SBPWG:Gaps/Gaps Draft v1

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Gap Seed List v1 June 30th

About the Version 1 Gap Seed List and Editing Methodology

The gaps below were first outlined by participants of the June 30th 2011 Working Group Meeting. This is a rough draft and should be considered a living document to be revised (or re-conceived!) as the contributors see fit. Edit ruthlessly, add comments, references, examples, questions - anything that will be helpful. Don't worry about messing anything up - the wiki allows us to revert to old versions!

At least one person should indicate they will take the lead for synthesizing comments into a clear, digestible paragraph outlining the gap, current practices and open questions (though everyone should feel free to add content!). Please indicate your chosen gap(s) to take the lead on by placing your name beside 'content lead' - first come first served. If you have additional gaps, or want to combine gaps, please add them to the list bottom of the list as a newly enumerated gap, and also indicate if it represents a split or merge of other gap(s). This is a work in progress, so give it a good shot, but expect the final product to change!

Please have a first draft of your paragraphs before our next meeting on July 27th!

(The list is not yet prioritized, but I have rearranged the list into three main groups, retaining the original numbering to preserve cross-listing. - JV)

A) How Information is Produced, Shared, Disseminated, Coordinated, and Protected

While new scientific knowledge is generated from a variety of sources (DIY, research institutions, and private industry, from around the world), all synthetic biologists benefit from access to the work of their peers. Furthermore, coordination among scientists minimizes redundant research, freeing up time and resources for the pursuit of new areas or the further development of existing areas. However, ownership of one's own work and the ability to profit from that work are important incentives that must be maintained if scientists and their supporters are to continue investing effort and money into new research. The conflict between these opposing ideals must be resolved for the full potential of synthetic biology to be realized. - JV

0. Relationship between DIY and Synthetic Biology Communities

Content Lead:
Should there be similar expectations of responsible conduct between institutional and non-institutional actors? Private and public?
How are we held mutually accountable for each others' actions? How do we best work together?

1. Ownership, Sharing and Innovation - Property Rights Frameworks for Synthetic Biology

Content Lead: Alissa
At what level in the abstraction hierarchy of envisioned biological designs should we instill property rights?
How does IP determine relationships, scaling, dissemination, commercialization of technology?
How do scientists deal with the fact that "we're not lawyers?"
How do we know if and how we should publish and or/share our parts/devices/organisms?

There is currently a lack of regulation and consensus in the synthetic biology field that will certainly need to be addressed as more researchers attempt to capitalize (or attempt to prevent further capitalization) on the outcomes of their research. The two industries that are most similar to synthetic biology, the software and the biotechnology industry, have both suffered from flawed US IP law (Rai and Boyle, 2007). In biotechnology there is the problem of nonobviousness, where broad patents have been issued even though some of the "discoveries" may be still be obvious to biologists in the field. Software was determined to fall under both copyright and patent law, which many feel was also not the best solution (Rai and Boyle, 2007). Broad patents and a crowded patent landscape are likely to hinder innovation in the field, and copyright protection is not likely to be awarded to DNA that has been genetically engineered since the core bases are still the same. There are advantages and disadvantages with each type of protection; the best may be new legislation which can be tailored specifically to synthetic biology, however this will take many years to implement.

In the near term, the efforts of the BBF and the Parts Registry may be the most useful in maintaining a "commons" by putting parts into the public domain, assuming they are able to obtain some patents that may force licensees/users to also contribute their parts, instead of just using the honor system. However, it will still be necessary to leave room for others to somehow patent products (biofuels/pharmaceuticals) or pathways made from these parts, in order to ensure that there is enough incentive (i.e. potential for profit/funding) for researchers and companies to continue using these registries for their projects.

Lastly, since synthetic biologists are not normally trained in IP law, it would be helpful to have some sort of specified liason between the synthetic biology and policy community.

Many ideas are illustrated further in Rai and Boyle, 2007. (AK)

2. Collaboration, Sharing of Parts and the Security / IP implications thereof

Content Lead:
exposure vs scooping
possibilities for interception of work by national security as in other fields?
parts registries - whether or not to release consent
unknown trajectory to privacy
institutionalization and access (e.g. cocaine available through Sigma to academic labs, not public)
e.g. of needing confidentiality, ownership agreements w/ labs before they will share their parts (Joe S)

9. International Collaboration and Competition

Content Lead:
How do we coordinate between countries re: regulation, safety, security?
How to balance competition, collaboration - where and how should we invest?
The internet changes everything

B) Public Communication between the Scientific Community and Other Sectors of Society

The scientific community does not exist in isolation, but rather is one aspect of human society populated by myriad groups with their own (concurrent, orthogonal, or opposing) agendas. Society as a whole determines what research may be performed (through laws and funding) and how the products of that research are used. Strong communication between scientists and the rest of society is important to ensure the perception and reality that scientific progress benefits society as a whole. - JV

3. Low National Scientific Literacy as an impediment to Constructive Dialogue around Emerging Technologies

Content Lead: Joseph De-Shung Shih
decelerating pace of scientific literacy in the US vs other countries
public perceptions frame tech developments
what are the best channels of scientific information that reach publics (e.g. blogs, realclimate.org, reddit, quora, Factcheck.org)
even within community we have a diverse community of new practitioners
Establishing Meaningful Dialogues with Diverse Stakeholders - How can deliver reliable information about synthetic biology to the publics?
How can we anticipate and respond proactively to public/societal sentiments on biotechnology?
e.g. ETC group letter to SB5 concerned that civil society wasn't included

Although the United States is still one of the scientific leaders of the world, the nation’s acceptance of new technologies and scientific practices such as synthetic biology is hampered by the decelerating pace and sometimes net decline in scientific literacy in general. General denial or misinterpretation of theories widely accepted in the scientific community such as climate change or evolution point to scientists’ inability to communicate effectively with the general public and with the decline in scientific knowledge within the public. This is especially concerning in regards to emerging technologies such as synthetic biology, where pervasive lack of knowledge allows negative rumors and exaggerations to abound within the public sphere. In order for synthetic biology to develop to the point where it has profound impact on people’s lives, synthetic biologists must clearly communicate the potentials and hazards to the general public. Diverse channels such as blogs, video, popular press, and popular literature are some of the potential means of communication between synthetic biology and the general public. Although some people may respond negatively to additional knowledge about the field, we need to establish meaningful dialogues with diverse stakeholders throughout society to build popular support for the potential of synthetic biology. Additionally, more synthetic biologists should actively participate in improving general science literacy in order to better communicate with the general public and build the pool of scientific talent in order to attract and educate future synthetic biologists. (JS)

4. Responding to Other Philosophies and Agendas

Content Lead:
Perhaps Related to (the same as?) 3, but dealing with explicitly antagonistic agendas (e.g. PETA?)
How to recognize, respect dissenting views, philosophies, moral frameworks, philosophies - should these impact decision making?
Are there limits to rational, constructive dialog?

6. Defining 'Poster Children' for Synthetic Biology

Content Lead:
We are much better at articulating risks and telling of stories of failures than the past or future successes. This frames our conversation with the public, govt, regulators etc.
So focused on not being Monsanto, GMOs that our conversations revolve around risk instead of benefits.
Possibly could details success stories: Insulin, Amyris, Selective Breeding, Antifreeze Tomatoes etc
Are there positive breakthroughs from the DIY community?
How do we relate how SB could touch and improve people's lives?

7. Practical Frameworks for Responding to Political Forces/Situtation that Frame Our Work

Content Lead:
Land Use Politics
Existing Systems of Belief

8. Biotechnology Innovation Roadmap

Content Lead:
Do we have a roadmap outlining near-term and long-term deliverables of synthetic biology, their context wrt other (bio)technologies and where they offer either new application areas and/or more cost effective solutions?
This would help us and other
What are the key decision points, areas for investment to accelerate innovation
Economic Forecasting for Synthetic Biology Technology Developments

10. Education, Training and Identity Across a Diverse Community of Practitioners

Content Lead: Megan
How savy should we expect researchers to be wrt the broader context of technology developments?
How do we engage and inspire leadership on practices in a way that aligns with our technical goals, interests?
How do deal with generational transfer of knowledge and immigration from a broad array of disciplines?

13. Developing Trust in a World of Profits and Secrets

Content Lead:
Relation to 2, 5
How can we be ambassadors for biosafety when we do not have knowledge of research ongoing at private companies and in secure govt labs?

C) Potential Negative Consequences

Synthetic biology has potential to do great good for the world, but it also has the potential for great harm. There exists the danger for the products of synthetic biology to be abused, misused, or unjustly distributed. Care must also be taken to prevent synthetic organisms from escaping human control and damaging human life or the environment. The risks of these negative consequences must be weighed against the potentially generated benefits when determining what research to restrict or entirely disallow. Alternatively, certain potentially dangerous research may be allowed to proceed, with regulation occurring only downstream at product implementation. - JV

5. Risk Analysis Frameworks for Emerging Technologies

Content Lead:
How do we deal with the unknown unknowns? Are we dealing with the known unknowns?
How can we claim, justify safety of things we haven't yet built?
How do we frame both risk and opportunity?
How do we do ecosystem clinical trials?
If we say it's safe, why should you trust us?
What are appropriate risk assessment frameworks for intentional & unintentional environmental release?
How do we approach regulation of cross-cutting technology platforms spanning multiple disjointed regulatory bodies set primarily by application area?
Can we develop experimental systems for assessing safety?
e.g. rE.Coli - ' safer chassis, but no regulatory framework so hard to commercialize
e.g. http://trib.com/news/state-and-regional/article_6945effb-0af4-53ab-ba93-af79461f1535.html
Risk Governance & SB report http://www.irgc.org/IMG/pdf/irgc_SB_final_07jan_web.pdf

11. Preparedness for Syn Bio (-Labeled) Accidents

Content Lead:
Mistakes will happen. Accidents will happen. Somebody can be expected to misused this technology - Do we have a community response plan? Who will be held accountable?
http://www.nature.com/nbt/journal/v27/n12/full/nbt1209-1109.html

12. Technology Distribution and Accessibility - Justice

Content Lead:
How do we develop the technology so that it doesn't serve/benefit only the privileged, elite?

Prioritization - My Gaps and Your Gaps

Participants at the Working Group Meeting were asked to list their top 2 gaps that 'somebody' should be resolving, and which amongst those they felt were their responsibility

Gaps Someone Should Mind

0.
1. JS, JV, DTE, AK
2.
3. RR, JS, JV, DTE, MF, AK
4.
5.RR. SA
6.
7.
8.MP
9.
10. MF, MP
11.
12. JV, SA
13.

Gaps I Should Mind

0.
1. DTE
2. JS ( already affected, part collab), RR, DTE
3. JS (educator), RR, JV++, DTE, AK
4.
5. RR, SA
6. DTE
7.
8. MP
9.
10. MP
11.
12.
13.