44 (1) A health information custodian may disclose personal health information about an individual to a researcher if the researcher, (a)  submits to the custodian, (i)  an application in writing, (ii)  a research plan that meets the requirements of subsection (2), and (iii)  a copy of the decision of a research ethics board that approves the research plan; and (b)  enters into the agreement required by subsection (5).  2004, c. 3, Sched. A, s. 44 (1). Same (1.1) For greater certainty, the decision of only one research ethics board is sufficient for the purposes of subclause (1) (a) (iii). 2020, c. 5, Sched. 6, s. 6. Research plan (2) A research plan must be in writing and must set out, (a)  the affiliation of each person involved in the research; (b)  the nature and objectives of the research and the public or scientific benefit of the research that the researcher anticipates; and (c)  all other prescribed matters related to the research.  2004, c. 3, Sched. A, s. 44 (2). Consideration by board (3) When deciding whether to approve a research plan that a researcher submits to it, a research ethics board shall consider the matters that it considers relevant, including, (a)  whether the objectives of the research can reasonably be accomplished without using the personal health information that is to be disclosed; (b)  whether, at the time the research is conducted, adequate safeguards will be in place to protect the privacy of the individuals whose personal health information is being disclosed and to preserve the confidentiality of the information; (c)  the public interest in conducting the research and the public interest in protecting the privacy of the individuals whose personal health information is being disclosed; and (d)  whether obtaining the consent of the individuals whose personal health information is being disclosed would be impractical.  2004, c. 3, Sched. A, s. 44 (3). Decision of board (4) After reviewing a research plan that a researcher has submitted to it, the research ethics board shall provide to the researcher a decision in writing, with reasons, setting out whether the board approves the plan, and whether the approval is subject to any conditions, which must be specified in the decision.  2004, c. 3, Sched. A, s. 44 (4). Agreement respecting disclosure (5) Before a health information custodian discloses personal health information to a researcher under subsection (1), the researcher shall enter into an agreement with the custodian in which the researcher agrees to comply with the conditions and restrictions, if any, that the custodian imposes relating to the use, security, disclosure, return or disposal of the information.  2004, c. 3, Sched. A, s. 44 (5). Compliance by researcher (6) A researcher who receives personal health information about an individual from a health information custodian under subsection (1) shall, (a)  comply with the conditions, if any, specified by the research ethics board in respect of the research plan; (b)  use the information only for the purposes set out in the research plan as approved by the research ethics board; (c)  not publish the information in a form that could reasonably enable a person to ascertain the identity of the individual; (d)  despite subsection 49 (1), not disclose the information except as required by law and subject to the exceptions and additional requirements, if any, that are prescribed; (e)  not make contact or attempt to make contact with the individual, directly or indirectly, unless the custodian first obtains the individual’s consent to being contacted; (f)  notify the custodian immediately in writing if the researcher becomes aware of any breach of this subsection or the agreement described in subsection (5); and (g)  comply with the agreement described in subsection (5).  2004, c. 3, Sched. A, s. 44 (6). Mixed disclosures (7) If a researcher submits a research plan under subsection (1) that proposes that a health information custodian that is an institution within the meaning of the Freedom of Information and Protection of Privacy Act or the Municipal Freedom of Information and Protection of Privacy Act or that is acting as part of such an institution disclose to the researcher personal health information, together with personal information within the meaning of those two Acts that is not personal health information, those two Acts do not apply to the disclosure and this section applies to the disclosure.  2004, c. 3, Sched. A, s. 44 (7). Transition (8) Despite subsection (7), nothing in this section prevents a health information custodian that is an institution within the meaning of the Freedom of Information and Protection of Privacy Act or the Municipal Freedom of Information and Protection of Privacy Act or that is acting as part of such an institution from disclosing to a researcher personal health information, that is personal information within the meaning of those two Acts, if, before November 1, 2004, the researcher entered into an agreement with the custodian under subclause 21 (1) (e) (iii) of the Freedom of Information and Protection of Privacy Act or subclause 14 (1) (e) (iii) of the Municipal Freedom of Information and Protection of Privacy Act
and the disclosure is within the scope of the agreement.  2007, c. 10, Sched. H, s. 16. Disclosure under other Acts (9) Despite any other Act that permits a health information custodian to disclose personal health information to a researcher for the purpose of conducting research, this section applies to the disclosure as if it were a disclosure for research under this section unless the regulations made under this Act provide otherwise.  2004, c. 3, Sched. A, s. 44 (9). Research approved outside Ontario (10) Subject to subsection (11), a health information custodian may disclose personal health information to a researcher or may use the information to conduct research if, (a)  the research involves the use of personal health information originating wholly or in part outside Ontario; (b)  the research has received the prescribed approval from a body outside Ontario that has the function of approving research; and (c)  the prescribed requirements are met.  2004, c. 3, Sched. A, s. 44 (10). Same (11) Subsections (1) to (4) and clauses (6) (a) and (b) do not apply to a disclosure or use made under subsection (10) and references in the rest of this section to subsection (1) shall be read as references to this subsection with respect to that disclosure or use.  2004, c. 3, Sched. A, s. 44 (11). (12), (13) Repealed:  2004, c. 3, Sched. A, s. 44 (14). (14) Spent:  2004, c. 3, Sched. A, s. 44 (14). Section Amendments with date in force (d/m/y) 2004, c. 3, Sched. A, s. 44 (14) - 01/11/2007 2007, c. 10, Sched. H, s. 16 - 04/06/2007 2020, c. 5, Sched. 6, s. 6 - 25/03/2020