - is a somewhat reckless gamble with a state university's resources.
61 As a speech pathologist has noted, "Even more startling than the [Dyer] article itself was its front-page placement and space allotment, this for an article appearing to provide no useful information whatsoever to the public. . . . How much more useful would an article about stuttering problems have been if readers had instead been informed of resources . . .. As a speech pathologist, I am particularly disheartened that the opportunity to help people prevent and treat stuttering problems was squandered in what seems to be efforts to engage in sensationalism, for what purpose or purposes one can only speculate." Ellen-Marie Silverman, "Paper Missed Chance to Better Inform Readers," Milwaukee Journal Sentinel, June 18, 2001, p. 10A.
62 There are a number of current ethical issues in human subjects research that really are deserving of academic reflection and public education by journalists. Here is but one example.
An April 2000 report of the DHHS Office of Inspector General, "Protecting Human Research Subjects," notes a great many "disturbing inadequacies." One, it says, is that "The increased commercialization of research and the growing importance of research revenues for institutions heightens the potential for conflicts of interest in clinical research."
On August 5, 2001, the Washington Post reported that overreaching by pharmaceutical companies had become so bad that "editors at the world's most prominent medical journals, alarmed that drug companies are exercising too much control over research results, have agreed to adopt a uniform policy that reserves the right to refuse to publish drug company-sponsored studies . . .." Susan Okie, "A Stand for Scientific Independence: Medical Journals Aim to Curtail Drug Companies' Influence," Washington Post, August 5, 2001, p. A1. The story was reported in Iowa City as, "Journals Adopt New Policy: Editors Aim to Clip Drug Companies' Influence," Iowa City Press-Citizen, August 5, 2001, p. 1A, and "Medical Journals Battle Drug Firms' Grip on Research," Iowa City Gazette, August 5, 2001, p. 3A.)
The author quotes "several observers of biomedical studies who have become alarmed about the influence of the drug industry on the integrity of medical research." A University of California professor of clinical pharmacy is quoting as saying that if negative results are published "you can still get pressure put on you for fear that you won't get any future funding." Companies not only control access to data, but may even control who writes the papers - or ghost writes them for the academics who "are too busy to take all the time needed to create the publication." She cites examples in which reports of side effects, no benefits, or cheaper alternatives have led to blocked publication or even lawsuits.
One would think the significance of an ethical issue of this magnitude would be worth at least as much media attention as masters' theses from 1939.
63 The Society of Professional Journalists' "Code of Ethics" is available online at http://www.spj.org/ethics/code.htm.
64 "As you can see, the woman 'featured' in Dyer's articles actually got more fluent over the four months." Dr. Robert W. Quesal, e-mail to author, June 21, 2001, with accompanying analysis of the Tudor study data.
65 Its ethics policy, violated by the journalist, provides:
"Under ordinary circumstances, reporters or photographers ought to identify themselves to news sources. There might be times, however, when circumstances will dictate not identifying ourselves. Only the Executive Editor or Editor may approve such exceptions."
To which the Executive Editor added in his editorial, "I didn't." David Yarnold, "Setting the Record Straight," The San Jose Mercury News, July 25, 2001.
66 The quote is from a promotional, public relations release from Patty Wise, the Mercury News' Public Relations Manager, distributed nationally by the PR Newswire Association, "to medical, family and features editors," June 8, 2001. It made both stories available to other papers -- prior to their publication in the Mercury News itself, thus insuring the re-enforcing impact of the national media blitz.
67 The false claim that the study was "revealed for the first time" in the Mercury News is particularly unethical given that the stories author, Jim Dyer, was himself one of those who wrote about it earlier in the Iowa City Mercury. James Dyer, "The Twisted Experiment of Dr. Wendell Johnson," The Iowa City Mercury, April 1992, p. 1. Franklin Silverman reported on the Tudor study as early as 1988 in the Journal of Fluency Disorders. It was also the subject of a novel by Jerry Halvorson in 1999.
68 The AP reported the resignation. Stories that appeared in Iowa City papers included: "Stutter Story Reporter Quits," Iowa City Press-Citizen, July 31, 2001, p. 1, and "Author of Stuttering Series Quits Paper; Reporter Criticized for Research Method," Iowa City Gazette, August 1, 2001, p. 8A.