Critical Care Research and Regulatory Compliance
After studying this chapter, you should be able to: Discuss the concept of research intent. Identify the regulatory authorities who are responsible for research conducted in the United States. Describe the responsibilities of the institutional review board (IRB). List the categories available to the IRB for review of research. Give examples of the materials the IRB will need to adequately review a research proposal. Describe the informed consent process. Discuss how the exception from informed consent (EFIC) impacts emergency and critical care research.
KeywordsData Safety Monitoring Board Institutional Review Board Review Authorized Representative Critical Care Research Expedite Review
- 1.PAD Trial Investigators. The public access defibrillation trial I. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med. 2004;351(7):637-646.Google Scholar
- 6.Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med – Medecine Clinique et Experimentale. 2004;27(3):129-134.Google Scholar
- 9.45 CFR 46 §102, Revised Oct 1, 2009; Accessed 22 February 2010.Google Scholar
- 11.Federal protection for human research subjects an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule. Congressional Research Service Library of Congress, 2005. Accessed at http://www.fas.org/sgp/crs/misc/RL32909.pdf).
- 16.Wang D, Bakhai A. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. London: Remedica, 2006.Google Scholar
- 18.Stone J. Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators. Cumberland, Md: Mountainside MD Press, 2006.Google Scholar
- 19.Hulley SB. Designing Clinical Research. Philadelphia, PA: Lippincott Williams & Wilkins, 2007.Google Scholar
- 20.45 CFR 46 §116, Revised Oct 1, 2009; Accessed 22 February 2010.Google Scholar
- 24.United states. Ethical and policy Issues in Research Involving Human Participants. Bethesda, MD:The Commission, 2001.Google Scholar
- 30.21 CFR 50 §24 Revised April 1, 2009; Accessed 22 February 2010.Google Scholar