3.4 3.4 Ethics
When you complete this section, you will be able to:
• Describe the purpose of an institutional review board and describe what kinds of expertise its members require.
• Describe informed consent and evaluate whether or not it has been given in specific examples.
• Determine when data have been kept confidential in a study.
• Evaluate a clinical trial from the viewpoint of ethics.
The production and use of data, like all human endeavors, raise 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. It will end your career when uncovered.
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 3.31
Provide all the critical information. Papers reporting scientific research are supposed to be short, with no extra baggage. But brevity can allow the 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.”24 The situation is no doubt worse in fields that screen published work less carefully.
204
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 individuals who are subjects in a study must give their informed consent before data are collected.
All individual data must be kept confidential. Only statistical summaries for groups of subjects may be made public.
The law requires that studies funded by the federal government obey these principles. 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.” When protocols are greater than minimal risk, a statistician is often included on the board to help determine benefits.
The board reviews the plan of the study and can require changes. It reviews the consent form to be sure that subjects are informed about the nature of the study and about any potential risks. Once research begins, the board monitors its progress at least once a year.
The most pressing issue concerning institutional review boards is whether their workload has become so large that their effectiveness in protecting subjects drops. 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.
USE 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.
Question 3.71
3.71 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 that 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”? Explain your choices.
205
(a) Draw a drop of blood by pricking a finger in order to measure blood sugar.
(b) Draw blood from the arm for a full set of blood tests.
(c) Insert a tube that remains in the arm so that blood can be drawn regularly.
Question 3.72
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.
(a) Why should review boards contain people who are not scientists?
(b) Do you think that one outside member is enough? How would you choose that member? (For example, would you prefer a medical doctor? A member of the clergy? An activist for patients’ rights?)
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 3.32
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 medical experiments in prisons.
Young 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?
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 or have suffered a stroke? In most cases, there is not time even 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.25
206
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. Confidentialityconfidentiality means that only the researchers can identify responses of individual subjects. The report of an opinion poll may say what percent of the 1500 respondents felt that legal immigration should be reduced. It may not report what you said about this or any other issue.
Confidentiality is not the same as anonymityanonymity. 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 anonymity is possible (mainly in surveys conducted by mail), it 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 individual 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 a PhD from the United States” was enough to identify her among all the citizens of Germany. Privacy and confidentiality of data are hot issues among statisticians in the computer age.
EXAMPLE 3.33
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 individuals 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.
207
USE YOUR KNOWLEDGE
Question 3.73
3.73 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.
Question 3.74
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?
(a) A government agency takes a random sample of income tax returns to obtain information on the average income of people in different occupations. Only the incomes and occupations are recorded from the returns, not the names.
(b) A social psychologist attends public meetings of a religious group to study the behavior patterns of members.
(c) A social psychologist pretends to be converted to membership in a religious group and attends private meetings to study the behavior patterns of members.
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:
• Randomized comparative experiments are the only way to see the true effects of new treatments. Without them, risky treatments that are no better than placebos will become common.
• Clinical trials produce great benefits, but most of these benefits go to future patients. The trials also pose risks, and these risks are borne by the subjects of the trial. So we must balance future benefits against present risks.
• Both medical ethics and international human rights standards say that “the interests of the subject must always prevail over the interests of science and society.”
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.
208
EXAMPLE 3.34
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.26
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 is the view 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:27 A clinical trial is justified if there is some evidence that the treatment will be effective. This evidence, however, is not sufficiently strong, to conclude that we would be harming the subjects who would receive the placebo.
Why is it ethical to give a control group of patients a placebo? Well, we know that placebos often work. What is more, placebos have no harmful side effects. In fact, 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 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 how the results of an experiment are interpreted. Here is an example.
EXAMPLE 3.35
Attentiveness improves by nearly 20%. 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 the tests taken three hours after breakfast were used in the claim.
The Federal Trade Commission investigated the marketing of this product. It 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.28
It is not sufficient to obtain appropriate controls. The data must be collected from all groups in the same way. Here is an example of this type of flawed design.
209
EXAMPLE 3.36
Accurate identification of ovarian cancer. Two scientists published a paper claiming to have developed an exciting new method to detect ovarian cancer using blood samples. When other scientists were unable to reproduce the results in different labs, the original work was examined more carefully. In the original study, there were samples for women with ovarian cancer and for 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 in that it could not control for changes over time in the measuring instrument.29
USE YOUR KNOWLEDGE
Question 3.75
3.75 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 on the rolls 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?
Question 3.76
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 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?
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 3.37
Personal space. Psychologists observe that people have a “personal space” and get annoyed 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 kept at it.30
210
This personal space experiment illustrates the difficulties facing those who plan and review behavioral studies:
• There is no risk of harm to the subjects, although they would certainly object to being watched through a periscope. What should we protect subjects from when physical harm is unlikely? Possible emotional harm? Undignified situations? Invasion of privacy?
• What about informed consent? The subjects in Example 3.37 did not even know they were participating in an experiment. Many behavioral experiments rely on hiding the true purpose of the study. The subjects would change their behavior if told in advance what the investigators were looking for. Subjects are asked to consent on the basis of vague information. They receive full information only after the experiment.
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 3.38
Domestic violence. How should police respond to domestic violence calls? In the past, the usual practice was to remove the offender and order him 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 him overnight, or warn the suspect and release him. 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 arrest the suspect or warn and release him, depending on the contents of the envelope. The researchers then watch police records and visit the victim to see if the domestic violence reoccurs.
The first such experiment appeared to show that arresting domestic violence suspects does reduce their future violent behavior. 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.”