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The challenge of local consent requirements for global critical care databases

Stuart McLennan| David Shaw| Leo Anthony Celi
What's New in Intensive Care
Volume 45, Issue 2 / February , 2019

Pages 246 - 248

No abstract available.

References

  1. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL (2013) An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 43:S16–S27 (Special report)
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  2. Celi LA, Mark RG, Stone DJ, Montgomery RA (2013) “Big data” in the intensive care unit. Closing the data loop. Am J Respir Crit Care Med 187(11):1157–1160
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  3. Johnson AE, Pollard TJ, Shen L, Lehman LW, Feng M, Ghassemi M, Moody B, Szolovits P, Celi LA, Mark RG (2016) MIMIC-III, a freely accessible critical care database. Sci Data 3:160035
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  4. Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, Kapral MK (2004) Investigators in the registry of the Canadian stroke network. Impracticability of informed consent in the registry of the Canadian stroke network. N Engl J Med 350(14):1414–1421
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  5. Dove ES, Bartha M, Knoppers BM, Zawati MH (2014) Towards an ethics safe harbor for global biomedical research. J Law Biosci 1(1):3–51
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  6. Spector T, Prainsack B (2018) Ethics for healthcare data is obsessed with risk—not public benefits. The conversation 2018. Available online at: https://theconversation.com/ethics-for-healthcare-data-is-obsessed-with-risk-not-public-benefits-89575. Accessed 16 Mar 2018
  7. Nyrén O, Stenbeck M, Grönberg H (2014) The European Parliament proposal for the new EU General Data Protection Regulation may severely restrict European epidemiological research. Eur J Epidemiol 29:227–230
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  8. Rumbold JMM, Pierscionek B (2017) The effect of the General Data Protection Regulation on medical research. J Med Internet Res 19(2):e47
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  9. Shabani M, Borry P (2018) Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation. Eur J Hum Genet 26:149–156
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  10. BBMRI-ERIC (2015) Position paper on General Data Protection Regulation 2015. Available online at: http://www.bbmri-eric.eu/wpcontent/uploads/BBMRI-ERIC-Position-Paper-General-Data-Protection-Regulation-October-2015_rev1_title.pdf. Accessed 16 Mar 2018

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