This course is offered to anyone interested or involved in the ethics of clinical research with human subjects. Participants represent multiple disciplines including research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students, and others.
Course Objectives
By the end of this course, participants are able to:
- 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 and apply relevant considerations for assessment of research risks and benefits.
- Explore the ethical requirement of fair subject selection and its application.
- Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
- Appreciate ethical challenges with conducting international collaborative research in low- and middle-income countries.
Course Syllabus
View the DRAFT syllabus for the 2026 course.
Background Requirements
There are no background requirements in terms of education, knowledge, or experience, just an interest in clinical research with human subjects. This course is readily accessible to the non-medically trained as well as to those in the field of scientific research. As a rule, background education includes a mix of MD, PhD, RN, MPH, MSW, MPH, and BA/BS.
Cost
There is no fee for this course.
Lecture Only
If your plan is to only watch/review the lectures (i.e. you are not looking to earn a certificate of completion) you do not have to register for the course. Just tune in at 8:30-11:30 am Eastern Standard Time at NIH VideoCast or watch on your own time once the recording is posted on the NIH VideoCast archive or Department of Bioethics website. Recordings are posted within 48 hours after each class session.
Certificate of Completion
In order to receive a Certificate of Completion you must complete the final exam.
Please email questions or comments to bioethics-inquiries@mail.nih.gov.
2026 Course Information
Our annual Ethical and Regulatory Aspects of Clinical Research course will be offered in Fall 2026 (September 23 – November 4). This year we are being hosted by the Office of Clinical Research Education and Collaboration Outreach, Clinical Center, NIH. Enrollment will begin on September 16th. Register online.
Please e-mail questions or comments to bioethics-inquiries@mail.nih.gov.
Materials from previous years can be viewed at the links below.