Team:Northwestern/SideProject

Communication, Self-Regulation, and Fidelity

The field of synthetic biology has unlocked an enormous number of new approaches to solving the world’s problems. Scientists have begun researching applications of this technology to health sciences, energy crisis, environmental cleanup, and even selective breeding of plants and animals. However, as this frontier involves tampering of life on its most fundamental scale, there are many understandable concerns as to its utilization. While some people fear that these tools may later be turned to people in a form of eugenics, others worry that some creation developed with the intention to help people might have some unforeseen negative consequences. If we as scientists wish to gain the trust of the general public, we must be as transparent and communicative in our pursuits as possible. Yet outside regulation can stymie innovation, as in the case of clinical research. Therefore to develop the best results with the best intentions, it is important for the synthetic biology community to be self-regulatory in the most legitimate sense. In this essay we will discuss some general fears, some unintended consequences, and regulatory success and failures, followed by a proposed solution. Throughout our discussion and alongside historical examples, we will employ Northwestern University’s 2010 iGEM project SCIN (Self-regenerating Chitin INduction) as a case study. Chitin is used in many industrial processes, is known to be a good biocompatible material for surgical thread, and improves the defense mechanisms in agricultural plants when used as a fertilizer. A cheap replenishing source of this polymer could be very valuable, but might this be harmful?

People will always fear what they do not understand. If we wish for society to trust the scientific community and share our passions, we must first help them to understand. People’s fear and/or repugnance for synthetic biology can probably be mostly arranged into three categories: playing God, Frankenstein’s monster, and the Mad Scientist. As the first is a religious one, we will not focus on it here and will instead leave it for the priests, monks, and philosophers of the world to discuss. In Frankenstein’s monster, people see the products of science let loose to maraud the world with unintended consequences – this is not a negligible risk. As tempting as it may be to engineer sterile mosquitoes or synthesize organisms that can hunt down and kill pathogens, the result could be a severe lapse in the current food chain or unexpected evolution of new pathogens.

While we should resist any knee-jerk impulse to abandon these possibilities for fear of the unexpected, we should have some idea of immediate consequences and move carefully. On the other hand, the Mad Scientist may be driven by greed or misguided nationalism to build a SuperBug the likes of which the world has never seen. If we wished to market our chitin-producing strain as a means to synthesize chitin for dietary use, we have an obligation to ensure that our strain consistently synthesizes the appropriate molecule rather than some toxic variant. Can it be made into a weapon? If so, how? What measures can we take to prevent malevolent alteration? It is our intent to argue that to both harness the great potential of synthetic biology and limit use of it for evil we must a) be reasonably transparent in our efforts and b) adhere to a code of honor that society can place reasonable faith in so that we may be sufficiently self-regulatory to ensure innovation.

External regulation has certainly been responsible for necessary scientific and industrial reforms. Governmental organizations such as the Environmental Protection Agency and Food & Drug Administration have been able to enact fundamental standards for ecological and patient protection. Today it would be impossible to conduct another Tuskegee Syphilis Study thanks to informed-consent regulations enforced by the FDA. However, too often these agencies propose measures subject more to political fashion than scientific evidence, meaning under- or misplaced-regulation. The EPA has been essentially neutered in recent years and often neglects important information. On the other hand, over-regulation leads to monstrous bureaucratic costs and months of wasted time, in the case of medicine leading to prolonged suffering and unnecessary deaths. In some countries, clinical studies require so much regulatory bureaucracy that it becomes impossible for any groups but for-profit organizations to conduct them in a manner inevitably slanted towards profit rather than need.

If we wish for society to see the research scientist as one driven by good intent, we must participate as citizens, listen to fears, and address them appropriately. No one trusts people that disregard their concerns, so we must acknowledge concerns as legitimate and take steps to quell those fears. To do this, a certain amount of transparency is crucial. While some questions of theology cannot be answered by the researcher, we can address fears of the Monster or Mad Scientist. We must determine people’s fears, by scientific poll or discussion so that we may either take them into major consideration or craft a respectful way to educate and dissuade society from them. We believe that the Synthetic Society Working Group should consider publishing an annual well-advertised report addressing primary concerns in layman’s terms so that anyone can understand where the research is headed. For instance, if the Northwestern iGEM team wished to allay fears that our organisms produced toxic relatives of chitin, we might publish clear test results that countered such concerns. While of course most people would still read this no more than they do Discover magazine, this would provide a source of accountability that the media could refer to and discuss. We must neither discard fears out of hand nor fail to communicate why unnecessary fears are unfounded. Some concerns may be legitimate; if we simply ignore or scoff at ones that are not, we will only harden public opposition to our research.

In the face of such opposition, it is too early to make a concerted attempt to roll back excessive regulation in synthetic biology. Before we ask the commonwealth to trust us, we must prove that we are worthy of such confidence. In effect, we must begin to regulate ourselves before we ask that other organizations scale back their own efforts. We were fortunate enough to be able to meet with Dr. Laurie Zoloth, Director of the Center for Bioethics, Science and Society and Professor of Medical Ethics and Humanities at Northwestern University, to discuss her views on the ethical necessities in biological research. She has proposed to fill a “vacant middle” with a culture that is open source when possible, creates incentives for honesty and good use of technology, and takes advantage of peer relationships between scientific colleagues to influence researchers to “do good.” If we know that some course will result in immediate good, it should be pursued. Dr. Zoloth has proposed something like a “Jedi code of honor” based on a moral, societal hermeneutic circle to move forward with the best intentions: will this benefit or harm society, and do our duties to society necessitate this research? We agree that for ultimately positive results in synthetic biology, there must be a cultural imperative to proceed in discovery with an eye to an empathetic, virtuous goal. Rather than traditional indoctrination, this sort of philosophy depends on personal mentorship at the level of the primary investigator and the peer; the scientist has a peer obligation as well as a personal obligation to a code of behavior in place because his friend is depending on him, not because the government has dictated it. We are miles away from this level of trust but unless there is a culture based on duty to the other, any effort to regulate is doomed to eventual failure.

While we must also attempt to ensure that a technology will not result in immediate evil, uncertainties are infinite and restrictive caution can lead to foreseeable suffering. However, Dr. Zoloth points out, if we are going to proceed there is a certain obligation to preempt the negative consequences we can foresee, as well as to commit to a certain level of fidelity. As in the case of the British Petroleum oil spill in the Gulf of Mexico, a scientist must accept responsibility for and take measures to correct his own mistakes when they lead to disaster. Since chitin has beneficial uses in industry, agriculture, and health, another means of consistent production via “biofactory” could decrease production costs and generate higher yields. In addition, if e. coli could be made to produce a hard shell on command, there could be many applications such as non-toxic waterproofing. Yet we can pinpoint three possible negative consequences of such a strain:

1. The strain produces some toxin related to chitin in addition to the chitin itself.
2. The strain produces pure chitin, and the extraction thereof results in a high incidence of allergic reaction among those that work with it.
3. The strain becomes airborne, resulting in lung infection and chitin deposition in the airways.

If our iGEM team decided to push our strain toward industrial use, we must take measures to prevent what we can and draft protocols for safe implementation. Extensive quality trials would be necessary to ensure that the chitin could be reliably extracted without any harmful toxins. We must make recommendations to prevent extraction employees from being exposed to large amounts of chitin, preventing the development of chronic allergies. Finally, it would even be responsible to program in a death signal if the e. coli contacted the human body. In this way, the scientist must be mindful of the interaction of people with any new life-forms; where problems are anticipated, he must design solutions. Nonetheless, there are unexpected consequences to every action – because of this we must guarantee a certain level of fidelity, that we will help if it hits the fan. If our strain evolved in a fashion resulting from our tinkering with its genome to a form that inflicted a plague on society, we must take responsibility and aid in solving any crises.

The future of synthetic biology is bright with the possibility of enormous contributions to the world, but we are not there yet. First we must confront a number of ethical concerns which we have had to consider before pursuing any new technology. However, as this field involves the calibration of life on a fundamental level, we must respect and address a myriad of issues with a concerted effort to either investigate or dissuade fear. In addition, to move forward with greatest efficiency and results, the synthetic biologist must imbue his students and colleagues with a sense of purpose and honor. It is only through always acting with the most faithful intent that we can prevent misappropriation of knowledge and evil applications. Lego-like “part” reductionism is a wonderful way to simplify our work with genetic constructs, but we should be cautious to avoid applying this reductionism to the ethical concerns of society.

Ethics

Prompt: Outline and detail a new approach to an issue of Human Practice in synthetic biology as it relates to your project, such as safety, security, ethics, or ownership, sharing, and innovation.

Resources:

• http://bioethics.northwestern.edu/faculty/zoloth.html

• http://www.feinberg.northwestern.edu/research/cores/units/ethics

• http://en.wikipedia.org/wiki/Medical_ethics

• http://en.wikipedia.org/wiki/Bioethics

• http://en.wikipedia.org/wiki/Synthetic_biology#Social_and_Ethical

Abstract

Ethics oriented Analysis of synthetic biology in general and in relation to the NU2010 Bacterial Skin project.

Outline

Preamble or Historical Perspective

Aversion to synthetic life, religious, uncanny valley, Frankensteinian fears

http://en.wikipedia.org/wiki/History_of_biotechnology

http://en.wikipedia.org/wiki/Asilomar_Conference_on_Recombinant_DNA

http://en.wikipedia.org/wiki/Timeline_of_biotechnology

http://www.wired.com/magazine/2010/07/pl_backstory_timemachine/

Medical (Societal) Ethics

Beneficence, Non-maleficence, autonomy (zoloth principle=fidelity), Justice, (Dignity, Truthfulness)

Moral (Individual) Ethics

Kant(Categorical Imperative, ends) vs Mill(Utilitarianism) vs Aristotle(Character)

Unique Ethical Problems

Ontological Epistemic

Project Specific Problems

Application-specific analysis