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Presentations: Schedule & short Description

  Monday, May 19 2003: The State-Of-The-Art In Embryo Research (Brigid L.M. Hogan) - A basic requirement for identifying relevant regulatory options is a good understanding of the current state of the art of embryo research. While the general public tends to equate embryo research to embryonic stem cell research, the range of research activities covered by this term is much wider and the type of institutional actors involved is diverse. IVF clinics, many biotech companies, and academic researchers in the field of developmental and reproductive genetics are all involved in embryo research that is only partly or wholly unrelated to stem cell research. This presentation will take an in-depth look at embryo research as conducted in the private sector and at research institutions, discuss current research topics, identify the institutional actors involved, and present likely future developments

  Monday, June 16 2003: Possibility and Limits of The Current Regulatory Framework (Gregory J. Glover) - Monitoring scientific progress, periodically assessing its potential risks and benefits, and devising appropriate measures are tasks that could currently be accomplished by a variety of administrative agencies, including the FDA, the NIH, and the CDC. Each of these agencies has the scientific and technical expertise necessary to monitor scientific and technological progress. However, it is not clear whether their statutory authority enables them to regulate stem cell research, cloning, PGD or any other field of research. These issues need to be explored in some detail before exploring new regulatory options.

 Thursday, July 17 2003: Constitutional Constraints (Steven Goldberg) - Imposing limits to scientific activities may raise constitutional challenges. For example, are first amendment rights infringed by efforts to regulate scientific research? Does a constitutionally protected right to privacy extend to PGD and other “reproductive” technologies? From a constitutional point of view, does it make sense to distinguish between basic and applied research? Probing these questions is an essential preliminary step before exploring new regulatory models.

  Tuesday, September 9 2003: Self-Regulation (Margot Priest) - In recent years, a variety of industries have adopted innovative programs of self-regulation. Examples include the nuclear power industry, several sectors of the chemical industry, the textile industry, and the timber industry. Programs of professional self-regulation such as ethical guidelines and the medical practices approved by the American Society for Reproductive Medicine may be regarded as a solid foundation on which to base a regulatory scheme. In this presentation, we will examine how regulators can assess the effectiveness of professional self-regulation, and will explore the possible roles that a self-regulatory scheme could play in achieving public policy objectives.

  Tuesday, October 7 2003: Technology Monitoring and Assessment (Daniel Sarewitz) - A timely and appropriate regulatory response presupposes a continuous assessment of potential risks and benefits of embryo research. This is easier said than done. Many benefits touted by scientists at this point are highly hypothetical. At the same time, it is often difficult to articulate in a precise fashion the risks associated with this research enterprise. Articulating the possible benefits and risks associated with these technologies, and estimating the uncertainties surrounding scientific and technical progress should precede any effort to promulgate new regulations. What methodologies are best suited for this task? Who should be actively involved in this exercise? What rules should govern this process? These are the questions we will discuss in this session..

   Monday, November 3 2003: Foreign Models of Technology Governance (Lori K. Knowles) - The British Human Fertilization and Embryonic Authority (HFEA) and the Canadian Assisted Human Reproduction Agency provide two examples of institutions designed to provide legal guidance in the field of embryo research. Their effectiveness and credibility as the ultimate judges of ethical dilemmas has yet systematically to be assessed. Furthermore, it is not clear whether these models could be adopted in the United States without significant changes. But any domestic regulatory effort should be informed by the experience of other countries

  Monday, December 1 2003: Delegation of Authority and Agency Discretion (David Epstein) - The delegation of authority to an administrative agency is a particularly delicate topic, as this agency likely will be called upon to decide highly visible and controversial issues with limited legislative guidance. Many find this apparent lack of accountability disturbing. Yet often, detailed legislation crafted by Congressional Committees that operate in a less than transparent way favors special interest groups to the detriment of the general public. Thus, some degree of regulatory discretion coupled with effective oversight mechanisms may be preferable to a purely legislation solution. In this session, we will examine the pros and cons of strictly limiting agency discretion vs. allowing regulators to make semi-autonomous decisions.

  Monday, February 2 2004: Public Attitudes about Reproductive Genetics (Kathy Hudson) – Public opinion can play a powerful role in shaping professional and public policy and sound policy in a democracy should be reflective of the public’s views and values. Yet, little is known about what American’s know, think and feel about reproductive genetic technologies. The Genetics and Public Policy Center has undertaken a multifaceted assessment of public attitudes and Kathy Hudson will discuss preliminary results and future plans. The on-going assessment uses a number of established quantitative and qualitative methods as well as some newer approaches in deliberative polling and public engagement. The Center’s first survey was conducted in the fall of 2002 and a second expanded survey will be fielded this winter. In addition, 21 focus groups with members of the general public and interviews with over 180 religious Americans have been completed. Interviews with individuals with specialized expertise and/or experience with reproductive genetics such as individuals with a known genetic disease, parents of children with genetic disease, persons with personal experience using reproductive technologies (particularly PGD), health care providers, and scientists are nearly completed. Finally, the Center intends to elicit more detailed, informed public opinion through deliberative polling and public engagement activities that will be underway this Spring. The Center will use the findings to shape proposed policy alternatives for reproductive genetics, to develop information and educational resources, and to inform the public and policymakers about where American’s stand on development and use of reproductive genetic technologies.

  Monday, March 1 2004: Human Rights and International Governance(George Annas) - The mobility of scientists and investment capital, and the relatively modest need for investment in physical infrastructure make it extremely easy for entrepreneurs and scientists to seek out jurisdictions that promise to keep regulatory barriers at a minimum. This is of course not a new problem, one that nations traditionally have addressed by entering multilateral agreements. Many of the questions that designing an international agreement would raise are similar to those discussed in the domestic context. Among them is deciding how much regulatory authority should be delegated to a suitable international organization, whether an existing international organization is suited for this task or whether a new one should be created, circumscribing the role of various interest groups in negotiating binding international rules, and in monitoring their implementation.

  Wednesday, April 14 2004: International Governance - A Certification Approach (Max Mehlmann) - "Reproductive tourism" and "research migration" are phenomena that will inevitably arise as a result of differences in domestic approaches to regulation. Countries with less restrictive regulations are likely to experience an influx of both individuals and research companies seeking to obtain services and conduct research that is either prohibited or highly restricted at home. Rather than negotiating an ecompassing multi-later agreement the US could envisage implemeting a certification approach that would delegate monitoring and enforcement authority to a variety of private actors such as trade and professional groups, and perhaps to non-governmental organizations.

  Monday, May 10 2004: Design for Regulation (Carl Coleman) - Regulators have considerable discretion in structuring the rule-making process. This is an area ripe for innovation. It is not unreasonable to assume that a suitably designed rule-making process could increase considerably the legitimacy of proposed rules and reduce the chance that a final rule will be challenged in court. To achieve these - admittedly ambitious - goals, considerable attention needs to be paid to several issues including representativeness, the risk of politicization and group polarization, the rules of decision-making (consensus, simple majority, super-majority, etc.), and the role of the general public.
  Monday, July 5 2004: Deliberation, Group Polarization & Regulatory Design (Cass Sunstein, TBC) - This presentation focuses on an often overlooked paradox of a deliberative approach to decision-making: in some cases, deliberation can exacerbate a conflict rather than contribute to its resolution. On the other end, it is hard to imagine a federal bureaucracy regulating a highly controversial technological field without engaging the general public. Fortunately, polarization is not the only possible outcome. Certain institutions are much more likely to promote consensus and mutual understanding than others. The presentation will examine the underlying causes of group polarization as well as institutions designed to mitigate or reverse this vexing phenomenon.

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