3 ms·

Biohacking in the sense of making E. coli grow on a different substrate, like in the ODIN kit, is pretty tame and unobjectionable. Promoting the manufacture an

Biohacking in the sense of making E. coli grow on a different substrate, like in the ODIN kit, is pretty tame and unobjectionable. Promoting the manufacture and administration of homemade vaccines, though, is human subjects research, or _very_ close to it. The current manner in which society handles human subjects research came about through reaction to specific offenses, the main ones being Nazi experiments, government studies such as the Tuskegee Syphilis Study, and common experimentation by clinicians on their patients. In reaction, definitions for human subjects research and principles to protect human subjects were established in the Nuremberg Code, Helsinki Declaration, and the Belmont Report. These principles exist not only to protect subjects but to avoid even the appearance of wrongdoing. Promoting experimental (biohacked) treatments and guiding people through administering them is not compatible with the currently accepted ethical framework for protection of human subjects, _especially_ if it's done with intent of generating scientific knowledge. That, I think, is a large factor in why government and corporate entities do not wish do be seen as supporting, even tacitly, biohacking on humans. If you do biohacking on yourself quietly, no one will really care, but publishing what you learned makes it scientific research, and if it was done to a human it's human subjects research. So yes, the root of the conflict probably is a lack of acceptance by the "official science cult", but this conflict does not seem arbitrary or frivolous. Extension of current approaches to human subjects research to accommodate a public DIY biology / biohacking community may be possible but seems tricky to do without accidentally deregulating the whole field.

ramblenode 5y ago
> Promoting experimental (biohacked) treatments and guiding people through administering them is not compatible with the currently accepted ethical framework for protection of human subjects, _especially_ if it's done with intent of generating scientific knowledge. > Extension of current approaches to human subjects research to accommodate a public DIY biology / biohacking community may be possible but seems tricky to do without accidentally deregulating the whole field. This is incorrect. The ethical framework and laws surrounding human subjects research pertain to institutions, not to individuals. In the US, there is no human subjects research board for unaffiliated scientists/hobbyists that could approve or deny their research based on ethical considerations, as there is for institutions. The Belmont Report that established IRBs was specifically motivated by institutional abuse of the kind you mention, not general quackery. Marketing of quackery falls under the purview of the US FDA. There is no regulator for independent science. If you are independent and including others in your research, you are only bound by general medical ethics. See https://www.weber.edu/IRB/irb_history.html https://www.weber.edu/IRB/irb_history.html
- jpeloquin 5y ago
  Yes, the fact that current regulations apply only to institutions is the point! When (unregulated) individuals function like scientific institutions, conflict results, because the current system was not designed with this in mind. The ethical framework does not apply only to institutions. Ethics are for everyone. Edit: If the prevailing attitude is that doing human subjects research as an individual ("biohacker") means research ethics can be ignored, because current regulations cannot punish you, it makes total sense that Paypal etc. would simply run away from it. Keep in mind that the article frames the biohacking effort as an equal alternative to institutional science. If it is to be seen as a legitimate and equal scientific enterprise, it needs to develop equivalent ethical governance.
- jpeloquin 5y ago
  > If you are independent and including others in your research, you are only bound by general medical ethics. The National Research Act and the Belmont report were created in opposition to this attitude. Henry Beecher led the fight (in the 1960s, preceeding the NRA and Belmont report) to make including others in your research be subject to research ethics, not just medical ethics, and to enforce this with regulation. The regulation was focused on institutions because at the time research was done by institutions. Now, post-internet and post-genetics revolution, we're retreading the same ground but with different details. A different approach is therefore warranted, but a free-for-all is just as unacceptable as it was in the early 20th century. I understand that this is unwelcome and is certainly inconvenient, but institutional science succeeded in regulating itself, and biohacking can do the same.
  - ramblenode 5y ago
    > A different approach is therefore warranted What is the different approach? 1. Autonomy (informed consent), 2. beneficence, 3. non-maleficence ("do no harm"), 4. justice (distribution of treatment where it is limited) are the principles that bind doctors who are operating on patients. What principles would you expect an independent researcher to uphold beyond what a doctor currently upholds? All other factors considered, as long as these principles are upheld, a doctor is free to try a new surgery for the purpose of exploring its effectiveness, i.e. engage in research. This is not new; private doctors have been testing procedures of varying risk without an IRB since the time of these commissions. Any researcher who violates these principles--where there is a harm to a research subject--is almost certainly liable under criminal fraud and torts laws. It is not a "free-for-all", as you characterize it.

ramblenode 5y ago

> Promoting experimental (biohacked) treatments and guiding people through administering them is not compatible with the currently accepted ethical framework for protection of human subjects, _especially_ if it's done with intent of generating scientific knowledge. > Extension of current approaches to human subjects research to accommodate a public DIY biology / biohacking community may be possible but seems tricky to do without accidentally deregulating the whole field. This is incorrect. The ethical framework and laws surrounding human subjects research pertain to institutions, not to individuals. In the US, there is no human subjects research board for unaffiliated scientists/hobbyists that could approve or deny their research based on ethical considerations, as there is for institutions. The Belmont Report that established IRBs was specifically motivated by institutional abuse of the kind you mention, not general quackery. Marketing of quackery falls under the purview of the US FDA. There is no regulator for independent science. If you are independent and including others in your research, you are only bound by general medical ethics. See https://www.weber.edu/IRB/irb_history.html https://www.weber.edu/IRB/irb_history.html

jpeloquin 5y ago
Yes, the fact that current regulations apply only to institutions is the point! When (unregulated) individuals function like scientific institutions, conflict results, because the current system was not designed with this in mind. The ethical framework does not apply only to institutions. Ethics are for everyone. Edit: If the prevailing attitude is that doing human subjects research as an individual ("biohacker") means research ethics can be ignored, because current regulations cannot punish you, it makes total sense that Paypal etc. would simply run away from it. Keep in mind that the article frames the biohacking effort as an equal alternative to institutional science. If it is to be seen as a legitimate and equal scientific enterprise, it needs to develop equivalent ethical governance.
jpeloquin 5y ago
> If you are independent and including others in your research, you are only bound by general medical ethics. The National Research Act and the Belmont report were created in opposition to this attitude. Henry Beecher led the fight (in the 1960s, preceeding the NRA and Belmont report) to make including others in your research be subject to research ethics, not just medical ethics, and to enforce this with regulation. The regulation was focused on institutions because at the time research was done by institutions. Now, post-internet and post-genetics revolution, we're retreading the same ground but with different details. A different approach is therefore warranted, but a free-for-all is just as unacceptable as it was in the early 20th century. I understand that this is unwelcome and is certainly inconvenient, but institutional science succeeded in regulating itself, and biohacking can do the same.
- ramblenode 5y ago
  > A different approach is therefore warranted What is the different approach? 1. Autonomy (informed consent), 2. beneficence, 3. non-maleficence ("do no harm"), 4. justice (distribution of treatment where it is limited) are the principles that bind doctors who are operating on patients. What principles would you expect an independent researcher to uphold beyond what a doctor currently upholds? All other factors considered, as long as these principles are upheld, a doctor is free to try a new surgery for the purpose of exploring its effectiveness, i.e. engage in research. This is not new; private doctors have been testing procedures of varying risk without an IRB since the time of these commissions. Any researcher who violates these principles--where there is a harm to a research subject--is almost certainly liable under criminal fraud and torts laws. It is not a "free-for-all", as you characterize it.