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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.
  • Describe the purpose, function, and challenges of IRBs.
  • Identify and apply relevant considerations for assessment of research risks and benefits.
  • Explore the ethical requirement of fair subject selection and its application.
  • Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
  • Appreciate ethical challenges with conducting international collaborative research 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.

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.

Certificate of Completion

In order to 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.

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

Step 2: Self-Register. The Self Registration Quiz is 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** (for NIH employees only) credits you must be registered for the course and complete at least 6 of the 7 Session Quizzes by November 23, 2022.

*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. View more information.

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. Direct learners to self-enroll and self-register (see above). 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.

2022 Course Information

Our annual Ethical and Regulatory Aspects of Clinical Research course will be offered in Fall 2022 (September 21–November 9). Materials from previous years can be viewed at the links below.

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