Research Compliance
Texas Tech Health El Paso's Research Division is dedicated to ensuring that all human research conducted on campus or at off-site locations complies with applicable federal regulations , state laws , and institutional policies . Our priority is to protect the rights, safety, and well-being of human research participants and to promote a culture of integrity and compliance within our research community.
The Research Compliance Officer (RCO) provides oversight and monitoring of research activities to ensure that our researchers uphold the highest ethical standards. This safeguards public trust in our research and supports the continued success of our research mission.
Report a Research Concern
If you have any concerns about the conduct of human research at Texas Tech Health El Paso, we encourage you to report them. All reports are treated with strict confidentiality and handled in accordance with federal regulations and institutional policies.
Anonymous Research Compliance Hotline:
1-866-294-9352
Your willingness to report any concerns helps protect human research participants and promotes compliance with ethical and regulatory standards.
Regulatory Compliance Program
The audit program consists of:
- Routine Regulatory Audits
- Directed Audits / For Cause Audits
- Chart Review Audits
- eCRT and Effort Statement Monitoring
Regulatory Compliance Process
The audit process includes monitoring activities such as:
- Review of investigator study records (including signed informed consent documents, study-related data collection forms, protocol and amendments, adverse event documentation, correspondence related to the study, drug/device accountability records, regulatory documentation, etc.)
- Review of source documentation (such as medical records)
- Observation of the informed consent process
- Interviews of investigators and research personnel
- Oversight of revenues and expenditures
- Review of Institutional Review Board (IRB) records
- Evaluation of industry-sponsored monitoring reports
- Ensuring that eCRT and Effort statement deadlines are met
Quick Guide to Research Compliance Requirements at Texas Tech Health El Paso
The information in this guide outlines research compliance requirements for faculty and staff conducting research at Texas Tech Health El Paso. Also, please review Texas Tech Health El Paso OP 73.08 for information about who can serve as a principal investigator for a research project or a grant at Texas Tech Health El Paso.
Research projects requiring review by the Institutional Review Board (human subjects), Institutional Animal Care and Use Committee (vertebrate animals), or Institutional Biosafety Committee (biological or chemical agents) will be required to be submitted to the appropriate committee using the iRIS software system. An account may be requested here: https://ttuep.imedris.net/.
An approved Institutional Review Board (IRB) protocol is required for each research project using human subjects (including, but not limited to, investigation of new drugs, medical/radiological/behavioral studies, tissues or blood, medical record reviews, surveys or questionnaires). Prerequisites for submitting a protocol for IRB review include successful completion of the CITI (www.citiprogram.org) Human Subjects Research Course and Conflict of Interest course. Other prerequisite courses may include: Clinical Research Coordinator, Good Clinical Practice, and Informed Consent Training. An up-to-date financial disclosure document is also required. Research involving human stem cells must be in accord with established NIH guidelines (see: https://stemcells.nih.gov/policy/pages/2009guidelines.aspx), and must be approved by the IRB and Texas Tech Health El Paso. For a complete list of requirements for the use of human subjects in research, please refer to Texas Tech Health El Paso’s Human Research Protection Program Manual. Additional information may be found at the Institutional Review Board Administration page. For other questions, please contact Raquelle Rosales, IRB #1 Research Compliance Specialist II or Brittney Espinoza, IRB #2 Research Compliance Specialist II.
An approved Institutional Animal Care and Use Committee (IACUC) protocol is required for each research project using vertebrate animals. Prerequisites for submitting a protocol for IACUC review include successful completion of the CITI (www.citiprogram.org) courses specific to the animals and procedures to be used and Conflict of Interest course. An up-to-date financial disclosure document is also required. Enrollment in the Occupational Safety and Health Program is also required. For a complete list of requirements for the use of vertebrate animals in research, please refer to the research committees page. For other questions, please contact Amanda Diazdeleon, IBC/IACUC Research Compliance Specialist II.
Research utilizing any biological or chemical agent or involving the use of recombinant or synthetic DNA requires approval from the Texas Tech Health El Paso Institutional Biosafety Committee (IBC) before it is initiated. For a complete list of requirements for the use of biological or chemical agents in research, please refer to the Institutional Biosafety Committee (IBC) page. For other questions, please contact Amanda Diazdeleon, IBC/IACUC Research Compliance Specialist II.
Texas Tech Health El Paso Radiation Safety Committee Approval is required. For research related radiation procedures that will take place at UMC, UMC Radiation Safety Committee Approval is required. Please email the Chair at jesus.diaz@ttep.edu with information regarding the procedures, and attach a copy of the protocol.
All Texas Tech Health El Paso investigators/personnel conducting research are required to submit an annual financial disclosure statement to the Office of Research via the iRIS platform at https://ttuep.imedris.net/. These statements are reviewed by the Texas Tech Health El Paso Conflict of Interest in Research Committee (COIRC) to determine if a perceived or actual conflict of interest may exist. A Conflict Management Plan will be required if such a conflict is identified. All investigators/research personnel and members of Texas Tech Health El Paso research compliance committees are also required to complete the online CITI Conflict of Interest training found at www.citiprogram.org. For guides on accessing and submitting the financial disclosure form within iRIS, or for more information, please refer to the Conflict of Interest in Research Committee page or contact Barbara Castellanos, Research Compliance Specialist I.
Conflicts of interest in the non-research realm or conflicts of commitment also may need to be addressed by Texas Tech Health El Paso employees. These issues are reviewed by the Texas Tech Health El Paso Conflict of Interest and Commitment Committee. For more information, please refer to the Office of Institutional Compliance page.
Research that will involve the transfer of information, technologies, or commodities to individuals (including US citizens) in a foreign country, or to foreign nationals in the U.S., are subject to Export Control laws. Export controls also govern potential use of a laptop computer, cell phone, or other devices containing Texas Tech Health El Paso information or data in a foreign country. Additional information can be found in Texas Tech Health El Paso OP 73.16. For related questions, please contact Josue Cardoza, Senior Research Compliance Specialist.
For a complete list of requirements for preparing and submitting grant applications, please refer to the Sponsored Programs page. For questions, please contact the Sponsored Programs (SP) office.
Questions regarding invention disclosures, patents, or licensing of inventions should be addressed to the Office of Research Commercialization at Texas Tech University. For more information, please refer to https://www.depts.ttu.edu/vpr/commercialization/ or contact Cameron Smith, TTUS Commercialization Director, or Hutton Jones, Senior Licensing Associate.