IndK)Pg

Research And Technical Assistance Contract Templates,

MSU Clinical Trial Contract Template,

And The

Accelerated Contract Execution Program Contract Templates And Forms

Page synopsis: This page contains:

A. Links to MSU contracts for industry support when not using the ACE Program options;

B. Link to the MSU clinical trial contract template;

C. Links to the ACE program’s forms and contract templates.

D. Link to the industry technical assistance (testing) contract template.

Most companies will use a standard purchase order or contract, neither of which probably drafted with an intended use being to provide the terms and conditions to support a research or creative endeavor at a public university. As a result, the terms and conditions will generally reflect the negotiating imbalance of a purchasing entity and supplier. This relationship is far from the collaborative one a public education and research institution expects to establish with the sponsors of a project to be conducted by the institution. The contracts below better document the desired relationship MSU wishes to establish with an industrial sponsor of a research or creative endeavor.

MSU Contracts for Industry Support (non-ACE Program)

Research Agreement

One page Cooperative Research Agreement

Suggested Informative Cover Memo

A cover memo found at the link below can be printed and forwarded with the proposal. Another option is to refer a potential sponsor to the link below. This memo is intended to alert the potential sponsor to MSU's major concerns that can arise in a contract. Other concerns may arise if the potential sponsor proposes their contract or if the sponsor modifies any of the MSU contract templates. However, based on CGA’s past success, it is anticipated that 99.99% of contracts will be successfully negotiated once each party explains its concerns and reasons for including a particular contract term or condition or seeking modification of any of the other party’s proposed terms and conditions.

Covermemo

MSU Clinical Trial Contract Template

As a public educational and research institution of the State of Michigan MSU agrees with the mission of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). AAHRPP states their mission as the following:

“Our mission
The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.” (Additional information about AAHRPP can be found on their Web site at http://www.aahrpp.org/www.aspx .)

Among the accreditation requirements is to have explicit protections for research participants in the contracts with sponsors of human subject research. MSU thus proposes the clinical trial contract template which can be downloaded at the link below. However, please note that if the sponsoring company continues to prefer to use its contract template then MSU will need to insure language protecting research participants is included in the company’s original contract or be inserted in order to comply with MSU’s obligations under its accreditation status. Other issues may also need to be discussed if not adequately addressed in a contract that is proposed to MSU by a sponsoring company.

MSU Clinical Trial Contract Template

Accelerated Contract Execution Program Contracts and Forms

ACE PI Information Sheet for use with the First Option, paragraph 4A

ACE Contract Drafting Information Sheetfor use with the First Option, paragraph 4B

ACE Program cover letter to accompany a contract under the Second Option

Uniform Research Agreement (Industrial)

Uniform Research Agreement (Non-Profit and Government)

Sponsored Research Agreement

Technical Assistance

There will be situations when a faculty or staff member will wish to provide technical assistance (testing) to a sponsor. The nature of this work is not research or creative but must still be related to the mission of the university.

The faculty handbook, at Section VI, "Research and Creative Endeavor", Guideline 7 under "Major Guidelines", counsels that "In seeking or accepting support for research, care should be exercised to insure compatibility with the functions and purposes of research at the University. Routine testing as an end in itself is considered incompatible with the purposes of University research." If this standard can be maintained then the Technical Assistance Agreement should be used to contract with a sponsor.

Agreements to provide technical assistance to a sponsor, regardless of the type of sponsor, e.g., industrial; non-profit, must now come within the jurisdiction of CGA due to the preference of the Office of the VP for Research and Graduate Studies. As a result, all of the same procedures applicable to agreements sponsoring research and creative endeavors will also apply to technical assistance agreements, i.e., a transmittal must be processed with consideration of indirect cost and the other issues found on the form, the proposed agreement will be reviewed and negotiated, if necessary, and signed on behalf of MSU by CGA, and the agreement will be administered in a CGA account.

Any questions you may have regarding technical assistance agreements can be directed to MaryJo Banasik at (517) 355-5040, ext. 262, or banasik@cga.msu.edu, or faxed at (517) 353-9812.

JFS 3 December 2005