Field Evaluation in the Intelligence and Counterintelligence Context Workshop Summary (2010) / Chapter Skim
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5 Ethical, Regulatory, and Cultural Considerations
5 Ethical, Regulatory, and Cultural Considerations
Pages 59-70
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From page 59... ...
ETHICAL CHALLENGES OF TRANSLATING RESEARCH INTO EFFECTIVE TECHNOLOGIES Adil Shamoo, chair of the medical ethics subcommittee of the Defense Health Board1 and editor-in-chief of Accountability in Research, opened the session with a discussion of ethical challenges of translating research in psychophysiology and neuroscience into technologies than can be used in intelligence and counterintelligence. Technologies based on psycho physiology include such things as the polygraph, voice stress analysis, the electrogastrogram, thermal imaging, and truth serums and narcoanalysis.
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From page 60... ...
The Helsinki Declaration of 1964 was produced by the World Medical Association to be a universally accepted set of ethics principles governing the behavior of doctors and other researchers doing studies with human subjects, and it included many of the same principles set out in the Nuremberg Code. In the United States the Tuskegee Syphilis Study, a controversial 40-year study of nearly 400 poor black farmers with syphilis, led to the establishment in the early 1980s of regulations to pro tect human subjects and later to the creation of the Office of Protections from Research Risks and to the requirement that federally funded human subjects research be overseen by institutional review boards.
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From page 61... ...
"These are the heart and soul of responsible conduct of research." A variety of regulations govern ethical issues dealing with human research, Shamoo noted, and which regulations apply to any particular research study depends on who is funding the study. If a study is funded by the federal government and it involves human subjects, the research ers must follow the Common Rule (45 CFR 46)
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From page 62... ...
Once a drug is approved by the FDA and marketed, it enters Phase IV, which is postmarketing surveillance looking for unexpected side effects that might not have shown up in the earlier clinical trials. Ethical Challenges Associated with Using Technologies Besides ethical issues related to human subject research, a variety of ethical issues are raised when technologies move beyond the research stage and are put to general use.
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From page 63... ...
It makes it possible to watch which parts of the brain are most active during different activities, which has potential for allowing researchers to determine, to at least some degree, what types of things a person is thinking about. It may be, for example, that more of the brain is activated when there is intentional deception than when one believes one is telling the truth, so some believe that fMRI or a similar imaging technology might someday serve as an accurate lie detector.
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From page 64... ...
This technique, which uses magnetic fields to induce changes in brain activity, influences such brain functions as visual perception, memory, speech, and mood, and it may have the potential to alter a person's social behavior or attitudes. One of the report's recommendations was that the army should examine transcranial magnetic stimulation for enhanced learning in soldiers.
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From page 65... ...
For instance, the usual research rules about informed consent and prior peer review do not apply to this kind of field testing. This doesn't mean that no ethical or regulatory standards apply, but it does mean that many of the usual requirements governing human subjects research may not apply, such as the Common Rule, FDA regulations, and certain Department of Defense regulations.
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From page 66... ...
Today, by contrast, there are many field trials undertaken in hospital emergency departments around the country, such as the testing of a new method to treat heart attacks, and they are considered to be clinical trials and therefore require informed consent from the patients and prior approval by an institutional review board. An FDA rule covers these emergency medicine trials and specifies the procedures that must be followed -- a situation that creates bureaucratic hurdles that frustrate many who do research in emergency medicine, Moreno said.
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From page 67... ...
"Field testing that includes development, testing, and evaluation designed to develop or contribute to generalizable knowledge is subject to prevailing ethical and legal conventions govern ing research." DISCUSSION The discussion session following the two presentations expanded on the speakers' comments and introduced some new topics as well. As Robert Fein noted, the ethical issues involved with field evaluation sometimes come face to face with various political and economic issues.
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From page 68... ...
On the issue of what constitutes research versus simple surveillance, planning committee member Robert Boruch of the University of Pennsyl vania noted that the level of record-keeping seems to play a large role. He mentioned a recent case involving researchers from a top-tier university who conducted a randomized trial in hospitals in which doctors and other health care providers were encouraged to wash their hands and engage in a series of other check-listed activities to enhance hygiene and reduce infection.
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From page 69... ...
The agency that produced the estimates was not interested in research ethics issues, he said -- from the agency's perspective, it was a quality control exercise rather than an example of research, and they had been going about it long before they came to think of it as research as a result of their partnership with Mandel and his team. From Mandel's perspective, however, he was engaged in research and was bound to go through the institutional review board process, even though the research had already been done.
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