Introduction

As the power and scope of biotechnology increases, humans are increasingly able to manipulate human cells, alter human and non-human genomes, and engineer new forms of life. While these developments promise new therapies and exciting scientific advances, they also have the potential to redefine the nature of human and animal form and function, and to release new pathogens or toxins into our environments. No consensus exists internationally on our aspirations, conceptualizations, directions, or limits of our biotechnological efforts. Biotechnology and the Ethical Imagination: A Global Summit (BEINGS 2015) will bring together stakeholders from around the world to creatively imagine an international consensus on the future of human cellular biotechnology. BEINGS 2015 includes discussions of the creation and use of scientific technologies that involve manipulation of human cells directly, or the manipulation of nonhuman cells that impact human well-being and human flourishing. BEINGS 2015 will concentrate on basic cellular science, basic research (including translational research), and development. We will frame the conversation as a discussion of the aspirations of science with related questions intrinsic to the scientific enterprise. Conversations will focus on the ethical parameters and policy implications of designated topics, including, for example, safety in biotechnological research, bioterrorism, research with human embryos, and intellectual property and ownership.
BEINGS 2015 will explicitly not include discussions related to agri-business (e.g., Genetically Modified Organisms for the purpose of generating food), nonhuman animal rights and animal experimentation, and clinical medicine and medical practice, although we will discuss technologies that may ultimately have applications for these topics. BEINGS 2015 will not be about clinical medicine or human experimentation – our discussions end at the clinic door – and so will not include ethical/policy guidelines for human physiological or cognitive enhancement, clinical medicine, or issues related to clinical trials (such as informed consent or first-in-human trials).

Guiding Questions

The following questions will run throughout the Summit, and will apply across the Topic areas below.  Topic G on Tuesday will be a summary discussion of these questions across all Topic areas.
  1. What should be the goals of biotechnology; is progress itself an ethical aim or obligation? How do we honor the sanctity of life (assuming that “sanctity of life” continues to be a morally useful construct)?  What is “human flourishing” insofar as biotechnology can contribute to it?
  2. How do we navigate the spectrum of differing perspectives on risk, such as those that take a more precautionary, risk-aversive approach to those that privilege provable harm approaches?
  3. How do we protect vulnerable populations, honor global cultural differences, and respect and include diverse opinions?
  4. Who should ultimately regulate technologies (e.g., government, private sector, self-regulation)?
  5. How do we assure fairness, justice, and global sharing of the fruits of modern biotechnology?

Program Agenda

Sun, May 17 (Tabernacle)
12:00- 5:00
On-Site Registration Open
5:00-7:00
Opening VIP reception at the Metro Atlanta Chamber of Commerce
Mon, May 18 (Tabernacle)
7:30-8:30
Breakfast
8:30-9:00
Welcome and Introduction
9:00-10:20
TOPIC A: ASPIRATIONS, GOALS
Biotechnology is in service of many goals, from making money, to curing disease, to understanding the basic nature of the organic world, to promoting human flourishing. How should we think about these differing goals as we move into our biotechnological future?  For example, while scientists, policy makers, and the general public acknowledge and share the ideal of “human flourishing,” people differ significantly in how to define it. Further, human flourishing may not be equitable - some may flourish more than others from novel biotechnologies (e.g., society-specific benefits may contribute to global inequalities). Also, there are risks, practical and conceptual, in engineering life. While some claim biotechnology builds on nature’s blueprint, others fear that we are venturing too far in altering the natural world when we attempt to reconstruct life itself. On the practical level, significant challenges exist in maintaining the integrity of research in translation and commercialization of new biotechnologies. What was once unachievable is now commonplace -- commercial entities can now provide consumers on demand DNA sequences or microbiome testing kits, leading to growing do-it-yourself (DIY) communities whose activities are outside of academic and corporate institutions and their regulated environments. All of these issues are complicated by media hype and gaps in communication between the public, scientists, and policy makers. In this session we will discuss the historical and evolving aspirations of cellular biotechnologies and the context for their use, and our hopes and fears for existing and emerging biotechnologies. We will also consider both the expected and unintended consequences for scientists and the general public. We will also discuss new models for promoting communication between the public, policy-makers, and scientists to ultimately drive innovation and practice.
10:30-11:50
TOPIC B: ALIEN ORGANISMS AND NEW (ID)ENTITIES
Cellular biotechnologies presently enable us to engineer novel organisms, which may ultimately be used for industrial, environmental, or therapeutic purposes. For example, recent advances in sequencing the microbiome of humans, nonhuman animals and plants have introduced the possibility of creating bacteria that could serve as biosensors in humans or human products. In addition, genetic manipulation of bacteria has allowed for novel ways to mediate environmental sustainability. Even couture designers are beginning to use bacteria, so-called factories of the future, to create clothing. In this session, we will discuss thorny issues related to navigating the use of such novel technologies and entities according to differing risk assessment frameworks; how introducing new organisms might modify existing social systems and ecosystems; and how to balance intellectual freedom to innovate with responsibility.
11:50-1:00
LUNCH (Delegates have lunch in house)
1:00-2:20
TOPIC C: BIOTERROR/BIOERROR
Cellular modification and synthetic biology have enabled the construction of biological systems that can provide creative solutions for environmental cleanup and potable water, and in the not too distant future, may deliver renewable energy. Yet, these technologies also have the potential to harm the environment or provide new tools for bioterrorism. What framework should be used to minimize risks while nourishing innovation? Further, a lack of consistent global regulation, with differing frameworks of risk (ranging from precautionary to proactionary) on these issues can inadvertently create a market for countries that may have more lenient laws. With such potentially lucrative differential markets, some countries may hesitate to regulate controversial technologies. When considering risks, is there a way to create a global “rule of law” that maintains opportunities for innovation while maintaining appropriate levels of concern for probability of harm – environmental, social, and physiological? In addition, how might cellular technologies be included in international regulations about bioterrorism? In this session, we will discuss potential consequences of cellular biotechnologies, the safety of synthetic biological materials and pathogens introduced into ecosystems, biocontainment, biosafety for workers, biosecurity, and boundaries for use.
2:30-3:50
TOPIC D: OWNERSHIP
Advances in technology now allow for the creation of artificial genetic material (RNA/DNA), and engineered microbes and plants. Should custom-designed genetic material or organisms be subject to patents and copyright? Assuming these novel technologies will create new markets, should they be considered the property of their creators or should their bioarchitecture and originating data be open access not only to other scientists, but also to a thriving cadre of biohackers in the DIYbio movement? Other topical questions include: What truly drives innovation? What are best practices for the scientific enterprise? Is open access good for this science despite its presenting obvious opportunities for harm? Does patenting violate human rights by reducing access? What are the obligations of high biotechnology-producing nations to emerging and low-income nations? Finally, are there models that allow for both intellectual property rights and greater access to materials not in the public domain?
4:00-5:15
TOPIC E: DONORSHIP
Scientists have benefited from the donation of human biological materials ranging from blood samples to human embryos. While the most controversial case is the status of human embryos, the rights and status of donors of human tissues in general are ambiguous at best. Human genetic research databases are growing world wide with a lack of clear regional, national, and international levels of governance. Maintaining privacy and protection for humans who donate samples becomes even more pressing with the move toward open and shared data resources (e.g., Genome Wide Association Studies). In an era where cyber attacks are all too familiar, can such data truly be secured? Embryos from in vitro fertilization (IVF) often go unimplanted and could be donated to research or commercial organizations. In both the cases of DNA and embryo donation, how do we ensure that donors’ wishes and integrity are respected, particularly for donors from marginalized communities and countries who may already have a history of exploitation? In this session, we will explore the role of potentially vulnerable individuals as donors, the status of the embryo in research, legacy use and communication of legacy use to donors of genetic material, and policies for commercial entities that offer personalized medicine services from stem cells. We will also discuss who ultimately benefits from these donations and how to ensure justice and fair distribution of the benefits of these cellular technologies. In addition, we will discuss how government and private sector entities might best collaborate to protect donors and create standards for bio- and stem cell banks.
6:00-9:00
GALA at the Georgia Aquarium
Tues, May 19 (Tabernacle)
7:30-8:30
Breakfast
8:30-9:50
TOPIC F: Emerging Themes - New Directions
  1. 8:30-9:00   Evaluating risk and harm
  2. 9:10-9:40   Who should regulate?

Day 1 of BEINGS will not only highlight the challenges of generating a consensus for our aspirations for and conceptualizations of human cellular biotechnologies, but also the challenges in creating global aspirational and regulatory guidelines that capture varying perspectives and regulatory models.  The opening session of Day 2 will be broken into two smaller directed panel sessions focusing on regulatory questions. The first will discuss perspectives on evaluating risk and harm (e.g. precautionary principle and provable harm) and the second which regulatory bodies should makes such assessments.

10:00-11:30
TOPIC G: Summary Discussion of Guiding Questions
  1. What should be the goals of biotechnology; is progress itself an ethical aim or obligation? How do we honor the sanctity of life (assuming that “sanctity of life” continues to be a morally useful construct)?  What is “human flourishing” insofar as biotechnology can contribute to it?
  2. How do we navigate the spectrum of differing perspectives on risk, such as those that take a more precautionary, risk-aversive approach to those that privilege provable harm approaches?
  3. How do we protect vulnerable populations, honor global cultural differences, and respect and include diverse opinions?
  4. Who should ultimately regulate technologies (e.g., government, private sector, self-regulation)?
  5. How do we assure fairness, justice, and global sharing of the fruits of modern biotechnology?
11:30-12:00
CLOSE OF DISTINGUISHED FACULTY PROGRAM
12:00-1:30
LUNCH (Delegates have lunch in house)
1:30-2:50
TOPIC H: Drafting Ethics and Policy Guidelines
Purpose of Consensus Document, drafting form and process, and target points for policy.
3:00
REGISTRANTS AND NONDRAFTING DELEGATES DEPART
3:00-6:00
TOPIC DRAFTING GROUPS MEET
Wed, May 20 (Westin Hotel)
9:00-9:30
Breakfast
9:30-12:00
TOPIC DRAFTING GROUPS MEET
12:00-1:00
LUNCH
1:00-3:00
TOPIC DRAFTING GROUPS MEET
3:00
ADJOURN