A geospatial analysis of persons opting out of an exception from informed consent out-of-hospital clinical trial

Resuscitation

Volumn 80, Issue 1, 2009, Pages 89-95

  Nelson, Maria J ^a   Warden, Craig ^a   Griffiths, Denise ^a   Zive, Dana ^a   Schmidt, Terri ^a   Hedges, Jerris R ^a   Daya, Mohamud ^a   Newgard, Craig D ^a  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

Census tract; Ethics; Geographic information systems; Informed consent; Research; U.S. Food and Drug Administration

Indexed keywords

ARTICLE; CONTROLLED STUDY; GEOGRAPHIC INFORMATION SYSTEM; GEOSTATISTICAL ANALYSIS; HOSPITAL DISCHARGE; HOUSEHOLD; HUMAN; PRIORITY JOURNAL; RESUSCITATION; RETROSPECTIVE STUDY; VETERAN;

CENSUSES; CLINICAL TRIALS AS TOPIC; GEOGRAPHY; HUMANS; INFORMED CONSENT; OREGON; PATIENT IDENTIFICATION SYSTEMS; REFUSAL TO PARTICIPATE; REGRESSION ANALYSIS; RETROSPECTIVE STUDIES; THERAPEUTIC HUMAN EXPERIMENTATION;

EID: 57649178811     PISSN: 03009572     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.resuscitation.2008.10.003     Document Type: Article

References (30)

1. Morris M.C. An ethical analysis of exception from informed consent regulations. Acad Emerg Med 12 (2005) 1113-1119
2. Richardson L.D., Rhodes R., Ragin D.F., and Wilets I. The role of community consultation in the ethical conduct of research without consent. Am J Bioeth 6 (2006) 33-35
3. McClure K.B., DeIorio N.M., Gunnels M.D., Ochsner M.J., Biros M.H., and Schmidt T.A. Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med 10 (2003) 352-359
4. U.S. Government Food and Drug Administration. Title 21 CFR (61 FR 51500). Federal Register; 1996.
5. U.S. Government Food and Drug Administration. Title 21 CFR (61 FR 51528). Federal Register; 1996.
6. Conduct of Emergency Clinical Research; Public Hearing, Department of Health and Human Services Food and Drug Administration, Proposed Rules Sess; 08/29/2006.
7. Vaslef S.N., Cairns C.B., and Falletta J.M. Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: From experimental design to institutional review board approval. Arch Surg 141 (2006) 1019-1023
8. Brasel K.J., Bulger E., Cook A.J., et al. Resuscitation outcomes consortium investigators. hypertonic resuscitation: design and implementation of a prehospital intervention trial. J Am Coll Surg 206 (2008) 220-232
9. Dickert N., and Sugarman J. Ethical goals of community consultation in research. Am J Public Health 95 (2005) 1123-1127
10. Baren J.M., and Biros M.H. The research on community consultation: an annotated bibliography. Acad Emerg Med 14 (2007) 346-352
11. Davis D.P., Garberson L.A., Andrusiek D.L., et al. A descriptive analysis of emergency medical service systems participating in the resuscitation outcomes consortium (ROC) network. Prehosp Emerg Care 11 (2007) 369-382
12. U.S. census bureau's guide to census tract resources [homepage on the Internet]. 2006 June 29, 2006. Available from: http://www.census.gov/geo/www/tractez.html.
13. Lawson A. Adjusting Moran's I for population density. Stat Med 15 (1996) 1591-1594
14. Oden N. Adjusting Moran's I for population density. Stat Med 14 (1995) 17-26
15. Waldhor T. The spatial autocorrelation coefficient Moran's I under heteroscedasticity. Stat Med 15 (1996) 887-892
16. Walter S.D. Assessing spatial patterns in disease rates. Stat Med 12 (1993) 1885-1894
17. Breiman L., Freidman J.H., Olshen R.A., and Stone C.J. Classification and regression trees (1984), Chapman & Hall, New York
18. Campbell H.M., Raisch D.W., Sather M.R., Warren S.R., and Segal A.R. A comparison of veteran and nonveteran motivations and reasons for participating in clinical trials. Mil Med 172 (2007) 27-30
19. The survey of the American consumer [homepage on the Internet]. New York: Mediamark Research & Intelligence; 2008. Available from: http://www.mediamark.com.
20. Facts about newspapers: A statistical summary of the newspaper industry [homepage on the Internet]. Arlington, VA: Newspaper Association of America; 2004. Available from: http://www.naa.org/info/facts04/readership-demographics.html.
21. Stone T.H. The invisible vulnerable: the economically and educationally disadvantaged subjects of clinical research. J Law Med Ethics 31 (2003) 149-153
22. U.S. Department of Health and Human Services. Protection of human subjects. Code Fed Regul Public Welfare; October 1, 1995; Title 45 (Sections 46-101 to 46-409).
23. Corbie-Smith G. The continuing legacy of the Tuskegee syphilis study: considerations for clinical investigation. Am J Med Sci 317 (1999) 5-8
24. Shavers V.L., Lynch C.F., and Burmeister L.F. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol 12 (2002) 248-256
25. Shavers V.L., Lynch C.F., and Burmeister L.F. Knowledge of the Tuskegee study and its impact on the willingness to participate in medical research studies. J Natl Med Assoc 92 (2000) 563-572
26. Freimuth V.S., Quinn S.C., Thomas S.B., Cole G., Zook E., and Duncan T. African Americans' views on research and the Tuskegee syphilis study. Soc Sci Med 52 (2001) 797-808
27. Katz R.V., Green B.L., Kressin N.R., Claudio C., Wang M.Q., and Russell S.L. Willingness of minorities to participate in biomedical studies: confirmatory findings from a follow-up study using the Tuskegee legacy project questionnaire. J Natl Med Assoc 99 (2007) 1052-1060
28. Wendler D., Kington R., Madans J., et al. Are racial and ethnic minorities less willing to participate in health research?. PLoS Med 3 (2006) e19
29. Krieger N. Overcoming the absence of socioeconomic data in medical records: validation and application of a census-based methodology. Am J Public Health 82 (1992) 703-710
30. Krieger N. Women and social class: a methodological study comparing individual, household, and census measures as predictors of black/white differences in reproductive history. J Epidemiol Commun Health 45 (1991) 35-42