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Human Subject Research

HUMAN SUBJECT RESEARCH
Public health professionals engage in many kinds of practice that border on research, such as quality assurance, outbreak investigations, and program evaluation. These practices are standard for public health practices but in some instances can also seem to fit the definition of research in under the Common Rule and/or the HIPAA rule.
Rules and ethical obligations that apply to surveillance may differ from those that apply to human subjects research. An institutional review board (IRB) is used to protect all human subjects who are going to be part of a research project.
Reflect on the ethical misconduct during the noted cases. Then select one of those cases, or Find a recent example of surveillance or other program in public health that you think resembles public health research. (You may locate the example through an online search or draw on one from your own public health experience.) Reflect on the ethical misconduct during the noted cases. Find out if the program went through an IRB process, and argue whether or not you think the program ought to have done so.

QUESTIONS

1. Identify the public health intervention you selected and explain why you think it also might be considered an example of public health research.

2. Discuss whether you think this intervention should or should not be subject to the usual legal and ethical rules for conducting human subject research. What is gained or lost if this kind of intervention would be subjected to an IRB process?
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(One ethical misconduct case that comes to my mind is the Tuskegee Syphilis Study)

Some References

1.Clearing_the_myths_of_time-Tuskegee_revisited.pdf

2. UseAbuseTuskegee.pdf

3. Gostin, O. L. (2008). Public Health Law: Power, Duty, Restraint
(2nd. ed). University of California Press.

4. Benedek, T. G. (1978). The â??Tuskegee Studyâ?? of Syphilis: Analysis of Moral Versus Methodological Aspects. Retrieved from
http://www.brown.edu/Courses/Bio_160/Projects2000/Ethics/TUSK

Solution Preview

The Tuskegee experiment is a glaring example of an effort to understand and document research findings on the syphilis disease. Individuals in this case were unknowingly infected with syphilis, and a number of individuals that were involved in this experiment were already infected with the disease, but were not told that they were infected with the disease, nor were they treated for this disease. One ...

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