Requirements for Contracts for Clinical Trials

Memorial University of Newfoundland and
The Eastern Regional Health Authority

1. The Parties will be defined as:
   i) The Investigator
   ii) Memorial University of Newfoundland
   (Signing Officer: Mr. Craig Perchard, Acting Director, Office of Research)
   iii) The Eastern Regional Health Authority
   (Signing Officer: Ms. Louise Jones, Senior Vice-President and Chief Nursing Officer)
   Signature spaces are required for all parties.
   Items ii) and iii) to be defined as the Institution.
   
2. An indemnification clause or separate letter of indemnity that names all components of the institution (as identified above) and the Human Investigations Committee as indemnitees. Also any exceptions for negligence of the indemnitees must be qualified with the following: "it being understood that the administration of any substance in accordance with the protocol shall not constitute negligence or malpractice for purposes of this agreement." The Institution does not indemnify sponsors of pharmaceutical studies.
3. A clause or statement concerning publication rights for both the sponsor and the investigator (Attachment 1).
4. A clause or statement of termination which allows termination rights for both the sponsor and the institution and provides compensation for institutional costs including non-cancellable commitments in the event of termination (Attachment 2).
5. Clauses concerning governing laws must state "Laws of Newfoundland and Labrador".
6. All cheques are to be made payable to Memorial University of Newfoundland and mailed to the attention of the Principal Investigator at the address provided by the Principal Investigator.
7. a. Study costs must include provision for institutional overhead (currently set at 30%).
   b. Memorial University is exempt from charging HST/GST on research contracts under HST/GST Publicly Funded Institutions rules.
   c. Ethics review fee is $2,500 CDN. Sponsors will be invoiced directly by the Human Investigations Committee (IRB) upon their initial review of the protocol. Payment for ethics review is not to be included in any payment for direct study costs.
8. Each study agreement must be accompanied by a payment schedule. Payment schedules must make provision for an advance payment. Provision must also be made for reimbursement of institutional costs in the event of non-enrolment (Attachment 3).
9. An insurance certificate is required from the Sponsor which names Memorial University of Newfoundland, the Eastern Regional Health Authority and the Principal Investigator as additional insured.
10. University policy requires the publication of all research contracts once in the bi-weekly University newspaper (The Gazette) and in the annual inventory booklet (Inventory of Sponsored Projects). The Eastern Regional Health Authority also requires the publication of research contracts in their annual reports. Therefore, for each study, written permission for this publicity is requested from sponsors. In consideration of confidentiality concerns of sponsors and the institutional policy requirement, this publicity is limited to the following four statistics:
    
    a) The name(s) of the Investigator(s)
    b) The name of the sponsor
    c) The study title (limited to a "short" title at sponsor's request)
    d) The projected total value for the study.
11. Notices and correspondence with the institution should be addressed as follows:
    
    Memorial University of Newfoundland
    Office of Research
    INCO Innovation Centre, Room IIC 2015
    230 Elizabeth Avenue
    St. John's, NL, CANADA, A1C 5S7
    ATTENTION: Director, Office of Research