Contracts

PHCRI negotiates, drafts and administers industry-sponsored research contracts/agreements.

Authority to Contract

Only the Hospital and the University have the legal authority to enter into contracts that are binding on the institutions. Contracts for research and other projects must be among Providence Health Care Society (PHC), The University of British Columbia (UBC), and the sponsoring agency.

Contract Negotiation

All contracts/agreements for sponsor-initiated clinical trials must be negotiated and documented in writing by the Manager, Clinical Research Contracts and Grants, Research Facilitation Office who reviews same on behalf of the hospital and the university.

All other contracts/agreements, e.g. grant-in-aid, investigator-initiated clinical trial, service, collaborative research, material transfer, and amendments to existing agreements, from commercial sources, and from government agencies; and academic centres requiring formal written contracts, both new and extensions and amendments, must be negotiated and documented in writing by the designated Officers/Managers in the UBC’s University- Industry Liaison Office (UILO) who reviews same on behalf of the hospital and the university the UILO is also responsible for licenses and other intellectual property agreements.

Procedures for Initiation of a Clinical Trial Agreement:

Once an investigator has a verbal agreement to participate in a commercially sponsored research project, s/he must forward a completed "Sponsored Initiated Clinical Trials Information Form" declaration form to the Grants and Contracts Coordinator, Research Facilitation Office. The Manager of Clinical Research Contracts and Grants will then contact the sponsor and begin negotiating the contract, once Application is submitted to the Research Ethics Board.

For grant-in-aid, investigator-initiated clinical trial, service, collaborative research, material transfer, from commercial sources, and from government agencies; and academic centres requiring formal written contracts, a UBC Research Project Information Form (RPIF) must be completed and forwarded to UILO. To determine the type of contract/agreement, please refer to the Sponsored Research Agreement Guide.

Execution of Documents

The PHC Board of Trustees or its delegate must execute all written documents to which PHC is a party. The PHC Vice President Research has been delegated the responsibility of signing all contracts for research and related projects. The Contracts Office will be responsible to obtain authorized signatures from the sponsor, principal investigator, PHC, and UBC.

Copies of Contracts & Grants:

Each signatory to a grant or contract will receive for their records a signed copy of said grant or contract/agreement.

Indirect Cost of Research

Under the Affiliation Agreements between PHC and UBC, and between PHC and Simon Fraser University (SFU), indirect costs generated as a result of commercially funded research at PHC is divided between the two institutions. Every grant, clinical trial agreement, service agreement, or collaborative research agreement funded by a commercial agency and administered by either PHC or UBC or SFU must include a standard Hospital/University indirect cost of 30% of the total project expenditure, which are used to support the research infrastructure.

The distribution of indirect costs is as follows:

(a) Clinical Trial Agreements: 1/5 to UBC, 1/5 to Research Services, 1/5 to the department of the principal investigator, 2/5 to the investigator

(b) Grants, Service Contracts and Collaborative Research Agreements: 1/2 to UBC, 1/2 to PHC.

Budgets

Budgets and budget amendments should reflect all of the costs associated with carrying out a research project, including personnel costs, services (e.g. laboratory, pharmacy, radiology etc), and reimbursement to study subjects for out-of-pocket expenses. Budgets must also include Hospital and University indirect costs. Budget amendments must be reviewed by the Clinical Research Contracts Manager and all parties sign off on the amendment prior to it taking effect.

Ownership of Contract Funds

Contract funds are held in trust by the Hospital or the University and are not the property of any individual. See: PHC Research Policies & Procedures: Section 3.0 Research Trust Accounts for more detailed information.

Right of Termination

The Hospital has the right to terminate the research if the Hospital determines in its discretion that the conduct of the research prejudices or has prejudiced the interests of the Hospital. In the event that an investigator wishes to appeal the Hospital’s decision to terminate a study, a letter clearly stating the rationale for such an appeal must be sent by the investigator to the Office of Research Services. Appeals must be filed within 30 days of receiving notice of the Hospital’s intent to terminate the study.