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

Assignments

Participants are expected to:

  • Complete assigned reading
  • View recorded lectures
  • Post detailed responses to case study questions each week during weeks 2-7
  • Participate in web-conference case study discussions each week during weeks 2-7
  • 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

Sara Ackerman, PhD MPH is a medical anthropologist working in the interdisciplinary fields of bioethics and implementation science. She is an associate professor in the Department of Social and Behavioral Sciences and Institute for Health and Aging at UCSF. She also serves as Associate Director of UCSF’s Implementation Science Training Program. Her current research focuses on ethical and social justice issues in emerging precision medicine initiatives, including the implications of diversity and inclusion efforts in genomics research, the challenges of implementing broad data sharing, and the use of community engagement strategies to enhance the communication of research findings to participants and the public.

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.