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One-time general consent for research on biological samples: Opt out system for patients is optimal and endorsed in many countries

BMJ 2006; 332 doi: (Published 16 March 2006) Cite this as: BMJ 2006;332:665
  1. Jan Willem W Coebergh, professor of cancer surveillance (,
  2. Evert-Ben van Veen, lawyer,
  3. Jan P Vandenbroucke, professor of clinical epidemiology,
  4. Paul van Diest, professor of pathology,
  5. Wolter Oosterhuis, professor of pathology
  1. Department of Public Health, Erasmus Medical Centre, Box 2040, 3000 CA Rotterdam, Netherlands
  2. MedlawConsult, Box 11500, 2502 AM The Hague, Netherlands
  3. Leiden University, Medical Centre, Box 9600, 2300 RC Leiden, Netherlands
  4. University Medical Centre Utrecht, Heidelberglaan 100, 3508 AB Utrecht, Netherlands
  5. Erasmus University Medical Centre, Rotterdam

    EDITOR—Wendler's valuable overview of empirical studies of patients' preferences about the use of residual (leftover) tissue for research is not complete.1 The discussion has already been settled by legislation in many countries.

    In 2004 the Danish act on patient rights was amended with an opt out system for using residual tissue for research. In 2004 the US Office for Human Research Protections (OHRP) issued guidance …

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