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:

• 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.
• Identify the critical elements of informed consent and strategies for implementing informed consent for
clinical research.
• Describe the purpose, function, and challenges of IRBs.
• Discuss controversial issues relating to human subject research, including, randomization, prisoners in
research, COVID related research, international research, etc.

Course Syllabus
View a draft version of the course syllabus. The final version will be posted as soon as it is available.

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, 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.

Register
To register for the course, complete the survey.

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 bioethics-
inquiries@mail.nih.gov.

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 bioethics-inquiries@mail.nih.gov.