The ethics of quality improvement research

Critical Care Medicine

Volumn 37, Issue 2, 2009, Pages 791-792

  Siegel, Mark D ^a   Alfano, Sandra L ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Expedited review; Human subjects research; Informed consent; Institutional review board; Quality improvement; Research ethics

Indexed keywords

CLINICAL PROTOCOL; DEVICE INFECTION; EDITORIAL; ETHICS; HEALTH CARE ORGANIZATION; INFORMED CONSENT; MEDICAL RESEARCH; PRIORITY JOURNAL; TOTAL QUALITY MANAGEMENT;

BIOMEDICAL RESEARCH; HUMANS; INFORMED CONSENT; QUALITY ASSURANCE, HEALTH CARE;

EID: 67650401359     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e318194c4d6     Document Type: Editorial

References (14)

1. Pronovost P, Needham D, Berenholtz S, et al: An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006; 355:2725-2732
2. Gawande A: A lifesaving checklist. New York Times. December 30, 2007. Available at: http://www.nytimes.com/2007/12/30/opinion/ 30gawande.html. Accessed October 22, 2008
3. Wenzel RP, Edmond MB: Team-based prevention of catheter-related infections. N Engl J Med 2006; 355:2781-2783
4. Borror KC: Human research protections under Federalwide Assurances FWA-5752, FWA-287, and FWA-3834. July 19, 2007. Available at: http://www.dhhs.gov/ohrp/detrm-letrs/YR07/ jul07d.pdf. Accessed October 5, 2008
5. Berenholtz SM, Pronovost PJ, Lipsett PA, et al: Eliminating catheter-related bloodstream infections in the intensive care unit. Crit Care Med 2004; 32:2014-2020
6. Hanson MD, Thomas A, Ingbar DH, et al: Letter to the Honorable Michael Leavitt. February 5, 2008. Available at: http:// www.hospitalmedicine.org/AM/ Template. cfm?Section =Advocacy-Policy&Template=/ CM/ContentDisplay. cfm&ContentID=16830. Accessed September 28, 2008
7. Baily MA: Harming through protection? N Engl J Med 2008; 358:768-769
8. Kass N, Pronovost PJ, Sugarman J, et al: Controversy and quality improvement: Lingering questions about ethics, oversight, and patient safety research. Joint Comm J Qual Patient Saf 2008; 34:349-353
9. Savel RH, Goldstein EB, Gropper MA: Critical care checklists, the Keystone Project, and the Office for Human Research Protections: A case for streamlining the approval process in quality-improvement research. Crit Care Med 2009; 37:725-734
10. Borror KC: Human subject research protections under Federalwide Assurances FWA5752, FWA-287, and FWA-3834. February 14, 2008. Available at: http://www.hhs.gov/ ohrp/detrm-letrs/YR08/feb08b.pdf. Accessed October 22, 2008
11. Lynn J, Baily MA, Bottrell M, et al: The ethics of using quality improvement methods in health care. Ann Intern Med 2007; 146:666-673
12. Miller FG, Emanuel EJ: Quality-improvement research and informed consent. N Engl J Med 2008; 358:765-767
13. Protection of human subjects: Basic HHS policy for protection of human research subjects. June 23, 2005. Available at: http:// www.hhs.gov/ohrp/ humansubjects/guidance/ 45cfr46.htm#46.102. Accessed October 19, 2008
14. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont report, ethical principles and guidelines for the protection of human subjects of research. April 18, 1979. Available at: http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.htm. Accessed August 15, 2008