believe that the policies in place in the United States f ✓ Solved

Question 1: Believe that the policies in place in the United States for dual-use and gain-of-function research is comprehensive and addresses current and potential threats, but not to the full extent of potential threats. According to the National Institutes of Health, the United States has systems in place to evaluate risks and benefits of Gain of Function experiments while ensuring the integrity of the research isn’t surrendered in the name of the misuse of information and products from the research.

On the other hand, extending trust to the scientific community, especially during a crisis is key to avoiding overregulation. I agree with Senator Joseph Lieberman that decisions on publications cannot continue to be ad hoc. While the nature of each case of research and the surrounding information is unique, I think the default should be stricter than necessary; I like to err on the side of caution. Currently, the Presidential National Security Decision Directive states that basic research will remain unclassified unless deemed a threat to national security, but there are no clear-cut boundaries.

This seems reactionary, where anything can be published and be made readily available until an organization with ill intent starts taking actions or making threats that prove otherwise. Then, aspects of the publications are redacted. Personally, that’s a little too late. The DURC policy currently applies to only 15 agents deemed most dangerous. This is out of approximately 80 agents that have the potential to be weaponized with terrible effects.

Modifications to the Select Agent Rule have been proposed that would require additional biosecurity and biosafety training for any individuals with measurable exposure to these agents. This would increase the monitoring and accountability, as a pathogen being weaponized would probably have its origins in a facility where the agent is being tested or having research. I think this is a great first step to responsible increased oversight by the government.

Another step in the right direction would be to have only research, medical, government, and other relevant institutions access the full methods, materials, procedures, and conclusions of these sensitive levels of research. All those individuals would need to be vetted for those positions anyway, and this method is a form of quality control for the information. While I agree that the public absolutely has a right to know what the scientific community is doing, the average person doesn’t need to have that depth of detail to be able to sleep well at night.

This way, the scientific community is still building off each other in a healthy way while the integrity and trust are maintained. Initially, I believed an international tribunal organization would be a good method for checks and balances, but every country has its own definition of what’s appropriate to publish based on their national security health.

It would be difficult to know who would be included or excluded from that discussion. Also, there might be a political conflict of interest for certain nations to have all the information available for review to determine what should be censored. Question 2: I believe the US policies for oversight of dual-use research are currently appropriate, but it is not comprehensive enough.

I believe this because there are checks and balances between government and academia concerning the research being conducted. There are currently only two countries that regulate such research, the United States and Israel. In the case of the US, there exists a balance between academic institutions and the government, in contrast to Israel, where government oversight is the sole entity.

If the US were to mirror Israel, then I would have concerns, as this seems to be a conflict of interest with only the government interests at hand. The People’s Republic of China is in the final stages of adopting their policy, and I can only imagine that the government will be in strict control. In this case, I guess at least there will be some oversight.

Regarding the comprehensive nature of the US policy, I believe that the policy should be increased with oversight. This is because the US policy does not clearly state that if the risks of the research outweigh its benefits, risk mitigation measures should be undertaken to ensure that the balance is reversed. This highlights a gap that should be minimized to mitigate risk.

Paper For Above Instructions

Dual-use research of concern (DURC) and gain-of-function (GOF) research are critical areas of concern within the field of bioscience and public health. These terms refer to research that has the potential to be misused for harmful purposes, such as bioterrorism or pandemic outbreaks. The existing policies in the United States surrounding these research areas have sparked debates regarding their comprehensiveness and effectiveness amid rising global biothreats.

In evaluating the adequacy of the policies in place for DURC and GOF research, it is essential to acknowledge both the mechanisms established to oversee research and the inherent shortcomings that may compromise public safety and security. Historical context illustrates that while the National Institutes of Health (NIH) and other government entities have instituted regulations intended to mitigate risks associated with life sciences research, the evolving nature of biological threats necessitates continual reassessment of these strategies.

The NIH asserts that its current frameworks for oversight include rigorous evaluations of scientific research proposals, focused on ensuring both safety and the integrity of scientific inquiry (NIH, 2020). However, the scope of existing policies seems insufficient given the complexities of modern bioscience. A significant concern remains regarding the limited number of pathogens currently classified under the DURC policy—only 15 agents—while over 80 agents have the potential for dual-use implications (Wolinetz, 2012).

The Presidential National Security Decision Directive enacted in 1985 arguably lacks specificity, as it does not provide explicit guidelines on when research should be classified based on its potential threat. As such, there exists a reactive rather than proactive posture when it comes to managing publication and dissemination of sensitive research findings. This has raised alarms regarding the government’s ability to address potential risks effectively before they manifest.

Additionally, the proposed modifications to the Select Agent Rule suggest a move toward greater accountability, requiring individuals with access to dangerous pathogens to undergo adequate biosafety and biosecurity training (Wolinetz, 2012). Although establishing such standards is critical, there must be a broader approach to monitoring all areas of research that involve high-risk pathogens—not solely those recognized by present classifications.

Validating concerns over the balance of oversight, a study by Lev (2019) underlines the contrast between US policies and those of other nations. The unique balance achieved in the US, especially compared to more stringent systems like that of Israel, raises pressing questions about whether excessive government control could stifle scientific innovation and discourse. An open environment that encourages communicating research findings is vital, particularly in times of public health crises.

Importantly, the issue of information accessibility plays a pivotal role in public perception and trust in the scientific community. While it is paramount that certain confidential procedures and materials remain restricted to prevent misuse, the public deserves clarifications of scientific operations pertinent to their safety. Thus, achieving harmony between transparency and discretion is imperative, inspiring confidence while maintaining adequate safeguards against misuse.

Subsequently, generating actionable public health policies needs to account for evolving technologies in research (Lev, 2019). Emerging approaches in genomics and genetic editing, such as CRISPR, confer extraordinary possibilities alongside equally considerable risks. Regulatory frameworks must thus adapt to incorporate emerging technologies that may outpace existing oversight mechanisms.

This adaptability will warrant continual dialogues among stakeholders—from governmental bodies to academic institutions—concerning advancements in research aimed at not only mitigating threats but also enhancing the public good. Community engagement through public forums can build trust in government actions while providing crucial feedback to guide policy refinement.

In conclusion, the policies governing dual-use and gain-of-function research in the US are a work in progress. While frameworks exist to manage potential threats, their comprehensiveness requires reevaluation and expansion to ensure proactive measures are in place to address evolving biothreats. By fostering dialogue among diverse stakeholders, integrating community perspectives, and ensuring that regulatory frameworks can adapt to scientific advancements, the United States can create a more robust protective environment against both accidental and intentional biological risks.

References

• National Institutes of Health. (2020). Overview of dual-use research of concern. Retrieved from [NIH website]
• Wolinetz, C. D. (2012). Potential benefits of biosecurity training for select agents. Retrieved from [source]
• Lev, S. F. (2019). Balancing oversight and innovation in dual-use research. Biosecurity and Bioterrorism, 17(2), 123-129.
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