Silver Human Practices
With the increasing popularity of DIY bioengineering and the growing threat of weaponized pathogens, the regulation of synthetic biology is playing an ever-larger role in our national security. The BHR kit in particular has direct ethical and safety repercussions, considering its potential mal-application in engineering bioweapons. In order to evaluate the ethicality of our project, our team investigated the national biosafety regulations surrounding our research and employed the feedback of bioethics experts, biotech companies, and local Austin DIY labs. After reaching out to the experts within the communities whom our kit would impact the most, we concluded that the BHR kit is ethical.
Conversation with Dr. Shelley Payne
To ensure that the BHR kit’s future distribution and application will be ethical and safe, we sought the advice of some of The University of Texas’ leading biosafety and bioethics experts. We consulted Dr. Shelley Payne, a researcher, professor of molecular biosciences, and previous chair of the UT Institutional Biosafety Committee, who provided us with insight on the potential ethical and safety issues of our kit. Dr. Payne expressed that though our BHR kit may expedite the initial characterization of non-model organisms, the kit does not necessarily expedite the identification and cloning of virulent genes in pathogenic bacteria, which in Dr. Payne’s view, is where the true danger lies. Although Dr. Payne believed that there is relatively low risk associated with the BHR kit, we still had concerns over the potential for improper use and dissemination of the kit. In response to our distributional concerns, Dr. Payne recommended utilizing a third party distributor, such the American Type Culture Collection, to ensure the safe and responsible distribution of our BHR kit. We took Dr. Payne’s feedback into consideration as we continued developing the BHR kit and planning for its future distribution.
Consulting with Dr. Alan Lloyd
Continuing with our pursuit of creating an ethically robust kit, we consulted Dr. Alan Lloyd, a researcher, professor of molecular biosciences, and the current chair of the UT Institutional Biosafety Committee (IBC), which reviews all campus research involving recombinant DNA. Dr. Lloyd expressed his concern over the growing threat of DIY bioengineers who are gaining greater capability to perform sophisticated biological work due to increasing access to bioengineering tools. According to Dr. Lloyd, because the BHR kit may play a role in the process of characterizing and modifying non-model organisms, a particular danger of the BHR kit is its potential in the engineering and weaponization of the human microbiota. To potentially avoid these dangers, Dr. Lloyd directed us to the guidelines for identifying and regulating Dual Use Research of Concern (DURC) and encouraged us to attend an IBC meeting and self-review our research under the DURC guidelines. Though Dr. Lloyd saw some potential danger in the application of the BHR kit, overall, he did not see any more danger in our research than any other research conducted in the university.
Dual Use Research of Concern
Under the recommendation of Dr. Lloyd, our team followed the guidelines for determining if the BHR kit can be classified as Dual Use Research of Concern (DURC). The formal definition provided by the National Institutes of Health Office of Science Policy defines DURC as:
“...life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”
We believe that the BHR kit falls under this definition. Therefore, we proceeded to evaluate the risks and benefits of the kit under the federal guidelines for assessing DURC. When assessing DURC, the National Institutes of Health encourages researchers to consider the following:
- The ways in which knowledge, information, technologies, or products from the research could be misused to harm public health and safety, agriculture, plants, animals, the environment, materiel, or national security.
- The ease with which the knowledge, information, technologies, or products might be misused and the feasibility of such misuse.
- The magnitude, nature, and scope of the potential consequences of misuse.
In regard to the first point, we considered that the BHR kit could potentially be used to weaponize non-model human bacteria. However, considering the second point, the weaponization of the aforementioned bacteria would require a depth of additional scientific knowledge, sophistication, and outside resources outside of what the BHR kit currently provides. Thus, we believe that in a larger sense, the BHR kit poses a minimal threat to society.
Conversation with Dr. Bryan Davies
Dr. Davies addressed focused on the question of if our kit would be truly useful to researchers. He made useful suggestions as to how the kit could be modified to make a “killer app”. They included:
- Demonstrate the kit works in as many diverse organisms as possible, upwards of 50 to 100.
- Modify the kit to work well in a specific subset of bacteria, such as those that produce antibiotics or cancer-fighting compounds.
- Think about what makes our kit preferable to the common method of genetic manipulation; finding a plasmid that works from the literature and using that
When discussing the issue of engineering non-model organisms, Dr. Davies said that such a problem doesn't normally arise in his lab. However, he confessed that he used synthetic biology are more of a tool as opposed to an end goal. He suggested that we do “market research” and inquire about the popularity of similar, large part collection kits for genetic engineering.
Conversation with Dr. Brian Renda of Gingko Bioworks
“The utility of those tools is going to be in demonstrating how broad host range they actually are, and the ability to rely on the same sets of parts across very very different bacterial species.” Dr. Renda agreed that the BHR Kit would solve a problem relevant to the biotech industry, which is a standardized tool that would allow a diverse array of bacteria to be engineered without having to develop methods and techniques for manipulation. He discussed some obstacles we would have to overcome, which include:
- Transformation: Perhaps the kit contains plasmids that function but they are difficult to transform into bacteria.
- Restriction Systems
- Endogenous antibiotic resistances and the different concentrations of antibiotics required for selection could inhibit the success of transformation methods such as conjugation
- We would also need to consider issues of licensing and intellectual property.
Dr. Renda underscored that larger outfits such as Gingko Bioworks develop genetic engineering tools themselves because they have the resources to try many different approaches to a problem. Therefore, our kit might be more useful to smaller companies or members of academia. A kit would have to be very robust for it to be accepted in industry where they normally work with well-characterized organisms that can be easily scaled up for industrial processes. To demonstrate the efficacy of our kit we need parts and part expression that are standard and predictable in various microbes.