CHAPTER EIGHT

OTHER AWARDS AND AGREEMENTS

Various types of non-federal awards/agreements are made to the Health Science Center and special considerations are inherent in the acceptance of these awards. All awards, as discussed elsewhere in this Manual, must adhere to the basic policy considerations of the Health Science Center, such as the ability to freely publish results.

8.1 Industry Sponsored Agreements

It is the policy of the Health Science Center to encourage interactions and research with the private sector. Such interactions are essential to the vitality of the Health Science Center and this activity is recognized as an integral part of the Health Science Center's mission and goals.

Research supported by industry should not commence prior to the execution of an agreement outlining each party's responsibilities. This agreement should contain basic understandings such as the agreed-upon statement of work, agreement on the Health Science Center's ability to publish (which may only be subject to review and comment by the sponsor), and the ownership of intellectual property. While it is the responsibility of Grants Management to negotiate the terms and conditions of these agreements, Principal Investigators/Project Directors should be familiar with the policies of the Health Science Center in order to convey these accurately to a potential sponsor. This will permit all parties to have a clear understanding of the proposed research project and will allow negotiations to proceed smoothly.

The following considerations are important in dealing with industrial sponsors:

Statement of Work
The statement of work should be in sufficient detail that allows both parties a clear understanding of the research project and the expected deliverables (e.g., the technical reports or a prototype). Allowances should be made for changes in research direction by the PI/PD. Should the statement of work change significantly, a provision should be made for a cost adjustment.

Time Period and Cost
A fixed period for the agreement should be stated with mechanisms for extension or renewal of the project. Full costs of the research should be paid by the sponsoring industry, including recovery of indirect costs at the Health Science Center's corporate research rate.

Conflict of Interest
Consideration should be given as to existing or potential conflicts of interest between the investigator, the Health Science Center, and the sponsoring organization.

Warranties and Guarantees
The Health Science Center conducts research programs using best and reasonable efforts, consistent with good scientific practices. As a result, it does not guarantee or warrant research products.

Termination
Conditions of mutual termination, such as the departure of a PI/PD or unforeseen circumstances, should be stated.

Endorsement of Research Results
Because the Health Science Center imposes no limitations on the freedom of the faculty in the choice of fields of inquiry or the media of public dissemination of the results obtained, any results obtained or disseminated are the sole responsibility of the PI/PD and do not carry institutional endorsement of the Health Science Center. Consequently, the Health Science Center does not permit the use of its name in advertising or promotional material related to the results of sponsored projects.

Sample Sponsored Research Agreement *
When the above considerations are used as guidelines, the final agreement should be one that is mutually beneficial to the Health Science Center and the sponsor. A sample research agreement, which may be sent to prospective sponsors, is included in this Manual as Appendix K.

8.2 Agreements With Foreign Sponsors

 On occasion, the Health Science Center enters into agreements with foreign governments, agencies, or corporations for the support of research and other sponsored programs. Agreements with foreign sponsors are treated identically to agreements with U.S. federal agencies, for-profit entities, and non-profit organizations. The University of Texas Regents Rules, however, require approval of agreements with foreign entities at the System level; consequently, Grants Management should be contacted as soon as possible when an agreement with a foreign entity is contemplated so that the additional approvals required will not overly delay agreement execution.

8.3 Clinical Drug and Investigational Studies

 As stated elsewhere in this Manual, clinical trial agreements are broadly defined as the testing of a drug or device on a human subject. Because clinical trials are a form of industry sponsored agreement, the considerations listed above in Section 8.2 apply to clinical trial agreements. In addition, the following other matters deserve specific attention.
Indemnification
Clinical trials are prone to legal action by third parties claiming to be harmed directly or indirectly by the research protocol. Both the investigator and the Health Science Center could be parties to a lawsuit emanating from clinical research. Therefore, it is important that clinical research is not undertaken until the Health Science Center and the sponsor enter into a clinical trial agreement which includes an appropriate liability/indemnification clause.

Payment for Injuries
In addition to an indemnification clause, the sponsor is normally expected to pay for any injuries to subjects that are the direct result of the study.

Confidentiality of Patient Records
Sponsors of clinical trials often require that records be provided that indicate the effects of drug intervention on patients involved in a study. It is the policy of the Health Science Center and its affiliated hospitals to maintain the confidentiality of patient records. The terms of the clinical trial make a distinction between research records, study records and patient records, the latter being strictly confidential.

Invoicing and payment on clinical drug and investigational studies are the responsibility of the investigator and/or the investigator's department or academic unit.

Sample Clinical Study Agreement *
A sample clinical study agreement is provided as Appendix L. Faculty are encouraged to contact Grants Management as soon as feasible to allow contract negotiation to take place in a timely manner.

8.4 Testing Agreements

Testing agreements are broadly defined as the conduct of a specific procedure on specific material supplied by the sponsor. An example of a testing agreement is the testing of a sponsor-furnished compound using Health Science Center-owned equipment. Acceptance of any testing agreements by the Health Science Center is contingent upon the agreement by the PI/PD, Chair, and Dean that the project is in accordance with the missions of the Health Science Center and that it contributes to the objectives of the Department and the School. Such acceptance would be through the approval signatures on the Certificate of Proposal (see Section 4.3). Other considerations of testing agreements are as follows:
Publication
While the data resulting from a testing agreement is often linked with the sponsor's materials (which may or may not be proprietary to the sponsor), the agreement should provide for publication by the Health Science Center of overall results or methods.

F&A Costs
While the Health Science Center does not have a published F&A rate for testing agreements, the sponsor should pay the existing corporate indirect cost rate.

Financial Considerations
Payment for testing or analysis performed on a piece of equipment purchased with federal funding may be accountable as program income to the federal award. In addition, faculty members are cautioned that any testing arrangement must be competitive with costs assessed by commercial organizations for comparable work, and that any inappropriate use of testing agreements may be subject to unrelated business income tax.

8.5 Equipment Loan Agreements

 Equipment loans are agreements whereby a sponsor loans certain equipment to the Health Science Center, such as hardware, software and/or documentation for research use. One such example is an agreement whereby the Health Science Center and the company participate in a joint research program using the company's equipment, and share the results, including data. This type of agreement usually does not involve money, but enables the Health Science Center and industry researchers the opportunity to use each other's facilities. This type of agreement may involve both Grants Management and Purchasing to ensure that the terms are consistent with those typically negotiated with an equipment vendor and places the Health Science Center in a position of minimal risk and liability. Other considerations of these equipment loan agreements are the eventual disposition of the loaned equipment, the cost of equipment maintenance, and possible confidentiality of equipment specifications or performance.

8.6 Material Transfer Agreements

 Material Transfer Agreements (MTA's) are contracts in which tangible research property or unique research resources, such as biological organisms or computer software, are provided by external sources to Health Science Center investigators for research purposes, or vice versa. Some standard considerations of MTA's are:
  1. Substances are generally biological materials that are not used on human subjects and do not involve liability to the donor for the recipient's use of the material;

  2. The recipient generally agrees to give intellectual property rights, such as licenses, to the donor, or limited rights if derivative materials are later developed;

  3. The recipient generally agrees to give intellectual property rights, such as licenses, to the donor, or limited rights if derivative materials are later developed;

  4. A report of research results is generally the deliverable in exchange for the use of the materials; and

  5. The donor may charge the recipient for costs of producing and shipping the material.
The Office of Intellectual Property Administration (x 7-6364) negotiates MTA's.

8.7 Intergovernmental Personnel Act Agreements

 Intergovernmental Personnel Act (IPA) agreements are contracts wherein a Health Science Center employee may serve or cross-train in federal agencies for limited, defined periods of time. While some or all of their salary and staff benefits are paid by the federal agency under Title IV of the Federal Intergovernmental Personnel Act, they are still considered Health Science Center employees. Normally, provisions have been made for their return to the Health Science Center. Faculty or staff contemplating an assignment under an IPA must consult with the appropriate chair or dean. They will review the appropriateness of the arrangement and the impact upon the Health Science Center. IPA agreements are handled through the Office of Grants Management; separate accounts will be established for each agreement.

8.8 Clinical Services Agreements

 Various departments of the Health Science Center provide clinical or patient care services to area agencies or hospitals. Such agreements are processed through the Office of Grants Management and require the same approvals as those of all other types of sponsored agreements. Generally, however, these expenses incurred under these agreements are handled by MSRDP and accounts are established within the MSRDP account series.