Research Agreements

• Execution of Clinical Trial Agreements
• Clinical Trial Master Agreements
• Budgets And Funding
  
• IRB Fee
• Payment Schedules For Clinical Trials
• W-9, IRS Identification, and Payment Information
• Clinical Trial Project/Grant Set-Up
• Clinical Trial Project/Grant Close-Out
• Clinical Trial Amendments
• Helpful Links
• Clinical Study Agreement Template

A Non-Disclosure Agreement (NDA) is often a precursor to a Clinical Trial. A company may want to send a protocol to the investigator so that he/she can decide whether to participate in the trial. The protocol may have confidential information that the company needs to safeguard. Once a sponsor or Contract Research Organization (CRO) has identified UT Health SA as a potential site for a clinical trial, a NDA may be sent to the principal investigator (P.I.) to sign. In order to protect UT Health SA and the investigator, this agreement must be reviewed and approved by OSP. NDAs are usually straightforward and require little change; however, some NDAs can include requests that OSP cannot honor. For example, as a State of Texas educational institution, UT Health SA cannot subject itself to the laws of other states. If the P.I. signs the NDA without UT Health SA review and signature, the P.I. will incur sole responsibility and UT Health SA will be unable to support him/her in the event that the terms of the NDA are breached. Please note that some sponsors do not require a NDA.

All incoming NDAs need to be negotiated and signed by OSP. To process your NDA, please:

1. Submit an agreement request through ERMSA to OSP.  Submission should include the agreement draft, or indicate if UT Health SA needs to draft the initial agreement.
2. Include the name, address, telephone number and email address of your contact.
3. If applicable, note within your submission any concerns you may have about the NDA.

UT Health SA’s standard template Non-Disclosure Form: Confidential Disclosure (.doc)

Outside professional activity of a faculty member often takes the form of consulting. Consulting that does not interfere with the faculty member’s teaching and research obligations is supported and encouraged by UT Health SA.  Faculty consulting provides opportunities for researchers to confront “real world” challenges, identify and work with practicing industrial collaborators, and contribute expertise that helps fuel economic development. These agreements, however, are personal agreements and, if not handled properly, can create risk as well as conflict with prior obligations of the faculty to UT Health SA.  The Office of Sponsored Programs (OSP) provides this guidance as an informal but hopefully helpful aid to those UT Health SA employees who do get involved with consulting activities. OSP will provide informal and confidential reviews of consulting agreements upon request by a faculty member. This review, however, should not be construed as legal advice and, when in doubt, the services of a qualified attorney should be sought.

Faculty are also advised that personal consulting agreements may result in conflict of interest situations with their university employment and, as such, must be disclosed to their respective department chairman.

The OSP recommends adding the following statement to any consulting agreement that a faculty member may negotiate:

“Consultant is an employee of The University of Texas Health Science Center at San Antonio and has responsibilities and research projects resulting from his/her activities as such an employee. Not withstanding any other provisions in this Agreement, the Company shall not have any rights to any work product, intellectual property and/or other works or materials created by Consultant as a result of employment with The University of Texas Health Science Center at San Antonio.”

Lab Testing Agreements (LTA) involve the P.I. testing a specific compound, device, or process for a sponsor. No data analysis will be performed by the principal investigator. Also no inventions should be anticipated.

To process your LTA, please provide the following:

1. Submit an agreement request through ERMSA to OSP.  OSP usually provides standard template agreement. Should sponsor request to use their agreement, please include the draft agreement within the submission.
2. Copy of Protocol or Statement of Work
3. Provide the name, address, telephone number and email address of your company contact.

All lab testing agreements will bet set up under PeopleSoft fund group 48006. A fully executed agreement from sponsor and the initial funds are needed for project/grant set-up. At the conclusion of the study, principal investigator is allowed to keep the residual balance. Balance can be transferred to a 48001 project upon official request by principal investigator once the testing is completed.

UT Health SA’s standard Lab Testing Agreement Template: Testing (.doc)

Incoming MTA Process Description

Material Transfer Agreements (MTA) are required when UT Health SA accepts a proprietary substance or product from an outside entity for use or testing. Also, MTAs are required to send materials to another academic/non-profit institution. MTAs for sending materials to for-profit entities are handled by the Office of Technology Commercialization. Typically these require that some deliverable is provided to that outside entity (e.g., a written report) and specify limitations on what can be done with the proprietary substance or product. These substances are often unique and can include biological materials, chemical compounds, pharmaceutical preparations, other types of tangible research materials and at times even software. While there is no financial commitment from either party, there are often issues of intellectual property, confidentiality, hazardous materials and protection of humans that must be addressed. Often times, materials are required to be transferred for which a subaward or clinical trial agreement is in place. When these agreements do not specifically stipulate the transfer of such materials, a separate MTA is required to be executed. The agreement must be in place and endorsed by both parties in order to protect the liability of both the Investigators and UT Health SA. If the outside entity is a signatory of the Uniform Biological Material Transfer Agreement (UBMTA) or can accept the terms of the UBMTA, this can speed up the processing.

All MTAs, whether for incoming or outgoing material, are negotiated and signed in the Office of Sponsored Programs.

MTAs vary in length and complexity. A few MTAs are simple one page agreements that require no negotiated changes and are signed and sent to the providing institution. Other MTAs can be as long as seventeen pages (the longest we have seen) and extremely complex. MTAs are negotiated documents that cannot be brought to OSP and immediately signed and sent to the providing company.

To process your MTA, please provide the following:

1. 1. Submit an agreement request through ERMSA to OSP.  Submission should include the agreement draft if one has been provided, or indicate if UT Health SA needs to draft the initial agreement.
   2. Please note that the MTA Intake Form is no longer required, as all necessary questions are provided within the ERMSA SmartForms in your submission.  Please answer all questions completely, as OSP requires this information to prepare the agreement.

If changes are required in the MTA (they almost always are), OSP will get in touch with the other organization and negotiate the changes. Once both parties agree upon the MTA language, the MTA is signed by a UT Health SA authorized representative. A copy will be sent to the P.I. After all parties sign the MTA, the materials are transferred. No project/grant is set-up since no funds are involved.

When faculty members transfer to/from UT Health SA, any material that the scientist brings/leaves must be accompanied by a MTA. New faculty members must provide OSP with a listing of materials that will be transferred from their prior institution. Once the incoming material list is received, OSP will execute MTAs for all incoming materials. For faculty members leaving UT Health SA, a listing of materials that will be transferred to their new institution must be provided so that OSP can execute MTAs with the transfer institution.

Research Agreements sets up a research study to be performed at UT Health SA. Financial support will be received and patient enrollment is not involved. Usually the principal investigator is the creator of the statement of work or protocol. If changes are required in the RA (they almost always are), OSP will get in touch with the other organization and negotiate the changes. Once both parties agree upon the RA language, the RA is signed by a UT Health SA authorized representative. A copy will be sent to the P.I.

To process your RA for execution, please provide the following to OSP:

1. Submit an agreement request through ERMSA to OSP.  Submission should include the agreement draft, or indicate if UT Health SA needs to draft the initial agreement. 
2. Include the name, address, telephone number, and email address of your contact
3. Copy of the statement of work
4. Memo detailing if any inventions will be anticipated during the performance of the study
5. LAR approval if applicable

All research agreements will bet set up under PeopleSoft fund group 44095. A fully executed agreement from sponsor and LAR approval if applicable is needed for project set-up. No initial funds are needed for the project/grant set-up. At the conclusion of the study the principal investigator is allowed to keep residual balance unless prohibited by sponsor. Balance will be transferred to principal investigator’s 48001 project.

UT Health SA’s standard Research Agreement Template: Sponsored Research (.doc)

For any other agreement type that is handled by OSP’s Agreements Team, the agreement process begins with submission of an agreement request through ERMSA.  If an agreement draft has been provided, include this within the submission.  Provide as much information as possible within the submission request, as this will assist OSP staff in preparing and negotiating an appropriate agreement in any situation.

If you are unsure of your agreement needs and wish to speak with an Agreements Specialist, please email contracts@uthscsa.edu.