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Cites, Sites, Sources and Notes

"Retroactive Moral Judgments and the Evolution of Ethics in Human Subjects Research: A Case Study in Context"

[June 30, 2001; last updated July 9, 2001]


Contents

Introductory Note

General Resources

Today's Standards -- and Continuing Abuses

Psychology's Special Problems

The Use and Abuse of Human Subjects in Developing Countries


Introductory Note

This paper does not pretend to be a doctoral dissertation, master's thesis, or academic paper.

It is primarily an opinion piece that puts the proposition that it is unethical, immoral, possibly illegal, and certainly unproductive, silly and unfair to express great moral outrage at the ethics of a college student's single human subjects research project in the 1930s.

Thus, the paper is not larded with footnotes or accompanied with the product of a thorough literature search. This "Cites and Sites" is more in the nature of a collection of illustrations -- although it contains links to some pretty thorough lists of cites and sites.

Virtually all the supporting research that was done came from the Internet and the rich lodes of material provided by a Google search (www.google.com) on such terms as human subjects, research, ethics and history. In some searches social psychology was also used. Links change over time, of course, but those used here were accurate as of June 30, 2001, unless a more current date is noted.

All the cases described in the paper are from U.S. Government or other sources listed here and believed to be reliable. Many are classics found in many textbooks and historical accounts.

The text is deliberately devoid of references to named individuals. Since the paper expresses a moral objection to the journalists, editorial and letter writers, and administrators who were willing to engage in the castigation, by name, of the researcher and supervisor of the 62-year-old study in question, the author considered it inappropriate to engage in the same behavior that was being criticized. In many cases their names can be discerned from public records, but they are at least not named in the paper.

-- N.J., June 30, 2001


General Resources

The National Library of Medicine's "Current Bibliographies in Medicine" series includes one on "Ethical Issues in Research Involving Human Participants," Current Bibliographies in Medicine 99-3, http://www.nlm.nih.gov/pubs/cbm/hum_exp.html. It runs 275 pages and includes nearly 5000 references; begin with the "Table of Contents." The Introduction notes the significance of the President's 1997 apology to the survivors of the Tuskegee Syphilis study in terms of the reforms that followed. For example, it says, "Contemporary safeguards such as [IRBs] are important, but by themselves are insufficient. Educating researchers and the public about research ethics is critical for the full protection of research participants." This bibliography is itself a consequence of that finding, and the work of the Bioethics Education Materials and Resources Subcommittee of the National Bioethics Advisory Commission.

The Nuremberg Code (1948), Declaration of Helsinki (1964), and Belmont Report (1979), are examples of basic documents available as links from a number of sites.

Of course, the U.S. Department of Health and Human Services' Office for Human Research Protections is a prime site for links to many of the basic documents both historical and current. http://ohrp.osophs.dhhs.gov/polasur.htm One of its pages provides links to educational material for researchers about human subjects ethics. http://ohrp.osophs.dhhs.gov/educmat.htm

Professor Lawrence M. Hinman at the University of San Diego maintains an "Ethics Update" site with many links. It focuses broadly on ethics rather than being limited to human subject research. It's found at http://ethics.acusd.edu/

A "Research Ethics" collection of links is maintained at Swinburne University of Technology in Melbourne, Australia. http://ecco.bsee.swin.edu.au/studes/ethics/ Among other things, it contains a handy list of the human subjects research ethical standards of international and U.S. bodies. The University also provides online a bibliography of 464 hard copy publications, "Teaching Research Ethics: Annotated Bibliography." http://ecco.bsee.swin.edu.au/studes/ethics/ethics-biblio.html

The Virginia Commonwealth University's site, "Ethics of Research Involving Human Participation," contains useful links. http://www.vcu.edu/hasweb/psy/faculty/fors/ethics.htm

Many of the Phase II cases cited in the paper came from the Department of Energy's Advisory Committee on Human Radiation Experiments Report, DOE Openness: Human Radiation Experiments. http://tis.eh.doe.gov/ohre/roadmap/achre/ The Committee was established by the President in 1994. Especially helpful is the general historical overview found in "Part I. Ethics of Human Subjects Research: A Historical Perspective." http://tis.eh.doe.gov/ohre/roadmap/achre/overpt1.html

The Society of Professional Journalists' "Code of Ethics" is available online at http://www.spj.org/ethics/code.htm .


Today's Standards -- and Continuing Abuses

The suggestion that today's research institutions and individuals possess a moral superiority to their predecessors, that there are standards in place today to prevent any possibility of the problems of earlier times, is a triumph of arrogance over experience. The abuses detailed in  DHHS Office of Inspector General's report, "Protecting Human Research Subjects," referred to in the paper, were published as recently as April 2000. It is available online in pdf format.  http://www.os.dhhs.gov/progorg/pei/reports/447.pdf

The NIH requirement of "education on the protection of human research participants for all investigations" was established even later, in October 2000. One institutional response has been a simple online summary presentation of some highlights that researchers are required to scan. An example is the University of Michigan's "Protection of Human Research Subjects Computer-Based Training for Researchers." http://www.umich.edu/~drda/training Stanford University offers a similar "Use of Human Subjects in Research: History" tutorial module. http://www.stanford.edu/dept/DoR/hs/History/his01.html

The idea that today's super-sensitivity about human subject research ethics is both preventing research that needs to be done, and producing unfair moral judgments about that which has gone before is supported by a couple of articles: Christopher Shea, "Don't Talk to the Humans," Linquafranca, vol. 10, no. 6, September 2000, http://www.linguafranca.com/print/0009/humans.html, and John R. Stanley's "Ethical Accusations: The Loss of Common Sense," Archives of Dermatology, vol. 136, no. 2, February 2000, http://archderm.ama-assn.org/issues/v136n2/ffull/dlt0200-4.html.

Shea discusses examples of IRBs interfering with research in anthropology, history, journalism, public policy (researchers' interviews with government officials) and urban ethnography.

He cites the case of one Ph.D. candidate in history who also works as an editor at a major local paper. "So during the day, when he's working on his dissertation, he is supposed to get permission from an IRB before he talks to a retired governor or columnist. . . . At night, he can call up anyone he wants and grill them."

Shea makes the distinction between what he characterizes as the ethical equivalent of "run[ning] a red light on a deserted street at 3:00 a.m." (by someone who was very nearly denied tenure for his offense) and some of the ongoing ethical violations:

"You would not get the impression that human-subject committees are overly aggressive from reading the newspapers. In September 1999 a young man died while undergoing experimental gene therapy at the University of Pennsylvania, and his father subsequently claimed that no one had fully explained the risks involved in the treatment. Since the fall of 1998 the National Institutes of Health (NIH) have shut down research programs at eight institutions, including Duke University Medical Center, the University of Illinois at Chicago, and Virginia Commonwealth University. The NIH cited violations that ranged from inadequate record-keeping to a failure to review projects that should have been vetted."
The statement that 95 percent of children with cancer are involved in clinical trials is from Timothy J. Eberlein, "Medical Insurers Should Pay for Clinical Trials of Experimental Cancer Treatments," Washington University St. Louis Record, Feb. 17, 2000. http://wupa.wustl.edu/record/archive/2000/02-17-00/articles/eberlein.html

There are undoubtedly dozens of less dramatic examples of practices raising ethical issues that have not yet been addressed in today's standards. By way of illustration, the author of this paper is currently a subject in a major research university's clinical trial of a new drug. It is apparently standard practice to require such subjects, who are taking at least some risk for no pay in a project from which everyone else is profiting, to sign a couple of waivers. One absolves the institution not only from any liability for harm, but even liability for negligence! The other seems especially uncaring. The testing institution, which is after all a major research hospital, expressly leaves any subjects who are harmed by the study entirely on their own in their search for subsequent medical care. Is this ethical? Under today's standards apparently it is. Will we take another view of the matter in the future? One would hope so. And, if so, will moral outrage then be voiced about those who utilized such overreaching waiver language today? One would hope not.

All of the above assumes, of course, that the only human subjects entitled to consideration are those with the good fortune to live in North America. The fate of subjects in developing countries, used by U.S. research institutions and corporations, is another matter. See The Use and Abuse of Human Subjects in Developing Countries, below.


Psychology's Special Problems

By definition, a large number of psychological experiments involving human subjects, if they are to be successful, require some misrepresentation of their purpose to the subjects.

This is especially so in the field of social psychology when testing hypotheses involving the impact of groupthink, or authority, on the perception, attitudes and behavior of the uninformed subjects of the study. By definition, if such studies are to be done at all, they require a number of instructed participants (who constitute the "group" and who know what's going on) and an innocent, uninformed individual. The experiment then tests how the unsuspecting human subject responds to the group's pressures. Such a study necessarily involves at least some measure of deception. If the human subject were fully informed it would ruin the study.

This dilemma is illustrated by a College of William and Mary professor, Dr. Kelly G. Shaver. The course is "Psychology 414: Experimental Social Psychology." http://www.wm.edu/PSYC/advsoc.html The course materials contain a link to a pdf file of presentation notes entitled, "Ethical Issues in Social Psychological Research." http://www.wm.edu/PSYC/exp2k/exp2k5.pdf One of the slides, headed "Deception As A Method," has bulleted:

The slide does not reveal what is said to students on these topics, but they do not seem to contemplate that deliberate deception is to be absolutely forbidden under all circumstances.

Shea, cited above, provides a dramatic example of after-study consequences from such psychological experiments:

"The history of psychology, for example, is studded with experiments whose designers gave too little thought to the well-being of their subjects. As the Atlantic Monthly recently reported, in the early 1960s the young . . . was among a group of Harvard students garlanded with electrodes and confronted by skilled lawyers who ridiculed and demolished what the students avowed were their most deeply held beliefs. No one explained the experiment in advance; the psychologists wanted to see how the students would handle the stress."
Who was Shea referring to as the "1960s young [student]"? It was "Theodore Kaczynski -- the future Unabomber."

The American Psychological Association has its own "Ethical Principles of Psychologists and Code of Conduct." http://www.apa.org/ethics/code.html  Moreover, there are other aspects of psychological research that attracts critics' attention. Enough so that it may constitute a sufficient body of literature for a college course, such as Dennis Fox's at the University of Illinois at Springfield in which he uses the collection of readings that he and Isaac Prilleltensky have edited in Critical Psychology: An Introduction (1997). Not surprisingly one of the book's chapters deals with ethics. A Web site provides a summary of that chapter. http://www.uis.edu/~fox/critpsy/book.html#4

Many professors now use Web pages in connection with their teaching. An example is provided by those of Dr. Melanie Green, University of Pennsylvania, and her "Psychology 170: Social Psychology" class. http://www.psych.upenn.edu/courses/psych170/ The questions and notes under "Research Ethics" on the "Research Methods" page are illustrative of the issues raised with students today. http://www.psych.upenn.edu/courses/psych170/methods.html

If we are concerned about the "informed consent" of prisoners, how much informed consent can a psychology major provide when participation is a requirement of a course, and the course is a requirement of the major? When the author of this paper was a college student in the 1950s and took a course in social psychology it was a requirement of the course to participate in the experiments of graduate students. Apparently the practice continues. See the "Announcements" page. http://www.psych.upenn.edu/courses/psych170/announce.html

Another example is California State University at Hayward Professor Joan Sieber's Social Psychology lecture on "Social Psychology and Ethics." http://www.telecom.csuhayward.edu/~psy3500/ethics1a.html

About.com, as the name suggests, has links to articles on a wide variety of subjects, including psychological research. "Classic Research on Social Conformity," http://sociology.about.com/science/sociology/library/blconformity.htm, contains links to classic studies by Solomon Asch, Stanley Milgram and Philip Zimbardo. "From Sing Sing to the Basement of Jordan," http://psychology.about.com/science/psychology/library/weekly/aa060100a.htm (there are four parts), provides a summary of Zimbardo's "Stanford Prison Experiment."

Professor Zimbardo created a simulated prison in the basement of a classroom building at Stanford to test the behavior of the students assigned the roles of guards and prisoners. Before it was over the prisoners had been strip searched, sprayed, chained, made to wear dresses and clean toilet bowls barehanded, deprived of sleep, made to do pushups, otherwise humiliated and degraded and brought to fits of hysterical crying. One "[broke] down emotionally as a way to escape the situation. [Another] developed a psychosomatic rash over his entire body." A fulsome report, complete with photos and videos, is provided at http://www.prisonexp.org/ courtesy of the creator and supervisor of the study.

The Milgram study is the one at Yale that involved subjects who followed orders to provide what they were told were subjects of a study with what they were told was as much as 450 volts of electricity (labeled, "Danger: Severe Shock"). It is discussed in "Obedience to Authority: Revisiting Milgram's Classic" (a five-part report). http://sociology.about.com/science/sociology/library/weekly/aa012501a.htm
 And see CSU Hayward Professor Sieber's lecture, "Obedience and Rebellion." http://www.telecom.csuhayward.edu/~psy3500/lect1.html

Experiments involving the inmates of the Holmesburg Prison in Philadelphia are the subject of a book by  Allen M. Hornblum, Acres of Skin (1998). An online bookstore's synopsis of Hornblum's book says, "From the mid-1950s through the mid-1970s, inmates of Philadelphia's Holmesburg Prison were used, in exchange for a few dollars, as guinea pigs in a host of medical experiments. Hornblum paints a disturbing portrait of abuse, moral indifference, and greed, as doctors, in conjunction with the University of Pennsylvania and prison officials, established the prison as a testing lab." The Foundation for Truth in Reality Bookstore Web page for Acres of Skinhttp://www.ftrbooks.com/psych/nazi/acres_skin.htm.

John R. Stanley, MD, "Ethical Accusations: The Loss of Common Sense," Archives of Dermatology, vol. 136, no. 2, February 2000,
http://archderm.ama-assn.org/issues/v136n2/ffull/dlt0200-4.html. (In a correspondence regarding Allen M. Hornblum's book, Acres of Skin: Human Experimentation at Holmesburg Prison (1998), the author of this letter says, "The first red flag indicating loss of common sense is to describe patch testing and skin biopsies as horrendous experiments. . . . These comparisons [of "what happened at Holmesburg Prison with Nazi human experimentation"], in my mind, are illogical and inflammatory, and have the potential of doing great harm . . .." The observation is almost directly applicable to the criticisms of the stuttering study, which was characterized as "the monster study," and also involved a comparison of the researcher and supervisor to Nazis.)

The review of Hornblum's book by Evelyne Shuster, Ph.D., in the Journal of Criminal Justice and Popular Culture, 6(1) (1998), 4-9, also asserts that "the research conducted at Holmesburg bears no resemblance to that conducted in Nazi concentration camps." The chapter on prison research is now closed," she says, and "prisoners of poverty rather than of stone are the current favorites of researchers. . . . [I]f we take human rights seriously, contemporary medical research on human subjects cannot afford to replace prisoners of stone with prisoners of poverty -- the poorest members of the poorest nations." It is on the Web at http://www.albany.edu/scj/jcjpc/vol6is1/shuster.html.


The Use and Abuse of Human Subjects in Developing Countries

The World Health Organization (WHO) is involved in evaluating the ethics of a number of aspects of medical care in developing countries. Among its concerns are ethical issues surrounding the use of human subjects in developing countries by researchers and corporations in the developed world. As with U.S. manufacturers' exploitation of developing countries' prison, slave and child labor in sweatshops at poverty wages, so have U.S. pharmaceutical companies sometimes dumped drugs in developing countries that have been rejected by the FDA for sale in the U.S. Similarly, the concern for human subjects research ethics when Americans are involved in studies tends to evaporate beyond our borders. As one author has put it, researchers are "changing their ethics ' at the customs desk.'" Paul M. McNeill, "Should Research Ethics Change at the Border?" The Medical Journal of Australia, 1998; 169: 509-510. http://www.mja.com.au/public/issues/nov16/mcneill/mcneill.html

The WHO has an ethics page on the Web. http://www.who.int/aboutwho/en/ensuring/ethics.htm It also has a page listing its ethics publications, "World Health Organization Publications: 1991-2001." http://www.who.int/dsa/cat98/ethic8.htm One of those publications refers to "current ethical controversies as experienced in Argentina, Brazil, Canada, Colombia, Chile, Spain, the United States, Mexico and Peru." Another asserts that there is "a growing perception that research involving human subjects is beneficial rather than threatening and that vulnerable groups, such as women, children, the elderly, and prisoners, should not be deprived arbitrarily of the opportunity to benefit from investigational drugs, vaccines or devices."

The Centers for Disease Control and Prevention has a "Human Subjects Research" page, http://www.cdc.gov/od/ads/hsr2.htm, and provides the text of the Council for International Organizations of Medical Sciences (CIOMS), "International Guidelines for Ethical Review of Epidemiological Studies" (Geneva, 1991). http://www.cdc.gov/od/ads/intlgui3.htm

As recently as March 2000 the New England Journal of Medicine reported a study reminiscent of Tuskegee done by researchers from no less prestigious research institution than Johns Hopkins. In the Rakai region of Uganda they monitored 415 couples of which only one partner was infected with HIV. The researchers did not inform the AIDS-free partners. Thirty months later 90 of the formerly healthy spouses had become infected. The journal's editor charged that the study was unethical by U.S. standards. "Ethics of Medical Research in the Third World," AllAfrica Global Media, Feb. 2, 2001. http://allafrica.com/stories/200102020128.html

Paul M. McNeill, cited above, reports that as a result of providing HIV-infected mothers with placebos as a part of studies in Thailand, Africa and the Caribbean, their children were unnecessarily, and deliberately, permitted to develop AIDS.

The author of this paper is the son of the supervisor of the 1939 study.



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