Responsible Conduct of Research (RCR) Online Course (Epi 201)

Responsible Conduct of Research (RCR) helps people starting their research careers learn how to address the ethical issues that inevitably arise in research. The course addresses requirements and regulations for human-subjects research, including IRB approval and consent. Key topics include conflicts of interest, research misconduct, authorship, and ethical challenges related to research in resource-poor countries.

Course Objectives

  1. Identify common ethical issues that clinical and translational researchers commonly face and the ethical guidelines for addressing these issues.
  2. Explain key elements of the federal regulations for research with human subjects, research misconduct, and conflicts of interest.
  3. Define informed consent. Give at least one historical example that has led to our current standards around consent. Describe challenges to and strategies for obtaining appropriate consent.
  4. Discuss pertinent issues related to authorship, including why authorship is an important and often difficult element within the research process.
  5. Identify key ethical issues related to conduct of research in resource-poor countries.
  6. Explore a wide array of ethical dilemmas by participating in scholarly dialogue around at least one topical case study each week.
  7. Provide constructive feedback on colleagues' ideas regarding ethical issues in research.

Grading

Participants enrolled in the Responsible Conduct of Research course may receive either:

  • A Grade of Pass / Fail (if matriculated through the UCSF Registrar)
  • A Certificate of Completion

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Schedule

Responsible Conduct of Research Online is a 7-week course. Participants are expected to devote at least 4 hours per week to individual work and online peer interaction. Topics include:

MODULE 1

  • Settling in
  • Pre-course assignments

MODULE 2

  • Assessment of Risks and Benefits in IRB Review
  • Practical Issues in IRB Review

MODULE 3

  • Informed Consent

MODULE 4

  • Conflicts of Interest

MODULE 5

  • What is Research Misconduct and Why Does It Matter?

MODULE 6

  • Authorship

MODULE 7

  • Research in Resource-Poor Countries

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Text

textbook

Lo, Bernard. Ethical Issues in Clinical Research: A Practical Guide. Lippincott Williams & Wilkins, Jun 3, 2009 -292 pages. ISBN 078178817X, 9780781788175

This book helps researchers to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major NIH grants in academic health centers.

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Assignments

Participants are expected to:

  • Complete assigned reading
  • View recorded lectures
  • Actively participate in at least one case study discussion each week
  • Participate in a scheduled web-conference at least 4 of 6 weeks
  • Complete weekly and end-of-course evaluations

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Case Studies

The following case studies have been explored in recent RCR courses. Each year several new case studies are substituted to keep the course current and relevant.

  • An Internet-based Intervention for Depression
  • Cognitive Impairment after Cardiac Surgery
  • Return of Genetic Findings in Research
  • Use of Neonatal Blood Samples for Research
  • Concerns about Data Integrity
  • Participation of an Inventor in a Clinical Trial
  • Conflicts of Interest During Peer Review
  • Influences of Research Misconduct on Meta-analysis
  • Is it Plagiarism? Is it Reprehensible?
  • Who is an Author?
  • Disputes over Authorship
  • Adding an Author
  • Sex Workers in Kenya
  • International Research Projects

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Faculty and Staff

Course Directors

Barbara Koenig, PhD is a medical anthropologist who works in the interdisciplinary field of biomedical ethics. She is a Professor in the Department of Social and Behavioral Sciences, Institute for Health and Aging, at UCSF. Previously she led biomedical ethics research programs at Stanford University and the Mayo Clinic. She co-chairs the “Responsible Conduct of Research” committee for the UCSF campus. She has pioneered the use of empirical social science methods in the study of ethical questions in science, medicine, and health; her research program has been funded by NIH for over two decades. Currently, she is studying return of incidental findings in genomic biobanks, newborn screening in an era of whole genome analysis, and using the techniques of deliberative democracy to engage communities. She is a fellow of the Hastings Center.

Julie N. Harris-Wai, PhD, MPH, staff scientist of the Kaiser Permanente Division of Research and associate director of the new Center for Transdisciplinary ELSI Research in Translational Genomics (known as CT2G), a three-year program that will explore the ethical, legal and social implications (ELSI) of genomics in health care.

Online Learning Architect

Chrisanne Garrett, MAED is the Online Education Architect for the Clinical and Translational Science Institute (CTSI) at UCSF. Ms. Garrett is a recognized leader in adult learning, distance education, and instructional design. She directed online education programs at the University of Kansas Medical Center and Graceland University prior to her employment at UCSF in 2008. She previously designed online and CME courses for the American Academy of Pediatrics, the United Way of Metropolitan Chicago, and the American Red Cross. Ms. Garrett earned Master’s degrees at The University of Maryland (Human and Organization Development) and University of Phoenix (Adult Education Distance Learning).

Course Manager

Asha Robertson is the Course Manager/Analyst for the CTSI Online Education Program at UCSF. Ms. Robertson brings significant experience and expertise to the administrative aspect of our Online education program, including managing our Designing Clinical Research courses as well as the How to Write a Successful PCORI Grant Application course. Ms. Robertson manages the Registration and Billing Processes as well as any administrative issues, and course completion processes.

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