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Critical Care Research and Regulatory Compliance

  • Michael R. Jacobs
Chapter

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.

Keywords

Data Safety Monitoring Board Institutional Review Board Review Authorized Representative Critical Care Research Expedite Review 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 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
  2. 2.
    Ornato JP, McBurnie MA, Nichol G, et al. The public access defibrillation (PAD) trial: study design and rationale. Resuscitation. 2003;56(2):135-147.PubMedCrossRefGoogle Scholar
  3. 3.
    Nichol G, Wells GA, Kuntz K, et al. Methodological design for economic evaluation in public access defibrillation (PAD) trial. Am Heart J. 2005;150(2):202-208.PubMedCrossRefGoogle Scholar
  4. 4.
    Sayre MR, Travers AH, Daya M, et al. Measuring survival rates from sudden cardiac arrest: the elusive definition. Resuscitation. 2004;62(1):25-34.PubMedCrossRefGoogle Scholar
  5. 5.
    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.PubMedCrossRefGoogle Scholar
  6. 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
  7. 7.
    Bramstedt KA, Kassimatis K. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clin Invest Med. 2004;27(6):316-323.PubMedGoogle Scholar
  8. 8.
    Criner GJ. Framing the forum: medical ethics in large-scale, interventional respiratory clinical trials. Proc Am Thorac Soc. 2007;4(2):171-175.PubMedCrossRefGoogle Scholar
  9. 9.
    45 CFR 46 §102, Revised Oct 1, 2009; Accessed 22 February 2010.Google Scholar
  10. 10.
    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.PubMedGoogle Scholar
  11. 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).
  12. 12.
    Gunsalus CK, Bruner EM, Burbules NC, et al. The illinois white paper: improving the system for protecting human subjects: counteracting IRB “mission creep”. Qual Inq. 2007;13(5):617-649.CrossRefGoogle Scholar
  13. 13.
    Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med. 2008;358(8):765-767.PubMedCrossRefGoogle Scholar
  14. 14.
    Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):2725-2732.PubMedCrossRefGoogle Scholar
  15. 15.
    Colt HG, Mulnard RA. Writing an application for a human subjects institutional review board. Chest. 2006;130(5):1605-1607.PubMedCrossRefGoogle Scholar
  16. 16.
    Wang D, Bakhai A. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. London: Remedica, 2006.Google Scholar
  17. 17.
    Katz MH. Study Design and Statistical Analysis: A Practical Guide for Clinicians. Cambridge: Cambridge University Press, 2006.CrossRefGoogle Scholar
  18. 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. 19.
    Hulley SB. Designing Clinical Research. Philadelphia, PA: Lippincott Williams & Wilkins, 2007.Google Scholar
  20. 20.
    45 CFR 46 §116, Revised Oct 1, 2009; Accessed 22 February 2010.Google Scholar
  21. 21.
    May T, Craig JM, Spellecy R. Viewpoint: IRBs, hospital ethics committees, and the need for “translational informed consent”. Acad Med. 2007;82(7):670-674.PubMedCrossRefGoogle Scholar
  22. 22.
    Silverman HJ, Luce JM, Lanken PN, et al. Recommendations for informed consent forms for critical care clinical trials [see comment]. Crit Care Med. 2005;33(4):867-882.PubMedCrossRefGoogle Scholar
  23. 23.
    Chenaud C, Merlani P, Ricou B. Research in critically ill patients: standards of informed consent. Crit Care. 2007;11(1):110.PubMedCrossRefGoogle Scholar
  24. 24.
    United states. Ethical and policy Issues in Research Involving Human Participants. Bethesda, MD:The Commission, 2001.Google Scholar
  25. 25.
    Baren JM, Fish SS. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med. 2005;12(11):1071-1077.PubMedCrossRefGoogle Scholar
  26. 26.
    Iltis A. Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk. Bioethics. 2006;20(4):180-190.PubMedCrossRefGoogle Scholar
  27. 27.
    Abramson NS, Safar P. Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. Ann Emerg Med. 1990;19(7):781-784.PubMedCrossRefGoogle Scholar
  28. 28.
    Dimond B. The Mental Capacity Act 2005 and decision-making: code of practice. Br J Nurs. 2008;17(2):110-112.PubMedGoogle Scholar
  29. 29.
    Jansen TC, Kompanje EJO, Druml C, Menon DK, Wiedermann CJ, Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med. 2007;33(5):894-900.PubMedCrossRefGoogle Scholar
  30. 30.
    21 CFR 50 §24 Revised April 1, 2009; Accessed 22 February 2010.Google Scholar
  31. 31.
    Hiller KM, Haukoos JS, Heard K, Tashkin JS, Paradis NA. Impact of the Final Rule on the rate of clinical cardiac arrest research in the United States. Acad Emerg Med. 2005;12(11):1091-1098.PubMedCrossRefGoogle Scholar
  32. 32.
    Cone DC, O’Connor RE. Are US informed consent requirements driving resuscitation research overseas? Resuscitation. 2005;66(2):141-148.PubMedCrossRefGoogle Scholar
  33. 33.
    Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L. Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research? Resuscitation. 2004;62(1):3-23.PubMedCrossRefGoogle Scholar

Additional Reading

  1. 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.PubMedGoogle Scholar
  2. Colt HG, Mulnard RA. Writing an application for a human subjects institutional review board. Chest. 2006;130(5):1605-1607.PubMedCrossRefGoogle Scholar
  3. 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.PubMedCrossRefGoogle Scholar
  4. Iltis A. Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk. Bioethics. 2006; 20(4):180-190.PubMedCrossRefGoogle Scholar
  5. 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.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Michael R. Jacobs
    • 1
  1. 1.Temple University IRB Committees A1 and A2 (Medical Intervention), Temple University School of PharmacyPhiladelphiaUSA

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