University of Manitoba - University Governance

Research Agreements Policy

POLICY:	RESEARCH AGREEMENTS
Effective Date:	June 20, 2006
Revised Date:
Review Date:	June 20, 2016
Approving Body:	Board of Governors
Authority:
Implementation:	President, delegated to VP (Research and International) & VP (Administration)
Contact:	Director, Research Grants & Contract Services
Applies to:	External Parties; All Employees

1.0 Reason for Policy

1.1 To set out the principles under which the University will enter into Research Agreements.

1.2 To set out the responsibilities of Principal Investigators performing research and research-related activities on behalf of the University under Research Agreements.

2.0 Policy Statement

2.1 Definitions

2.1.1 Research Agreement means a legally enforceable agreement containing contractual terms and obligations between the University and a sponsor or provider of materials with respect to the performance of research and research-related activities or the use of materials.

Research agreements include:

2.1.1.1 Research Contracts: agreements between the University and a sponsor to perform research and research-related activities on behalf of the sponsor, in exchange for payment of costs. Research contracts include, among other things:

(a) Clinical Research Agreements: agreements between the University and a sponsor to perform, on behalf of the sponsor and in exchange for payment of costs, health research which is conducted on human beings, predominantly patients; and

(b) Clinical Trial Agreements: agreement between the University and a sponsor to perform, on behalf of the sponsor and in exchange for payment of costs, prospective biomedical or behavioural research on human subjects, predominantly patients, designed to answer specific questions about biomedical behavioral interventions.

2.1.1.2 Material Transfer Agreements: agreements between the University and a provider of material governing how, when and for what purpose the material that is being provided can be used.

2.1.1.3 Research Agreements are not:

(a) Research Grants: funds that are awarded by a sponsor to perform research and research-related activities without contractual terms or obligations; or

(b) Technical Service Agreements: agreements that do not involve the undertaking of research but rather the use of existing knowledge, skills or expertise to provide a service for a sponsor.

2.1.2 Principal Investigator means the individual or individuals, including the co-investigator(s) who is/are primarily responsible for carrying out the research and research-related activities under the terms of the Research Agreement.

2.2 Principles Guiding the Acceptance of Research Agreements

2.2.1 Research Agreements must adhere to the following principles in order to ensure the ability of academic staff members and students to pursue learning and research freely, and to ensure that knowledge is disseminated and intellectual property is developed with concern for the public interest;

2.2.1.1 The design, direction and conduct of the research shall remain with the University, as developed through the Principal Investigator.

2.2.1.2 The academic progess of students participating in research, under a Research Agreement, must not be impeded.

2.2.1.3 The University prohibits secret or classified research. The University, through the Principal Investigator, shall be free to present or publish fully the results of research under Research Agreements subject to:

a) Protecting intellectual property rights arising out of the research, in which case, time for securing appropriate protection may be given, provided that:

(i) the University, through the Principal Investigator, shall, in any event, be free to fully present or publish the research results not more than twelve (12) months from the submission of the final report to the sponsor; and

(ii) the timely submission to and acceptance by the Faculty of Graduate Studies of the thesis of a graduate student participating in the research shall not be delayed nor shall the University's freedom to select thesis examiners be affected.

b) Maintaining confidentiality of the information and providing for a short delay (normally not to exceed 60 days) in publication of the research results only in order to allow the sponsor or provider provided confidential information pursuant to the Research Agreement.

2.2.1.4 The University shall normally retain ownership of all intellectual property developed in the performance of the research, such intellectual property to be handled in accordance with University of Manitoba Board of Governors Bylaw "Patents and Copyright". Sponsors are normally granted a non-exclusive royalty-free licence for their non-commercial research purposes and may also be granted a royalty-bearing licence for commercial use, subject to negotiated terms and conditions.

2.2.1.5 For research involving human subjects, the University, through the Principal Investigator, shall be free to disclose safety concerns that arise during the research to the research participants or their guardians, sponsors, Research Ethics Boards and regulators if and when, at the discretion of the University, through the Principal Investigator, such disclosure is necessary to protect the health of the research participants. Where applicable, Research Agreements shall also provide suitable mechanisms for termination, if and when the University, at its discretion, deems termination necessary to protect the health of the research participants.

2.3 Responsibilities of Principal Investigators under Research Agreements

2.3.1 The Principal Investigator under a Research Agreement is responsible for ensuring compliance with relevant terms and conditions of the Research Agreement and with applicable University policies, including:

2.3.1.1 performing the work as stipulated and described in the Research Agreement and submitting reports and other deliverables in the form and by the dates specified in the Research Agreement;

2.3.1.2 ensuring that all persons, particularly students and other trainees (i.e., postdoctoral fellows), working under the Research Agreement are aware of and agree to comply with all applicable terms and conditions, particularly those relating to publication, confidentiality and intellectual property;

2.3.1.3 ensuring that the University's educational commitment to its students is maintained. Students and other trainees working under a Research Agreement must be allowed to develop research projects or programs in accordance with normal academic criteria. In particular, their research projects or programs should not be changed solely by reason of the Research Agreement. Students should not be coerced nor should they undertake to participate in research under a Research Agreement if progress in their degree programs will be significantly delayed;

2.3.1.4 authorizing expenditures in accordance with the budget outlined in the Research Agreement and the policies and procedures of the University, notably, Policy "Financial Administration and Control of Research and Special Fund Accounts";

2.3.1.5 ensuring that the appropriate unit administrative officers (i.e., department head, dean/director) and the Office of Research Services are informed as soon as possible of any circumstance which could prevent the satisfactory completion of the Research Agreement; and

2.3.1.6 complying with other relevant University governing documents including University Policies "Additional Academic Appointments for Full-Time Academic and Support Staff", "Conflict of Interest Guidelines", "Guidelines on Responsibilities for Research Ethics", "Care and Use of Animals", "Ethics of Research Involving Human Subjects".

3.0 Accountability

3.1 The University Secretary is responsible for advising the President that a formal review of the Policy is required.

3.2 The Vice-President (Research and International) is responsible for the communication, administration and interpretation of this policy.

4.0 Secondary Documents

4.1 The Vice-President (Research and International) and the President may approve Procedures which are secondary to and comply with this Policy.

5.0 Review

5.1 Formal Policy reviews will be conducted every ten (10) years. The next scheduled review date for this Policy is June 20, 2016.

5.2 In the interim, this Policy may be revised or rescinded if the Approving Body deems necessary

5.3 If this Policy is revised or rescinded, all Secondary Documents will be reviewed as soon as reasonably possible in order to ensure that they:

(a) comply with the revised Policy; or
(b) are in turn rescinded.

6.0 Effect on Previous Statements

6.1 This Policy supersedes the following:

(a) all previous Board/Senate Policies, Procedures, and resolutions on the subject matter contained herein;
(b) all previous Administration Policies, Procedures, and directives on the subject matter contained herein; and
(c) all previous Faculty/School Council Policies, guidelines and directives stemming from Faculty/School Council Bylaw, on the subject matter contained herein.

7.0 Cross References

Policy: Financial Administration and Control of Research and Special Fund Accounts

Policy: Additional Academic Appointments for Full-time Academic and Support Staff

Policy: Conflict of Interest Guidelines

Policy: Care and Use of Animals

Policy: The Ethics of Research Involving Human Subjects

Policy: Guidelines on Responsibilities for Research Ethics