Synthetic Society/Community Organization and Culture

Summary

The community organization and culture group has two primary goals

Identify and prioritize tasks to be coordinated and done on a community-wide basis.

Elucidate what mechanism(s) by which those task can best be accomplished.

Based on our discussions, there are three main tasks that currently need attention from the synthetic biology community

propose the form that govermental regulation of synthetic biological systems should take in order to best promote the safety of the public and the growth and development of the field.
develop and implement standards of fabrication, testing and operation for synthetic biological parts, devices and systems.
create and develop educational materials to train synthetic biologists.

An additional proposal is to develop a code of conduct to which synthetic biologists adhere. However, we are unsure of just how great an impact such a code would have. We think that the most important purpose of such a code might be to improve public perceptions of synthetic biology and therefore leave this issue to the Synthetic Society/Understanding, Perception & Ethics group to address.

We believe that the most practical approach to organizing the community is to use the model of a professional society. However, some questions remain to be addressed.

Is it preferable to operate under the auspices of an existing biological engineering professional society or found a new one?
Can we leverage existing entities like The BioBricks Foundation, iGEM or the Registry of Standard Biological Parts to help achieve our goals?
How can we continue to emphasize decentralized contribution to the field's direction and shape? (i.e. OpenWetWare, synthetic biology mailing lists, iGEM).

Upcoming tasks

Brainstorm names of outside people we want to bring in to voice opinions
1. Here's the emeritus professor in STS I mentioned at the last meeting: Charles Wiener If you think his input would be helpful, I'll contact him. Sophia

Actions that could be coordinated on a community-wide basis

prescribe a code of conduct
develop educational materials
organize conferences
promote a motto for the community (i.e. "Don't be evil")
publish journals
develop and establish standards
propose (and perhaps implement) safety regulations for synthetic systems and organisms
give awards of excellence

Methods to coordinate community-wide action

iGEM serves to help form a cohesive community since it brings people together on an annual basis
Synthetic Biology conference
a single charismatic figure who prescribes a philosophy for the field that others buy into (for instance, Richard Stallman and/or Linus Torvalds in the free software movement)
found a new organization to better represent the entire community
- how does it gain widespread acceptable and legitimacy?
- who would do the work of starting it?
use existing institutions to give legitimacy to our proposed initiatives
- government at the local, state or federal level
- universities
- National Academy of Science, National Academy of Engineering, National Research Council
- NIH principles and guidelines
- The BioBricks Foundation
- existing bioengineering professional societies

Meta-level questions to be addressed

Is thinking about community organization and culture a waste of time?
Do we actually need to write down standards of practice or can they just exist as community norms?
What would a code of conduct for synthetic biologists look like?
What standards of practice, if any, are needed beyond that of existing disciplines?
Can this small group of people speak for the community or have their ideas accepted by the community? What about people outside the mainstream synthetic biology research community?
If we do want to implement a community code of conduct, how should it be done?

Existing models for community organization

Professional engineering societies

There are a number of professional societies in the "bioengineering" space. it would be good to (i) list these and (ii) understand what their missions are. Endy 21:37, 11 January 2006 (EST)

IEEE EMBS

The Engineering in Medicine and Biology Society of the IEEE advances the application of engineering sciences and technology to medicine and biology, promotes the profession, and provides global leadership for the benefit of its members and humanity by disseminating knowledge, setting standards, fostering professional development, and recognizing excellence. The field of interest of the IEEE Engineering in Medicine and Biology Society is the application of the concepts and methods of the physical and engineering sciences in biology and medicine. This covers a very broad spectrum ranging from formalized mathematical theory through experimental science and technological development to practical clinical applications. It includes support of scientific, technological, and educational activities. (from http://embs.gsbme.unsw.edu.au/)

BMES

"To promote the increase of biomedical engineering knowledge and its utilization." They use NIH definition of bioengineering: Biomedical engineering integrates physical, chemical, mathematical, and computational sciences and engineering principles to study biology, medicine, behavior, and health. It advances fundamental concepts; creates knowledge from the molecular to the organ systems level; and develops innovative biologics, materials, processes, implants, devices and informatics approaches for the prevention, diagnosis, and treatment of disease, for patient rehabilitation, and for improving health. (from http://www.bmes.org/).

Biomedical Engineering Society Code of Ethics (Approved February 2004)

Their code of ethics from http://www.bmes.org/pdf/2004ApprovedCodeofEthicsShortForm.pdf

Biomedical engineering is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Since public health and welfare are paramount considerations in each of these areas, biomedical engineers must uphold those principles of ethical conduct embodied in this Code in professional practice, research, patient care, and training. This Code reflects voluntary standards of professional and personal practice recommended for biomedical engineers.

Biomedical Engineering Professional Obligations

Biomedical engineers in the fulfillment of their professional engineering duties shall:

Use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public.
Strive by action, example, and influence to increase the competence, prestige, and honor of the biomedical engineering profession.

Biomedical Engineering Health Care Obligations

Biomedical engineers involved in health care activities shall:

Regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern.
Consider the larger consequences of their work in regard to cost, availability, and delivery of health care.

Biomedical Engineering Research Obligations

Biomedical engineers involved in research shall:

Comply fully with legal, ethical, institutional, governmental, and other applicable research guidelines, respecting the rights of and exercising the responsibilities to colleagues, human and animal subjects, and the scientific and general public.
Publish and/or present properly credited results of research accurately and clearly.

Biomedical Engineering Training Obligations

Biomedical engineers entrusted with the responsibilities of training others shall:

Honor the responsibility not only to train biomedical engineering students in proper professional conduct in performing research and publishing results, but also to model such conduct before them.
Keep training methods and content free from inappropriate influence from special interests.

The Bioengineering Division of the American Society of Mechanical Engineers

The Bioengineering Division is focused on the application of mechanical engineering knowledge, skills and principles from conception to the design, development, analysis and operation of biomechanical systems. The Division's technical activities are organized through the Fluid Mechanics, Design & Rehabilitation, Heat & Mass Transfer in Biotechnology, Cell & Tissue Engineering and Solid Mechanics Technical Committees.

American Instiute for Medical and Biological Engineering

The American Institute for Medical and Biological Engineering was founded in 1991 to establish a clear and comprehensive identity for the field of medical and biological engineering - which is the bridge between the principles of engineering science and practice, and the problems and issues of biological and medical science and practice. Public policy objectives:

To increase funding for research in medical and biological engineering throughout the National Institutes of Health (NIH), with the specific goals of growing the budget of National Institute of Biomedical Imaging and Bioengineering (NIBIB) to billion in five years and providing added funding to support young innovators.
To identify and help reduce barriers to engineering innovations that have the potential to enhance quality of life and improve national competitiveness, with an emphasis on assisting young innovators and emerging technologies.
To implement a strategic communications program to educate public policy makers, the media and the general public about the valuable role that medical and biological engineering plays. The AIMBE Hall of Fame is a key communications and educational tool.
To identify and promote best practices for cooperation between academia, government and industry regarding the transfer of engineering innovations and biomedical education.
To activate or create partnerships with leaders in business, consumer organizations, education and the health professions, thereby increasing support for the contributions made by medical and biological engineering to society and helping break down barriers to further innovation.

Institute of Biological Engineering

The Institute of Biological Engineering (IBE) is a professional organization which encourages inquiry and interest in biological engineering. IBE supports:

Scholarship in education, research and service
Professional standards for engineering practices
Professional and technical development of biological engineering
Interactions among academia, industry and government
Public understanding and responsible uses of biological engineering products.

Assigned to: Austin

Codes of conduct

From The Center for the Study of Ethics in the Professions (CSEP): Codes of ethics for every imaginable professional category and group http://ethics.iit.edu/codes/codes_index.html Here's one for biologists http://ethics.iit.edu/codes/coe/Biologists.html and one for engineers from ABET http://ethics.iit.edu/codes/coe/abet-a.html
From the same site, a bibliography related to bioethics: He argues first that a code of ethics can be understood as a convention between members of a profession. The convention articulates certain ideals, and helps members of the profession to resist pressure to diverge from those ideals. Davis then asks why engineers have an ethical obligation to abide by their code of ethics. His answer rests on a notion of fairness: if an individual has chosen to reap the benefits created by other people’s adherence to a code, then that individual ought to live up to the same standards.

Asilomar

One important point is that according to the meeting notes, Asilomar was "blessed" and/or coordinated by the National Academy of Sciences and the National Research Council. So Asilomar gained legitimacy though existing private organizations.

How did the BSL system arise from Asilomar?
- A group of 140 prominant scientists met to determine if they could self-regulate safety and ethics of experimentation to be done. Their work, summarized in the meeting notes, describes the self-imposed classifications and restrictions on biological research. This meeting first defined the different Bio-Safety levels used in modern biological research.

Meeting at the time

Meeting notes from Asilomar
- Document detailing the groups conclusions.
The Pandora's Box Congress, Rolling Stone, June 19th, 1975 (no link)
- a great article in the Rolling Stone about the meeting. Ask Drew or Sri for a copy.

Retrospectives

"Asilomar Revisited: Lessons for Today?"
- Marcia Barinaga, Science, Volume 287, Number 5458, pp. 1584 - 1585, March 3, 2000
Asilomar and Recombinant DNA.
- Paul Berg's (chairman of the meeting at Asilomar) article discussing the details of the meeting, and its applicability today. In short, Berg doesn't think it could happen today. However, Berg believes that one important point about Asilomar was that it was the scientists themselves who initially voiced concerns over the safety of recombinant DNA technology rather than the public. The public was largely unaware of the breakthrough. So before the public could react to the idea of recombinant DNA, Asilomar occurred and a solution to perceived problems was issued. Such a situation may resemble where we are in synthetic biology today.

NIH regulations and recommendations

NIH Requirement for instruction in the responsible conduct in Research
- Initial Policy Letter, NIH/
- All students and post-docs on training grants must recieve such training.
- No forced curriculum, but NIH provides resources to allow teaching (videos, discussion primers, books, et cetera). Program directors are strongly encouraged to cover topics related to conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management.
- Each individual program is reviewed.

Recommendation to publish in open-access journals
- A voluntary proposal that calls for all supported by NIH grants to publish their papers in OA journals, or to place them in a repository such as PMC post-publication.
- The actual policy memorandum.
- NIH page on public policy
- A usefel external FAQ

Assigned to: Sri

Monsanto

What kinds of regulations does Monsanto have to adhere to in order to grow its crops? FDA? EPA?
- Legal Review of US Regulation of biotech A summary of federal regulations begins on pg. 223.
- Levidow, Les. 2001. "Precautionary Uncertainty: Regulating GM Crops in Europe". Social Studies of Science 31:6, 842-874. Levidow argues that scientific uncertainty is an artifact of social conflict and debate and does not necessarily reflect a paucity of scientific information. He emphasizes the socio-cultural values implicit in regulatory science.
- Science Policy Forum on Monitoring and Labeling GM Products
- In 1986, federal regulatory agencies (USDA-APHIS, FDA, EPA, OSHA) and research organizations (NIH, NSF) jointly established the Coordinated Framework for Regulation of Biotechnology.
  - One or more of these agencies oversees each GM product, depending on the gene or crop.
  - These regulations were not tailored to biotech, but applied already enacted agricultural and pharmaceutical regulations to biotechnical products in a patchwork fashion.
    1. The USDA regulates plants, plant pests, and veterinary biologics ("safe to grow");
      - Before field testing a new GM crop, research organizations must first file either a notification or a permit application with the USDA. The notification is used for well-known or low-risk crops; the USDA evaluates the safety of unknown or high-risk crops before approving permits. The USDA-APHIS site has more details.
      - The USDA guidelines regulating research that plans to introduce GMOs into the environment is here.
    2. The EPA oversees new microorganisms, microbial and plant pesticides, and new uses for pesticides ("safe for the environment");
    3. The FDA is responsible for food, animal feed, medical and veterinary drugs, and food additives ("safe to eat").
  - The framework emphasized regulating products rather than biotechnical processes.
- Monsanto and other biotech companies are not federally liable for any damages to persons, property, or environment caused by their GMOs, but common-law tort principles and state statutes continue to apply.

Assigned to: Sophia

Institutional review boards

Institution-level committees that review sensitive research projects (for example, those having to do with human subjects).

Assigned to: Larry

International bodies

United Nations Educational, Scientific and Cultural Organization (UNESCO)

UNESCO has five functions including as a standards setter and mechanism for collecting and distributing information in certain fields. And it does some work in science policy. As expected, a lot of effort is focused either on environmental issues or on building infrastructure for science in developing countries. They do seems to have a very large and diverse set of initiatives. Assigned to: Reshma

Journals

Do journals have any prescribed standards?

Nature

publication policies
can't find detailed policies

Science

terms and conditions

PNAS

policies
includes a policy that the researcher must have followed NIH physical and biological containment guidelines

Assigned to: Reshma

Medicine

Hippocratic oath

modern version
There appears to actually be a lot of dispute over the Hippocratic oath and exactly what it should contain. And there are different versions so not all doctors necessarily adhere to the same oath. Interestingly, the modern version linked here contains the phrase "I must not play god." It also includes a section on calling in outside help when it may aid a patient's recovery. I was a bit incorrect on one point which is that most students do take some form of the oath upon graduation, they just don't necessarily take the same oath since there are different versions. Within the medical profession, there is disagreement about how relevant the oath is to the profession today.