Clinical Research Ethics

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The clinical research ethics resource provides expertise to researchers seeking advice regarding ethically complex aspects of their biomedical research. The service is available to assist investigators throughout the life of a research project, from the initial design phase of the study through dissemination of research findings. This resource demonstrates a commitment to safety and a high degree of research ethics at the institutional level and supports training of students in graduate and professional training programs, along with regularly-scheduled seminars on the ethical conduct of research.

What is the Clinical Research Ethics Consultation Service?

This free service is available to researchers who seek advice regarding ethically complex aspects of their biomedical research. The service is available to assist investigators throughout the life of a research project, including:

  • Initial design phase
  • Grant application preparation
  • IRB application process (ethics- related questions and concerns)
  • Study implementation
  • Data analysis
  • Manuscript preparation
  • Dissemination of findings

The service is also available to investigators and their teams who may want to review past research projects that posed ethical challenges and how they responded to those challenges.

Types of Consultations We Offer

The Clinical Research Ethics program offers consultations about any ethical topic or question connected to health sciences research. We offer three types of consultations:

  • General Compliance Ethics - We provide support for researchers who would like assistance identifying and resolving ethical issues involved in ensuring that a proposed or planned research project satisfies regulatory or institutional ethics policies.
  • Research Project Ethics - This line of consultation focuses on identifying unique and usually highly project-specific opportunities to create ethical value as a natural consequence of pursuing a line of research.
  • Translation Ethics - We offer consultations designed to help researchers identify potential socially beneficial pathways for translating their research. These consultations use a process called Boundary Object Mapping. Boundary objects are any object that facilitates the formation of cooperative networks out of people drawn from otherwise quite different social and professional worlds by being legible (though not with the same meaning) to everyone who interacts with the relevant boundary object.

Consultation Scheduling

To initiate a consultation, please email the Clinical and Translational Science Center Clinical Research Ethics Director, Mark Fedyk at All consultations are strictly confidential.

Frequently Asked Questions

Bioethics is the study of moral issues in the life sciences, including clinical medicine and biomedical research. A major domain in the field, research ethics, studies a range of issues that relate to the ethical conduct of biomedical research. From a historical perspective, most work in the field focused on issues central to the ethical conduct of clinical research, such as refining the informed consent process; assuring that benefits outweigh risks; and ensuring the just distribution of the burdens and benefits of research across the population. More recently, matters such as the ethical implications of obtaining and using genetic and genomic information, creating biospecimen research repositories, mapping the human brain, and conducting comparative effectiveness research have gained prominence.

Examples of the kind of questions that the consultation service might assist with include, but are not limited to, the following:

  • Am I confident that the anticipated benefits of my research will outweigh its risks?
  • How do I know if the consent process that I plan to use for my research is the most appropriate one, given the special characteristics of my research population?
  • Should I do anything about the fact that my research is controversial in the eyes of many in the public?
  • How should authorship be assigned on manuscripts?

The service is staffed by faculty affiliated with the UC Davis Bioethics Program. It may also draw upon clinical and other investigators with significant research ethics expertise.