Ethical and Regulatory Aspects of Clinical Research

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:

Course Syllabus

View a final version of the course syllabus.

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.


There is no fee for this course, but a textbook, The Ethical and Regulatory Aspects of Clinical Research (JHU Press) is required. The course textbook is "Ethical and Regulatory Aspects of Clinical Research: Readings and Commentaries (JHU Press, ISBN 9780801878138)." You can order the book on-line from the FAES Bookstore @ NIH or other on-line purveyor of books.


Registration for the 2021 course will open in the fall.

Group Registration

In the past, we facilitated the enrollment of groups of learners who complete the course as a group off site. We will not be offering this option this year. Each learner interested in completing the course can register online. Learners who complete 3 sessions will receive a Certificate of Completion. For questions email

Privacy Act Notification Statement

You be participating in a government sponsored class offered by the National Institutes of Health Clinical Center's Department of Bioethics. View the agency's Privacy Policy.

If you register for the course, you will sign up using this Qualtrics website using your first name, your last name, and your email address. View the Qualtrics privacy policy. Your name will be used to compile a class roster. When we contact you, you may wish to optionally provide your advanced degree information for your Certificate of Completion. By proceeding to the registration form, you have acknowledged the collection/storage of all information entered.

The Department of Bioethics will use the Canvas Web platform to store your name and email address in order to communicate class details with you. View the Canvas privacy policy.

Please e‐mail questions or comments to

2021 Course Information

The next iteration of Ethical and Regulatory Aspects of Clinical Research will begin in September 2021 and there is no fee for this course.