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DATA ETHICS
Data collection, like all human endeavors, raises ethical questions. The biggest ethical issue involves collecting data from people, especially when an experiment that imposes some treatment on people is being implemented. Consequently, there are some basic standards of data ethics that must be observed when collecting data from human subjects through experimentation or sample surveys. Basic Data Ethics:
- Planned studies should be reviewed by a board to protect the subjects from harm.
- All subjects must give their informed consent before data are collected.
- All individual data must be kept confidential. Only summaries can be made public. Discuss the following studies with regard to ethics: Tuskegee Study (Quotation from the Report of the Tuskegee Syphilis Study Legacy Committee, May 20, 1996. A detailed history is James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment, Free Press, 1993.) In 1930, 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 share croppers 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 work leaked out and forced an end to the study in 1970s. Lasting impact of Tuskegee Study: NPR story from 10/2/06, “Female Hormone May Help Heal Brain Injuries” http://www.npr.org/templates/story/story.php?storyId=6179995&sc=emaf
Personal Space Study (R. D. Middlemest, E. S. Knowles, and C. F. Matter, “Personal space invasions in the lavatory: suggestive evidence for arousal, “ Journal of Personality and Social Psychology, 33 (1976), pp 541-546.) 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 rest room. They block off urinals to force men walking in to use either a urinal next to an experimenter (treatment group) or a urinal separate 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. Domestic Violence (Freeman website) 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 fact 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 treatment in random order. The police either arrest the suspect or warn and release him, depending on the contents of the envelope. The researcher 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 the evidence, arrest has become the common police response to domestic violence. :
washingtonpost.com EPA Devises Rules on the Use of Data From Pesticide Tests on Humans Standards Would Continue to Allow Some Studies Involving Children and Pregnant Women, Critics Say By Juliet Eilperin Washington Post Staff Writer Thursday, August 11, 2005; A The Environmental Protection Agency is set to release the first-ever federal standards governing use of data from tests that expose human subjects to toxic pesticides, but lawmakers and some medical experts said the rules fail to adequately protect children and pregnant women. The proposal -- which was obtained yesterday from the advocacy group Public Employees for Environmental Responsibility and will become public within weeks -- would limit the instances in which pesticide manufacturers could expose children and pregnant women to toxic chemicals, and would establish an independent board to gauge whether such human experiments meet established ethical standards. But the new rules, which will be subject to public comment before taking effect in about six months, allow some tests on vulnerable subjects and do not apply to studies conducted before the guidelines become law. Much of the controversy centers on whether it is acceptable to expose children and pregnant women to pesticides under any circumstances. One EPA official, who asked not to be identified because the agency has not published its proposal, said the EPA wanted to let manufacturers keep the option of testing on children such products as mosquito and tick repellents to ascertain their efficacy. For months, lawmakers have been dueling with Bush administration officials over how drastically they should curb tests that expose humans to toxic chemicals, including an insecticide used in chemical warfare during World War I. Two weeks ago, Congress prohibited the EPA from considering data culled from such experiments until the government enacts stricter national standards. For years, federal officials allowed manufacturers to conduct human studies on the grounds that they provided a clearer picture of how pesticides could affect the environment and public health. President Bill Clinton imposed a moratorium in 1998 out of concern that such tests harmed volunteers; although President Bush initially backed the moratorium, his administration abandoned it in 2003 to satisfy a court ruling in favor of pesticide makers, which argued that the federal government had not engaged the public fully enough before banning the information. EPA officials now consider data from human experiments on a case-by-case basis when judging whether to approve pesticides.
EPA spokeswoman Eryn Witcher said the new rule is "a landmark regulation that will extend very rigorous protections to the public.... Our proposal bans the intentional dosing of pregnant women and children with pesticides for toxicity studies, follows the recommendations set by the nation's highest science review panel, and adheres to the highest ethical standards set for federal agencies." However, Sen. Barbara Boxer (D-Calif.), who led the fight in the Senate to restrict pesticide testing on human volunteers, wrote a letter yesterday to EPA Administrator Stephen L. Johnson saying the proposal "fails to adequately ensure that people, including the most vulnerable among us, are protected from unethical industry tests in which human subjects swallow, inhale, are sprayed with, or are otherwise exposed to toxic pesticides." "I am writing to you so that you are personally aware that EPA appears to be heading on a course at variance with the dictates of Congress, as well as religious groups, public health and environmental groups that supported congressional action," Boxer added. "There is still an opportunity for EPA to change course. However, if you go forward with this approach, I am also putting you on notice that I will use every means available to ensure that EPA complies with congressional direction." Witcher said the agency will be able to comment in greater detail once the new rules are finalized, and "there will be ample opportunity for public feedback" before they take effect. Leo Trasande, assistant director of the Mount Sinai Center for Children's Health and the Environment, said after reviewing the proposal that the agency is on "a dangerous slippery slope" that could allow pesticide makers to conduct questionable studies as long as they said they were not aimed at gauging their products' toxicity. "EPA is again failing in its duty to protect children from pesticides and other toxic exposures," he said. CropLife America spokesman George Clarke, whose group represents the country's biggest pesticide manufacturers, said yesterday he will not comment on the EPA's plan until it is formally unveiled. © 2005 The Washington Post Company
More from this interview at : http://www.msnbc.msn.com/id/14091979/site/newsweek/ Allegra Goodman’s “Intuition” March 2006, Dial Press, NY. Recommended book (Good plot and characters, very well written—shows you what life in a research lab is really like. Trust me, it’s excellent!) Excerpt: As Feng examined the mice in one cage, Marion studied those in another. In silence Feng and Marion held each mouse gently, with gloved thumb and forefinger grasping the fold of skin behind the neck. Positioned on their backs, the mice flailed their legs helplessly and could not turn or bite while Feng and Marion measured their tumor with tiny calipers. Cliff had injected six groups of mice with breast cancer cells. Nine mice in each group. Fifty-four in all. After the tumors developed, he’d injected three groups with his virus, and set three groups aside for his control. Each experimental group had received a different genetic variant of the virus. The mice in two groups with the virus had already died, and those in the third group were close to death as well. Marion couldn’t help tsking for a moment at the waste. She wasn’t proud of sacrificing living creatures for the idle repetition of failed experiments. “Marion,” Feng said. He rarely spoke while working, and she started, surprised to hear his voice. “What is this?” He was turning a mouse slowly in his hand. “Is this mouse correct?” “What do you mean?” “Is it from the protocol?” Feng asked. “I’ve already checked that. This is the correct mouse. This is number 363,” she said, pointing to the metal tag on the mouse’s ear. “Then where is it?” Feng asked. “Where is what?” “The tumor,” he said. She took the mouse herself and turned and felt the wriggling body in her hands. Instinctively, the creature flexed its feet as Marion palpitated the first set of mammary glands. The tumor was barely perceptible, scarcely protruding on the animal’s neck. “Now look at this one. 365.” Feng lifted another mouse from the cage. “This one last week had a tumor 0.5 cm in diameter. Where is it now?” “They began to examine all the mice, comparing tumor size with the records in Feng’s lab book. Nearly all had tumors as big as, or slightly bigger than, they had seen before. Three mice, however, had tumors significantly smaller. How could this be? Somehow three tumors had actually shrunk. Marion and Feng looked at each other. After repeated failure, could one of Cliff’s viral variants actually have some effect? What had changed here? What had Cliff done? The variation of the virus was R-7. Cliff had scrawled a note on the blue index card labeling this cage of mice. But he’d never gotten R-7 to work effectively in live animals before. Were these three mice significant? Or were they outliers of some kind---tainted by some other condition? This was the difficulty with animal research: so many different things could go wrong. Cancer cells would not grow or grew too slowly, blood work was inconclusive, animals died of some extraneous illness. Despite all Marion’s
precautions, there had been an outbreak in the colony years before. Only a few animals had died, but Marion had terminated all her experiments anyway. “The mice were exposed to pathogens, and they’re tainted,” she’d announced at the lab meeting. “Obviously we can’t study cancer and some other unknown infection as well. What would we be looking at?” What were they looking at now? Probably nothing. And yet…What were the chances that Cliff had actually happened onto something? If there was a real cause and effect, if R-7 actually reversed the progress of cancer growth, then they must find out how. Marion was not excited; she would never pin her hopes on one such observation, but she could not let it pass either. (pgs. 26-7) (p.40) …Now suddenly seizing on Marion and Feng’s observations, Sandy found value in Cliff’s work. Marion had done some thinking about the genetic strains of mice that Cliff had used and how the genetic material in R-7 might have worked with these particular animals. But Sandy broke in to preview his plan of attack. They would seize on Cliff’s slim results as the linchpin for the lab’s new grant proposal. Prithwish and Robin would prepare new cells for analysis. “Meanwhile, Cliff and Feng will prepare four new groups of mice for injections.” Sandy beamed at them all, and Cliff and Feng and Prithwish could not help beaming a bit back at him, reflecting a little of his radiant imagination. It was up to Marion to douse them with disclaimers. “As you know,” she said, “connections like this can be tenuous at best. Myriad other factors can come into play. This set of experiments could amount to nothing. And there is always an opportunity cost when we—“ “Yeah, yeah, yeah,” Sandy interrupted. He met Marion’s skeptical look with a nearly irresistible expression of warmth and mischief. He actually put his arm around her shoulders and gave her a hug and a shake. “Nothing ventured, nothing gained.” Editorial Reviews From Publishers Weekly Starred Review. In another quiet but powerful novel from Goodman ( Kaaterskill Falls ), a struggling cancer lab at Boston's Philpott Institute becomes the stage for its researchers' personalities and passions, and for the slippery definitions of freedom and responsibility in grant-driven American science. When the once-discredited R-7 virus, the project of playboy postdoc Cliff, seems to reduce cancerous tumors in mice, lab director Sandy Glass insists on publishing the preliminary results immediately, against the advice of his more cautious codirector, Marion Mendelssohn. The research team sees a glorious future ahead, but Robin, Cliff's resentful ex-girlfriend and co-researcher, suspects that the findings are too good to be true and attempts to prove Cliff's results are in error. The resulting inquiry spins out of control. With subtle but uncanny effectiveness, Goodman illuminates the inner lives of each character, depicting events from one point of view until another section suddenly throws that perspective into doubt. The result is an episodically paced but extremely engaging novel that reflects the stops and starts of the scientific process, as well as its dependence on the complicated individuals who do the work. In the meantime, she draws tender but unflinching portraits of the characters' personal lives for a truly humanist novel from the supposedly antiseptic halls of science.
