Record Level Data Request Process

This APPLICATION FORM is for use in requesting use or disclosure of health data from BORN Ontario (formerly OPSS) of the Children’s Hospital of Eastern Ontario (CHEO) (including any databases within the custody or under the control of BORN Ontario), for research or statistical purposes, whether the data is de-identified or personally identifiable personal health information.

Process For Data Request

1. Complete this APPLICATION FORM.

2. Send electronically to both:  science@BORNOntario.ca and privacy@BORNOntario.ca

   Indicate in your email if you are sending a signed copy, by mail or fax, to: 

   Research Requests
   BORN Ontario
   CHEO Research Institute | Centre for Practice-Changing Research Building
   401 Smyth Road |Ottawa, ON | K1H 8L1

3. The Application Form consists of four sections. Each section requires input from the applicant. As only complete Application Forms will be considered, please review all sections and requirements carefully.

4. Completed Application Forms are reviewed by BORN. To facilitate communication between the researcher and BORN, please ensure that all contact information is accurate.

5. A risk assessment for potential privacy concerns will be conducted on the data requested. Data will be de-identified to the degree possible. Please think carefully about the data elements and cohort you are requesting and be prepared for an iterative process, as BORN will need to discuss your data needs.

6. Before any health data is provided by BORN Ontario, researchers will be required to enter into a separate DATA SHARING AGREEMENT.

7. In addition to the terms of the DATA SHARING AGREEMENT each person who will have access to the data is required to sign a CONFIDENTIALITY PLEDGE and furnish proof to BORN that they have done so before any person is permitted to have access to the data.

8. Where data requested are sufficiently aggregated, in the view of BORN Ontario, to afford limited or no risk of re-identification, BORN may, in its discretion, decide that some portion of this process may be omitted.

Statutory Authority to Use or Disclose Personal Health Information for Research

All requests made to BORN for access to health data for the purposes of research including quality assurance projects, including personally identifiable personal health information and de-identified personal health information contained in any databases under the current or future custody and control of BORN, will be managed in accordance with the provisions of the Personal Health Information Protection Act (PHIPA). For the purposes of this application process, all requested health data will be treated as if it is personally identifiable personal health information.

BORN Ontario operates under the auspices of a Health Information Custodian (the Children`s Hospital of Eastern Ontario) and has direct control over some databases of personal health information which include the Niday Databases.

BORN has applied to the Ministry of Health and Long-Term Care to be prescribed as a registry of personal health information for the purposes of facilitating or improving the provision of health care under s. 39(1)(c) of PHIPA. Registry status requires review and approval, by the Information and Privacy Commissioner/ Ontario, of all BORN privacy and security policies and procedures. Registry status will facilitate the integration of the Maternal Multiple Marker Screening Database, the Ontario Midwifery Database, and the Fetal Alert Network (FAN) database and Ontario Newborn Screening Program database with the Niday Perinatal Database and the Niday SCN/ NICU Database to improve the capacity to conduct research to facilitate and improve the provision of appropriate health care to the maternal-fetal and child populations in Ontario.

For applications relating to Personal Health Information:

As a Health Information Custodian or a prescribed registry, BORN is permitted to use or disclose personal health information about an individual for research provided that the researcher:

• submits an application in writing;
• submits a research plan as described below;
• submits a copy of the decision of a research ethics board that approves the research plan; and
• enters into an Agreement as required by s.44(5) of PHIPA.

The research plan must be in writing and must set out:

• the affiliation of each person involved in the research;
• the nature and objectives of the research and the public or scientific benefit of the research that the researcher anticipates;
• the following prescribed matters:

1. A description of the research proposed to be conducted and the duration of the research;

2. A description of the personal health information required and the potential sources;

3. A description of how the personal health information will be used in the research, and if it will be linked to other information, a description of the other information as well as how the linkage will be done;

4. An explanation as to why the research cannot reasonably be accomplished without the personal health information and, if it is to be linked to other information, an explanation as to why this linkage is required;

5. An explanation as to why consent to the disclosure of the personal health information is not being sought from the individuals to whom the information relates;

6. A description of the reasonably foreseeable harms and benefits that may arise from the use of the personal health information and how the researchers intend to address those harms;

7. A description of all persons who will have access to the information, why their access is necessary, their roles in relation to the research, and their related qualifications;

8. A description of the safeguards that the researcher will impose to protect the confidentiality and security of the personal health information, including an estimate of how long information will be retained in an identifiable form and why;

9. Information as to how and when the personal health information will be disposed of or returned to BORN Ontario;

10. The funding source of the research;

11. Whether the researcher has applied for the approval of a research ethics board and, if so the response to or status of the application; and

12. Whether the researcher’s interest in the disclosure of the personal health information or the performance of the research would likely result in an actual or perceived conflict of interest with other duties of the researcher.

Before the disclosure of health data to a researcher, the researcher shall enter into an agreement with in which the researcher agrees to comply with the conditions and restrictions, if any, that BORN imposes relating to the use, security, disclosure, return or disposal of the information.

A researcher who receives health data from BORN Ontario must:

1. comply with the conditions, if any, specified by the Research Ethics Board in respect of the research plan;

2. use the information only for the purposes set out in the research plan as approved by the Research Ethics Board;

3. not publish the information in a form that could reasonably enable a person to ascertain the identity of the individual;

4. not disclose the information except as required by law and subject to the exceptions and additional requirements, if any, that are prescribed;

5. not make contact or attempt to make contact with the individual, directly or indirectly, unless BORN first obtains the individual’s consent to being contacted;

6. notify BORN Ontario immediately in writing if the researcher becomes aware of any breach of this subsection or the agreement described in subsection (5); and

7. comply with the terms of the Data Sharing Agreement as required by s.44(5) of PHIPA.

Any concerns about the form or privacy issues should be directed to: privacy@BORNOntario.ca

Any concerns about data elements or process for approval please contact:
Science@BORNOntario.ca