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How does the ethical principles of research relate to how unethical Cornell research is ?

How does the ethical principles of research relate to how unethical Cornell research is ?

Social Psychology (10th Edition)
Social Psychology (10th Edition)
10th Edition
ISBN:9780134641287
Author:Elliot Aronson, Timothy D. Wilson, Robin M. Akert, Samuel R. Sommers
Publisher:Elliot Aronson, Timothy D. Wilson, Robin M. Akert, Samuel R. Sommers
Chapter1: Introducing Social Psychology
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How does the ethical principles of research relate to how unethical Cornell research is ?

using children in placebo-controlled trials. Would that fact outweigh any objections to such trials? Give reasons for your answers. *Alexis Jetter, "Efforts to Test Drugs on Children Hasten Drive for Research Guidelines," New York Times, 12 September 2000, http://www.nytimes.com/2000/09/12/ science/12 ETHI.html (6 March 2008). CASE 2 Research and Medicine Collide in Haiti (New York Times)-The impoverished patients who step from the dirt sidewalk into the modern AIDS research clinic run by Cornell Medical College in Port-au-Prince, Haiti, are offered a seemingly simple arrangement. "We would like to test your blood because you live in an area where AIDS may be common," the English version of the clinic's consent form reads. "We will provide you with medicine if you fall sick and cannot afford such care." But the transaction is not as straightforward as it sounds. Many Haitians who visit the clinic are at once patients and subjects of United States- financed medical research, and circumstances that are bad for their health are sometimes best for re- search results. That conflict is especially true in Cornell's most tantalizing research in Haiti, a study of sex part- ners, only one of whom is infected with the AIDS virus. Researchers, seeking clues to developing a vaccine, study the blood of both partners, particu- larly the uninfected ones who continue to be ex- posed to the virus through unprotected sex. They are trying to find out whether some people have natural protections against infection with the AIDS virus that could be replicated in a vaccine. The Haitians are ideal research subjects, largely because they are not receiving the kind of care now standard in the world's developed countries. Condom use is low in Haiti, for cultural and other reasons. Anti- retroviral drugs that are successful at suppressing Chapter 6: Human Research 287 the virus are unavailable except to the very wealthy, and are not included in Cornell's promise to provide medicine. Nearly 20 years after Cornell opened the clinic, it provides some of the best AIDS treatment avail- able in a country devastated by the epidemic, fight- ing the myriad illnesses that result from AIDS. But that is a lower standard of care than patients receive routinely at American institutions, including the hospital affiliated with Cornell in New York City. If the research were done in the United States, experts agree, the physicians would be obligated to prescribe the anti-retrovirals and deliver the most effective possible counseling against unprotected sex. The ethical questions posed by Cornell's work among Haiti's poor are at the heart of a global debate about AIDS research that is roiling international health organizations from Geneva to Thailand, chal- lenging ethics formulations established decades ago. "It's really like a Faustian bargain," said Marc Fleisher, a member of the committee at Cornell that reviews research on humans. "It's like, since we're making this a better place, we're going to exploit it in a way we could never get away with in the United States," said Mr. Fleisher, the outside member on a board made up mostly of university employees who are doctors. Cornell doctors defended the couples study as vitally important and stressed that its subjects re- ceive the same counseling about the dangers of AIDS and the same care as other patients at the Haitian clinic. United States standards for research on humans were strongly influenced by outrage over the Tuske- gee syphilis study earlier this century, which misled impoverished black subjects for years while track- ing their disease, and withheld treatment even after penicillin was discovered. Today's subjects are not to be pressured to par- ticipate in research, according to Federal regula- tions. They are to be fully informed about the research's purposes and risks. They must receive the best available therapy for their illnesses and be told about any findings relevant to their health. In theory, the same rules apply to federally fi- nanced studies overseas. But an examination of
Transcribed Image Text:using children in placebo-controlled trials. Would that fact outweigh any objections to such trials? Give reasons for your answers. *Alexis Jetter, "Efforts to Test Drugs on Children Hasten Drive for Research Guidelines," New York Times, 12 September 2000, http://www.nytimes.com/2000/09/12/ science/12 ETHI.html (6 March 2008). CASE 2 Research and Medicine Collide in Haiti (New York Times)-The impoverished patients who step from the dirt sidewalk into the modern AIDS research clinic run by Cornell Medical College in Port-au-Prince, Haiti, are offered a seemingly simple arrangement. "We would like to test your blood because you live in an area where AIDS may be common," the English version of the clinic's consent form reads. "We will provide you with medicine if you fall sick and cannot afford such care." But the transaction is not as straightforward as it sounds. Many Haitians who visit the clinic are at once patients and subjects of United States- financed medical research, and circumstances that are bad for their health are sometimes best for re- search results. That conflict is especially true in Cornell's most tantalizing research in Haiti, a study of sex part- ners, only one of whom is infected with the AIDS virus. Researchers, seeking clues to developing a vaccine, study the blood of both partners, particu- larly the uninfected ones who continue to be ex- posed to the virus through unprotected sex. They are trying to find out whether some people have natural protections against infection with the AIDS virus that could be replicated in a vaccine. The Haitians are ideal research subjects, largely because they are not receiving the kind of care now standard in the world's developed countries. Condom use is low in Haiti, for cultural and other reasons. Anti- retroviral drugs that are successful at suppressing Chapter 6: Human Research 287 the virus are unavailable except to the very wealthy, and are not included in Cornell's promise to provide medicine. Nearly 20 years after Cornell opened the clinic, it provides some of the best AIDS treatment avail- able in a country devastated by the epidemic, fight- ing the myriad illnesses that result from AIDS. But that is a lower standard of care than patients receive routinely at American institutions, including the hospital affiliated with Cornell in New York City. If the research were done in the United States, experts agree, the physicians would be obligated to prescribe the anti-retrovirals and deliver the most effective possible counseling against unprotected sex. The ethical questions posed by Cornell's work among Haiti's poor are at the heart of a global debate about AIDS research that is roiling international health organizations from Geneva to Thailand, chal- lenging ethics formulations established decades ago. "It's really like a Faustian bargain," said Marc Fleisher, a member of the committee at Cornell that reviews research on humans. "It's like, since we're making this a better place, we're going to exploit it in a way we could never get away with in the United States," said Mr. Fleisher, the outside member on a board made up mostly of university employees who are doctors. Cornell doctors defended the couples study as vitally important and stressed that its subjects re- ceive the same counseling about the dangers of AIDS and the same care as other patients at the Haitian clinic. United States standards for research on humans were strongly influenced by outrage over the Tuske- gee syphilis study earlier this century, which misled impoverished black subjects for years while track- ing their disease, and withheld treatment even after penicillin was discovered. Today's subjects are not to be pressured to par- ticipate in research, according to Federal regula- tions. They are to be fully informed about the research's purposes and risks. They must receive the best available therapy for their illnesses and be told about any findings relevant to their health. In theory, the same rules apply to federally fi- nanced studies overseas. But an examination of
15 years of records related to the Haiti couples re- search shows that it has received scant scrutiny from Government officials in Washington. And the Government's rules barely address the moral ambiguities of AIDS research in indigent countries.... Dr. Warren D. Johnson, the chief of interna- tional medicine and infectious diseases at Cornell, called the couples study "a very high priority," though he said it had been temporarily suspended while the university concentrated on other research in Haiti. "This is the critical group in the world- couples-that's where the war is to be fought," he said. At least 97 couples have been enrolled in the blood study since 1991, records show, but Dr. Johnson said only 30 couples are still being followed. The study will be expanded to new couples early next year, he said, and coordinated with AIDS vaccine trials, which are expected to start in Haiti this fall using similar couples as subjects. Cornell's clinic in Haiti offers strong induce- ments to subjects. It is the only center in the country providing free screening and treatment for H.I.V., venereal disease, and tuberculosis, a common com- plication of AIDS. The thousands who flock to it are too poor to buy food, let alone the simple medicines and vitamins that serve as "a powerful incentive for study participation," in the words of one Cornell grant report. The head of the clinic, Dr. Jean William Pape, is a Haiti native and Cornell professor who has studied AIDS in Haiti for two decades. Dr. Pape, who trained at Cornell, defended the treatment of research subjects in the couples study, saying they benefited from the same counseling and free condoms available to everyone who visits the clinic. Dr. Pape said that offering the life-saving drugs to the handful of research subjects would be an unethical lure to participate. Treating all H.I.V.- infected citizens, he said, would cost 10 times Haiti's health budget. If the research on couples succeeds, he said, it could help lead to a vaccine against AIDS. "You have to take into account people who mean well for their country and not impose on them things that you feel are good for Western ideas," he said.... The Haitians were valuable for another reason. Unlike AIDS patients in the United States and Europe, they were not receiving the anti-retroviral drugs that proved effective in halting the disease's progress. The lack of those drugs "may allow identification of novel findings not easily studied in the U.S.A.," Dr. John L. Ho, a Cornell immunologist, wrote in an application for Federal funds. In 1995, the Federal Government awarded Cornell an extra $60,000 to expand this part of the Haitian couples study.... Ethical standards for Federally financed studies require that patients be told why researchers want to study them. But the written consent form ap- proved at Cornell and read aloud in Creole to each potential subject does not mention that the study focuses on couples in which one sexual partner has tested positive for H.I.V. The form tells subjects their blood is being tested because "you live in an area where AIDS may be common." It promises all patients that H.I.V. test results will be kept confidential.... After reviewing clinic materials, Marie Saint Cyr, a native of Haiti who now directs an AIDS pro- gram for women in Harlem, said there was a "clear conflict of interest" between the desire to collect in- formation from research subjects and the obligation to effectively warn patients at risk. "If you know somebody is positive and is having sex with a partner who is negative, you have a life and death situation in front of you," she said. "You have to do individualized counseling to really tap into what those people value in life, to confront them with the reality of H.I.V. and AIDS. This in no way addresses those serious things."* Is the Cornell research ethical? Should subjects in the study get the same AIDS treatment available to people in the United States? Should the researchers provide stronger warnings to subjects about the dan- gers of not using condoms? Is the informed consent process morally acceptable? Explain your answers. *Nina Bernstein, "Strings Attached: For Subjects in Haiti Study, Free AIDS Care Has a Price," New York Times, 6 June 1999, http://www.nytimes.com/pages/health (6 March 2008).
Transcribed Image Text:15 years of records related to the Haiti couples re- search shows that it has received scant scrutiny from Government officials in Washington. And the Government's rules barely address the moral ambiguities of AIDS research in indigent countries.... Dr. Warren D. Johnson, the chief of interna- tional medicine and infectious diseases at Cornell, called the couples study "a very high priority," though he said it had been temporarily suspended while the university concentrated on other research in Haiti. "This is the critical group in the world- couples-that's where the war is to be fought," he said. At least 97 couples have been enrolled in the blood study since 1991, records show, but Dr. Johnson said only 30 couples are still being followed. The study will be expanded to new couples early next year, he said, and coordinated with AIDS vaccine trials, which are expected to start in Haiti this fall using similar couples as subjects. Cornell's clinic in Haiti offers strong induce- ments to subjects. It is the only center in the country providing free screening and treatment for H.I.V., venereal disease, and tuberculosis, a common com- plication of AIDS. The thousands who flock to it are too poor to buy food, let alone the simple medicines and vitamins that serve as "a powerful incentive for study participation," in the words of one Cornell grant report. The head of the clinic, Dr. Jean William Pape, is a Haiti native and Cornell professor who has studied AIDS in Haiti for two decades. Dr. Pape, who trained at Cornell, defended the treatment of research subjects in the couples study, saying they benefited from the same counseling and free condoms available to everyone who visits the clinic. Dr. Pape said that offering the life-saving drugs to the handful of research subjects would be an unethical lure to participate. Treating all H.I.V.- infected citizens, he said, would cost 10 times Haiti's health budget. If the research on couples succeeds, he said, it could help lead to a vaccine against AIDS. "You have to take into account people who mean well for their country and not impose on them things that you feel are good for Western ideas," he said.... The Haitians were valuable for another reason. Unlike AIDS patients in the United States and Europe, they were not receiving the anti-retroviral drugs that proved effective in halting the disease's progress. The lack of those drugs "may allow identification of novel findings not easily studied in the U.S.A.," Dr. John L. Ho, a Cornell immunologist, wrote in an application for Federal funds. In 1995, the Federal Government awarded Cornell an extra $60,000 to expand this part of the Haitian couples study.... Ethical standards for Federally financed studies require that patients be told why researchers want to study them. But the written consent form ap- proved at Cornell and read aloud in Creole to each potential subject does not mention that the study focuses on couples in which one sexual partner has tested positive for H.I.V. The form tells subjects their blood is being tested because "you live in an area where AIDS may be common." It promises all patients that H.I.V. test results will be kept confidential.... After reviewing clinic materials, Marie Saint Cyr, a native of Haiti who now directs an AIDS pro- gram for women in Harlem, said there was a "clear conflict of interest" between the desire to collect in- formation from research subjects and the obligation to effectively warn patients at risk. "If you know somebody is positive and is having sex with a partner who is negative, you have a life and death situation in front of you," she said. "You have to do individualized counseling to really tap into what those people value in life, to confront them with the reality of H.I.V. and AIDS. This in no way addresses those serious things."* Is the Cornell research ethical? Should subjects in the study get the same AIDS treatment available to people in the United States? Should the researchers provide stronger warnings to subjects about the dan- gers of not using condoms? Is the informed consent process morally acceptable? Explain your answers. *Nina Bernstein, "Strings Attached: For Subjects in Haiti Study, Free AIDS Care Has a Price," New York Times, 6 June 1999, http://www.nytimes.com/pages/health (6 March 2008).
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