Clinical Trials Studio: The Clinical Trials Studio is an initiative supported by a multidisciplinary team of accomplished clinical trialists aiming to assist UTMB investigators with beginning and refining their clinical trials. We assist researchers at any career level, and we provide feedback on trials at any stage of development: https://www.utmb.edu/its/enhancing-research/clinical-trials-studio/about-us
ITS Biostatistics & Bioinformatics Walk-in Studio: A walk-in (no appointment necessary) studio to assist in research study design, generating or retrieving data, guidance with analysis of collected data, and any questions related to biostatistics, bioinformatics, or health informatics. The service provides highly qualified experts at NO COST. The studio is held the 3rd Monday of each month, 1:00pm-2:00pm, 6.110 Research Building 6.
Research Ethics Consultation Service: The Research Ethics Consultation Service (RECS) aims to promote ethics regarding scientific research and development through the Institute for Translational Science (ITS) and the broader community of the University of Texas Medical Branch (UTMB). The RECS uses an integrative and collaborative approach to create an environment that enables ethical decision-making through openness, ongoing discussion, tailored training, and research regarding research ethics and integrity concerns: https://www.utmb.edu/its/enhancing-research/ethics-support
IRB Protocol & Consent Templates: The Protocol template to be used is contingent upon the type of study being conducted (chart review, clinical trial, bio/data repository, etc.). Additionally, consent templates to be used are contingent upon the type of the study and the risk level (minimal risk vs. greater than minimal risk) of the study. Templates can be found here: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/templates-forms
Investigational Drug/Device submission: For clinical Investigations requiring an Investigational New Drug (IND) or an Investigational Device Exemption (IDE), the Office of Research Integrity and Regulatory Affairs supports the research investigator with guidance on regulatory standards and best practices, regulatory submissions, clinical trial management, risk-based monitoring for clinical studies, and compliance: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/research-integrity-regulatory-affairs
Biosafety & Shipping of Biologics: The Department of Biosafety is responsible for programs concerning the safe use of recombinant and/or synthetic nucleic acids, infectious agents, and potentially infectious materials such as human sourced materials in the research, teaching, and clinical laboratories at the University of Texas Medical Branch (UTMB). This includes training, auditing, and consulting with researchers, laboratory personnel, faculty, and healthcare staff concerning compliance with the federal and state laws and regulations in these areas: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/biosafety/home
UTMB Data Safety & Monitoring Board (DSMB) Service: The standing Data Safety Monitoring Board (DSMB) was established to meet the need of UTMB investigator-initiated studies requiring a DSMB. The board is tasked with providing services to ensure the ethical conduct of clinical trials and to ensure and protect the rights and safety of patients enrolled in a trial: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/research-integrity-regulatory-affairs/data-safety-monitoring-board/overview