Clinical Trial Agreements (CTAs) and Sponsored Research Agreements (SRAs) govern the terms of research between the University and an industry sponsor, and are executed for trials following a sponsor- or investigator-initiated protocol.
Clinical trials, generally funded by pharmaceutical and medical device companies, are an important part of the Food and Drug Administration (FDA) approval process to ensure the safety and efficacy of the drug or device being brought to market.
Other sponsored research is generally funded by pharmaceutical and medical device companies, and are typically initiated after a PI has submitted a proposal to the sponsor.
The Contracts team is responsible for the review negotiation, and execution of CTAs and SRAs. The department is responsible for completing and submitting to Contracts the Review & Approval (R&A) Form, negotiating the budget with the sponsor, and submitting the requisite documents to the appropriate review boards (Institutional Review Board, Animal Welfare Committee, etc.).
Departments should forward all CTA/SRA drafts - and company contact information - to their Sponsored Projects Specialist for review and negotiation. While the Specialist is negotiating the agreement, the department should be concurrently completing its responsibilities as detailed above.
Typical components of a CTA/SRA are as follows:
All CTAs are agreements between the University and the sponsor. The PI may be named as an employee of the University, but will not be a named party to the Agreement.
UTHealth is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). As such, all CTAs and SRAs executed by the University must include standards which address AAHRPP’s overarching principles for protecting human research participants.
As an academic medical institution, the University strives to create a vibrant academic environment. As such, the University cannot accept language which seeks to make raw source data or documentation, including the results of the study, confidential. Additionally, the University is an agency of the state of Texas, and therefore, all agreements entered into by the University are subject to public disclosure under the Texas Public Information Act.
Timely publication and dissemination of the results of research performed by faculty are important principles behind UTHealth’s mission as an academic medical institution. Research sponsors are afforded a period of time to review and comment upon on the content of such publications, to protect intellectual property, and to ensure their confidential information is not improperly published, but the University does not accept terms that restrict faculty from freely publishing the results of their research.
Indemnification is addressed in all clinical trial agreements, and the terms may differ depending on the entity developing the protocol or providing the funding.
Sponsor-Initiated Protocols: University faculty members conducting a sponsor-designed clinical trial protocol are following the sponsor’s instructions. Therefore, the University cannot be held responsible for any injury or damages resulting from work performed during a clinical trial, or from a sponsor’s use of the University’s results of the study. As a state agency, the University is subject to the laws and Constitution of Texas, can indemnify only to extent of it is negligence.
For Investigator-Initiated Protocols: When the protocol is developed by the investigator, the sponsor is generally not required to provide indemnification. However, if the industry-sponsor is providing funding source may provide limited indemnification. The industry sponsor generally expects indemnification from the University.
The UT System and UTHealth encourage the development of intellectual property to enhance research, scholarship, teaching, and discovery for the best interest of the public, the creator, and the research sponsor.
For Sponsor-Initiated Protocols: Patent rights for inventions made in the direct performance of a sponsor-developed clinical trial protocol, involving little or no PI involvement in the conception or development of the protocol, are generally granted to the sponsor. However, the University reviews patent terms on a case-by-case basis.
For Investigator-Initiated Protocols: When the protocol is developed and the work is performed by the investigator, the University and PI will maintain ownership of the study documentation and data.
Under most circumstances, if a study participant sustains any injury or adverse event as a result of their participation in the study, the University will arrange for the care of subject.
For Sponsor-Initiated Protocols: University policy specifically prohibits billing the study subject or a third-party for the costs of treating such injuries. Therefore, all research-related subject injuries resulting directly from study drug or device administration, or procedures carried out in accordance with the sponsor-designed protocol are the financial obligation of the sponsor.
For Investigator-Initiated Protocols: Generally, industry sponsors will not be responsible for any study-related subject injuries. However, injury liabilities will be examined on a case-by-case basis for investigator-initiated protocols, and will be dependent upon the specifics of the work being performed and the drugs or devices provided by the sponsor.
To support the indemnification detailed in this section, including subject injury liabilities, the sponsor must maintain a sufficient level of insurance. The University is self-insured and during the term of the agreement will maintain in force adequate insurance to cover its indemnification obligations.
The University is a constitutional corporation of the State of Texas and contracts accepted by the University also will be interpreted under Texas law. The University will also consider contractual silence regarding this issue, but generally will not subject itself to the laws of any other jurisdiction.
Generally, clinical trial budgets are based on a fixed price-per-subject amount with a payment schedule. Such schedules usually provide for regular payments upon the completion of milestones (e.g., enrollment of a certain percentage of subjects, submission of a certain number of case report forms, etc.). These payments should include all applicable indirect costs.