National Institutes of Health Clinical Center

Ethical and Regulatory Aspects of Clinical Research

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Course Objectives

By the end of this course, participants are able to:

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, SW, 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 book is available in the FAES Bookstore in Building 10 and also can be ordered from commercial bookstores and websites.

Off-site Group Participation

If you would like to participate in the Ethical and Regulatory Aspects of Clinical Research course from a remote site via video cast AND you would like to receive a certification of your participation, you must have a supervisor for the remote group. Please note the requirements below. If you do not want or do not need a certificate and would like to participate online, the course sessions are available live or can be viewed a few days after each session.

The designated supervisor of a group will be responsible for:

  1. Seeking approval to participate from the Department of Bioethics (301-496-2429) or and naming the group
  2. Ensuring that all participants at the remote site register individually online under the correct group name (selected from the drop down menu)
  3. Sending the names of all registered group participants to the Department of Bioethics, 2 weeks before the first day of the course
  4. Verifying participant attendance at each session on the provided sign-in sheet
  5. Returning the completed scanned sign-in sheet via email by COB of the date of the session
  6. Notifying the Department of Bioethics if additional people are added to the group
  7. Informing group participants that an evaluation will be sent electronically to those who have attended each session and participants will have 24 hours to complete and submit the form
  8. Reminding group participants that completion of the evaluations, pre and post tests are required in order to receive a certificate

At the end of the course, certificates will be sent within 4 weeks to each registered off-site participant who attended the full course at the email address that they registered with.

2017 Course Information

Past Years' Courses

2016 Course Information

2015 Course Information

2014 Course Information

2013 Course Information

2012 Course Information

Videocasts of Past Lectures.

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