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.
- Identify common ethical issues that clinical and translational researchers commonly face and the ethical guidelines for addressing these issues.
- Explain key elements of the federal regulations for research with human subjects, research misconduct, and conflicts of interest.
- 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.
- Discuss pertinent issues related to authorship, including why authorship is an important and often difficult element within the research process.
- Identify key ethical issues related to conduct of research in resource-poor countries.
- Explore a wide array of ethical dilemmas by participating in scholarly dialogue around at least one topical case study each week.
- Provide constructive feedback on colleagues' ideas regarding ethical issues in research.
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
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:
- Assessment of Risks and Benefits in IRB Review
- Practical Issues in IRB Review
- Informed Consent
- Conflicts of Interest
- What is Research Misconduct and Why Does It Matter?
- Research in Resource-Poor Countries
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.
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
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
Julie Harris-Wai, PhD, MPH is an Assistant Professor in the Department of Social and Behavioral Sciences and the Program on Bioethics at UCSF. She received her PhD in Public Health Genomics at the University of Washington, followed by a fellowship in population health sciences with the Robert Wood Johnson Foundation’s Health and Society Scholars Program. Dr. Harris-Wai is currently conducting research on multiple projects examining the ethical and social implications of big data and genomic technologies in pediatric and prenatal populations. She also collaborates on multiple research projects, where she specializes in using stakeholder and community engagement strategies to inform research governance and public health policy. The goal of her work is to identify methods for incorporating community perspectives into research and clinical programs in order to improve the appropriate translation of research into clinical care. Dr. Harris-Wai has helped to lead the Responsible Conduct of Research course for the past four years.
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.