Ethical and Regulatory Aspects of Clinical Research

Welcome

The Ethical and Regulatory Aspects of Clinical Research (ERACR) course is presented by the Bioethics Department of the NIH Clinical Center and is offered by OCRECO through two course options: live or asynchronous. Both the live and asynchronous options were created through a partnership between the Bioethics Department of the Clinical Center and the Office of Clinical Research Education and Collaboration Outreach. The ERACR course introduces participants to the ethical principles, regulatory requirements, and practical considerations that guide clinical research involving human participants. Through topics such as informed consent, risk-benefit assessment, fair participant selection, and the role of institutional review boards, learners develop a systematic approach to recognize and address ethical issues in clinical research. Course participants include research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students and others. 

The course is offered in both live and asynchronous formats to accommodate different learning preferences.

Course Objectives

• Utilize a systematic framework for evaluating the ethics of a clinical research protocol.
• Identify, define, and consider ethical issues in the conduct of human subject research.
• Apply appropriate codes, regulations, and other documents governing the ethical conduct of human subject research to their own research.
• Describe the purpose, function, and challenges of Institutional Review Boards (term used in the US to refer to Research Ethics Committees).
• Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
• Identify and apply relevant considerations for assessment of research risks and benefits.
• Explore the ethical requirement of fair subject selection and its application.
• Identify challenges and opportunities related to genetics research and research with stored samples.
• Appreciate ethical challenges with conducting international collaborative research in low- and middle-income countries.