Ethical and Regulatory Aspects of Clinical Research
The Fall 2012 course has ended. Check back during the summer of 2013 to register for the Fall 2013 course.
This course is offered to anyone interested or involved in clinical research involving human subjects. The course is advertised to the NIH community at large and, though not advertised outside of NIH, often draws people from outside of NIH, including fellows from the Western IRB in Olympia, WA, who have attended via satellite for the past 3 years. The target audience, thus, cannot be specifically defined nor easily categorized, and includes multiple disciplines including, but not restricted to, physicians, psychologists, nurses, social workers, administrative staff, students, and others.
Course ObjectivesBy the end of this course, participants will be able to:
- Utilize a systematic framework for evaluating the ethics of a clinical research protocol.
- Apply appropriate codes, regulations, and other documents governing the ethical conduct of human subject research to their own research.
- Discuss controversial issues relating to human subject research, including Phase 1 research, randomization, children in research, international research, etc.
- Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
- Describe the purpose, function, and challenges of IRBs.
- Appreciate the experience of human subjects who have participated in research protocols.
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. There is no penalty for cancellation. If you have registered, but find you cannot attend the course, please notify Mertis Stallings, firstname.lastname@example.org.
2012 Course Schedule & Materials
Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 26, 2012
- Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
- History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
- Do the Codes Apply to My Research? Nuremberg, Helsinki, the Belmont Report, CIOMS, and the Common Rule - Ivor Pritchard PhD
Session 2: IRB review, Informed Consent and Investigator Panel - October 3, 2012
- Purpose and Function of IRBs: Successes and Current Challenges - Barbara Karp MD
- Informed Consent - Christine Grady RN PhD
- Investigator panel - Kathleen Morton RN MSN (NCI); Maryland Pao MD (NIMH); Kristina Rother MD MHSc (NIDDK) and Antonio Fojo MD PhD (NCI)
Session 3 - October 10, 2012
- Fair Subject Selection - Dave Wendler PhD
- Coercion, Undue inducement, and Incentives in Research - Alan Wertheimer PhD
- Ethical issues in research with children - Robert Nelson MD PhD
Session 4 - October 17, 2012
- Risks and Benefits - Dave Wendler PhD
- Research Involving Persons at Risk for Impaired Decision-Making - Donald Rosenstein, MD
- Participant panel
Session 5 - October 24, 2012
- Exploitation - Alan Wertheimer PhD
- Ethical Issues in International research - Joe Millum PhD
- Mock IRB
Session 6 - October 31, 2012 - Cancelled due to Hurricane Sandy
- Ethics of Placebo Controlled Trials - Frank Miller, PhD
- Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
- Conflicts of Interest - Steve Joffe MD MPH
Session 7 - November 7, 2012
- Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
- How to think about Incidental Findings - Ben Berkman JD
- Case Discussion
NB: Instructions on how to print multiple slides on one sheet of paper from the pdfs above are available.