do you feel that there should be “high level” (such as FDA) regulations on individuals and companies who are self-experimenting with medications and devices?
do you feel that there should be “high level” (such as FDA) regulations on individuals and companies who are self-experimenting with medications and devices?
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APA 7th Edition
As a senior project manager for several trials, I have had instances during interviewing the potential participant about their medications, in which they mentioned they were taking medications that their physician had created. What is this medication? Was it approved? Were there any trials? Is this going to interact with the meds in our proposed trial? Would it cause any interactions that could be classified as an SAE? Who do I need to touch base about this – sponsor, IRB? If this happened during my capstone project, what would be my next steps? Something to think about!
Take a look at the following:
HBO’s Vice News Tonight reported on a man who injected himself with an untested experimental gene therapy developed by a startup company that practices biohacking, also called do-it-yourself biology, which operates outside traditional scientific and government regulations. The man hoped that the therapy would cure his HIV. But should people experiment on themselves, especially with unregulated DIY products?
Karen J. Maschke, a Hastings Center research scholar and editor of IRB: Ethics & Human Research, spoke on the show about the safety risks and ethical
Biohacking is an open innovation and social movement that seeks to further enhance the ability of the human body. This includes humans trying to get cyborg like features, achieve hyper human senses, and also seek out new medicines and cures for disease via the promotion of self-experimentation.
Raising awareness about Biohacking may increase the prevalence of chronic diseases and extensive demand smart devices and drugs across the globe. For example. Apple Watch is one the most popular products in continuously health monitoring and tracking devices. “watchOS” launched by Apple featured G5 Continuous Glucose Monitor (CGM) which become popular among the iPhone users across the globe.
Being involved with clinical research, whether clinical, operational or regulatory, do you feel that there should be “high level” (such as FDA) regulations on individuals and companies who are self-experimenting with medications and devices? If so, how should this be monitored? Should there be consequences? What are your thoughts?
Additional resources:
- Genome at Home https://www.wired.com/2011/08/mf_diylab/ (Links to an external site.)
- Regulating Genetic Biohacking Regulating Genetic Biohacking.pdf
- This start-up raised millions to sell ‘brain hacking’ pills, but its own study found coffee works better https://www.cnbc.com/2017/11/30/hvmn-nootrobox-study-smart-pill-less-effective-than-caffeine.html (Links to an external site.)
- Biohacking and the Strange Future it Brings https://www.sdentertainer.com/lifestyle/biohacking-and-the-strange-future-it-brings/ (Links to an external site.)
- Is it time to regulate biohacking? California thinks so. https://www.msn.com/en-us/news/technology/is-it-time-to-regulate-biohacking-california-thinks-so/ar-AAFK8cu
Requirements: Per instructions
Subject: Health & Medical
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