3.77 Did you give informed consent? You were asked to participate in a study by a friend who is recruiting subjects. You trust your friend and you tell her that you are willing to do whatever is needed for the study. Have you given informed consent? Explain your answer.

3.78 Are the data confidential? You have participated in a study, and the results were published in an article in a very prestigious journal. Only summary information was published. The policy of the journal requires that all data used in the articles it publishes be available to the public, and it archives the data on a website. When you examine the data, you realize that you have a unique set of characteristics that would allow someone who knows you very well to identify which data are from you. Someone who does not know you would not be able to do this. Are the data confidential? Explain your answer.

3.79 Is the IRB responsible? An institutional review board (IRB) approved an experimental cancer vaccine for use in a clinical trial. The subjects were patients who had advanced disease and had received standard treatments with no success. Of the 94 subjects who received the vaccine, 26 died during the study. Their deaths were not due to the vaccine. Some family members of the subjects sued the hospital, the study director, the company that made the vaccine, a university official, individual members of the IRB, and the university bioethicist who consulted with the IRB.³¹ Discuss this case from the point of view of ethics. Include any additional information that you would need to form your opinion.

3.80 What is wrong? Explain what is wrong in each of the following scenarios.

3.81 How should the samples have been analyzed? Refer to the ovarian cancer diagnostic test study in Example 3.36 (page 209). Describe how you would process the samples through the mass spectrometer.

3.82 The Vytorin controversy. Vytorin is a combination pill designed to lower cholesterol. It consists of a relatively inexpensive and widely used drug, Zocor, and a newer drug called Zetia. Early study results suggested that Vytorin was no more effective than Zetia. Critics claimed that the makers of the drugs tried to change the response variable for the study, and two congressional panels investigated why there was a two-year delay in the release of the results. Use the Internet to search for more information about this controversy and write a report about what you find. Include an evaluation in the framework of ethical use of experiments and data. A good place to start your search would be to look for the phrase “Vytorin’s shortcomings.”

3.83 The General Social Survey. One of the most important nongovernment surveys in the United States is the National Opinion Research Center’s General Social Survey. The GSS regularly monitors public opinion on a wide variety of political and social issues. Interviews are conducted in person in the subject’s home. Are a subject’s responses to GSS questions anonymous, confidential, or both? Explain your answer.

3.84 Anonymity and confidentiality in health screening. Texas A&M, like many universities, offers free screening for HIV, the virus that causes AIDS. The announcement says, “Persons who sign up for the HIV Screening will be assigned a number so that they do not have to give their name.” They can learn the results of the test by telephone, still without giving their name. Does this practice offer anonymity or just confidentiality?

3.85 Anonymity and confidentiality in mail surveys. Some common practices may appear to offer anonymity while actually delivering only confidentiality. Market researchers often use mail surveys that do not ask the respondent’s identity but contain hidden codes on the questionnaire that identify the respondent. A false claim of anonymity is clearly unethical. If only confidentiality is promised, is it also unethical to say nothing about the identifying code, perhaps causing respondents to believe their replies are anonymous?

3.86 Use of stored blood. Long ago, doctors drew a blood specimen from you as part of treating minor anemia. Unknown to you, the sample was stored. Now researchers plan to use stored samples from you and many other people to look for genetic factors that may influence anemia. It is no longer possible to ask your consent. Modern technology can read your entire genetic makeup from the blood sample.

3.87 Political polls. The presidential election campaign is in full swing, and the candidates have hired polling organizations to take regular polls to find out what the voters think about the issues.

3.88 Should poll results be made public? Some people think that the law should require that all political results be made public. Otherwise, the possessors of poll results can use the information to their own advantage. They can act on the information, release only selected parts of it, or time the release for best effect. A candidate’s organization replies that it is paying for the poll to gain information for its own use, not to amuse the public. Do you favor requiring complete disclosure of political poll results? What about other private surveys, such as market research surveys of consumer tastes?

3.89 Informed consent to take blood samples. Researchers from Yale, working with medical teams in Tanzania, wanted to know how common infection with the AIDS virus is among pregnant women in that country. To do this, they planned to test blood samples drawn from pregnant women.

Yale’s institutional review board insisted that the researchers get the informed consent of each woman and tell her the results of the test. This is the usual procedure in developed nations. The Tanzanian government did not want to tell the women why blood was drawn or tell them the test results. The government feared panic if many people turned out to have an incurable disease for which the country’s medical system could not provide care. The study was canceled. Do you think that Yale was right to apply its usual standards for protecting subjects?