Building Blocks of Applied Research Ethics: Theory and Practice

The key elements of responsible research are based on the disciplines of philosophy, history, ethics and law. This two-day intensive course provides the foundation for understanding the concepts of research ethics in the U.S. and the tools to apply them in research settings. Philosophical content will include: Virtue, Kantianism, utilitarianism, communitarianism, natural rights and divine command theory. The course will discuss historic seminal events such as the Tuskegee Syphilis Study, Willowbrook State School, radiation experiments, and basic documents such as the Nuremberg Code and Belmont Report. In addition, the two-day session will introduce and explore fundamental issues in research such as autonomy, informed consent and conflict of interest.

Ethical Conduct of Human Subject Research

The course will provide an understanding of how research is used to construct medical and scientific knowledge, and, within this context, will explore the use of human subjects in research. Key components to be explored include social goals of research, risks and benefits of human subject involvement, barriers and access to studies, and selection of subjects. Concepts and lessons will be applied through specific focus on institutional review boards (IRBs) as the primary institutional body for review of human subjects research. The course will include extensive simulation of IRB processes. Particular attention will be paid to the use of special populations (e.g., pregnant women, children, prisoners, persons who are mentally ill/emotionally challenged) in research.

Genetics and Research: Unique Issues and Conflicts

With the completion of human genome mapping, research in genetics has grown exponentially and has become increasingly central to both national and international research agendas. Unique issues raised by genetic research include genetic privacy/confidentiality; the reach of genetic information beyond the individual’s autonomy to the family; population-level genetic screening and testing; the implications of genetically defined race, gender and identity; ownership of genetic material; stem cell research; tissue banking; somatic and germ cell therapy. Students will develop an overview of the genetic research enterprise in the contemporary United States. They will also gain appreciation of the essential role of genetic ethics to the dilemmas of our society. In addition to learning about specific implications of genetic knowledge and information, students will develop an increased capacity to apply ethical standards to genetic research in practice.

Responsible Conduct of Research

This course explores standards of conduct in research. These standards play a key role in attaining the public’s trust and support for research; in advancing the goals of science; and in promoting collaboration and cooperation among researchers. These standards affect management of data, intellectual property, peer review, conflict of interest, scientific misconduct, animal research, economics of research, and the interaction of research with politics, media, industry, academia, government, and community. All of these issues will be explored, and students will engage in a variety of exercises designed to promote their understanding of and facility with these concepts.

International Research: Issues, Conflicts, Dilemmas

International research has become more important and more pervasive because in recent years a majority of clinical trials have moved from developed nations to developing nations. This has meant that the subjects used for those trials live in cultural contexts very different from that in the United States.  Such subjects also have to reckon with lack of health care infrastructure; barriers to treatment and clinical trials; and political realities, ethical values and national priorities that create a “frame” for research very different from that which exists in the United States.  This course will provide an overview of the current state of international research, and examine the unique issues raised by its practice including the danger of ethical imperialism, and the tension between relativism and universalism.  Specific topics to be explored will include oversight of research in developing countries; human subject protections in international research; HIV research in developing countries; industry-sponsored clinical trials in developing countries.  Case studies will be used to engage students directly with course material.

Capstone

The capstone course is a culminating intellectual and skill-based project that will integrate all of the material covered in the certificate program curriculum. Students will be encouraged to develop a capstone that emerges out of and/or connects them to a workplace setting, and that can be of use to them as they develop their new career directions. They will receive guidance throughout the project from program faculty. The project is an opportunity for students to apply and gain facility with the concepts and methods learned over the course of the program.

Possible capstone projects include: developing policies and procedures for an IRB; preparing a white paper on ethical guidelines for the student’s profession; analyzing and developing a case study; designing an informed consent template and writing the protocol for its use; formulating guidelines for human research protection law; writing a policy briefing on a recent research ethics issue.