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H . T . G . A . A .   |   RESEARCH ASSIGNMENT   |   WEEK 1

ETHICAL FUTURE OF BIOLOGY

Assignment: Design one “governance” action to ensure an “ethical” future for biotechnology Some example actions for ensuring non-maleficence (e.g. preventing harm) include: require ethics and safety training to get access to labs and materials, pre-registering potentially dangerous experiments, product safety standards and testing, licensing all synthetic biologists, create a whistleblowing mechanism for bad behavior, developing a safety innovation prize, etc.)

Concerns in Research Involving Risky / Pandemic Research

1. Goals & Rationale

The NIH has lifted its controversial ban on federal funding risky research and experimentation on easily transmittable, deadly pathogens in December in 2017. They examined the costs and benefits of allowing gain-of-function research, and created a framework document for these proposals to be approved and carried out. This is on the broad perspective.

There are many voices from all perspectives carried out regarding this change of approach regarding gain-of-function experiments, or generally risky research, especially considering the history of these research has introduced rather modest result rather than impactful discoveries that can help human prevent or establish solution against pandemics. Furthermore, the current issue is focused on worrying that human error could lead to the accidental release of a developed / enhanced virus, that regardless of what NIH approves, could very likely still cause destructive effects.

I’m interested in modifying the current system for the better, so that the human operation aspect of these experimentations are taken into consideration during this approval process, and that there is a continuity in oversight rather than just “The investigator and the institution where the research would be carried out have the demonstrated capacity and commitment to conduct it safely and securely” or just “allow for appropriate management of risks and ongoing Federal and institutional oversight of all aspects of the research throughout the course of the research” without any specific actions.



2. Design & Requirements

Human Error

- not only just oversight of the process, but also better interactions between the multiple layers of the hierarchy of the system
- reinforced simple systems: lab-partners, proper system that integrates both in and out of the lab transportation and disposal of potential harmful material to have complete
- limitation of lab access
- multiple risky research (e.g. malaria) was conducted as part of “student-project” within the nearby undergrad buildings with no supervision or warning of school administration, showing that there are multiple loopholes in systems.

Facilities Oversight
- unified lab training + specified training to deal with emergency situations
- awareness of surrounding, to avoid accidental contamination: public display of research progress if experiment is gain-of-function.

Bio - Engineering
- use safer approaches ( e.g. comparisons of gene-sequences using parts of a virus, rather than a whole live one ).



3. Assumptions & Risks of “Success”

Under the new NIH guidelines, there is an ambiguous statement that suggests that the government would potentially allow a risky experiment if there is no safer alternative method of addressing the same question, and individual research may be carried out without consideration of their impact. In the end, there can be well-rounded the solution but the reinforcement of these can always be problematic due to insufficient awareness of the situation.

One could also resort to safer approaches by avoiding direct experimentation on full, functional virus, where the research can be done on a larger scale without worrying about the consequences of pandemics, or look to more a more public publication or result so the collection of experiments can yield much more generalizable information than dangerous gain-of-function experiments.

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