Register for the course Ethical and Regulatory Aspects of Clinical Research. This 7-week course covers essential topics in the ethics of clinical research and is designed for researchers and research teams, clinical staff, IRB members, and others interested in the ethics of clinical research. Presentations are given by experts from both within and outside the NIH.

The course will be broadcast live. The course meets Wednesday mornings from 8:30 –11:30 am Eastern. We will meet from September 20, 2023 to November 1, 2023. In addition to lectures, we will host conversations with experts and engage in case discussions. All NIH employees are welcome to join the course in Lipsett. If you are not an NIH employee but are local and would like to attend in person please email Holly Taylor at holly.taylor2@nih.gov

This course is available to anyone via live video-cast at http://videocast.nih.gov. There is no charge.

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We will be using CANVAS learning management system to coordinate course activities. Because it’s built using web standards, CANVAS runs on Windows, Mac, Linux, iOS, Android, or any other device with a modern web browser.

Certificate of Completion

In order to have access to course materials and receive a Certificate of Completion you must self-enroll in the course and self-register.

Step 1: Self-enroll. If you self-enroll you will have access to course materials (e.g. readings) posted in CANVAS. Use this link to self-enroll in CANVAS. https://canvas.instructure.com/enroll/GEB769

If you want a Certificate of Completion you must also self-register.

Step 2: Self-Register. The Self Registration Form posted on the Homepage for the course as well as under the TAB labeled Quizzes.

The course meets 7 times (7 sessions). There is a Session Quiz for each session. To receive a basic Certificate of Completion you must complete at least 3 Session Quizzes.

If you want to receive Nursing CEU* or Clinical Research Curriculum** (available to NIH employees only) credits you must be registered for the course and complete at least 6 of the 7 Session Quizzes.

Next Steps

Once you self-enroll and self-register you will receive an email with additional course information including a request to complete a Pre-Course Assessment. We will ask you to complete a similar Assessment at the end of the course. The Assessment is anonymous therefore your performance on the Assessment will not be recorded by name or linked across time.

If your institution or group has participated from a satellite location in the past we are not organizing proctored groups. Each individual from your institution will self-enroll and self-register directly. You can ask that learners forward their 2023 Certificates of Completion to your attention. For more information click https://bioethics.nih.gov/courses/ethical-regulatory-aspects.shtml.

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 https://faes.org/content/faes-bookstore-nih or other on-line purveyor of books. Additional readings will be recommended.

Individuals with disabilities who need sign language interpreters and/or reasonable accommodation should contact 301-496-2429 or bioethics-inquiries@mail.nih.gov. Federal TTY Relay number is 1-800/877-8339. Requests should be made at least 5 days in advance of the event.

*Nurses will receive 22 contact hours of CEU credits. Credits are provided through the Maryland Nurses Association, an accredited approver of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

** Successful completion of this course is required for the Clinical Research Curriculum Certificate. For more information, see https://ocr.od.nih.gov/crcc.html

This 7-week course covers essential topics in the ethics of clinical research and is designed for researchers and research teams