Protocol for Access to Patient Data

OVERVIEW

Patient health information collected by the Faculty of Dental Medicine and Oral Health Sciences is governed by the rules described in the Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information. At McGill, the Secretary-General is responsible for maintaining the privacy of personal information. Normally access to personal information requires an application to the Commission d'acces a l'information du Quebec. Such an application may not be necessary, however, if there is an acceptable process in place.

PROTOCOL

1. Researchers who need access to patient information should first request approval from the McGill Research Ethics and Compliance Office (REB). The request must include:
   1. The name of the database the researchers wishes to access
   2. The names of all the people who will have access to the information
   3. The exact nature of the information that is being requested
   4. If the request would/could lead to the exposure of identifying patient information, the researcher must obtain individual consent from the patient prior to obtaining information from the database. In this case, the researcher must also submit the letter that will be sent to eligible patients explaining:
      1. The nature of the study
      2. Who will have access to the information,
      3. What information is being collected
2. Once ethics approval is obtained, the researcher should send their request for access to patient data to the Associate Dean of Clinical Affairs, who will review the request for clarity and appropriateness. In cases where anonymized information is requested, the Associate Dean will assign a member of the clinic staff to retrieve the information. In cases where identifying information may/will be shared with the researcher, clinic staff will send eligible patients a letter explaining the research (point 1.b, above) and obtain their consent.
3. Clinic staff will contact eligible patients. Patients who are interested in participating in the study will be invited to contact the researcher.
4. Only Clinic staff have direct access to patient information.
5. The Faculty will assess a fee to cover administrative costs.
6. Researchers must store study information in a separate database according to the guidelines of the granting agency.
7. The Faculty will keep a record of the details of every request for information.

Note: Researchers who wish to use clinic facilities (i.e., operatories) for research will have to submit their projects for internal scientific review and then request access to the clinic.