The Contract Support Services (CSS) unit of the Research Support Services reviews contracts and other legal documents associated with conducting research at Ascension Texas Market facilities. A contract may be required for any research study that (1) involves receipt or payment of funds from or to an external entity, (2) involves use of equipment provided at no cost, (3) involves sharing of PHI, or (4) has a PI who is NOT a member of the Medical Staff or is not an associate of Ascension.
Usually only one contract, the Clinical Trial Agreement (CTA) between Ascension Seton and the study sponsor is needed per study. Occasionally additional contracts may be necessary if the study is complex and other relationships exist such as between Ascension Seton and an outside vendor who will provide research-related services.
Signed contracts provide protections by clarifying in a legally enforceable document, what is required and prohibited in connection with a study. A required contract must be executed before a study may commence. A study that starts without a signed contract
The first draft of the contract is typically provided by the research Sponsor. For some projects, Ascension Seton or Providence provides the first draft of the contract to be negotiated. The CSS Research Contract Manager is responsible for getting all research-related contracts reviewed, finalized and signed. CSS has an established a six-week turn-around goal for agreements required for projects that have been assigned a CR # and a two-week turn-around goal for non-disclosure agreements.
Contract Review & Negotiation
Submit your draft sponsor-provided research contract in MS Word format along with the Research Administration internal tracking number (CR-XX-XXX) that has been assigned to the project through the Site Approval Tool. If you don’t have a CR#, provide the following three items so that a number may be assigned:
- Final study protocol
- Name of the Principal Investigator
- Name of the IRB that will review protocol for approval
All contracts that require a Ascension Seton, Providence, or Ascension signature must undergo a legal review. Examples of these types of contracts are:
- Clinical Trial Agreement (CTA)
- Material Transfer Agreement (MTA)
- Non-Disclosure Agreement (NDA)
- Data Use Agreement (DUA)
For most research-related contracts with industry or other sponsors, the following areas are usually addressed:
- Intellectual property rights (i.e. patents, copyrights, trade/service marks)
- Publication rights
- Catholic Directives
- Corporate Compliance
- Subject Injury
At times a research contract needs to be amended due to a change in the scope of work, length of the agreement, or other reason. An amendment is typically initiated by the Sponsor or other funding source and is executed by both parties. Email proposed amendments to email@example.com
Certain officers at Ascension Seton and Providence are authorized to sign contracts and other legal documents associated with conducting research. Physicians are generally not authorized to sign research contracts on behalf of Ascension Seton or Providence.
Contracts are legally binding. The Principal Investigator, Research Coordinator(s) and others involved in the research are obligated to adhere to the conditions of the contract. Departments such as Sponsored Projects Finance may be obligated to prepare and submit invoices as detailed in the contract in order for Ascension Seton or Providence to receive payment.
Questions About Contracts?
The Research Enterprise, Contract Support Service unit welcomes your questions about research-related contracts. Email us at firstname.lastname@example.org