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. These courses are offered to anyone interested or involved in the ethics of clinical research with human subjects.
| Registration is currently closed for both options. Updated information coming soon. |
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 IRBs.
- 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 the perspective of individuals who have participated in research.
- Appreciate ethical challenges with conducting international collaborative research in low- and middle-income countries.
The optional course textbook, Ethical and Regulatory Aspects of Clinical Research: Readings and Commentaries (JHU Press, ISBN: 9780801878138) is available for purchase from several online book retailers and through the NIH FAES bookstore. An additional reference textbook for further study is: The Oxford Textbook of Clinical Research Ethics (Oxford University Press, ISBN: 9780199768639).