Experimental Design and Ethics

Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments. In this module, you will learn important aspects of experimental design. Proper study design ensures the production of reliable, accurate data.

The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory variable. The affected variable is called the response variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The different values of the explanatory variable are called treatments. An experimental unit is a single object or individual to be measured.

The following video explains the difference between collecting data from observations and collecting data from experiments.

You want to investigate the effectiveness of vitamin E in preventing disease. You recruit a group of subjects and ask them if they regularly take vitamin E. You notice that the subjects who take vitamin E exhibit better health on average than those who do not. Does this prove that vitamin E is effective in disease prevention? It does not. There are many differences between the two groups compared in addition to vitamin E consumption. People who take vitamin E regularly often take other steps to improve their health: exercise, diet, other vitamin supplements, choosing not to smoke. Any one of these factors could be influencing health. As described, this study does not prove that vitamin E is the key to disease prevention.

Additional variables that can cloud a study are called lurking variables. In order to prove that the explanatory variable is causing a change in the response variable, it is necessary to isolate the explanatory variable. The researcher must design her experiment in such a way that there is only one difference between groups being compared: the planned treatments. This is accomplished by the random assignment of experimental units to treatment groups. When subjects are assigned treatments randomly, all of the potential lurking variables are spread equally among the groups. At this point the only difference between groups is the one imposed by the researcher. Different outcomes measured in the response variable, therefore, must be a direct result of the different treatments. In this way, an experiment can prove a cause-and-effect connection between the explanatory and response variables.

The power of suggestion can have an important influence on the outcome of an experiment. Studies have shown that the expectation of the study participant can be as important as the actual medication. In one study of performance-enhancing drugs, researchers noted:

Results showed that believing one had taken the substance resulted in [performance] times almost as fast as those associated with consuming the drug itself. In contrast, taking the drug without knowledge yielded no significant performance increment.¹

When participation in a study prompts a physical response from a participant, it is difficult to isolate the effects of the explanatory variable. To counter the power of suggestion, researchers set aside one treatment group as a control group. This group is given a placebo treatment–a treatment that cannot influence the response variable. The control group helps researchers balance the effects of being in an experiment with the effects of the active treatments. Of course, if you are participating in a study and you know that you are receiving a pill which contains no actual medication, then the power of suggestion is no longer a factor. Blinding in a randomized experiment preserves the power of suggestion. When a person involved in a research study is blinded, he does not know who is receiving the active treatment(s) and who is receiving the placebo treatment. A double-blind experiment is one in which both the subjects and the researchers involved with the subjects are blinded.

Ethics

The widespread misuse and misrepresentation of statistical information often gives the field a bad name. Some say that “numbers don’t lie,” but the people who use numbers to support their claims often do.

A recent investigation of famous social psychologist, Diederik Stapel, has led to the retraction of his articles from some of the world’s top journals including Journal of Experimental Social Psychology, Social Psychology, Basic and Applied Social Psychology, British Journal of Social Psychology, and the magazine Science. Diederik Stapel is a former professor at Tilburg University in the Netherlands. Over the past two years, an extensive investigation involving three universities where Stapel has worked concluded that the psychologist is guilty of fraud on a colossal scale. Falsified data taints over 55 papers he authored and 10 Ph.D. dissertations that he supervised.

Stapel did not deny that his deceit was driven by ambition. But it was more complicated than that, he told me. He insisted that he loved social psychology but had been frustrated by the messiness of experimental data, which rarely led to clear conclusions. His lifelong obsession with elegance and order, he said, led him to concoct sexy results that journals found attractive. “It was a quest for aesthetics, for beauty—instead of the truth,” he said. He described his behavior as an addiction that drove him to carry out acts of increasingly daring fraud, like a junkie seeking a bigger and better high.²

The committee investigating Stapel concluded that he is guilty of several practices including:

• creating datasets, which largely confirmed the prior expectations,
• altering data in existing datasets,
• changing measuring instruments without reporting the change, and
• misrepresenting the number of experimental subjects.

Clearly, it is never acceptable to falsify data the way this researcher did. Sometimes, however, violations of ethics are not as easy to spot.

Researchers have a responsibility to verify that proper methods are being followed. The report describing the investigation of Stapel’s fraud states that, “statistical flaws frequently revealed a lack of familiarity with elementary statistics.”³ Many of Stapel’s co-authors should have spotted irregularities in his data. Unfortunately, they did not know very much about statistical analysis, and they simply trusted that he was collecting and reporting data properly.

Many types of statistical fraud are difficult to spot. Some researchers simply stop collecting data once they have just enough to prove what they had hoped to prove. They don’t want to take the chance that a more extensive study would complicate their lives by producing data contradicting their hypothesis.

Professional organizations, like the American Statistical Association, clearly define expectations for researchers. There are even laws in the federal code about the use of research data.

When a statistical study uses human participants, as in medical studies, both ethics and the law dictate that researchers should be mindful of the safety of their research subjects. The U.S. Department of Health and Human Services oversees federal regulations of research studies with the aim of protecting participants. When a university or other research institution engages in research, it must ensure the safety of all human subjects. For this reason, research institutions establish oversight committees known as Institutional Review Boards (IRB). All planned studies must be approved in advance by the IRB. Key protections that are mandated by law include the following:

• Risks to participants must be minimized and reasonable with respect to projected benefits.
• Participants must give informed consent. This means that the risks of participation must be clearly explained to the subjects of the study. Subjects must consent in writing, and researchers are required to keep documentation of their consent.
• Data collected from individuals must be guarded carefully to protect their privacy.

These ideas may seem fundamental, but they can be very difficult to verify in practice. Is removing a participant’s name from the data record sufficient to protect privacy? Perhaps the person’s identity could be discovered from the data that remains. What happens if the study does not proceed as planned and risks arise that were not anticipated? When is informed consent really necessary? Suppose your doctor wants a blood sample to check your cholesterol level. Once the sample has been tested, you expect the lab to dispose of the remaining blood. At that point the blood becomes biological waste. Does a researcher have the right to take it for use in a study?

It is important that students of statistics take time to consider the ethical questions that arise in statistical studies. How prevalent is fraud in statistical studies? You might be surprised—and disappointed. There is a website (www.retractionwatch.com) dedicated to cataloging retractions of study articles that have been proven fraudulent. A quick glance will show that the misuse of statistics is a bigger problem than most people realize.

Vigilance against fraud requires knowledge. Learning the basic theory of statistics will empower you to analyze statistical studies critically.