Courses for Non-Attorneys

The following Summer Institute courses may be appropriate for non-attorneys. If you are interested in any of these courses and are not a lawyer or a law student, please contact Matt Pierce before registering in order to make sure you understand the scope of the course and the type of material that will be covered. Non-attorneys who register for these courses may be provided with some additional reading just to make sure they have a basic understanding of the legal framework governing the topics that the courses address.

Day Courses (9 am - 5 pm)

June 16 - 17

Pharmaceuticals & the Law (D. Kracov & M. Ruggiero): As the government increasingly determines virtually every aspect of how drugs are developed and delivered to patients, it is important to understand the complex framework governing pharmaceutical innovation and patient access to new therapies. This course will provide an introduction to the range of legal and policy issues relevant to the biopharmaceutical industry, including: 1) the regulation of drug and biologic development, approval, and promotion; 2) laws and regulations governing access to biopharmaceuticals and other types of care under large government healthcare programs; 3) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; 4) "healthcare reform" policy trends, including cost containment, expanding coverage for the uninsured, and improving the quality of healthcare; 5) statutory intellectual property protections for biopharmaceuticals, including patent-related processes and various exclusivities; and 6) the interplay between biopharmaceutical regulation and product liability. This is one of three courses focusing that can be counted towards a Pharmaceutical Law Series Certificate of Completion. Academic credit requirement: TBA

June 18 - 19

Bioethics & the Law (H. Gertner): This class will examine how the legal policy systems reconcile competing values and interests in controversies surrounding the practice of medicine. Case law, legislation, advisory policies, and institutional policies will be examined, as well as selected commentary from the legal, medical, and philosophical perspectives. Substantive topics may include:ethical issues at the beginning of life, including abortion, maternal-fetal conflicts, and embryo disposition, the definition of death, the right to refuse treatment, medical decisions regarding treatment for incompetent patients (including children), physician assisted suicide, organ transplantation, and research involving human subjects. This is one of three courses that can be counted towards a Bioethics & the Law Series Certificate of Completion. Academic credit requirement: TBA

June 23 - 24

The Law & Ethics of Assisted Reproductive Technologies (S. Crockin): This course will examine and analyze the underlying, competing, and evolving laws, policies, and ethical tensions arising from the assisted reproductive technologies (ARTs). Over the past thirty years, since the birth of the world’s first IVF baby, these ongoing medical advances have challenged existing laws and spawned the need for new ones, all while continuing to make front page news. Disputes and issues involving the ARTs frequently involve—and challenge—existing family, health, contract, and constitutional law, and also intersect with controversial law and policies involving abortion, personhood, and stem cell research. Students will come away from this course with an understanding of the legal and ethical aspects of the ARTs and an ability to analyze the legal and ethical dimensions of both current and emerging reproductive technologies. This is one of 3 courses focusing on Bioethics and can be counted towards a Bioethics and the Law Certificate of Completion from American University Washington College of Law. Academic credit requirement: Take home exam, due 3 weeks after the course ends. This is one of three courses that can be counted towards a Bioethics & the Law Series Certificate of CompletionAcademic credit requirement: TBD.

June 25 - 26

The Law & Ethics of Human Subjects Research (L. Odwazny) Research involving humans as research subjects incurs special ethical and legal responsibilities – some are voluntary, and some are mandated by law.  Largely in response to notable and horrific scandals, frameworks for ethical protections for the conduct of human subjects research developed in the 20th century, and the field of research ethics has been burgeoning for the past 50 years with a vast increase in bioethical commentary.  The U.S. legal system for regulating the conduct of human subjects research developed concurrently, culminating in 1991 with the current Federal regulatory structure.  The U.S. Federal system of regulating human subjects research is based on ethical principles and sets the minimum legally allowable standards for the conduct of Federally funded human subjects research -- and continues to be a contentious and hotly debated regulatory scheme.  This course is designed to encourage an understanding of the interrelationship of law and ethics in the protection of human subjects in research:  to this end, the course will provide the historical context for the development of the discipline of research ethics; an overview of the U.S. and international codes of research ethics, with a focus on the substance and operation of current U.S. law; and a case-based exploration of controversial issues at the intersection of law and ethics. This course can be counted either towards a Pharmaceutical Law Series Certificate or a Health Care Fraud and Compliance Series Certificate. Academic credit requirement: Paper due 3 weeks after the course ends.

Evening Courses

June 16 - 21 (6:00 - 9:00 pm, Monday - Thursday and 9:00 am to 12:00 pm Saturday, June 21)

Health Care Economics & the Law (N. Bath): This course will examine how the Affordable Care Act and related health reform legislation attempts to slow rising health care costs. Slowing health care costs is one of the greatest domestic challenges of this century. Health care spending continues to outpace economic growth and is expected to account for 20% of the US economy by 2021. (By comparison, in 2010, other OECD countries spent on average about 9.5% of their GDP on health care.) Therefore, anyone who works on health care policy must understand the major economic theories upon which our current health care laws are based. This course will examine the extent to which current laws incorporate these theories and how these theories are applied to two discrete areas of health care reform: 1) health insurance coverage (both public and private) and 2) provider payment. We will discuss competing schools of thought in both of these areas of health reform, focusing in particular on the role economic arguments play (implicitly or explicitly) in major public policy debates. We will also discuss the changing role of economic analysis in the political process – particularly with regard to the Congressional Budget Office, as well as how economics impacts health care jurisprudence in these two areas. This is one of two courses that can be counted toward a Health Care Economics and the Law Course Series Certificate of Completion . Academic credit requirement: TBD.

Blended Course

June 14 - July 25

Epidemiology & the Law (M. Pierce): Epidemiology is the study of the determinants and distribution of disease, injury, and other health-related states within and across populations. Epidemiology informs and intersects with health law in a variety of ways. Among other things, epidemiology can be used to determine causation in personal injury suits; safety and effectiveness in drug trials; and, at the broadest level, the impact that our laws have on our health and well-being. A basic understanding of epidemiology can help attorneys and policymakers more effectively assess empirical research and determine when and how to consult with epidemiological experts. The goal of this course is to provide participants with a basic understanding of epidemiology by introducing them to fundamental epidemiological and statistical concepts and examining how these concepts can be applied to health law policy, practice, and theory. Participants should leave this course with a better understanding of how to leverage epidemiology to achieve their legal and policy goals. Academic credit requirement: Two exercises and a take home exam, due 2 weeks after the course ends.

In-class sessions for Epidemiology and the Law meet at the following times:

  • Saturday, June 14: 9:30 am - 11:30 am
  • Friday, July 11: 9:00 am - 11:00 am
  • Saturday, July 19: 9:00 am - 11:00 am
  • Friday, July 25: 9:00 am - 11:00 am