Rio Salado Community College High Level Regulations on Biohacking Discussion

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Rio Salado Community College



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!

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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 (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 (Links to an external site.)

Biohacking and the Strange Future it Brings (Links to an external site.)

Is it time to regulate biohacking? California thinks so.

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High-Level Regulations on Biohacking – Outline
Thesis Statement: Therefore, high-level regulations should be developed for biohacking
practices that require qualified professionals, such as the grinder biohacking practices, because
their negative impacts outweigh their benefits.
I. Types of biohacking
A. There are three major types of biohacking. The first one involves manipulating one’s
body through nutrition.
B. This form of biohacking mostly focuses on the use of steroids in diets.
II. Consequences
A. Biohacking should monitor through high-level regulations to minimize its negative
impacts on people.
B. Though the practice has several benefits to humans and their productivity, its negative
impacts are unpredictable.


High-Level Regulations on Biohacking


High-Level Regulations on Biohacking
Before discussing whether high-level regulations such as the ones developed by the Food
and Drug Administration (FDA) are necessary for self-experimenting medication and devices, it
is necessary to weigh their benefits and challenges. In this case, mos...

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