Write an essay based on what you know about the drug discovery process so far and the key players involved, do you think anything should have been done differently before this study began?

In Module 1, Week 2, we were introduced to the key players involved in drug discovery. For this discussion, let’s dive deeper into the roles of these key players and the decisions they have to make.
Review the article, “Hennepin Healthcare suspends trial of paramedics administering ketamine”
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by the Associated Press. This article describes a recent study that has come under scrutiny for potential unethical practices. After reading through the article, please answer the questions listed under “What to Include”.
Resources
Module 1: Week 2 Content
Rubric for Discussions
“Hennepin Healthcare suspends trial of paramedics administering ketamine”
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by the Associated Press
“FDA says HCMC doctors kept ketamine study going after pledging to stop”
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by Andy Mannix
“Judge throws out patient’s ketamine lawsuit against HCMC”
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by Andy Mannix
What to Include
Complete your discussion by submitting a written post that includes answers to the following questions:
What is your initial reaction to this story? Based on what you know about the drug discovery process so far and the key players involved, do you think anything should have been done differently before this study began?
The purpose of the IRB is to make sure patients are protected and that a study is ethical. According to the articles, an IRB approved this study and allowed it to be classified as a “waiver of consent” study. Outside officials are now disagreeing with this classification and say it is unethical. Did the IRB fail at their job? If the local paper had not done its own investigation, this may have never been discovered. Do you think there should be checks and balances instituted nationwide for IRBs to prevent studies such as this one from happening? If so, what sort of checks and balances do you suggest be implemented?
Now read the article, “FDA says HCMC doctors kept ketamine study going after pledging to stop”
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by Andy Mannix and “Judge throws out patient’s ketamine lawsuit against HCMC”
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by Andy Mannix. What is your reaction? Do you have any further ideas on what could be done to prevent this from happening again?
Submit a peer response to two fellow students. Please comment on their responses. Do you agree with their answers? Why or why not? Peer responses should be submitted in written format.

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