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.
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.
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.
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.
Registration for the 2021 course will open in the fall.
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 firstname.lastname@example.org.
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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.