A diagnostic lab discovers that a reagent used in a test gives incorrect results in 5% of cases, but management wants to continue using the reagent without informing clients to save money. What ethical principles are violated in this scenario? How should the laboratory management address this situation?
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Medical technology has developed numerous procedures for testing for various diseases, drug use, etc. All such procedures are prone to some error. There is therefore a real concern with the occurrence of "false positives" (saying a subject has the condition when he in fact doesn't) and "false negatives" (saying the subject does not have the condition when he actually does). Suppose that a decision is made to test all driver's license applicants for drug use (or: all college athletes for drug or steroid use; or: all prison inmates for AIDS). Let's consider what the false positive rate might be under a variety of circumstances. a) Suppose first that everyone is tested for the condition, and that in reality two percent of the population has the condition. Suppose also that the test procedure used has 95% reliability — that is, whatever your condition, the test evaluates it correctly 95% of the time. What is the false positive rate? The false negative rate? b) One way to lower the false positive rate is to modify the test in a way that will make it harder to get a "positive" reading and easier to get a "negative" one. This will affect the reliability of the instrument. Let's suppose such a modification is made, which increases the chance of correctly identifying a person without the condition to 97.5%, but lowers the chance of correctly identifying a person with the condition to 90%. Now, what is the false positive rate for the problem in Part A? The false negative rate? c) Another way to lower the false positive rate is only to test some members of the population — those deemed particularly "at risk" or for whom there is some "probable cause" to suspect the presence of the condition. Let's suppose such a preliminary screening is done, eliminating much of the population from consideration. Of the remaining group, on whom the test is done, suppose that fully one-half have the condition of interest. Repeat Part A. Now, what are the false positive and false negative rates? d) What are the relative costs of false positives and false negatives? What implications do these results have for various testing programs?
Lien L.
Dr. Carley Featherstone is disappointed that the IACUC has rejected her research protocol because it involves the mouse ascites method of monoclonal antibody production. She appeals to the IACUC, citing her long use of this practice, prior approval to use the method at her previous institution in another state, and the loss of time that an immediate switch to in vitro methods would entail. She asks for permission to continue using the ascites method for 3 years while she phases in the in vitro production methods. The IACUC denies the appeal. She then resubmits the protocol, reporting that since she has found a commercial source for the monoclonal antibody, she no longer needs to produce it herself. The protocol is quickly approved. Dr. Emanuel Louis, a member of the IACUC, has a conversation with Dr. Featherstone a few months later. She tells him that her commercial source is a custom contract lab that she has engaged to produce the antibody using her cell lines and to her specifications (i.e., using the mouse ascites method). Is Dr. Featherstone's solution legal? Is it ethical? Why or why not? Dr. Louis comes to you for advice. Does he have any obligation to report this information to the IACUC?
Madhur L.
Meghan has been working with Dr. Tarner on a research study for the past year and a half. The have been collecting data on rat's flavor preferences. They have found some very promising results and presented their results at an international conference. They have recently submitted their findings to a top tier academic journal for publication. The reviewers of the manuscript had questions about some of the data that was presented in the manuscript. Meghan went back and reread the results section of the manuscript and also went back and looked at the data that was collected and entered in the statistics program, SPSS. She noticed that she mismeasured some of the solutions that were collected. Instead of measuring 50mls. of solution she actually measured 100mls. of the solution. Reflection Questions: Should Meghan not to tell Dr. Tarner about the error? What might happen if Meghan does tell Dr. Tarner about her error and then Dr. Tarner tells the editors of the journal? What are the ethical concerns is Meghan tells Dr. Tarner about her error, but Dr. Tarner does not the editors about the error?
Tavis L.
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