UTMB offers various studios, consult services, and other resources aimed at helping researchers with study development from conception to implementation.
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.
ITS Biostatistics & Bioinformatics Studio: Biostatistics, bioinformatics, and health informatics
experts are available to help you design your study and generate, retrieve and analyze data. Consultations are available at no cost. The studio is held the 3rd Monday of each month, 1:00 pm-2:00 pm, and requires an appointment. Complete
the request form here: Biostatistics and Bioinformatics Studio. For more information, contact Heidi Spratt, PhD, hespratt@utmb.edu.
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.
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.
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.
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.
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.
Office of Institutional Compliance (OIC): The OIC is responsible for developing an institutional compliance program that will promote compliance with
all applicable legal requirements, foster and help ensure ethical conduct, and provide education, training, and guidance to all employees and faculty. This includes an anonymous compliance hotline.
Scientific Integrity: The faculty, staff, and students of UTMB have an affirmative duty
to ensure the integrity of all science conducted at UTMB or by UTMB personnel, and primary responsibility for responding to and reporting allegations of research misconduct to the Scientific Integrity Official at UTMB.