Examine what the main options are that one might take in responding to the case, as well as the potential consequences (good and bad) of each.

Case Study 1 Assignment

1) Review the case study in (pages 2-3) and start your assignment by following the instructions bellow:

2) Write a short paper (4) pages suggested, double-spaced, 12 point font) discussing the ethical issues involved in the case you pick and providing your own ethical analysis of the case.

In writing your analysis of the case, please review the discussion of analyzing issues in applied ethics found in the video lectures in Learning Module 1 and in chapter 1 of Ethics and Public Health: Module Curriculum (pp. 3-4) for suggestions on how to approach cases in ethics.

In writing your paper, make sure to address the following issues:

Summarize the basic features of the case in your own words. What do you see as the main issue or ethical question as you see it?

Describe the relevant empirical/factual and conceptual issues involved in the case (as well as what information might be useful to have that is not given).

Discuss what persons or groups are potentially affected in the case (the stakeholders).
Identify the relevant ethical principles, rights or values that might be applicable in the case.

Examine what the main options are that one might take in responding to the case, as well as the
potential consequences (good and bad) of each.

Present your own view as to what the best response is and your reasons for thinking this is the best
response (including the ethical values, principles, or rights you would appeal to). Be as detailed as you can in describing what this response would involve or entail.

There may be other issues that students think it is important to discuss in relation to the case chosen, so this list is not meant to be exhaustive. Students should feel free to address other issues if they believe that these issues are important for understanding the case and their response to it.

3) The list above is meant as a general guide to the kinds of issues that you should make sure to cover in your case study discussion and cases will be graded based on the content of your response to these issues. However, students will also be grades on several other factors as well, including:
Case study responses should demonstrate familiarity with other relevant course material and should cite such material where appropriate.

Citations should be properly formatted in APA style (guidelines on APA style formatting are widely available, but if you need guidance, please let me know so that I can point you to appropriate resources).
Papers should be well written and carefully proof read. Grammatical and stylistic matters do affect the presentation of your ideas and will be considered in grading.
The rubric on which the case study will be graded (including how points will be assigned based on the various factors) will be provided shortly, you might wish to review it while working on your response.

Case Study 3: Anchorage Needle Exchange Program

An NIH sponsored study in Anchorage, Alaska was designed to determine whether over-the-counter sale of sterile drug injection equipment was more effective than needle exchange programs (NEPs). The study randomly assigned 600 intravenous drug users (IDUs) and 500 former IDUs to one of two arms: those in one arm were enrolled in a needle exchange program, and those in the other were given a map of pharmacies in Anchorage that sold syringes.

Researchers also sought to determine which method of needle distribution was more effective in preventing infectious diseases such as hepatitis and HIV, which are transmitted by shared needles. To this end, subjects were tested for hepatitis and HIV before and after the study period, with the number of new cases of those diseases indicating which method was preferable. Researchers additionally wanted to determine whether the availability of clean needles would cause a relapse in recovered users. Hepatitis B vaccination vouchers were provided to all participants. The conclusion of the researchers was that NEPs do not increase IV drug use.

Case Study 3: Discussion

Many ethical objections to this study were raised. Sidney Wolfe, MD, director of Public Citizen’s Health Research Group, opposed the study on the grounds that it was unnecessary since the study questions have already been answered by other experiments (Caplan and Annas 1999). Art Caplan, PhD, and George Annas, JD, MPH, add that the study would be unethical regardless of whether or not it was redundant: “the ethical argument invoked in defense of this morally repugnant design was that the knowledge to be gained could not be gained by any other methods and was of such value as to justify the design. This, of course, is precisely the justification some defenders of the Tuskegee trial argued at the time the study was being challenged as unethical” (Caplan and Annas 1999).

The most frequent objection centers on the fact that one group of study participants was deprived of the option of obtaining free needles and was thereby at increased risk of contracting hepatitis or HIV. Drug users assigned to the pharmacy arm might be prevented from buying needles due to poverty, lack of transportation, or denial by pharmacists (Recer 1996).

“The clinical trial at issue was constructed so as to leave subjects open to preventable infection by a serious disease by limiting their knowledge and their options” (Caplan and Annas 1999). Further criticisms focused on the use of the incidence of hepatitis B and HIV as endpoints of the study.

George Annas believes that the use of Hepatitis B (for which there is a vaccine) as an end point of the study is in violation of the 1947 Nuremberg Code, under which “no human experiment is to be conducted that could induce life-threatening—and preventable— harm” (in Benowitz 1997). However, the question of whether the experiment can be considered to “induce” hepatitis B is also a subject of debate. Nonetheless, in response to such claims, the NIH added the provision that participants be given vouchers for Hepatitis B vaccines. However, some critics argue that the vaccines themselves, and not just vouchers, should have been given (Recer 1996).

Caplan and Annas argue that the study allowed researchers to “stand by and observe as their subjects develop devastating diseases that could be prevented.” (1997). Others suggested that “treatment of the underlying medical condition and the social context were not addressed by the intervention, leaving the subjects persistently vulnerable to the possibility of disease.

The disconnect between the researchers’ agenda and the needs of the community under study parallels the Tuskegee study” (Corbie-Smith 1999b). Finally, the study was criticized for encouraging participants to break the law: “drug injectors in the study…are also instructed how to talk and dress in order to convince a pharmacist to sell them a syringe, a violation of local Anchorage law” (Lurie and Wolfe 1999).

Other commentators seek to justify the Anchorage study in its own terms and to distinguish it from the Tuskegee study. “Whereas in Tuskegee the PHS used the social circumstances of poor African- American men to manipulate them into a study that would deprive them of treatment, proposals to provide sterile injection equipment seek to address the vulnerable situation of those exposed to HIV by offering a potentially life-saving intervention….Only insofar as the original study failed to offer hepatitis B vaccination to participants did it arguably involve an ethical lapse—a lapse addressed by the NIH despite the recommendations of its ethical review panel” (Fairchild and Bayer 1999b). Needle exchange programs didn’t exist in Anchorage before the study, so drug addicts were not deprived of a service that they had grown used to—their access either improved or stayed the same. Like the men in the Tuskegee Study, some of the participants in the Anchorage trial were actively denied one type of intervention: they were refused access to the NEP.

In addition, none of the men were offered counseling or assistance in treating their addiction, just as the Tuskegee men were not told how to prevent the transmission of syphilis. However, the Anchorage participants were not prohibited from entering drug rehabilitation if they so chose, while at least some TSUS enrollees were actively prevented from seeking treatment for syphilis. Entrance into the Anchorage study was voluntary, and none were deceived.

Questions for Additional Discussion

􏰀  What aspects of the Anchorage study, if any, make it unethical? Would it make a difference if the research question had already been answered satisfactorily elsewhere, or if a NEP had been operating in the area previously and had been open to all, or if the pharmacy arm participants hadn’t been instructed in breaking the law? Does the inclusion of former IV drug users in the study, in a situation in which they might be tempted into a relapse by the easy availability of sterile needles, raise any ethical problems?

􏰀  As in the TSUS, the AIDS perinatal studies, and the KKI lead study, in the Anchorage study the development of disease was used as one of the study’s endpoints. Under what conditions, is the transmission or development of disease an appropriate endpoint?

􏰀  What is the level of risk that participants in this study might justifiably be asked to incur? Why? Is the Common Rule’s definition of ‘minimal risk’ relevant in this study (see Fact Sheet)? Does the actual level of risk faced in daily life by the current and former IDUs enrolled in this study differ?

􏰀  The Anchorage study was an NIH-sponsored study conducted by non-IDUs. To what extent is it ethically beneficial or ethically problematic that the study was conducted by “outsiders” to the community being studied (i.e., the drug-using community). Would it have been appropriate, for example, for former IDUs to have been recruited to work with researchers to recruit current IDUs as participants in the Anchorage study? In what ways would they have played a role like that of Nurse Rivers in the TSUS?

􏰀  Imagine yourself as a researcher hoping to enlist the support of African-American community leaders in a large urban setting for a pilot needle exchange project targeting African-American IDUs. First, who, or what sorts of leaders, would you approach? What would you anticipate their response would be to your proposed project? How would your plans differ if you were approaching another minority community in your area, and how might leaders of that community respond?

􏰀  How would you respond if African-American community leaders charged that you were pursuing a NEP as a cheap alternative to providing effective drug treatment and that such NEPs are in reality part of a genocidal conspiracy to eliminate poor African-Americans, just like the Tuskegee project was (see Fairchild and Bayer 1999b)?

Additional Resources
Fisher, D. (2000). Does Needle Exchange Cause an Increase in Drug Use? Presented at APHA meeting, abstract online at http://apha.confex.com/apha/128am/techprogram/paper_1914.htm.
Fisher, D. (2002). Selection effect of needle exchange in Anchorage, Alaska. Journal of Urban Health Mar 2002, 79 (1), 128-35.

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