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The production and use of data often involve ethical questions. We won’t discuss the telemarketer who begins a telephone sales pitch with “I’m conducting a survey.” Such deception is clearly unethical. It enrages legitimate survey organizations, which find the public less willing to talk with them. Neither will we discuss those few researchers who, in the pursuit of professional advancement, publish fake data. There is no ethical question here—faking data to advance your career is just wrong. But just how honest must researchers be about real, unfaked data? Here is an example that suggests the answer is “More honest than they often are.”
EXAMPLE 3.28 Provide All the Critical Information
Papers reporting scientific research are supposed to be short, with no extra baggage. Brevity, however, can allow researchers to avoid complete honesty about their data. Did they choose their subjects in a biased way? Did they report data on only some of their subjects? Did they try several statistical analyses and report only the ones that looked best? The statistician John Bailar screened more than 4000 medical papers in more than a decade as consultant to the New England Journal of Medicine. He says, “When it came to the statistical review, it was often clear that critical information was lacking, and the gaps nearly always had the practical effect of making the authors’ conclusions look stronger than they should have.”27 The situation is no doubt worse in fields that screen published work less carefully.
The most complex issues of data ethics arise when we collect data from people. The ethical difficulties are more severe for experiments that impose some treatment on people than for sample surveys that simply gather information. Trials of new medical treatments, for example, can do harm as well as good to their subjects. Here are some basic standards of data ethics that must be obeyed by any study that gathers data from human subjects, whether sample survey or experiment.
Basic Data Ethics
The organization that carries out the study must have an institutional review board that reviews all planned studies in advance in order to protect the subjects from possible harm.
All subjects in a study must give their informed consent before data are collected.
All subject data must be kept confidential. Only statistical summaries for groups of subjects may be made public.
The law requires that studies carried out or funded by the federal government obey these principles.28 But neither the law nor the consensus of experts is completely clear about the details of their application.
Institutional review boards
The purpose of an institutional review board is not to decide whether a proposed study will produce valuable information or whether it is statistically sound. The board’s purpose is, in the words of one university’s board, “to protect the rights and welfare of human subjects (including patients) recruited to participate in research activities.” The board reviews the plan of the study and can require changes. It reviews the consent form to ensure that subjects are informed about the nature of the study and about any potential risks. Once research begins, the board monitors the study’s progress at least once a year.
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The most pressing issue concerning institutional review boards is whether their workload has become so large that their effectiveness in protecting subjects drops. When the government temporarily stopped human-subject research at Duke University Medical Center in 1999 due to inadequate protection of subjects, more than 2000 studies were going on. That’s a lot of review work. There are shorter review procedures for projects that involve only minimal risks to subjects, such as most sample surveys. When a board is overloaded, there is a temptation to put more proposals in the minimal-risk category to speed the work.
Apply Your Knowledge
The exercises in this section on ethics are designed to help you think about the issues that we are discussing and to formulate some opinions. In general, there are no wrong or right answers but you need to give reasons for your answers.
3.72 Who should be on an institutional review board?
Government regulations require that institutional review boards consist of at least five people, including at least one scientist, one nonscientist, and one person from outside the institution. Most boards are larger, but many contain just one outsider.
3.73 Do these proposals involve minimal risk?
You are a member of your college’s institutional review board. You must decide whether several research proposals qualify for lighter review because they involve only minimal risk to subjects. Federal regulations say that “minimal risk” means the risks are no greater than “those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” That’s vague. Which of these do you think qualifies as “minimal risk”?
3.73
(a) Minimal. (b) Minimal. (c) Not minimal.
Informed consent
Both words in the phrase “informed consent” are important, and both can be controversial. Subjects must be informed in advance about the nature of a study and any risk of harm it may bring. In the case of a sample survey, physical harm is not possible. The subjects should be told what kinds of questions the survey will ask and about how much of their time it will take. Experimenters must tell subjects the nature and purpose of the study and outline possible risks. Subjects must then consent in writing.
EXAMPLE 3.29 Who Can Give Informed Consent?
Are there some subjects who can’t give informed consent? It was once common, for example, to test new vaccines on prison inmates who gave their consent in return for good-behavior credit. Now, we worry that prisoners are not really free to refuse, and the law forbids almost all medical research in prisons.
Children can’t give fully informed consent, so the usual procedure is to ask their parents. A study of new ways to teach reading is about to start at a local elementary school, so the study team sends consent forms home to parents. Many parents don’t return the forms. Can their children take part in the study because the parents did not say “No,” or should we allow only children whose parents returned the form and said “Yes”?
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What about research into new medical treatments for people with mental disorders? What about studies of new ways to help emergency room patients who may be unconscious? In most cases, there is not time to get the consent of the family. Does the principle of informed consent bar realistic trials of new treatments for unconscious patients?
These are questions without clear answers. Reasonable people differ strongly on all of them. There is nothing simple about informed consent.29
The difficulties of informed consent do not vanish even for capable subjects. Some researchers, especially in medical trials, regard consent as a barrier to getting patients to participate in research. They may not explain all possible risks; they may not point out that there are other therapies that might be better than those being studied; they may be too optimistic in talking with patients even when the consent form has all the right details. On the other hand, mentioning every possible risk leads to very long consent forms that really are barriers. “They are like rental car contracts,” one lawyer said. Some subjects don’t read forms that run five or six printed pages. Others are frightened by the large number of possible (but unlikely) disasters that might happen and so refuse to participate. Of course, unlikely disasters sometimes happen. When they do, lawsuits follow—and the consent forms become yet longer and more detailed.
Confidentiality
Ethical problems do not disappear once a study has been cleared by the review board, has obtained consent from its subjects, and has actually collected data about the subjects. It is important to protect the subjects’ privacy by keeping all data about subjects confidential. The report of an opinion poll may say what percent of the 1200 respondents felt that legal immigration should be reduced. It may not report what you said about this or any other issue.
anonymity
Confidentiality is not the same as anonymity. Anonymity means that subjects are anonymous—their names are not known even to the director of the study. Anonymity is rare in statistical studies. Even where it is possible (mainly in surveys conducted by mail), anonymity prevents any follow-up to improve nonresponse or inform subjects of results.
Any breach of confidentiality is a serious violation of data ethics. The best practice is to separate the identity of the subjects from the rest of the data at once. Sample surveys, for example, use the identification only to check on who did or did not respond. In an era of advanced technology, however, it is no longer enough to be sure that each set of data protects people’s privacy. The government, for example, maintains a vast amount of information about citizens in many separate databases—census responses, tax returns, Social Security information, data from surveys such as the Current Population Survey, and so on. Many of these databases can be searched by computers for statistical studies. A clever computer search of several databases might be able, by combining information, to identify you and learn a great deal about you even if your name and other identification have been removed from the data available for search. A colleague from Germany once remarked that “female full professor of statistics with PhD from the United States” was enough to identify her among all the 83 million residents of Germany. Privacy and confidentiality of data are hot issues among statisticians in the computer age.
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EXAMPLE 3.30 Data Collected by the Government
Citizens are required to give information to the government. Think of tax returns and Social Security contributions. The government needs these data for administrative purposes—to see if we paid the right amount of tax and how large a Social Security benefit we are owed when we retire. Some people feel that people should be able to forbid any other use of their data, even with all identification removed. This would prevent using government records to study, say, the ages, incomes, and household sizes of Social Security recipients. Such a study could well be vital to debates on reforming Social Security.
Apply Your Knowledge
3.74 Should we allow this personal information to be collected?
In which of the following circumstances would you allow collecting personal information without the subjects’ consent?
3.75 How can we obtain informed consent?
A researcher suspects that traditional religious beliefs tend to be associated with an authoritarian personality. She prepares a questionnaire that measures authoritarian tendencies and also asks many religious questions. Write a description of the purpose of this research to be read by subjects in order to obtain their informed consent. You must balance the conflicting goals of not deceiving the subjects as to what the questionnaire will tell about them and of not biasing the sample by scaring off religious people.
Clinical trials
Clinical trials are experiments that study the effectiveness of medical treatments on actual patients. Medical treatments can harm as well as heal, so clinical trials spotlight the ethical problems of experiments with human subjects. Here are the starting points for a discussion:
The quoted words are from the 1964 Helsinki Declaration of the World Medical Association, the most respected international standard. The most outrageous examples of unethical experiments are those that ignore the interests of the subjects.
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EXAMPLE 3.31 The Tuskegee Study
In the 1930s, syphilis was common among black men in the rural South, a group that had almost no access to medical care. The Public Health Service Tuskegee study recruited 399 poor black sharecroppers with syphilis and 201 others without the disease in order to observe how syphilis progressed when no treatment was given. Beginning in 1943, penicillin became available to treat syphilis. The study subjects were not treated. In fact, the Public Health Service prevented any treatment until word leaked out and forced an end to the study in the 1970s.
The Tuskegee study is an extreme example of investigators following their own interests and ignoring the well-being of their subjects. A 1996 review said, “It has come to symbolize racism in medicine, ethical misconduct in human research, paternalism by physicians, and government abuse of vulnerable people.” In 1997, President Clinton formally apologized to the surviving participants in a White House ceremony.30
Because “the interests of the subject must always prevail,” medical treatments can be tested in clinical trials only when there is reason to hope that they will help the patients who are subjects in the trials. Future benefits aren’t enough to justify experiments with human subjects. Of course, if there is already strong evidence that a treatment works and is safe, it is unethical not to give it. Here are the words of Dr. Charles Hennekens of the Harvard Medical School, who directed the large clinical trial that showed that aspirin reduces the risk of heart attacks:
There’s a delicate balance between when to do or not do a randomized trial. On the one hand, there must be sufficient belief in the agent’s potential to justify exposing half the subjects to it. On the other hand, there must be sufficient doubt about its efficacy to justify withholding it from the other half of subjects who might be assigned to placebos.31
Why is it ethical to give a control group of patients a placebo? Well, we know that placebos often work. Moreover, placebos have no harmful side effects. So in the state of balanced doubt described by Dr. Hennekens, the placebo group may be getting a better treatment than the drug group. If we knew which treatment was better, we would give it to everyone. When we don’t know, it is ethical to try both and compare them.
The idea of using a control or a placebo is a fundamental principle to be considered in designing experiments. In many situations, deciding what to use as an appropriate control requires some careful thought. The choice of the control can have a substantial impact on the conclusions drawn from an experiment. Here is an example.
EXAMPLE 3.32 Was the Claim Misleading?
The manufacturer of a breakfast cereal designed for children claims that eating this cereal has been clinically shown to improve attentiveness by nearly 20%. The study used two groups of children who were tested before and after breakfast. One group received the cereal for breakfast, while breakfast for the control group was water. The results of tests taken three hours after breakfast were used to make the claim.
The Federal Trade Commission investigated the marketing of this product. They charged that the claim was false and violated federal law. The charges were settled, and the company agreed to not use misleading claims in its advertising.32
It is not sufficient to obtain appropriate controls. The data from all groups must be collected and analyzed in the same way. Here is an example of this type of flawed design.
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EXAMPLE 3.33 The Product Doesn’t Work!
Two scientists published a paper claiming to have developed a very exciting new method to detect ovarian cancer using blood samples. The potential market for such a procedure is substantial, and there is no specific screening test currently available. When other scientists were unable to reproduce the results in different labs, the original work was examined more carefully. The original study used blood samples from women with ovarian cancer and from healthy controls. The blood samples were all analyzed using a mass spectrometer. The control samples were analyzed on one day and the cancer samples were analyzed on the next day. This design was flawed because it could not control for changes over time in the measuring instrument.33
Apply Your Knowledge
3.76 Should the treatments be given to everyone?
Effective drugs for treating AIDS are very expensive, so most African nations cannot afford to give them to large numbers of people. Yet AIDS is more common in parts of Africa than anywhere else. Several clinical trials being conducted in Africa are looking at ways to prevent pregnant mothers infected with HIV from passing the infection to their unborn children, a major source of HIV infections in Africa. Some people say these trials are unethical because they do not give effective AIDS drugs to their subjects, as would be required in rich nations. Others reply that the trials are looking for treatments that can work in the real world in Africa and that they promise benefits at least to the children of their subjects. What do you think?
3.77 Is this study ethical?
Researchers on aging proposed to investigate the effect of supplemental health services on the quality of life of older people. Eligible patients of a large medical clinic were to be randomly assigned to treatment and control groups. The treatment group would be offered hearing aids, dentures, transportation, and other services not available without charge to the control group. The review board felt that providing these services to some but not other persons in the same institution raised ethical questions. Do you agree?
Behavioral and social science experiments
When we move from medicine to the behavioral and social sciences, the direct risks to experimental subjects are less acute, but so are the possible benefits to the subjects. Consider, for example, the experiments conducted by psychologists in their study of human behavior.
EXAMPLE 3.34 Personal Space
Psychologists observe that people have a “personal space” and are uneasy if others come too close to them. We don’t like strangers to sit at our table in a coffee shop if other tables are available, and we see people move apart in elevators if there is room to do so. Americans tend to require more personal space than people in most other cultures. Can violations of personal space have physical, as well as emotional, effects?
Investigators set up shop in a men’s public restroom. They blocked off urinals to force men walking in to use either a urinal next to an experimenter (treatment group) or a urinal separated from the experimenter (control group). Another experimenter, using a periscope from a toilet stall, measured how long the subject took to start urinating and how long he continued.34
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This personal space experiment illustrates the difficulties facing those who plan and review behavioral studies:
The “Ethical Principles” of the American Psychological Association require consent unless a study merely observes behavior in a public place. They allow deception only when it is necessary to the study, does not hide information that might influence a subject’s willingness to participate, and is explained to subjects as soon as possible. The personal space study (from the 1970s) does not meet current ethical standards.
We see that the basic requirement for informed consent is understood differently in medicine and psychology. Here is an example of another setting with yet another interpretation of what is ethical. The subjects get no information and give no consent. They don’t even know that an experiment may be sending them to jail for the night.
EXAMPLE 3.35 Reducing Domestic Violence
How should police respond to domestic-violence calls? In the past, the usual practice was to remove the offender and order the offender to stay out of the household overnight. Police were reluctant to make arrests because the victims rarely pressed charges. Women’s groups argued that arresting offenders would help prevent future violence even if no charges were filed. Is there evidence that arrest will reduce future offenses? That’s a question that experiments have tried to answer.
A typical domestic-violence experiment compares two treatments: arrest the suspect and hold the suspect overnight or warn and release the suspect. When police officers reach the scene of a domestic-violence call, they calm the participants and investigate. Weapons or death threats require an arrest. If the facts permit an arrest but do not require it, an officer radios headquarters for instructions. The person on duty opens the next envelope in a file prepared in advance by a statistician. The envelopes contain the treatments in random order. The police either make an arrest or warn and release, depending on the contents of the envelope. The researchers then watch police records and visit the victim to see if the domestic violence reoccurs.
Such experiments show that arresting domestic-violence suspects does reduce their future violent behavior.35 As a result of this evidence, arrest has become the common police response to domestic violence.
The domestic-violence experiments shed light on an important issue of public policy. Because there is no informed consent, the ethical rules that govern clinical trials and most social science studies would forbid these experiments. They were cleared by review boards because, in the words of one domestic-violence researcher, “These people became subjects by committing acts that allow the police to arrest them. You don’t need consent to arrest someone.”