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Critical Care Research and Regulatory Compliance

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Critical Care Study Guide

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Abstract

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.

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Additional Reading

  • Amdur RJ, Speers MA. A practical guideline for identifying research intent with projects that collect private, identifiable health information. Am J Clin Oncol. 2003;26(3):e7-e12.

    PubMed  Google Scholar 

  • Colt HG, Mulnard RA. Writing an application for a human subjects institutional review board. Chest. 2006;130(5):1605-1607.

    Article  PubMed  Google Scholar 

  • Silverman HJ, Luce JM, Lanken PN, et al. Recommendations for informed consent forms for critical care clinical trials. Crit Care Med. 2005;33(4):867-882.

    Article  PubMed  Google Scholar 

  • Iltis A. Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk. Bioethics. 2006; 20(4):180-190.

    Article  PubMed  Google Scholar 

  • Mosesso VN, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the public access defibrillation (PAD) trial experience. Resuscitation. 2004;61(1):29-36.

    Article  PubMed  Google Scholar 

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Author information

Authors and Affiliations

  1. Temple University IRB Committees A1 and A2 (Medical Intervention), Temple University School of Pharmacy, Philadelphia, PA, 19104, USA

    Michael R. Jacobs BS, PharmD

Authors
  1. Michael R. Jacobs BS, PharmD
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Editor information

Editors and Affiliations

  1. School of Medicine, Temple University, N. Broad St. 3420, Philadelphia, 19140, USA

    Gerard J. Criner

  2. Dept. Medicine, Temple University, N. Broad Street 3401, Philadelphia, 19140, USA

    Rodger E. Barnette

  3. School of Medicine, Temple University, N. Broad St. 3420, Philadelphia, 19140, USA

    Gilbert E. D'Alonzo

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Jacobs, M.R. (2010). Critical Care Research and Regulatory Compliance. In: Criner, G., Barnette, R., D'Alonzo, G. (eds) Critical Care Study Guide. Springer, New York, NY. https://doi.org/10.1007/978-0-387-77452-7_12

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  • DOI: https://doi.org/10.1007/978-0-387-77452-7_12

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  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-0-387-77327-8

  • Online ISBN: 978-0-387-77452-7

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