Working directly with the THR Research Attorney, THRE is responsible for the negotiation of agreements with sponsors on behalf of THR and their entities. This includes clinical trial agreements, sub-award agreements, vendor agreements and purchase service agreements. Additionally, Research Administration staff ensures research patient bills are properly coded and billed; submits requests for approval to the CMS for device A & B studies on behalf of the THR entity; and allocates study revenue/funds (sponsored and grant funded) to include the transfer of revenue to the appropriate entity/cost center, invoicing sponsors, paying vendors, etc. Those engaged in research activities need to be acutely aware of the robust operations and regulations in the research enterprise and more importantly, the consequences of not following those regulations. A central infrastructure, consistent processes, and compliance are the keys to managing risks and ensuring success. To ensure and initiate proper review of your study, a Study Questionnaire must be completed or for study modifications the Study Modification Questionnaire must be completed.

Research Billing

It is the policy of Texas Health Resources to consistently and fully comply with all laws and regulations pertaining to the billing of research-related charges for our patients.

To ensure that patients are properly identified as participating in a research trial, a special admissions form (SAF) is used to communicate the service and is required to be submitted within 24 hours of each rendered hospital service. The specific SAF for your study will be sent to you electronically. If you have questions or need another copy of your SAF, please reach out directly to the Research Billing Analyst.

Clinical Trial Agreements and Budgets

A clinical trial is defined as the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments or diagnostics, or comparisons of approved drugs, devices, treatments or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Clinical Trial Agreements and Budgets should be sent directly to Research Administration. An electronic version of the contract and budget are required for review for all THR studies to ensure compliance. If THR is defined as engaged, THR will be required to be a party to the Clinical Trial Agreement (CTA) and the CTA will be required to be submitted to Research Administration in an editable Word format. If THR is solely being used for a purchased service (see section below, Research Activities versus Commercial Services), the non-hospital related budget items may be redacted prior to providing it to THR Research Administration.  THR policy requires the utilization of  a percent of the THR ChargeMaster for sponsored clinical trials. This percent is reviewed by the Research Activities and Compliance Committee to ensure that it is the same pricing structure that is used for THR’s self-pay patients.

As a nonprofit institution, Texas Health is bound by certain policies and regulations regarding what it can and cannot accept in a clinical trial contract. These policies are designed to protect the welfare of individuals participating as research subjects, foster the Hospital's mission of research and community service, and minimize the various forms of liability associated with human research.

When negotiating clinical trial contracts, Texas Health primarily focuses on securing acceptable contract clauses regarding high-risk issues such as subject injury, indemnification, confidentiality, ownership of data, patent rights and publication rights.

The Association for the Accreditation of Human Research Programs (AAHRPP) standard I-8 should be applied to all agreements and consents. Please click here for THR approved language.

  • Indemnification

    Texas Health cannot bear the financial responsibility for any injury or damages resulting from the performance of the clinical trial. Consequently, Texas Health requests that the sponsor maintain a policy or program of insurance sufficient to support this obligation. The sponsor’s obligation to assume all financial responsibility does not apply to injury or damage to the extent caused by: 1) Texas Health's Investigator and/or research teams failure to adhere to the protocol; 2) Texas Health's Investigator and/or research teams failure to comply with FDA or other governmental requirements; or 3) the negligence of a Texas Health Investigator and/or research team member.

  • Subject Injury

    As a matter of policy, in the case of subject injury resulting directly from study drug administration or study procedures carried out in accordance with the sponsor designed protocol, Texas Health will provide reasonably necessary medical treatment. Texas Health policy specifically prohibits billing the subject or a third-party for the costs of treating such injuries. Therefore, Texas Health requires reimbursement for the cost of such treatment from the sponsor. Human subject welfare is a primary concern for Texas Health and exceptions to these terms cannot be accommodated.

  • Governing Law
    Contracts accepted by Texas Health must utilize the State of Texas as the governing law. Texas Health will also consider contractual silence regarding this issue, but cannot negotiate any other terms.
  • Termination
    Generally, either party must have the ability to cancel the agreement by giving reasonable notice. In the event of premature termination, Texas Health will seek reimbursement from the sponsor for all costs and uncancellable obligations incurred up to the termination date. In addition, untimely withdrawal from the protocol could jeopardize the welfare of human subjects. Therefore, Texas Health requests that the sponsor cooperate with Texas Health to safely withdraw subjects from the protocol should thirty-days notice not be sufficient.
  • Patient Care Costs and Coverage Analysis

    A Coverage Analysis is an independent review of a human research study to determine which clinical procedures and services are billable to insurance and which are not. It is a systematic review of clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) to determine the billing status of items and services that are documented in the research protocol and/or research plan.

    When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to ensure appropriate billing.

  • Fees for Coverage Analysis (CA)
    Industry Sponsored studies will be billed for CA build and CA amendment build. This may be a separate stand-alone fee or incorporated into the Study Start Up fee.

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Research Overhead

Texas Health Resources (THR) has the responsibility to assure that the trial is developed and managed in compliance with the federal regulations along with the policies and procedures guiding clinical trials at THR. THR charges a standard overhead of 35% on total direct costs and any pass-through costs coming through THR for clinical trial research. Based on our expenses that are not directly attributable to a specific study our accounting department has determined that our current overhead is 35% for commercially sponsored studies. Therefore, we are expected to charge trial sponsors for all direct costs associated with the development, management and conduct of the clinical trial. Overhead is charged to each visit/expense and is not considered part of the compensation to the Investigator.

THR's Grant F&A rate:

Rate Grant/Study Description where rate would apply
60% All projects submitted to a Federal agency (i.e. NIH, DOD, etc.). These studies will usually involve THR patients and/or a THR clinical site, and typically, indirect costs will be additive to the direct cost budget.
35% Commercially sponsored clinical trials or observational/database studies
26% Federal or non-federal grants with no or minimal direct involvement of THR patients and/or a THR hospital/clinic (e.g., grants held by THR that support a community program)
15% Non-profit foundations without a published rate
42% Used when a THR facility or resource is solely being used within a grant as a vendor.
10% For grants equal to or less than $25,000 total cost. This will be a one-time fee applied to the total grant budget.

CMS Approval for Device A & B Studies

In order to bill standard of care costs for category A or B device trials, you must obtain Medicare approval.

Research Administration will review paperwork if Medicare request for approval was submitted by the sponsor or will submit the paperwork directly to Medicare on behalf of THR, as needed. For category A or B device trials, an approval from Medicare must be received by Research Administration prior to the providing approval for release of the IRB approved consent.

Informed Consent Form

A copy of the informed consent MUST be placed in the patient’s paper chart EACH time they come for hospital services, even if all charges are standard of care. This is very important in order to ensure that coding properly codes the claim even if procedures are considered standard of care. Even if the patient had a hospital visit a few days prior and the informed consent was placed in the chart at that time, another copy of the consent must be placed in the chart for the new visit date.

Research Activities versus Commercial Services

THR facilities and laboratories sometimes provide tests or other services to researchers solely on a commercial basis (e.g., an appropriately qualified THR laboratory performs analyses of blood samples for investigators solely on a commercial basis). An agreement for the provision for ALL commercial services for research must go through Research Administration to ensure the appropriate agreements are in place prior to the services being rendered.

Provision of such services solely on a commercial basis does not constitute THR human subject research and does not require THR HRPP review, provided that all of the following conditions are met:

  • (i) The research is not otherwise conducted at THR;
  • (ii) The research does not otherwise involve THR employees or agents (e.g., as co- or sub- investigators, as study coordinators, in planning or analysis, or receiving publication credit) or in which THR is defined as engaged;
  • (iii) The commercial services are genuinely non-collaborative, meriting neither professional recognition nor publication privileges; and
  • (iv) The commercial services adhere to commonly recognized professional standards for maintaining privacy and confidentiality.

However, if THR personnel are involved in any way that is more than merely providing a commercial service, then prospective review and approval of THR IRB is required.

Compliance

If you have a concern or want to report an issue and wish to remain anonymous, you may contact the Texas Health Resources System Compliance Hotline at 1-800-381-4728 or SystemCompliance@TexasHealth.org.

Non-THR Research Staff

For individuals listed on a study that are not a THR/THPG employee or credentialed at a THR hospital, you are considered non-THR research staff.  Depending on the data and/or facility that will be accessed, you may need to be set up as a Non-CSO contractor specifically for the research project you will be participating in.  You may utilize the Non-CSO Contractor Decision Tree. You will be required to complete the Contractor Questionnaire and NON-CSO Packet.  A THR employee or THR credentialed individual is required to be on all THR studies.

Research Administration Information

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