Research - Administration

Disclosures

In order to facilitate confidential discussions, St. Michael's provides the following confidential disclosure agreement templates for use by its academic community.

St. Michael's researchers are not signatories for the hospital and may not sign on behalf of the hospital. Any researcher who enters into a confidential disclosure agreement, signs the agreement on his or her own behalf, not on behalf of the hospital.

Confidential Information

Where St. Michael's or a Hospital researcher is providing confidential information to an external entity, one of the following agreements must be downloaded, signed by the external entity and provided to the Hospital signing authority for signature prior to the disclosure of confidential information.

Clinical Research Protocols

When deciding whether to be a research site in an industry-sponsored study, researchers may be asked to sign a confidential disclosure agreement prior to reviewing the company's protocol. St. Michael's will review and sign these agreements if Hospital employees are expected to see the protocol prior to submission to the research ethics board.

In order to expedite confidential discussions regarding clinical research protocols, St. Michael's will accept the following templates:

The national template confidentiality agreement for pharmaceutical studies was developed by the Federation of National Specialty Societies of Canada and the Canadian Medical Association in consultation with the Canadian Medical Protective Association. Please note that this template does not include St. Michael's as a party and must be appropriately modified to include the hospital as a party. Please contact our contract reviewers to modify the template.

In its review of confidential disclosure agreements from other sources, St. Michael's expects the following:

  • The purpose of the discussions should be clearly set out (specify the study title and name of potential investigator).
  • The length of confidentiality obligations must have an end date (for clinical research protocols, this should not be longer than 10 years).
  • The receiving party should be entitled to keep at least one copy of the confidential information in its legal files.
  • The governing law should be the laws of Ontario and federal laws of Canada and the jurisdiction should be the courts of Ontario and the federal courts of Canada or the agreement should be silent with regard to governing law and jurisdiction.

Other issues to be negotiated will depend on the context of the agreement.