Animal Law, Welfare, Interests, and Rights, Second Edition (Elective Series) (Aspen Elective)

There will also be an open book in-class exam at the end of the semester. Working for social justice is an important part of the professional obligations of all lawyers, and for many law students, their initial motivation for pursuing a legal education.

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This course is designed to introduce students to the ways in which lawyers committed to social justice engage with communities, individual clients, social and political causes and legal systems to help effect social change. We will examine the types of lawyers working toward social justice, the ways in which lawyers help shape claims in social justice cases, and finally, how lawyers use their skills and training to engage in political struggles and movements to achieve social justice for the communities, causes, or individual clients that they represent.

Through readings, discussion, and independent studies of legal cases and movements in social justice, students will explore different models of social justice lawyering and the barriers present both in the representation of under-served communities and in pursuing a career in public interest law. Students will also have an opportunity to explore more deeply how they plan to be a lawyer engaged in social justice work, either in their pro bono or full-time future practice.

While enrolled in Law Social Justice Lawyering , with prior professor approval, students may submit a page research paper and earn an additional one credit for the course. This paper is in addition to all the other course requirements, including the five written assignments, but may be related to your case study presentation. You must meet with Professor Berlin or Gordon by September 1, , which is the last day of the drop-add period, if you would like to seek an additional credit and if you plan to use your paper to satisfy one or more of these requirements.

This course will provide students with an enhanced and vital understanding of law firms as business entities in a competitive and global market. Based on feedback from employers, interviews with hundreds of lawyers and published accounts from law firm leaders, it is clear that technical legal ability will be necessary but not sufficient to excel in the practice of law or any business endeavor in coming decades. The topics will be explored through the review and analysis of literature, statutes, and case studies, and will include a basic financial analysis of the operations of law firms.

Assignments will be collaborative and will simulate the client advisory process allowing students to gain experience providing legal advice and business recommendations. Associate Dean and Senior Lecturing Fellows Bruce Elvin and George Krouse '70 will lead, teach and organize the seminar, with senior law and business leaders from the United States and abroad serving as guest lecturers many weeks.

A study of legal and policy issues relating to the family. Topics include requirements for marriage, nontraditional families, obligations at divorce, establishing parenthood, and adoption. Grading is based on a final examination, class participation, and written work relating to a visit to family court and completion of a divorce settlement exercise. This course examines the constitutional and statutory doctrines regulating the conduct of American foreign relations. Topics include the distribution of foreign relations powers between the three branches of the federal government, the status of international law in U.

Where relevant, we will focus on current events, such as military detention of alleged terrorists, human rights litigation against multinational corporations, the prosecution of piracy, and controversies over immigration enforcement. An introduction to federal income taxation, with emphasis on the determination of income subject to taxation, deductions in computing taxable income, the proper time period for reporting income and deductions, and the proper taxpayer on which to impose the tax.

Many attorneys are required to evaluate financial data, notably financial statements from corporations, on a regular basis. The need is not limited to corporate attorneys; indeed litigators in securities, antitrust, malpractice, or general commercial litigation frequently must analyze financial information.

This course serves to both introduce basic accounting principles and practices and their relationship to the law, as well as to study a number of contemporary accounting problems relating to financial disclosure and the accountant's professional responsibility. Students with accounting degrees, MBAs or who have taken more than a couple of accounting courses are not permitted to enroll.

Also, Business Essentials may not be taken concurrently with this course. This course examines the legal doctrines, theories, and arguments arising out of the free speech and religion clauses of the First Amendment. A comprehensive introduction to the principal theories of trademark law and unfair competition, copyright law, patent law, and related state and federal doctrines.

This course offers a general introduction to the international legal system and provides a foundation for more specialized courses. Topics covered include the sources, actors and institutions of international law; the application of international law by U. The course examines the basic principles of labor law: It focuses on the major federal legislation in this area - the National Labor Relations Act - as opposed to other laws governing workplace conduct wage-hour, anti-discrimination, etc. The class covers the history of the Act, who is covered under its provisions, the jurisdiction of the National Labor Relations Board and judicial review of its actions, how unions are formed, collective bargaining, unfair labor practices and the procedures to remedy same, and economic weapons used in labor disputes strikes, boycotts, lock-outs, etc.

The class also analyzes labor law from a multi-disciplinary perspective, with attention given to psychology, economic history, politics, and emerging cultural trends the rise of social media as a means of union organizing, for example. It is taught using a combination of lecture, case analysis, and classroom simulations. It is the goal of this course to provide the student a firm grounding in the basics of labor law, with a practical appreciation of the passions labor conflict generates.

This is an introduction to the principles and concepts of commercial law and bankruptcy and their interplay. The course will start with a brief overview of the more innovative aspects of sales law, and then will introduce such basic commercial law concepts as letters of credit, documents of title, and negotiable instruments. The course then will focus on secured transactions under Article 9 of the Uniform Commercial Code, including the concepts of security interests, collateral, perfection and priority, and foreclosure. That will bring in the natural interplay with such bankruptcy law concepts as property of a bankrupt debtor's estate, automatic stay of a foreclosure action, use by a debtor of property subject to a security interest, adequate protection of the secured party's interest, rejection of executory contracts, bankruptcy trustee's avoiding powers, preferences, fraudulent conveyances, postpetition effect of a security interest, set-offs, and subordination.

The course also introduces principles of international insolvency and bankruptcy. This course Principles is intended to give a solid, conceptual and practical grounding in all of the basic commercial and bankruptcy law issues that you are likely to encounter in your practice. This course uses consumer bankruptcy as a lens to study the role of consumer credit in the U.

The class will focus on the key aspects of the consumer bankruptcy system, including who files bankruptcy, what causes bankruptcy, the consequences of bankruptcy, and the operation of the bankruptcy system. We will discuss each of these issues in the larger context of consumer debt and consumer law, and will also cover the foreclosure crisis, student loans, and issues related to debt, race, and gender.

The readings will come from law and non-law sources, including the work of a variety of social scientists. The course is intended to introduce law students to essential principles of accounting, financial statement analysis, finance, business valuation, the economics of the firm, financial instruments, capital markets, and corporate transactions.

This course explores laws and policies that affect decisions on United States ocean and coastal resources. We examine statutes, regulations, attitudes, and cases that shape how the United States and several states use, manage, and protect the coasts and oceans out to — and sometimes beyond — the mile limit of the Exclusive Economic Zone. We cover government and private approaches to coastal and ocean resources, including beaches, wetlands, estuaries, reefs, fisheries, endangered species, and special areas.

Banking has evolved rapidly in just a few years. Global trade and investment has been supported and promoted by an emerging global financial system. This has in turn encouraged the growth of giant universal banks, based in the United States, the United Kingdom, mainland Europe, and in China and Japan. The debate over big banks and "too big to fail" concerns continued to be an important public policy concern in the Presidential election campaign. After nearly a decade of reform, however, the framework remains fundamentally controversial, at least in the United States, and executive and congressional efforts to reverse the Dodd-Frank and Basel models are currently on the main national political agenda.

The walls between the three main sectors of finance - banking, securities and insurance - have broken down, yet at their core banks continue to be somewhat unique in their functions and the challenges they present for financial stability. This course serves as an introduction to the field of corporate crime, which now covers a large realm of government and law firm practice. The course will give students a first exposure to: This field is large, complex, and developing rapidly.

This course therefore can cover only a selection of topics, and will emphasize policy and the need to confront gaps and uncertainty in doctrine. As there is no unitary body of black letter law in this field, this is not that kind of course. Coverage is likely to include mail and wire fraud, perjury and obstruction of justice, securities fraud including insider trading and accounting fraud , the Foreign Corrupt Practices Act, corporate criminal liability, grand jury powers and procedure, representation of entities and individuals, the Fifth and Sixth Amendments in the corporate context, plea and settlement agreements, and sentencing.

The materials consist of a course pack and occasional handouts. Assigned reading averages about 80 pages per week. The grade will be based primarily on a take home exam, with some weight given to class participation. Use of laptops, smartphones, tablets, and the like will be prohibited during class meetings. This seminar is derived from the three-credit Children and the Law course. Where the latter is a broad survey of the law governing decision making for children and the relationship between parents and the state that arises in that context, this seminar focuses in on the three areas of the law that tend to generate the most cultural and legal controversy: The course can be used to satisfy the upper-level writing requirement.

There are no prerequisites. However, because the subject matter builds on the foundations of constitutional law, property, and torts, it will be useful to have taken these classes. Their clients increasingly include multinational corporations and foreign governments who carry out commercial transactions, invest in public infrastructure, and exploit natural resources often in collaboration with other corporations and governments of diverse nationalities around the globe.

Clients may also include citizens and community groups affected by such projects. Given the sometimes conflicting interests of the various stakeholders, some of these undertakings evolve into complex disputes that cross not only geographic borders, but also cultural, linguistic, political, and jurisdictional boundaries. Rights and remedies of private parties may be available, either alternatively or additionally, through national courts, local arbitration forums, and diplomatic protection. And mediation of international disputes is on the rise, under existing institutional rules or through ad hoc proceedings such as before the Permanent Court of Arbitration PCA.

As you prepare yourself to represent global clients, you must be equipped to navigate the available forums and the applicable legal regimes to advance their interests. This course will take students through an evolving, hypothetical international dispute, to empower students with practical knowledge, skills, and strategy.

Each module of the course will require students to explore a different dispute resolution forum and address a different facet of the dispute governed by a different source of law including treaties; contracts and concessions; and local, foreign, and customary international law. Students will be required to read selected excerpts from leading cases and treatises and to engage in substantive discussion and debate in class. Students will also be required to complete practicum exercises to develop transferable skills for all forms of international arbitration and litigation.

This course will explore selected topics in Law and Politics of American Democracy. We will examine the way the law and other forces have shaped the structure of American political participation, and we will consider alternative directions American democracy might take. What decides legal cases? One obvious answer is: Judges apply the law to the facts of a case and an answer presents itself.

This simple understanding of how law and the judicial process work may be true in many cases, but it is not true in all of them. Social scientists have sought to explain judicial decisionmaking by reference to a variety of non-legal factors, including judges' personal characteristics, their caseloads, and their relationships with each other.

The social scientific study of courts raises a host of interesting questions. For example, on a multi-member court like the Supreme Court, does it matter which Justice is assigned to write the opinion, or will the majority or the whole Court bargain to the same outcome anyway? If opinion assignment matters to outcomes, how might judges' choices about the division of labor influence the content of the law?

How do higher courts ensure that lower courts comply with their decisions? Does the need to police lower courts alter legal doctrine, giving us more bright line rules and fewer fuzzy standards? Similarly, does the fact that certain groups, like the Chamber of Commerce, are repeat players, affect the outcome of cases? Does it affect doctrine? Finally, does it matter who is under the robes? Does the ideology of the judge, or her race or gender, matter to the outcome of cases? If so, is it possible to predict how judicial characteristics will shape the law?

Should our answers to these questions affect how we choose judges? This course that will examine these questions and many like them. In law schools, these sorts of questions get limited attention: Social scientists take a very different approach, studying the behavior of judges rather than legal doctrine and trying to understand what accounts for judicial outcomes and the shape of legal institutions.

This course will marry the social science literature and the questions it raises to a set of normative problems within the law itself. This is an advanced civil procedure class taught in the Moot Courtroom for those interested in large scale litigation, with an emphasis on practical application and stand-up courtroom 3-minute "mini- oral arguments" on many of the key cases. The course will focus on the problems of large multi-party and multi-forum civil cases and how courts and litigants deal with them.

Coverage will include the practical steps litigators need to take as well as decision points at the outset of litigation, joinder devices, especially but not only class actions; federal multi-district transfer and consolidation; litigation over the appropriate federal or state forum, coordination among counsel in multi-party cases, ethical issues, big-case discovery problems; ad hoc federal-state litigation coordination; judicial case management techniques and issues; and ways of accelerating or terminating potentially or actually protracted cases, including settlement, alternative dispute resolution, representative trials, mini-trials and claims processing facilities.

The Criminal Justice Ethics course is centered on the law governing lawyers operating in the criminal justice system. It explores some of the critical issues facing lawyers in the roles of defense counsel, prosecutor, judge, etc. Case studies and problems are drawn from North Carolina cases, including some of the Duke Wrongful Conviction Clinic's cases of actual innocence.

Lawyers face non-legal, analytical issues every day. Business lawyers need to understand a business in order to represent their client properly. Litigators need to judge the best route in adopting a litigation strategy. Family lawyers routinely need to value a business.

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Environmental lawyers need to understand economic externalities. Social lawyers need familiarity with financial instruments that have positive and negative attributes. In these and many other situations, lawyers tend to learn on the job, and even then the pressures of the moment often means that they learn just enough to move on to the next problem. This course is designed to help all lawyers develop a more systematic way of thinking about their work.

Students taking this course will find it foundational in running a business, advising a business, or litigating business matters that go beyond the strict letter of the law. In this sense, this is not your standard doctrinal law school course. Rather, it is designed to give students the tools necessary to interact with the business community and run a company or firm.

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While there is no prerequisite for this course, students should be comfortable with numbers and graphs. A high school level of mathematics is required and students should be ready to use algebra, fractions, exponents, and the like. There will be no calculus. The course grade will be made up of class participation, roughly weekly problem sets, case analyses, and a final examination.

This survey course studies the legal and policy issues governing water resource allocation in the United States. Students will be introduced to both the Prior Appropriation systems of the western United States and the Reasonable Use systems dominating the eastern states. We will study the law applied to groundwater use as well as issues of federalism. We will examine the issues from the perspective of different user groups. This course analyzes the legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries.

Innovation in biopharmaceuticals, medical devices, health services, and health care delivery is central to the heavily regulated life sciences sector, and thus the sector offers a window into multiple intersections of scientific innovation, regulatory policy, and law. Innovation in this sector is also shaped by multiple bodies of law e. Although this course focuses on innovation in the life science industries, this focus will produce lessons for innovation policy in other regulated and less-regulated industries.

A comprehensive course on the law of literary and artistic property, with emphasis on mastering the technical intricacies of the Copyright Act and its many complex recent amendments, including the cyberspace rules introduced by the Digital Millennium Copyright Act.

Subject matter treated will include literary characters; musical works; pictorial, graphic, and sculptural works; industrial designs; motion pictures and plays; sound recordings; computer programs and databases. Throughout the course effort is made to clarify the relations between artistic property and industrial property especially trademarks and unfair competition law in the United States and at the international level.

Students are encouraged to think critically about the unresolved economic and policy issues facing creators and innovators in an Information Age, issues that often reflect a larger, ongoing debate within the framework of the world's intellectual property system, and the course will prepare them for the practice of copyright law at any level. The course will focus on the process by which a corporate debtor achieves reorganization pursuant to the provisions of Chapter 11 of the Bankruptcy Code. Prior familiarity with bankruptcy principles and debtor-creditor law is not required.

These will be incorporated in the course as it unfolds. Some familiarity with business organization is helpful but not necessary. The subject will be covered primarily from two perspectives: Topics to be covered include: This 3 credit course is designed to expose law and business students to the methods and theories that underlie corporate restructuring transactions. The course emphasizes the business strategies and valuation techniques that drive corporate transactions, while also illustrating the role of the law in such transactions.

The coursework is practical, with each law student working with a group of MBA students to complete case-oriented assignments. Ideally, the law students learn from the business students and vice versa. In most years, student evaluation is based on these collaborative written assignments and class participation, and no final exam is required.

Check with the instructor for assignment details in any given year. The course begins with an overview of the structure of the large-scale, public corporation, the conflicts of interest that exist between managers and stockholders, and the market forces and regulations designed to resolve such conflicts. Analytical techniques for valuing particular transactions will be discussed.

Specific types of transactions will be examined, including, but not limited to mergers, acquisitions, tender offers, LBOs, divestitures, liquidations and reorganizations. In most cases, both financial and legal implications will be explored. Guest speakers help enhance the practical, real world perspective of the class. Business Associations is required for all law students. Other corporate law courses such as Securities Regulation and Law of Corporate Finance can be helpful but not required.

Some prior exposure to the principles of finance is strongly recommended. Please note that this course meets on the Fuqua half-semester schedule, which begins in mid March and ends in late April. This course is designed to familiarize law students with the principles of corporate finance. In the world of corporate finance, the distinction between lawyers and investment bankers has blurred. Whether negotiating a merger agreement, acquisition, or divestiture, rendering a fairness opinion, preparing for an appraisal hearing, litigating securities class action or derivative suits, issuing new securities, taking a firm private via an LBO or public via an IPO, corporate lawyers and investment bankers work side-by-side.

Lawyers without an appreciation of the basics of corporate finance are at a distinct disadvantage. This course will also provide important tools for litigators to work with financial expert witnesses and calculate damages. Even students who do not plan to venture into the corporate world will benefit from this course.

The financial principles covered are essential for lawyers intending to do estate or tax planning, litigate divorces, or draft the compensation agreements for business entities of all types. A study of the provisions of the Internal Revenue code governing the tax effects of the major events that occur in the life span of a corporation, including the taxation of distributions to shareholders and the formation, reorganization, and liquidation of corporations. No papers are required, but class participation is expected. Students interested in taxation should take this course; it also has application to general corporate practice mergers and acquisitions.

It is strongly recommended that students take Business Associations before taking Corporate Taxation. The course will examine the legal framework governing energy production and consumption in the United States, and policy approaches for balancing energy needs with other societal goals. The course will include three main modules: Key themes will include:. This course uses the lens of international debt finance to provide students with an advanced course in securities law, corporate law, and contract law.

In the area of international debt finance, particular attention will be paid to debt issuances by sovereign nations. Given that much of this market is centered in New York and London, the focus of the course will be on U. Particular attention will be paid to how lawyers and their clients both the sovereigns and the investment bankers think about how to structure their contracts and what disclosures to make to the public regarding these contracts.

Finally, attention will also be paid to the question of how domestic law private law principles can be utilized to solve or at least ameliorate the problem of third world debt with particular reference to Sub Saharan debt. Constitutional, Statutory, and Policy Considerations This seminar introduces students to the legal standards that govern public schools in the United States. Constitutional topics include the right to a public education, the financing of public schools, desegregation and equal opportunity of students, limitations on student speech, school discipline and the right to due process, religion in schools, and privacy rights of students.

Policy topics include school reforms, such as charters and vouchers, and the ongoing inequities in US public schools, and the school-to-prison pipeline. A research paper is required; successful completion of the paper will satisfy the upper-level writing requirement. A course pack will be used in lieu of a textbook. This course examines the role of the federal government in the criminal justice system, focusing on significant federal offenses criminalizing fraud, public corruption, drugs, money laundering, racketeering, firearms, and terrorism.

We will also consider prosecutorial discretion, plea bargaining, and sentencing in the federal system. The objective of this course is to master doctrine and to learn how to debate federal criminal law's merits and proper limits. Public policy, theory, critical thinking, and oral advocacy will be emphasized.

Federal criminal law is recommended either for second- or third-year students. It is especially helpful for students who will have a federal judicial clerkship, and those who anticipate a career in litigation. The course will address the ways that torts, constitutional law, federal and state statutes and regulations, and societal norms protect individual privacy against government, corporations and private actors in a variety of areas including: The course may also address briefly privacy issues and laws in an additional country, such as China, for purposes of further comparison.

Students will gain a broad understanding of the breadth, diversity and growing importance of the privacy field. What are the government policies that support science? How is science regulated and controlled? What can science contribute to law and policy? How do the states, the federal government and international agencies interact to set science policy? How do disparate regulations and law impact research and translation? How is scientific research funded? These questions and more will be explored by looking at the interaction of law, science, and policy. The class is a mix of law, ethics and science students, and learning how to talk to one another in a common language is an important element of the course.

Classes will include consideration and analysis of cases studies. There are no prerequisites for the course, and there is no requirement that students have either graduate or upper-level undergraduate training in the sciences. Course evaluation will be based on class participation, student presentation, weekly discussion questions, a short paper, and a final exam.

This course focuses on section of the United States Code, a Reconstruction-era statute that enables private parties to sue any other person who "under color" of law deprives them of the "rights, privileges, or immunities secured by the Constitution and laws" of the United States. Class participants will become familiar with the theoretical, procedural, and practical aspects of civil rights litigation, including constitutional and statutory claims, defenses and immunities, and available remedies, including attorney fees.

Code provisions concerning discrimination in housing, contractual relations, employment, and voting are examined where relevant. The alternative asset classes of private equity and hedge funds represent a significant and growing share of investment activity worldwide and are at the center of many of the most pressing current issues in finance and financial law.

While traditionally lightly regulated, both areas have received increasing regulatory attention, particularly since the global financial crisis. Both also figure prominently in major ongoing debates concerning financial stability, market efficiency, corporate governance, financial innovation and complexity, and even income inequality. This course introduces private equity and hedge funds from the perspectives of finance, regulation, and legal practice, covering the foundational issues of securities, tax, organizational, and fiduciary law that they raise. Students will learn the basic regulatory framework applicable to fund structuring, fund managers and sponsors, fund offerings, and fund investments and gain experience with the key agreements among the parties involved.

In addition, the course will critically assess the current regulation of private equity and hedge funds and proposals for reform. Through reading materials, course discussions, guest lectures, and group work, students will gain insight into the perspective of fund managers, advisors, investors, those who transact with such funds, and those who regulate the fund industry. Prior coursework in securities regulation and taxation may be useful, but is not required. This two-credit course will consider and analyze corporate mergers and acquisitions and the process of initiating and completing a corporate acquisition.

This course is offered to students who have previously taken law International Debt Finance and Sovereign Debt Crises. This course will examine a number of topics related to the law of animals, including various issues that arise under the laws of property, contracts, torts, and trusts and estates.

It will also examine various criminal law issues and constitutional law questions. The class will consider such issues as the definition of "animal" as applicable to anti-cruelty statutes, the collection of damages for harm to animals, establishing standing for animal suits, first amendment protections, and the nuances of various federal laws. This outplacement course will provide students the opportunity to work on legal matters related to animals.

Students are required to complete a minimum of hours of outplacement work under the supervision of practicing attorneys over the course of the semester. Placements may be with local attorneys in private practice handling veterinary malpractice cases, for example , local district attorneys' offices working on cruelty prosecutions , or national animal advocacy organizations such as the Humane Society of the United States, the Animal Legal Defense Fund, or People for the Ethical Treatment of Animals.

The course instructor will assist in making the placements for the students and will maintain close communication with both the students and the placement supervisors on the amount, type, and quality of the work performed. The outplacement will require legal drafting such as preparation of complaints, examination outlines, and legal memoranda. Students' grades will be based on the quality of their clinical work assessed by the outplacement supervisor and the course instructor.

This course concentrates on possible relationships between law and literature. The major themes will be depiction of law and lawyers in popular and highbrow fiction; relationship between the interpretation of legal and literary texts; law in utopia and dystopia; crime and punishment; romantic conception of authorship in copyright, interpretation, and social theory. The course involves considerable reading, including works from some of the major academic debates in the ''law and literature movement'' and from cognate debates in legal interpretation.

A study of the rules governing federal taxation of gratuitous wealth transfers. Working with both statutes and cases to develop an understanding of the Estate and Gift Taxes, we will consider not only the mechanics of these two taxes and the intertwined Generation Skipping Tax , but also their basic policies, history, and selected concepts concerning estate planning implications of transfer tax.

There is no prerequisite. Introduction to basic principles of food and drug laws and examination of how significant doctrines of constitutional, administrative, and criminal law have been elaborated and applied in the food and drug context. Exploration of the complex interplay of legal, ethical, policy, scientific, and political considerations that underlie the FDA's regulatory authority, its policy-making, and its enforcement activity. This installment focuses on the nature of the Article III judicial power and its place in the constitutional scheme.

We begin with the justiciability doctrines standing, ripeness, mootness, and finality , then move on to Congress's control over federal court jurisdiction and adjudication in non-Article III courts e. This installment also focuses on the relationship between federal and state courts, including the U. Supreme Court's power to review state court decisions, the Erie doctrine's restriction on the common lawmaking powers of federal courts, and the parameters of federal question jurisdiction. This survey course examines topics in law relating to gender through a series of different theoretical perspectives.

Topics include employment, the family, domestic violence, school sports, sexual harassment, pornography, prostitution, rape, affirmative action, women in legal practice, pregnancy, and sexual identity. Some film is used in class. Evaluation is by an end-of-term exam and three short "reaction papers. This course will consider how firms should manage and protect this intellectual capital.

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We will examine the management of intellectual capital from the vantage point of different types of firms—from start-ups to large incumbents—operating in different market environments. We will consider how firms should protect their intellectual capital, using not only patents, but lead time advantages, complementary marketing and manufacturing capabilities and secrecy, and extract value from their intellectual capital through commercialization and licensing. We will also consider when firms should share their intellectual capital with other firms—even rivals, and how firms should go about acquiring the intellectual capital of others.

Building upon the research literatures of economics, organizational behavior, management, and the law, the course will have particular focus on technology intensive industries such as pharmaceuticals, biotechnology, computers, semiconductors, software and telecommunications. A survey of the legal environment of the health services industry in a policy perspective, with particular attention to the tensions and trade-offs between quality and cost concerns. Topics for selective study include access to health care; private and public programs for financing and purchasing health services; the economics of health care and health care costs; the role of professionalism versus the new commercialism in health care; the legal and tax treatment of not-for-profit corporations; regulation of commercial practice in professional fields; fraud and abuse in government programs; the application of antitrust law in professional fields; the internal organization and legal liabilities of hospitals; public regulation of institutional providers, including certification of need; personnel licensure; private personnel credentialing and institutional accreditation; liability for medical accidents; legal liabilities associated with the administration of health benefits; and public regulation of managed-care organizations.

Study of the diverse legal problems encountered by a single industry, particularly one as important, complex, and intrinsically interesting as health care, may appeal to students generally interested in public policy and in law and economics as well as those with specific interests in the health care field. This seminar is available to students currently enrolled in Law or who have taken it in a previous semester.

It is designed to supplement Health Law and similar graduate-level health policy offerings and will explore contemporary issues in health law and policy. Topics to be considered will include: Medicaid reform, competition policy, individual insurance markets, payment reform, provider strategy, and employee benefits design. Some sessions will be organized around guest presentations from policymakers, policy thought leaders, and prominent academics.

This is a reading seminar, which will cover the East Asian law relating to the economic development, business practices, and financial regulation, exclusively focusing on Japan, Korea, and China. The legal system and economic development of these three countries have several features in common, if compared to the Western legal tradition, but the different history, culture, and politics of each country made its legal system distinctive to each other.

This course aims to examine both these commonalities and distinctions, and thereby enhance our understanding of these three countries today. We will only cover the laws and practices relating to the corporate business and financial regulation, most of which have been inherited from the West. Such legal system has very little to do with the East Asian legal tradition. In most cases, it was previously based on the European Civil Law system, and recently more and more influenced by the Anglo-American laws and regulations.

In this regard, the notions that have been often employed to explain the East Asian distinctions, such as Asian value, Confucianism, and traditional culture, will be rarely used or emphasized in this class. Rather, this course intends to examine how these three countries have struggled to incorporate the Western legal system—with or without its underlying assumptions and background social environments—into their society in a surprisingly limited time. To be sure, such transplant has not always been successful, and we can learn several lessons both from success and failure.

This course will examine the role of social movements in the development of U. Conventional theories of judicial independence do not define a legitimate role for social movements, but recent advances in legal scholarship have underscored the co-constitutive relationship between law and social movements. Accordingly, this course will explore how participants in social movements engage the Constitution and how these encounters shape constitutional doctrine, social institutions, public discourse, and movements themselves. We will investigate the processes of mobilization and counter-mobilization and reflect on how movements often spur constitutional change through means other than constitutionally specified procedures.

We will also consider why movements fail and will critically analyze rights-based approaches to reform. The course will place particular emphasis on the involvement of social movement actors in the transformation of civil rights law. Course readings will draw from a wide range of historical, sociological, and legal sources. This course will provide an overview of selected law and policy topics in immigration law. It will consider the following questions: When and why may noncitizens be forced to leave? How should choices about admission and removal be implemented?

Discussion will be based on a variety of sources, including statutes, caselaw, administrative enforcement guidance, social science research, and legal scholarship. Assessment will be based on written papers and class participation. Good lawyering requires advocacy outside of the courtroom. Lawyers regularly communicate with current and prospective clients, governmental officials, the media, and other general audiences. They also must advocate for themselves—whether in their job searches or within their professional settings. Accordingly, this seminar will introduce skills to make students more effective in their interpersonal communication, teamwork, and persuasive public speaking.

Class sessions will feature a combination of lectures, individual and group presentations, discussion, and in-class exercises. Students will routinely receive feedback on their performances through self-reflections, peer evaluations, and instructor evaluations. Each guest will also discuss how interpersonal communication and public presentation skills shape their day-to-day responsibilities. This one credit course will explore the development and practices of the of the World Trade Organization's dispute settlement system.

The WTO is unique among large international organizations in that it has a formal judicial body with compulsory jurisdiction over all WTO members. This class will examine the creation of this system, rules regarding jurisdiction and standing, and procedures for initial reports and appeals. In addition, the course will discuss compliance proceedings and the WTO's remedy regime. Class time will consist of a mix of lecture, guest speakers, and a simulation of WTO judicial proceedings. In the world of venture capital and private equity, there is no difference between a good business person and a good lawyer.

They both must know capitalization structure and law, and they both must know tax and accounting. Many never achieve this mastery, and those who do only get there after many years of practice. This course helps the law and business student drive to the top of their game sooner and more effectively than their peers from other institutions.

The goal is to focus on the formation of deals. We look at the business reasons that parties come together, we look at the business reasons that deals fail to meet expectations, and we look at the business reasons that deals work. This is especially important in private equity and venture capital deals, where exit strategies have to be anticipated from the very outset of a deal.

Law and economics is one of the most influential schools of thought in modern legal theory. The ideas propounded by the economic analysis of law are gaining increasing traction in court decisions as well as in legal policy. This course explores the methodology of economic analysis in the legal context and discusses several of its provocative insights. This course will examine the major contributions of the economic analysis of law in the classical common law categories of contract, tort and property, as well as in other areas that may not initially appear to be amenable to economic reasoning.

The course does not require any background in economics. The course explores both the existing tax rules and the widespread policy concerns under discussion in the US and globally about current international tax law. International trade and the World Trade Organization attract a lot of attention and debate.

Why do almost all economists say that liberalizing trade flows is a good thing? Why do politicians — even ones who purportedly support free markets — often rail against import competition and "unfair trade"? How does trade liberalization interact with other public policy choices such as protecting the environment or promoting the economic development of poor countries? The course will offer you an in-depth, practical knowledge of substantive WTO law drawing heavily on case law.

It will address the basic principles of trade in goods and trade in services, as well as some of the more specialized WTO agreements on, for example on trade remedies subsidies, anti-dumping and safeguards. From a more procedural side, the course will pay close attention to the unique WTO mechanism for the solution of global trade disputes, with special reference again to recent and ongoing cases Part II.

It will conclude by examining U. Although this course will necessarily address key principles and theories undergirding the international trade law system, one of its driving themes will be the actual practice of this discipline in the United States and at the WTO. The course will be graded based on class participation and an open-book final exam. Legislation is one of the most important forms of law in modern American society. Indeed, it has been said that we are living in an 'age of statutes. In this course, we will examine the legal theory and practice of the making and enforcement of statutes.

The course will begin with a study of the legislative process, with special attention to theories that seek to understand why some bills succeed where others fail. The next unit of the course will consider statutes as a unique source of law, comparing them to the common law and the Constitution. We will then move to the heart of the course, which will focus on how judges and other legal actors agencies, enforcers, etc. There will be a take-home final for this course.

The law of how we use nature - timber, mining, bioversity, fisheries, water rights, and agriculture. Also an introduction to the historical and constitutional geography of American public lands: There is special attention to the historical and political origins of our competing ideas of how nature matters and what we should do with it, from economically productive use to outdoor recreation to preserving the natural world for its own sake. Attention also to the complicated interplay of science and law. This course provides a comprehensive introduction to patent law and policy.

No technical background is required. The course begins by addressing the history of patents as well as the policy arguments for and against using patents as a mechanism for inducing innovation. Following this introduction, students learn the basics of patent drafting and prosecution, patent claims, and claim construction.

The class then addresses in depth the central patentability criteria of subject matter, utility, nonobviousness, and disclosure. Other topics of importance that are covered in the class include: Legal Theory is a 3-credit lecture and discussion class with enrollment capped at The course will be organized around a set of essential questions: Where does law come from?

What, if anything, makes it legitimate? What does equality before the law mean? Does law prevent violence, or merely channel it? Does the law create the economy, or does economic life frame and limit the law? What is the right way to interpret a legal text? How should our understanding of law be affected by the fact that we live in a democratic country, a free-market country, a country with a written constitution?

We will consider and approach these questions by way of major schools of legal thought, testing the theoretical approaches against our concrete sense of the problems a legal system has to address, and the shapes these problems take today. The class requirements include regular attendance and a take-home final exam. No prior exposure to legal theory, philosophy or political theory is required.

Given its intricacy, practical significance, and usefulness as a window into tort law more generally, products liability is an ideal subject for an upper-level torts course. This dedicated products liability course offers students the opportunity to delve more deeply into the thorny legal doctrines and problems of proof that arise in the practice of products liability law.

The course also gives students the chance to revisit many issues of general importance to tort law, including: Although some contextual materials on trade policy will be read, the course will not focus on general principles of international trade law. Rather, it will focus on the legal and economic implications of the new international intellectual property standards in the light of prior Conventions, with particular regard to such topics as patents; copyrights and related rights including software, databases, sound recordings ; trademarks; integrated circuit designs; trade secrets; and industrial designs.

Other topics will include the interface with antitrust law; the enforcement provisions i. Since September 11, , transnational terrorism has been treated as both crime and war. This course will explore the reasons for this novel development and consider its ramifications for public international law, the law of war, and U. The course will cover the tax consequences of organizing, operating, and liquidating entities including related issues taxed as partnerships.

This one-credit seminar in advanced legal research introduces students to specific sources and strategies for international, foreign, and comparative legal research. It covers key primary and secondary sources in both print and electronic formats, including freely available and subscription-based resources. The subjects examined include treaty law, the law of international organizations, European Union law, civil law and other foreign legal systems, as well as selected topics in international private law.

The course emphasizes the research process, strategies, and evaluation of print and online sources in a changing information environment. In response to the report of the President's Commission, Splicing Life, the RAC decided to address ethical issues more intensely by appointing a task force on human gene therapy, subsequently modified into a standing Subcommittee on Human Gene Therapy. This body eventually established the benchmarks for review and approval of protocols to apply the techniques of gene transfer to human beings in a set of "Points to Consider," which was first issued in and subsequently modified on a number of occasions.

For several years, protocols were reviewed first by the subcommittee and then by the RAC; by , it was decided that, since the RAC was devoting most of its own time to human gene protocols, the subcommittee's work was redundant and all proposals would come directly to RAC. On all matters, the RAC is advisory to the Director of NIH, who publishes the committee's recommendations in the course of announcing which studies have been approved for NIH funding or sponsorship.

The RAC is a multidisciplinary committee, a majority of whose members are physicians and scientists who work in some aspect of molecular biology or genetics. The committee also includes lawyers, social scientists, ethicists, and members of the general public with an interest in genetic disease. Although traditionally chaired by one of its scientific members, the current chair is an ethicist with long involvement in genetic engineering issues. As a federal advisory committee, its meetings are announced in the Federal Register and are open to the public; when important new scientific projects are before the committee for review, media attention is often intense and the group's recommendations are given extensive coverage.

At the present time, the protocols that come before the RAC usually involve the transfer of genes to serve as markers on cells being administered in experimental therapies or to enhance the effectiveness of various immunological methods of fighting diseases like cancer and AIDS; in addition, some studies involving gene transfer to treat single-gene diseases have been approved.

Beyond such somatic cell gene therapy, the "Points to Consider" state that the RAC will not now entertain proposals for gene transfers that would affect germ-line cells. In light of developments in molecular genetics, it may soon become necessary to consider when if ever , under what conditions, and for what reasons it would be appropriate to broaden gene therapy to germ-line cells, or for purposes of genetic enhancement. No attention has been given to such issues because RAC meetings for several years have been absorbed with protocols under the existing guidelines.

Having recognized that the capabilities arising out of the Human Genome Initiative are likely to have a profound impact on individuals and society, NIH created the ELSI Working Group to explore such issues as fairness in the use of genetic information with respect to insurance, employment, and the criminal justice system; privacy of genetic information; and the influence of genetic information on reproductive decisions see Appendix A and the background paper by Hanna in this volume for further descriptions of the ELSI Working Group.

Today, a sizable portion of the budgets for both NCHGR and DOE from 3 to 5 percent is formally designated to support studies on the identification and examination of these broader impacts of genetic science.

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This seems to be the first instance in which a portion of a science budget has been devoted specifically to the study of the ethical, legal, and social impacts of science. In all other instances, we have allowed the technology to develop and to be applied, and the resulting ethical, legal, and social dilemmas to arise, and then attempted to resolve them largely in retrospect.

The impact of the ELSI program is not yet clear. Arguments that it is overly academic and not adequately representative of society merit consideration see Hanna, this volume. At the same time, however, many observers and even some critics seem to agree that the ELSI program is indeed stimulating effective ethical inquiries into genetic technologies and encouraging the molecular biology community to design their technological studies accordingly.

Such an effect would be of great benefit to the genome project, and the success of this earmarked ELSI funding program could serve as a very useful model for other areas of science. Following discussions with NIH Director James Wyngaarden about proposed research that involved the transplantation of human fetal neural tissue into patients with Parkinson's disease, Dr. Windom requested that a panel be formed to investigate the issue and formulated ten questions the panel was to address. Wyngaarden believed that the research was extremely important, but that it also had the potential to stir controversy and perhaps even to send a message to the public that NIH encouraged abortions Childress, Windom responded to Wyngaarden's concerns by issuing a moratorium on the use of fetal tissue in federally funded transplantation research until NIH could convene a panel to deliberate the issue and offer recommendations.

Nominations were submitted by members of Congress and the executive branch, and by other interested parties; categories for nominations included ethicists, lawyers, biomedical researchers, physicians, public policy experts, and clergy. The panel selection process was closely watched by outsiders on both sides of the abortion debate. Retired federal judge Arlin Adams, appointed as chairman of the panel by an internal NIH committee, was a Republican who was opposed to abortion.

When the panel met for the first time in September , it was asked to respond to ten questions pertaining to the ethical implications of fetal tissue transplantation research. Concerns about the source of the tissue to be used in such research-elective abortions-figured heavily in these questions.

In the course of this three-day meeting it became apparent that a single meeting did not allow sufficient time to address such complex and controversial issues. The panel had also intended to meet in executive session, but amidst vigorous public outcry it was decided that panel deliberations would be open to the public. At the September meeting, the panel heard from more than 50 invited speakers, as well as from representatives of various interest groups.

The panel held a second meeting in October and a third in December, at which it prepared its final report to the assistant secretary. Volume 1 contained responses to the ten questions, along with panel members' votes on each question; a summary of the current scientific literature relevant to human fetal tissues transplantation research; three concurring statements; two dissenting statements; and a final dissenting letter.

Volume 2 of the report contained text of the testimony submitted to the panel. The majority of panel members 17 out of 21 voted in favor of permitting fetal tissue transplantation research, provided that a woman's decision to abort be kept carefully separated from research. The panel's report was unanimously approved by the Advisory Committee to the NIH Director, which urged acceptance of its recommendations, including the lifting of the moratorium on federal funding of fetal tissue transplantation research utilizing tissue from induced abortions, and the development of additional policy guidance by NIH as needed.

The recommendations of the panel were not accepted, however, and the moratorium that had been declared prior to their meeting continued. Following a public outcry over apparent abuses of "do not resuscitate" orders in health care facilities, Governor Mario Cuomo of New York decided to appoint a multidisciplinary panel under the leadership of his Commissioner of Health, Dr. David Axelrod, to advise the executive and legislative branches on a range of bioethical topics.

Because of the strongly held views of several religious communities in the state on some of these issues, the New York State Task Force on Life and the Law has had in addition to the usual mixture of researchers, physicians, lawyers, and philosophers a larger representation of religious leaders than the equivalent federal advisory commissions see Appendix A and the background paper by Brody for further descriptions of the New York State Task Force. In other ways, however, the New York group is quite similar to its federal counterparts.

By it had issued eight reports on topics ranging from surrogate parenting to the determination of death, from health care proxies for incompetent patients to procuring and distributing organs for transplantation. Although the task force has attempted to develop a consensus position on the issues it addresses, its reports have sometimes contained dissenting positions. By holding its meetings in private, it does not use the meeting process itself to foster a consensus within the general community or to test its tentative conclusions by airing them before the community.

Its reports are usually oriented toward practical recommendations for changes in state policy and hence are subject to public examination during the hearings held on any legislation proposed as a result. The task force operates with annual appropriations, and its small staff is supplemented by the volunteered services of consultants.

Beginning in , an active grassroots group emerged in New Jersey to involve lay people and health care professionals alike in responding to the medical and legal developments reflected in such landmark cases as In re Quinlan. This group, the Citizens' Committee on Biomedical Ethics, encouraged the legislature to establish an official body in in the wake of the Conroy case regarding the withdrawal of artificial nutrition and hydration from an incompetent, dying patient.

The State of New Jersey Commission on Legal and Ethical Problems in the Delivery of Health Care-known informally as the New Jersey Bioethics Commission-was mandated to ''provide a comprehensive and scholarly examination of the impact of advancing technology on health care decisions" and specifically to recommend policies to the governor, the legislature, and the citizens of New Jersey NJ. Public Law , Ch. The group was large 27 members and included 4 legislators and 9 members designated from executive agencies and major statewide professional and health care organizations.

Its membership, which included representatives from law, medicine, nursing, science, humanities, theology, health care administration, and the New Jersey Citizen's Committee, was appointed by the governor, the Senate president, and the speaker of the General Assembly see Appendix A for further description of the New Jersey Bioethics Commission.

Within its broad mandate, the commission chose to focus its half-dozen reports on three areas: The commission also established ad hoc task forces on other topics ethics, AIDS, protection of vulnerable subjects ; these groups, which included noncommissioners, made recommendations to the parent body. Besides obtaining consultants' advice and supporting research to supplement the work of its small staff of two to five professionals , the commission took testimony at public hearings. Its work resulted in considerable public and professional education on its topics in NewJersey and in the adoption of two statutes on the determination of death and on advance directives for health care.

However, conflicts within the commission and between the staff and commissioners particularly the legislator members brought its work to an end in after six years. Experience with officially established and supported efforts to examine bioethical issues is too limited to justify definitive conclusions, but it is sufficient to support some general findings. Since the broadest and best documented experience involved the National Commission and the President's Commission, our analysis begins with them and then widens to encompass other federal and state panels. The two national commissions had several features in common: There were also some marked differences between the two commissions: The President's Commission mandate was broader, more responsive to varied public concerns, and thus more publicly visible.

Its first publication, Defining Death , was eagerly awaited by various professional groups and legislators who had been involved in ongoing debate over policies that differed in only minor respects. The report presented a proposed resolution of the policy issues, and it also presented two very important consensus documents: Thus, this publication eliminated the perception that the relevant professionals could not agree as to who should count as having died and what should count as a good statute, factors that had posed barriers to adoption of legislation in many states.

The criteria for determination of death were also published shortly thereafter AMA, , which led to widespread awareness of the report itself. Many of the later reports were awaited by engaged and eager audiences, although these concerned publics were smaller or less visible than the audience that welcomed Defining Death. In the last month of its term, the President's Commission published two reports that had broader appeal and receptive audiences: The former document had been circulated to hundreds of concerned citizens in draft and it included not only clear recommendations about practice but also extensive appendices outlining palliative care, statutes on advance directives, and policies on foregoing treatments.

The Deciding report specifically addressed a series of troubling dichotomies e. Also, its prose and presentation was specifically designed to be accessible to any health care professional. By chance, the report was released just as the "Baby Doe" case and the federal response to it was unfolding, and it took a much more temperate tone than the official federal response. For these reasons, Deciding was one of the "best sellers" printed by the Government Printing Office, which made it available at cost. It remains a classic reference used in court cases, professional literature, and education.

Securing also had an eager public, since allocation and equity were at least as central to public concern in as now. However, this report underwent many changes as the commission gained new members in its final months. The central ethical argument stayed largely intact, but many examples and much strong language were excised. The report thus ended up being an academic discourse on the role and function of commissions, rather than affecting the public issue of access to health care.

The National Commission spoke primarily to federal officials responsible for human subjects regulations and to the biomedical research community including members of IRBs. The President's Commission, on the other hand, chose to address many constituencies which varied depending upon the topic.

As a result, its reports on some subjects were virtually unknown to readers who were concerned solely with other topics, although specialists in bioethics generally kept abreast of-and commented on-the commission's work across the board, just as they had the work of the National Commission.

Both commissions considered some reports more important than others, and these same reports were usually regarded as more influential and important by outsiders as well see background paper by Gray in this volume. The central characteristics of both commissions were that they undertook to study complex and sometimes quite highly charged topics; they were able to do so in a thoughtful way because they operated outside the usual political channels; and they were influential both because they operated with an official mandate and because they produced reports that were accessible to the intelligent lay person as well as the scientific or ethical expert.

The ideal of impartiality, one of the primary characteristics of ethical discourse, may not have been met completely, but the work of these commissions was a serious approximation. They both attempted to examine all sides of the issues and to move beyond the limits of self-interest and advocacy to find broad grounds of agreement on controversial positions. Two other influential characteristics of these commissions also stand out: Ethics committees appointed by professional organizations and study groups established by bioethics centers have much to contribute, but the public and its representatives do not place any particular weight on the recommendations of these groups, which are neither accountable to the public nor burdened with obligations toward the broad and unbiased inquiry that is incumbent upon public panels.

Further, while state and local ethics committees both those appointed by governmental entities and those established by institutions and professional groups can play important roles, many of the most troublesome issues do not stop at state borders, and some process for national deliberation and formulation is needed. Not all states or localities have the resources or interest to mount an effective effort, but they may still be able to benefit from the conclusions and recommendations of a national commission.

Many of the issues being studied are of greatest concern to the federal government, such as the ethics of various types of research supported by federal agencies. And even when the issues involve matters of state law and policy such as the regulation of health care professionals and institutions or the rules of family law , a national inquiry avoids duplication and may have the added advantage of leading to uniformity among the states on issues where differences in policy or regulation can produce undesirable results.

The greater the visibility of a panel, however, the greater the danger that its work will be encumbered by bureaucratic, ideological, or political interference. In this sense, the sort of independence that the National Commission and especially the President's Commission enjoyed was critical to the work of these groups. The movement from departmental to presidential status and the freedom from the polarizing issue of abortion made the latter more independent and gave it greater visibility, higher prestige, and better access to sources of information and advice, both inside and outside the government.

The close relationship between an ethics panel and its appointing officer can also have beneficial results in terms of having its recommendations implemented. But there are other means of ensuring that the panel will be listened to; in the end, it is more likely to be widely influential because of the thoroughness of its inquiries and the soundness of its recommendations than because of its political connections.

Moreover, the danger of too much entanglement with the political process particularly when appointments are made by the legislative branch or involve legislators is clearly evident in the experience of the Biomedical Ethics Advisory Committee and the NewJersey Bioethics Commission. Society can also handle the ethical issues related to developments in biomedicine through legal mechanisms such as courts, regulation, and legislation. Ethics commissions and other consensual mechanisms can be useful, but since these issues reflect choices among competing values, as well as assessments of available data, even groups composed of highly expert and well-intentioned professionals can produce markedly different decisions about bioethical questions.

See background paper by Gostin for further description of the ways in which courts, regulation, and legislation can impact such decisions. In our litigious society, courts often are the forum where ethical quandaries related to biomedicine first make their appearance and demand resolution. Courts therefore are necessary participants in the bioethics debate, although their special institutional features both facilitate and detract from their effectiveness in making health policy. On the positive side, common law courts have developed for centuries a tradition of ethically relevant decision making that places a high value on reasoned explanation of judicial holdings.

The practice of justification by precedent obliges courts to draw on settled legal principles, thereby reducing the likelihood of ill-considered or arbitrary judgments. Courts determine ethical issues in the context of specific cases; this heightens the immediacy of the questions, but, especially in the case of lower court decisions, also usefully limits the negative impact of poorly reasoned opinions. A dramatic case, such as Quinlan or Cruzan, provides a gripping narrative through which abstract ethical concerns are made concrete for varied publics.

At the same time, the tiered structure of the court system, the existence of multiple jurisdictions, and the practice of writing dissenting opinions all serve to open up judicial reasoning to public criticism and improvement. On the negative side, courts employ an adversarial process that is not necessarily conducive to dispassionate analysis or fact finding. Unlike legislatures, courts are compelled to resolve the issues related to specific cases and individuals that come before them, even if the basis for a principled decision has not been fully laid. Yet courts are fundamentally reactive, in that they cannot make policy unless decisions are put to them.

This lack of capacity may be especially evident when courts are confronted with conflicts arising out of developments in biomedical science and technology. Finally, the decentralized nature of the court system leads to contradictory and confusing ethical pronouncements that may take years to sort out through legislation or an authoritative higher court ruling.

The institutional strengths and weaknesses of courts have been revealed in instances where new treatments raised ethical questions that were submitted to the courts. For example, judicial leadership on questions concerning the use of life-supporting technologies began with the New Jersey Supreme Court's decision about Karen Ann Quinlan's right to be disconnected from a life support system. Since then, a series of decisions by federal and state courts on refusing or withholding care have guided the nation's policy on these issues.

Most significant was the Supreme Court's decision in Cruzan, which held that competent patients had a "liberty interest" in refusing treatment and provided an impetus for state legislation. Many state courts have extended this right of refusal to people who are incapable of making a decision by respecting the decisions of surrogates, particularly family members see the background paper by Gostin in this volume.

In some cases, courts have turned to other bodies for guidance in defining the circumstances under which treatment can be terminated. The President's Commission report on foregoing treatment was instrumental in leading most courts to reject the distinction between withholding and withdrawing treatment, between ordinary and extraordinary treatments, and between terminal and nonterminal cases. In other cases, courts have acted independently to set out procedures and criteria for decision making, ranging from second opinions to the use of ethics committees or ombudsmen.

Many times state legislatures became involved in these issues; they acted only some time after court decisions and usually followed policies implicit in those decisions. The most recent national actions in this area came about when Congress passed the Patient Self-Determination Act, which was implemented on December 1, The law requires health care providers to inform their patients of the right to accept or refuse medical care, including the right to give advance directives on the use of medical means of sustaining life.

Other times, state legislative action has preceded court decisions and set policy in this area, most notably in natural death acts, determination of death which many states enacted before any court action as well , surrogacy, and, in recent times, reproductive decisions. An example is the California Natural Death Act of , which preceded all court decisions, including Quinlan. Courts have also been involved in a major way in the field of reproductive rights.

Beginning with the landmark cases of Griswold v. Connecticut and Roe v. Wade, the courts for nearly two decades defined the reproductive rights of women. In the early cases, the Supreme Court found a constitutional right of "privacy" even though no mention of the concept appears in the Bill of Rights. In Griswold the Court used the newly identified right to privacy to prevent states from interfering with the sale and distribution of contraceptives. The Court explained that contraception concerns "the most intimate of human activities and relationships.

In Roe the Supreme Court stated that the constitutional promise of privacy protects not only the right to use contraceptives but also the right to decide whether to carry a fetus to term and the privacy of a woman's relationship with her physician see the background paper by Gostin in this volume. In recent years, there has been a significant erosion of privacy rights. The Court has upheld the authority of the state to restrict the use of public employees and facilities for the use of nontherapeutic abortions see Gostin.

The Court also upheld a regulation prohibiting federally funded family planning clinics from counseling or referring women to abortions the so-called "gag rule" see Gostin. In Planned Parenthood of Southeastern Pennsylvania v.

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Casey see Gostin , the Court changed the legal standard by which to evaluate restrictions on abortion. This rule may allow states to place new restrictions on access, timing, and information provision in abortion decisions. In spite of these retrenchments, it has been argued that the extension of the right to privacy since has had profound and positive effects on reproductive policy see Gostin. Prior to the Supreme Court's entry into the area, neither the legislative nor executive branch produced policies that adequately recognized the need to balance the interests of pregnant women against those of the state or the fetus.

Current efforts to protect reproductive privacy use the same "fundamental rights" analysis that the Supreme Court employed in Roe v. State legislatures are also emulating thoughtful court rulings on related reproductive issues such as surrogate motherhood and artificial reproduction. Courts will continue to play an important role in the deliberation of emotionally charged issues in health care and biomedical innovation where no formal policy is in place and where there is a fundamental claim of human rights by individuals and groups.

If, as has frequently occurred in certain states, legislators have not proactively addressed issues of this character that flow from biomedical advances, the courts have been and will be required to take the lead in resolving the legal and ethical issues that arise in particular cases. For, while legislatures may choose not to act, courts cannot avoid this burden once a case is before them. For example, courts have been involved in such issues as the right to die and the ownership of sperm in a sperm bank.

If no statute provides a definite answer, courts must decide which precedents seem most helpful, whether the scientific aspects are supported by sound data, whether the common law provides guidance, and so on. Many court decisions in these areas read like laws-some even set up specific administrative procedures to handle future cases-and they provide a blueprint for subsequent legislation.

Courts will also continue to play a significant secondary role through their power to review federal regulations. Regulations can take several forms-instructions, findings, definitions of terms, and so on-but a prescribed set of actions, including solicitation of public comment, must take place before federal regulations become effective.

It has become common for interested parties to pose legal challenges to regulations in either their proposed or final form. These challenges may be made on several grounds-the law does not authorize them, they do not follow the law, the issuing process was faulty, and so on. Some of these issues also have strong ethical elements. For example, the Supreme Court has rejected challenges against several regulations issued by the Secretary of Health and Human Services that limited women's rights to abortion as established by Roe v. Courts have to take the limited view imposed upon them by the case as presented and by precedent; legislatures are buffered by special interests and any legislation is inevitably marked by compromises.

Public bioethical deliberation can provide the broader view that the courts, which are set up to focus on individual cases and circumstances, cannot easily provide and can attempt an impartiality that legislation cannot always achieve. The existence of bioethical opinion may inform the courts, as did the President's Commission opinion on foregoing life support in the Herbert case California Court of Appeals, Barber v.

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Bioethics is generally regarded as a subject first developed in the United States. Until recently, a clear majority of books and articles in the field was published here, and the number of academic departments, courses, and conferences was far greater in the United States than abroad. In the past few years, however, bioethics has rapidly internationalized. Hospitals the world over have sprouted ethics committees, new journals are appearing in foreign languages, and regional and international bioethics societies have been formed.

While the United States has been notable for launching new initiatives and sponsoring numerous activities on bioethics in the academic world, it has not been as active in the support of governmental bioethics activity. Since the demise of the President's Commission in , the United States has had no national bioethics commission, despite the still-increasing public and academic fascination with bioethical issues. In Europe, governments have taken the initiative in this area; elsewhere, development of bioethics is often prodded by governmental organizations. Multinational organizations also have begun to deal with bioethical issues.

A brief examination of the structure and agendas of some of these bodies may provide valuable guidance for future government-sponsored efforts in our own country. A number of international organizations have been active in the field of bioethics. In , it constituted a steering committee on bioethics representing a variety of professional backgrounds and geographical areas, which in turn organized "international dialogues" on ethical issues arising in such subjects as battered children, human genome research, and family planning. Over the years, CIOMS groups have offered international ethical guidelines on a number of topics, ranging from protection of human subjects of medical experimentation and to ethical review of epidemiological studies In addition, the Office of Health Legislation of the World Health Organization keeps track of bioethics actions of governments and multinational bodies, some of which are reported in its quarterly International Digest of Health Legislation.

Noelle Lenoir, an attorney and member of France's Conseil Constitutionnel. Thus far this committee has held one meeting; another is planned. The Council of Europe CE , an organization created by European governments in part for cooperation in cultural and scientific affairs, has also become active in bioethics. CAHBI's aim is "to fill the political and legal gaps that may result from the rapid development of biomedical sciences," but it must achieve the voluntary consensus of member states.

In , the CE elevated the group to full legal status and gave it a new acronym: However, the committee recently held a Framework Convention for Bioethics, designed to present norms on a variety of issues for consideration by the European members of CE. The convention, which was open to nonmember states, considered general ethical principles related to organ transplantation, medical research on humans, including embryos, and the use of genetic information for nonmedical purposes.

The council also empaneled a commission on ethical issues in reproductive technology, known as the Glover Commission after its chairman, Oxford philosopher and bioethicist Jonathan Glover. The government of the European Community EC , which is distinct both in members and in function from the CE, has not yet sought to establish a general European bioethics commission.

In three instances, however, the EC has initiated working groups on specific topics: A fourth initiative involves the establishment of a research program in bioethics, offering grants to scholars on a competitive basis. This appears to be the world's sole general fund for investigator-initiated bioethics research. Congress relies on its Office of Technology Assessment.

PAHO's general counsel sits on the board of directors of the International Association of Bioethics, an international bioethics group founded in Planning is currently under way to establish a Pan American Institute of Bioethics, to be located at the University of Chile in Santiago. The institute, slated to begin its work in , is charged to provide a "permanent place for.

Given the novelty of bioethics research and policy in Latin America, its prospectus does not suggest the kind of intergovernmental authority vested in the European organizations PAHO, Other international organizations dealing with bioethics include international medical specialty societies and international bioethics societies. The IAB, headquartered in Australia, provides a forum for diverse views on bioethical issues but does not itself take positions on any of them. None of the other organizations has yet attempted to form an international bioethics commission.

Bioethics commissions have been widely used in other English-speaking countries. National Institutes of Health. Bioethical issues have been discussed in regard to potential legislation by Law Reform Commissions of both the Canadian government and the various provinces. Canada's Royal Commission on New Reproductive Technologies is a notably well-funded initiative that has only partially escaped the kind of political heat generated by abortion politics that doomed the Biomedical Ethics Advisory Committee in our Congress.

It is charged with performing a comprehensive and authoritative review of Canadian laws and practices on present and forthcoming reproductive technologies. The commission has a large professional staff, has sponsored considerable research, and held hearings and open meetings around the country. Its reports were recently published in Latin American countries are just beginning to establish bioethics commissions. In Mexico, a Commission Nacional de Bioetica, sponsored by the federal government and reporting to the Ministry of Health, was created in The commission's broad mandate includes oversight on environmental as well as medical issues.

Despite the growing number of national bioethics commissions, few commissions make a visible and significant impact on national debate and policy. There is considerable diversity of approach among the well-established commissions, and the United States can learn from the experience of each of them. Three models of national deliberation on bioethics merit particular attention: Denmark, A Populist Model. Denmark's national bioethics committee is notable for at least two reasons. First, the country has not one but two national bioethics commissions, with overlapping areas of interest.

Second, one of these commissions has a uniquely active program of public education. It was created in the wake of the Helsinki II declaration on human experimentation and has been chaired by one of its drafters. CSEC originally played its role through a voluntary arrangement of professional groups, but in it was given statutory authority.

CSEC is at the apex of a system of human subjects review boards that covers the whole of Denmark; it acts on disputed proposals and in cases in which a matter of principle must be decided. In , Parliament created a second council, the Danish Council of Ethics, with a mandate to consider a broader range of bioethical issues. The council's 17 members are predominantly laypersons. Though the reports are written by the members of the council, it has a slightly larger staff than is common in Europe: The council's public education efforts go beyond anything attempted by U.

In considering the definition of death, for example, the council held public hearings and financed local debates. It produced a film that was shown not only on national television but also in movie theaters. The council produced booklets and brochures explaining the basic facts about the definitions of death and distributed them at public libraries. The council reportedly gathered the editors of 20 newspapers and induced them to carry articles and exchanges on the subject; 1, articles and editorials were published over three years, drawing hundreds of letters to editors. A competition for young people invited art works on the concept of death; the winner of a poster contest won the privilege of display as the cover of the council's annual report.

It gathered educational materials and prepared teaching material for education on these ethical issues in the context of 17 subjects, ranging from biology and philosophy to drama, music, and literature. These were sent to every high school in the country. The council held a short-story contest, in cooperation with a newspaper, which drew hundreds of entries. The Danish Council of Ethics appears to be closer to the grass roots than any other foreign commission, but it is not without its critics. Its findings on the definition of death rejected the current global consensus, which favors a brain death formulation, a step that drew criticism from members of the other Danish group, the CSEC.

The two commissions also disagreed on the propriety of preserving brain tissue for research and teaching purposes. Moreover, the council's own surveys revealed widespread misunderstanding about brain death, not only before but also after the massive public education campaigns. CCNE has over 40 members, drawn not only from scholarly specialties and professional groups but also representative of philosophical currents in France.

The chair is appointed by the president, and half of the membership is renewed every two years. Members are not paid, and several have publicly complained about the lack of staff. CCNE has issued over 30 reports thus far on topics ranging from the testing of drug addicts in employment to genetic fingerprints to reproductive technology.

The committee also issues statements on topical questions, such as the introduction of RU the so-called abortion pill and sex-determination procedures in the Olympics. Meetings are closed, and minutes, which are released to the public, do not reflect the identity of those making the remarks. However, a two-day public symposium is held each year see the background paper by Charo for a further description of the CCNE.

Questions can be brought to the committee by members of the government, presidents of the two houses of parliament, or by public institutions involved in research. CCNE also takes up topics of its own choosing. The committee typically creates a subcommittee for each question or topic, which eventually reports to CCNE as a whole. The latter has occasionally rejected a subcommittee's report. CCNE aims to play a central role in the country's deliberations over bioethical issues. Its unusually large size permits wider representation of views and interests.

It attempts to enunciate general principles for the whole of French society e. The committee not only carries out studies of the chief bioethical issues of the day, but also involves itself in day-to-day controversies arising in the hospitals and courts. High in visibility and prestige, its meetings have been addressed on several occasions by the President of the Republic. Its outgoing chairman has been venerated as a public sage, the more-or-less official national voice on bioethics.

Its deliberations and findings are covered extensively by the press; the newspaper Le Monde covers the commission closely, providing reportage and commentary even on its philosophical deliberations. Thus, the French model, as opposed to the Danish one, might be characterized as prescriptive, elite, and centralized. United Kingdom, A Private Model. Bioethics policy is developed in many ways and in many bodies in the United Kingdom.

Its research councils, particularly the Medical Research Council, publish an ethics series that focuses primarily on human subjects issues. Most prominent among the bioethics councils was the recent Warnock Commission on embryos and reproductive technology. Closely studied by academics as well as patients and physicians, its recommendations were largely embodied in new legislation. However, the government has rejected suggestions that it create a national bioethics commission with a broader mandate. Explanations for this reticence vary; one reason seems to be the past prime minister's wish to avoid placing undue restrictions on scientists.

In this respect, as in others, the United Kingdom is out of step with its fellow European states; prominent bioethicists have complained that without a national commission they are not able to identify and pursue the "British position" on these issues in pan-European councils and conferences. With an interest in a national commission rising in the face of governmental refusal to go along, a private solution has been attempted. The Nuffield Foundation, an educational and charitable trust, was asked to consider the organization of a private body that would function like the governmental bioethics bodies in other European states.

The new Nuffield Council on Bioethics was founded after elaborate soundings of professional, scientific, legal, and consumer groups. Its 15 members do not represent constituencies but are chosen for diversity. The council aims to stimulate coordination between the diverse groups now contributing to bioethics policy; to anticipate new problems, and to increase the public's awareness of the issues and of their importance. Several working groups have already been set up.

The staff consists of an executive director and two administrative assistants. The Nuffield Council on Bioethics, as a private advisory body, will have no regulatory role. Nevertheless, the foundation's initiative was welcomed by the government, and one of its staff is government salaried. The council seems to be fixed in the minds of British bioethicists as the national body.

Indeed, in its makeup and procedures, the council is conducting itself just as it would if it were a creation of the national government. Whether it will achieve the same influence and authority in national deliberations over bioethical issues as its governmental counterparts abroad remains uncertain. This brief survey of bioethics commissions abroad permits no firm judgments on relative successes and failures. However, the differences between national approaches suggest a number of questions that might be considered by the United States in designing its own mechanisms for deliberation on bioethics.

Until recently, most bioethics commissions abroad have been topical-i. Topics have been selected in advance by the sponsor. The French commission, however, is wide ranging and seemingly permanent, with the power to investigate topics of its own choosing. Other commissions established in Europe since the founding of the French commission, and perhaps in imitation of it, have also been general, self-generating, and open ended.

Among the most influential commissions have been some single-topic efforts, such as the Warnock Commission in the United Kingdom. The independence of ethics commissions abroad has been regarded by most observers as essential to its moral authority. Whether based in the legislature or in the executive branch, all commissions but the U. Most answer to, and are located within, the ministries of health.

President's Commission, which was administratively located outside the departmental structure of the executive branch, has not been seen as a precedent. Meetings are generally closed. In some cases, members of the public may offer their views. Some commissions hold periodic public symposia. One reason offered for the lack of public access is that some commissions rule on particular cases and therefore require confidentiality.

All governments have striven to ensure lay membership on their commissions; in some cases, physicians and scientists are in a clear minority. No survey data exist regarding public perceptions of the commissions as independent or as "captured. Bioethics commissions may be evaluated in many dimensions such as productivity, influence, and soundness.

Very little evaluation has been done in any country to date. In this sense, all countries are flying blind. Soundness is the most difficult of the criteria to assess, but it is among the most important. In responses to a survey conducted by OTA, the firmer the commentator's credentials in academic bioethics, the lower his or her opinion of the soundness of the bioethics commission reports.

Complaints that commission's findings are poorly argued, or even not argued at all, are common. Only a few commissions have followed the U. A different perspective emerges in some of the solicited comments and in the literature: Thus a finding that represents a compromise between conflicting commissioners representing diverse constituencies would be regarded as a successful one, even if none of the commissioners could or would wish to support the compromised conclusion with data or argument.

National bioethics commissions differ in their basic purpose. In some instances, they are directly advisory to parliaments; their existence is justified by the need to develop legislation on complex technological and scientific issues that can go slower and deeper than the usual legislative process permits. In other cases, the commission exists to stimulate and educate the public.

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Still others take on the role of distilling and articulating the national sensibility on these matters. All the commissions have a chair and numerous commissioners, though they vary in size by a factor of four. Large commissions can be more representative, but sacrifice working efficiency. More striking is the difference in the size of the staff. Most have hardly any, although in a few cases the staff is larger and well trained. Only Canada has provided to its bioethics commission a staff comparable to that of the National Commission or the President's Commission in the United States.

As noted above, there is considerable complaining among commissioners over the lack of staff. Particularly in international councils, the national bioethics committees are increasingly seen as defining their nation's position on bioethics issues. To this extent, they act as national spokesperson, even though few commissioners are elected to their posts. In the United States, commissions have not been regarded as bioethics policymakers except and until their recommendations have been adopted as law e.

As new entities multiply within and outside of government, the designation of a national voice will become more difficult, and the goal itself open to further question. When Americans are confronted with a change in the moral landscape arising from a change in our capacities to affect the world e. What should I do? And what should our government do? For example, when we worry about environmental degradation, we think of what each individual should recycle and what action the federal government should take with regard to environmental pollutants. When we worry about mapping the humane genome, we focus on the opportunities and risks for individuals afflicted with undesirable genotypes, and on the government's role in regulating the use and abuse of this information.

Between the isolated individual and the impersonal actions of government, however, lie numerous social institutions composed of deeply ingrained, patterned sets of behaviors that shape our expectations and opportunities Bellah et al.