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OFFICE OF CLINICAL RESEARCH EDUCATION AND COLLABORATION OUTREACH

Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online)

Welcome

The Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) course is an asynchronous, online offering of the “Ethical and Regulatory Aspects of Clinical Research” live course presented by the Bioethics Department of the NIH Clinical Center. This course is offered to anyone interested or involved in the ethics of clinical research with human subjects.

Course Objectives

Syllabus

  • 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.

General Information

OCRECO Step by Step: Register, Enter Course Site, Begin Learning, Complete Final Exam, Receive Certificate

  • This online, asynchronous course is offered annually, at no cost. After registering, participants may begin their study immediately.
  • There are 7 modules with a total of 22 lectures.
  • There is a comprehensive online final exam consisting of 40 questions. A score of 80% must be achieved to receive a Certificate of Completion.
  • There is no academic credit or continuing medical education (CME) credit offered for this course.

Important Dates

Registration January 13, 2025 – May 2, 2025
Course Access January 13, 2025 – May 30, 2025
Final Exam Deadline May 16, 2025 (12PM US ET)

Supplemental Materials

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).

Course Collaborators

This asynchronous course was created through a partnership between the Bioethics Department of the Clinical Center and the Office of Clinical Research Education and Collaboration Outreach.

The course content is organized and delivered by the NIH Clinical Center Department of Bioethics as a live offering in the fall of every year. Learners interested in the more interactive format of a live course are encouraged to visit the Department of Bioethics website: https://www.cc.nih.gov/bioethics/courses/ethical-regulatory-aspects. The online/asynchronous version of the course available here, offers the lectures in a self-paced format.

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