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Definition Of Secondary Analyses Of Clinical Data

The secondary use of data refers to the use in research of clinical data already contained in participant’s health record and collected through the normal provision of routine care.

The Provincial Personal Health Information Protection Act of Ontario (PHIPA) sets forth the following requirements for the secondary use of clinical data in research:
  • The scientific question being asked is valuable and justifiable;
  • Appropriate measures are being taken to protect the privacy of the individuals, to ensure the confidentiality of the data, and to minimize harm to participantss;
  • The patients regarding whom the data refer will not be directly contacted by the researchers without their prior express and informed consent;
  • Identifying information will not be released to researchers outside the hospital without the patient’s express and informed consent;
  • Individuals to whom the data refers have not previously objected to such secondary use;
  • The data being collected would normally be obtained in the provision of care (section 29 (2)). As a consequence, the REB must ensure that the research plan limits its analysis to those data fields that would normally be available in the health record (departmental or centralized chart). If an investigator wishes to look at variables that are supplemental to care (e.g., in many instances, this could include race and SES), the individual’s express and informed consent must first be obtained and the research plan approved by the board.
  • It should be noted that PHIPA (health privacy legislation in Ontario) allows researchers to use clinical data to answer questions on the basis of 'implied consent'. Implied consent can be assumed if the institution has posted public notices to advise patients of the different uses that it makes of personal health information & that an REB has approved the research plan. CHEO has fully implemented the legislation and posted notices are found in high traffic areas around the hospital.
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