Ethics and Responsible Conduct of Research

Course Leader

Bettie Steinberg, PhD

Academic Schedule

This is a one-semester course, held every 3 years in the late winter/spring semester (2017, 2020, etc); meets for 1.5 hrs weekly.

Prerequisites

There are no prerequisites for this course.

Overall purpose/objective

The purpose of the course is to provide graduate students (physicians, physicians-in-training, scientists-in-training) with clear guidelines for ethical decisions in the field of biomedical research, i.e. promote a greater understanding of ethical issues that arise in biomedical research. The course will cover the historical framework for a need for ethical standards in research, changing concepts in research ethics with time, current regulatory requirements for animal or human research, guidelines for appropriate authorship decisions, peer review, collaborative research, ownership of data and intellectual property, scientific record keeping, conflicts of interest, scientific misconduct, and ethical dilemmas in basic, translational, and clinical research.

Conduct of the course

This course is taught through didactic lectures using “Scientific Integrity, 3rd Edition”, as a guide. In addition, students will learn through case presentations and group discussions of the cases.

After completion, students will be able to:

  • Describe current regulatory requirements for both animal and human subject research
  • Define current accepted practices, codes of ethics and institutional guidelines
  • Comply with standards of practice, codes of ethics, and federal, state, institutional mandates/guidelines
  • Examine and evaluate specific research activities and projects for their ethical soundness
  • Discuss ethical dilemmas in biomedical research
  • Manage/solve ethical dilemmas in biomedical research

Assessment

Attendance of course lectures and participation in class discussions is mandatory. Excused absences must be approved in advance.

Formative: Throughout the course, students will be assessed on participation in discussions.

Final grades will be comprised of attendance (30%), participation (30%), and case presentations (40%). A minimum score of 80% is required to pass the course.

Readings

On Being A Scientist: Responsible Conduct in Research. 2nd Edition, National Academy Press.

Faculty case studies text: “Scientific Integrity, 3rd Edition” by F.L. Macrina, ASM Press, Washington D.C., 2005. In addition, students will be required to read recent cases and present a case related to the ethical conduct of research.