Introduction to Clinical and Translational Research: Introduction to Research Ethics - Session 6

This online lecture reviews the history and development of the guidelines and federal regulations addressing ethical considerations associated with clinical and translational research.

About this Resource

Systems of medical ethics intended to protect patients and ensure trust between physician and patient are as old as the practice of medicine. Ethical guidelines for biomedical research are indeed similar to those of clinical care, but they are different in important ways - particularly in clinical and translational research. While physicians are required to put their patient's interests above all other considerations, researchers must balance the needs of the patient with the interests of science and knowledge.

An expert in healthcare law, policy and ethics summarizes the historical roots of contemporary ethical guidelines in clinical and translational research, including ethical breaches during the 20th century in Europe and the US that led to the establishment of our current system of Institutional Review Boards (IRBs) and other principals that seek to protect research participants while advancing scientific goals. The lecturer reviews the ethical principals that researchers are required to consider as they design and conduct studies, including issues of informed consent and patient confidentiality. The lecturer also discusses problems and ethical gray areas that remain unresolved under current practices and regulations, such as IRB bias toward their home institutions and conflicts in multicenter studies with differing IRB policies.

Course Syllabus/Topics

  • Principals of Medical Ethics
  • Understanding Distinctions between Medical and Research Ethics
  • History and Development of Modern Research Ethics
  • World Medical Association and Declarations of Helsinki
  • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and The Belmont Report
  • Structure and Function of Institutional Review Boards
  • Informed Consent, Patient Privacy, and Confidentiality of Personal Data
  • IRB Bias and other Unresolved Issues in Clinical and Translational Research Ethics
  • Research Integrity

Recommended background

Please complete the following prior to attending the short course, "Study Population and Study Design in Clinical/Translational Research, Session Two."

  • Pre-test on Clinical Translational Research
  • View the two-part video resource
  • Participant Break-out Session Guide

Suggested Readings

  • Liu R1, Wang X, Chen GY, Dalerba P, Gurney A, Hoey T, Sherlock G, Lewicki J, Shedden K, Clarke MF. The prognostic role of a gene signature from tumorigenic breast-cancer cells. N Engl J Med. 2007 Jan 18;356(3):217-26.
  • Slamon DJ1, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.
  • Pritchard KI, Shepherd LE, O'Malley FP, Andrulis IL, Tu D, Bramwell VH, Levine MN; National Cancer Institute of Canada Clinical Trials Group. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med. 2006 May 18;354(20):2103-11.
  • Stark A1, Kucera G, Lu M, Claud S, Griggs J. Influence of health insurance status on inclusion of HER-2/neu testing in the diagnostic workup of breast cancer patients. Int J Qual Health Care. 2004 Dec;16(6):517-21.


Yes. Participants who complete the course receive a Certificate. Participants must watch the videos and attend the in-person session.

No. In addition to K Scholars, this course is open to faculty, clinicians, community health workers, fellows, post-docs, TL1 and F trainees, as well as medical, OT/PT, pharmacy and other students who intend to conduct clinical and translational research.

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.