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Recruitment Into Research Under Personal Health Information Protection Act (PHIPA)

Personal health information (PHI) can flow freely between members of the circle of care in responding to a patient’s clinical needs. Within a hospital setting, the circle of care includes the attending physician and the health care team (e.g., residents, nurses, technicians, clinical clerks and other employees assigned to the patient) who have direct responsibilities for providing care to the individual. The researcher is not included in the circle of care.

PHIPA permits the secondary uses of personal health information (PHI) for research, if an institution has posted notices advising patients that research will be conducted on the information recorded in their charts. Under these circumstances, the patient’s consent can be assumed or implied. REB approval is however, required for this type of research, typically involving retrospective chart reviews and databases. The REB can approve the research use of PHI with implied consent when it can be shown that it was not possible to secure express consent (s. 44, 3 d). In addition, when PHI is used for research, the investigator must ensure that he/she (in accordance with section 44 requirements):
  • Complies to any conditions set out by the Board;
  • Uses PHI only for the purpose set out in the research plan;
  • Not publish information in a form that could identify individuals;
  • Not disclose information unless required or permitted by law;
  • Not make contact or attempt to make contact with the individual unless the Health Information Custodian (HIC), or an agent thereof, first obtains the patient’s consent for the release of information to the investigator;
  • Notifies the HIC of any breaches in confidentiality (unintended disclosures, loss or theft of data).
Express consent is however, required for any departures from the standard of care that are being implemented in order to address research questions. Express consent is also required for the release of personal health information to a researcher to determine a patient’s eligibility to participate in research or to recruit a patient into a research study.

When the researcher is also the patient’s clinician, a number of other considerations apply.

  • The Board requires, whenever possible, that prospective participants be first approached to participate in research by a member of the care team who is not part of the research staff. This person should have legitimate access to the PHI that speaks to a participant’s eligibility for the study. For example, the head of a clinic or service that normally follows a certain group of patients could send an information letter to prospective participants advising them of the study and requesting that they make contact with the research team or give their permission for the release of their health and contact information to the research team.
  • When the researcher-clinician is the only individual available to approach eligibleparticipants, the Board may require additional measures be taken to ensure that consent is entirely voluntary and uninfluenced by the patient-practitioner relationship. The Board makes these decisions on a case-by-case basis.
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