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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, enrollment of pregnant women in research, COVID related vaccine research, and research conducted in low and middle income countries.

Course Syllabus

View a final version of the course syllabus PDF Icon.

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

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 on Canvas. 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.

If you want to receive a Certificate of Completion (complete at least 3 sessions), receive Nursing Continuing Education credit (only available for Nurses, complete 6 of 7 sessions) or apply course completion to NIH Clinical Research Curriculum Certificate (NIH employees only, complete 6 of 7 sessions) you must register. Registration closed October 6, 2021. The course will be offered again in 2022. You must use a web-browser other than Internet Explorer to use Canvas.

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. Registration closed October 6, 2021. The course will be offered again in 2022. Learners who complete 3 sessions will receive a Certificate of Completion. For questions email bioethics-inquiries@mail.nih.gov.

Privacy Act Notification Statement

You will 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.

Session feedback evaluations will be completed using the SurveyMonkey website. View the SurveyMonkey privacy policy.

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.

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.