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Posted: December 11th, 2022
Week 12 Discussion Post – 300 words
Week 12 Discussion Post – 300 words
ANSWER ALL QUESTIONS
SUPPORT
1. Do you think that design of the SUPPORT study was ethical, why or why not?
2. In your opinion, did the SUPPORT study team deviate from the ethical principles during the informed consent process?
3. Place yourself in the shoes of the researcher conducting the SUPPORT trial, what steps could you have taken to fulfill the concerns raised by OHRP.
4. The article “Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants” mentioned the distinctions between “Treatment” and “Research” (Therapeutic Treatment and Experimental Research), how can a potential subject determine the difference between both if approached during an extremely vulnerable time based on the clinical setting, such as an Intensive Care Unit? What would you do as a researcher to ensure the subjects (or their legal representative) that you are recruiting understand the difference?
5. Some neonatologists were noted to have had concerns about the use of low oxygen support, and study investigators should have been aware of these risks. What reasons do you think could have swayed the research team to leave this risk off of the consent form? Please explain.
Required Reading:
Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT. The New England journal of medicine. 2013;368(20):1929-1931. doi:10.1056/NEJMe1304996. Accessed September 3, 2022.
Annas GJ, Annas CL. Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants. Journal of Contemporary Health Law and Policy. 2013;30(1):1-36. Accessed September 3, 2022.
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