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

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.

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.

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 32% 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 32%. 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. Please reach out to the Grants Office for THR’s F&A rate.

CMS Approval for Device A & B Studies

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.