Ethics and regulation of clinical research (CLRES 2050)

CLRES 2050 Live aims to enhance students’ ability to think about the ethical dimensions of research, especially research involving human subjects, and to participate thoughtfully and knowledgeably in the ethical design and review of research protocols. By the end of the course, students should be able to: (1) Describe the historical context for today’s heightened scrutiny of clinical research, (2) Identify and explain the basic concepts, values, and potential ethical conflicts associated with the conduct of human subjects research, (3) Define the elements of scientific misconduct, (4) Demonstrate a commitment to integrity in the conduct of scientific research, (5) Demonstrate a commitment to advocate for the rights and welfare of human research subjects, (6) Analyze a research protocol from the ethical point of view according to criteria developed by federal regulatory agencies and local Institutional Review Boards, (7) Explain a scientific research protocol in language that promotes laypeople’s understanding sufficient to provide meaningful informed consent and (8) Demonstrate communication skills adequate to obtain a potential research subject’s meaningful informed consent.


Develop appropriate methods to recruit and retain study participants for a selected research design.

Generate a plan for data security/management.

Design appropriate, ethically sound, and hypothesis-driven clinical studies.

Define bias in clinical and translational research.

Recognize scientific misconduct and conflict of interest.

Demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting the rights, well-being, and dignity in the recruitment and retainment of human subjects in clinical research.

Give examples of the informed consent process including an understanding of the risk/benefit criteria and its impact on the patient/volunteer.

* Highlight denotes properties specific to the Clinical Pharmaceutical Sciences track.