Health care operations activities that may constitute research: The department of veterans affairs's perspective

IRB Ethics and Human Research

Volumn 36, Issue 1, 2014, Pages 9-11

  Tsan, Min Fu ^a   Puclisi, Thomas ^a  

^a DEPARTMENT OF VETERANS AFFAIRS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE DELIVERY; HEALTH SERVICES RESEARCH; HUMAN; HUMAN EXPERIMENT; KNOWLEDGE BASE; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; POLICY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; REVIEW; STANDARD; UNITED STATES;

DELIVERY OF HEALTH CARE; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HEALTH SERVICES RESEARCH; HUMAN EXPERIMENTATION; HUMANS; KNOWLEDGE BASES; ORGANIZATIONAL POLICY; UNITED STATES; UNITED STATES DEPARTMENT OF VETERANS AFFAIRS;

EID: 84894518572     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (15)

1. Department of Health and Human Services. Protection of Human Subjects. Subpart A. Basic HHS Policy for Protection of Human Research Subjects. 45 CFR 46.
2. Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered research. Proposed criteria and potential implications. JAMA 2000; 283: 2275-2280 (Pubitemid 30246780)
3. Baily MA, Bottrell M, Lynn J, Jennings B. The ethics of using QI methods to improve health care quality and safety. Hastings Center Report 2006; 36(4): S1-S40 (Pubitemid 44358490)
4. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infection in the ICU. NEJM 2007; 355: 2725-2732
5. Miller FG, Emanuel EJ. Quality-improvement research and informed consent. NEJM 2008; 358: 765-767 (Pubitemid 351281639)
6. Baily MA. Harming through Protection? NEJM 2008; 358: 768-769. (Pubitemid 351281640)
7. Quality Improvement Activities-FAQs. Office for Human Research Protections, Department of Health and Human Services. http://answers.hhs.gov/ ohrp/categories/1569.
8. VHA Operations Activities That May Constitute Research. VHA Handbook 1058.01, October 28, 2011. http://wwwi.va.gov/vhapublications/ViewPublication. asp?pub-ID=2456.
9. See ref. 4, VHA Handbook, October 28, 2011.
10. See ref. 3, Quality Improvement Activities
11. see ref 4, VHA Handbook, October 28, 2011.
12. See ref. 3, Quality Improvement Activities
13. see ref 4, VHA Handbook, October 28, 2011.
14. See ref. 4, VHA Handbook, October 28, 2011.
15. U.S. Food and Drug Administration. Protection of Human Subjects. 21 CFR 50.