Responsible Conduct of Research Course for Clinical Researchers

Responsible Conduct of Research (RCR) helps clinical researchers learn how to address the ethical issues that inevitably arise in research. Using video lectures, readings, case studies and weekly real-time small-group discussions via Zoom, the course addresses requirements and regulations for human-subjects research, including IRB approval and consent. Key topics include research ethics, conflicts of interest, research misconduct, authorship and ethical challenges related to research in resource-poor countries.

Course Objectives

  1. Identify 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. Review historical examples that have led to current standards of informed consent. Discuss 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

Schedule

Responsible Conduct of Research is a 7-week online course. Participants are expected to devote at least 4 hours per week to individual work and small-group discussion via Zoom. Topics include:

  • Clinical Research Regulations and IRB Review
  • Informed Consent
  • Conflicts of Interest
  • What is Research Misconduct and Why Does It Matter?
  • Big Data and Genomic Research Ethics
  • Authorship
  • Research in Resource-Poor Countries

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.

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 for 6 of the 7 weeks
  • Complete weekly and end-of-course evaluations

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

Faculty and Staff

Course Director

Anita Ho, PhD, MPH is an associate professor in the UCSF Bioethics Program and the Centre for Applied Ethics at the University of British Columbia. She is also a scientist at the Centre for Health Evaluation and Outcome Sciences in Vancouver, and a section editor in research ethics for BMC Medical Ethics.  Ho’s current research focuses on consent and data utilization issues involved in cluster randomized controlled trials, various conceptions of autonomy as applied to clinical and research settings, supportive decision making in diverse healthcare settings, ethical implications of AI health technologies, end-of-life care, and global health ethics.

Senior Course Advisor

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.