Day_8_102016_PHI+015+Presentation

Day_8_102016_PHI+015+Presentation - Dr Rulli PHI 015...

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October 20, 2016 Dr. Rulli PHI 015: Introduction to Bioethics 1
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Today’s Agenda Essay 1 due today Midterm exam, November 3 Bring your own scantron Payment of Research Subjects Emanuel, Wendler, Grady article: What Makes Clinical Research Ethical? 2
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Scantrons 3 - services/tda.html *Bring student ID # or fill in beforehand
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Paying Subjects for Research Should we pay subjects to incentivize them to do research? If so, how much is too much? Concerns about undue inducement
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Examples NIH Malaria infection study, N1H1 virus studies: $1,800-3,000 Skin biopsy study: $100/biopsy Scottish study: 600 British pounds to drink orange juice laced with pesticides National Institutes of Mental Health: paid $100 for healthy subjects to take ketamine (“date rape” drug)
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What to Pay? 3 Models for Payment: 1. Market Model- payment based on supply and demand 2. Wage-Payment Model- scale is based on other unskilled but essential jobs. Payment for labor/time. 3. Reimbursement Model- reimburses subject for expenses (time away from work, travel, etc.) Dickert and Grady, “What’s the Price of a Research Subject?”
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Seeing the Difference in Application Case: There is a study testing the effect of a protease inhibitor on the bioavailability of a narcotic pain medication. The study participants are healthy subjects. They must take the protease inhibitor daily for 12 days and come to the clinic 8 times. For 2 of the visits the participants must be in the clinic all day. Overall, the study takes 29 hours, including a screening exam, administration of the pain medication with blood collections, and follow up. The study offers no direct benefit, it involves discomfort of blood collection, and the meds might cause diarrhea, nausea, Dickert and Grady, “What’s the Price of a Research Subject?”
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Seeing the Difference in Application Market Model: would depend on the market. Maybe $1,125 ($25/hr + $200 for taking the meds + $200 for completion) Wage-Payment Model: $390 total.$10/hr (1998); around the national average for non-farm production workers, $50 for inconvenience of taking meds, $50 for the blood draws Reimbursement Model: reimbursement for travel, meals, parking. $195 Alternative: reimbursement for wages: would vary widely by profession Dickert and Grady, “What’s the Price of a Research Subject?”
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Pros/Cons for Each Model Market Model: Pros: meets demand, completion bonuses ensure completion, eliminates financial sacrifice of participation Cons: undue inducement? Competition among researchers, escalating prices, incentivizes participant deception? Dickert and Grady, “What’s the Price of a Research Subject?”
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Pros/Cons for Each Model Wage-Payment Model: Pros: Lessened undue inducement, standardized payment reducing competition between studies, reduces financial burden of participation Cons: less effective at enrolling people, attracts the poor rather than the wealthy, inappropriate commercializing of research?
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