Pre-Clinical/Animal Research

Research activities related to the care and use of animals may require approval from the Institutional Animal Care and Use Committee (IACUC). More information can be found on the IACUC website.

Animal Research Information

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Pre-Clinical/Animal and General Research Training

UTMB offers various training, resources, and guidance related to the use of animals in research.

Researcher Training and Safety: Researchers working with animals must complete mandatory training with AALAS as well as with ARC (see below).

Animal Resources Center Training: UTMB’s Animal Resources Center provides access to training on use of Cayuse for animal orders and for animal handling. Basic animal handling classes using mice, rats or hamsters, include behavior, restraint, signs of pain and distress, SQ & IP injections and saphenous vein blood collection. On-request classes are structured to your specific protocol needs.

Employee Health Annual Research Questionnaire: All personnel directly working with animals must receive a health clearance from Employee Health. Animal allergies are a significant occupational health hazard for animal users. Personnel are expected to speak with their care provider when changes in their health status occur and will be expected to complete a yearly update with the Employee Health.

Animal Resources Center: UTMB's Animal Resources Center is responsible for provision of care to all vertebrate animals on campus. The ARC provides a comprehensive program of veterinary care, animal husbandry, technical advice and assistance and facilities to advance research involving animals on the UTMB campus. The ARC is fully AAALAC International accredited, PHS assured and USDA approved. It comprises eight campus facilities with approximately 108,000 square feet of assignable space. Housing and care is provided for all common research species from amphibians and rodents to primates, sheep and swine. Biocontainment housing is available up to animal biosafety level 4 (ABSL 4).

Conflict of Interest Training & Disclosures: All UTMB faculty, professional staff, students, and employees engaged in research must complete COI training and submit an annual disclosure statement. Click on Outside Activity Portal (bottom of screen).

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Study Development and Study Monitoring

UTMB’s Post Approval Monitoring program offers services related to animal research protocols following IACUC approval.

Post-Approval Monitoring Program: UTMB’s Post-Approval Monitoring (PAM) program is designed to interact with the research staff in a collegial, educational manner. The program helps to ensure the well-being of the research animals as well as provide opportunities to refine IACUC protocols through protocol review and observation. Every animal research laboratory is visited by the program’s Protocol Advisors and Liaisons. These visits consist of protocol discussions with lab staff, observations of animal procedures, and debriefing meetings when needed. Outcomes of these visits are beneficial to the researcher by either confirming that procedures are humane and compliant, or, identifying protocol ‘drift’ and helping to amend protocols to prevent future concerns.

The PAM program offers these services:

-Updates in animal program information through laboratory staff meetings
-Comparison of IACUC protocols with procedures to maintain compliance and animal welfare
-Review protocols/amendments prior to IACUC submission
-Annual training course on writing IACUC protocols and other topics related to animal research

Institutional Office of Regulated Nonclinical Studies: The Institutional Office of Regulated Nonclinical Studies (ORNcS) provides the infrastructure to support regulated studies performed under Quality Management Systems utilizing the Good Laboratory Practice regulations as a reference standard. The mission for ORNcS is to provide scientific support and regulatory oversight during the planning and conduct of in vitro and in vivo nonclinical studies where derived data are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including products submitted via the Animal Rule pathway.

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Safe Conduct of Research

Resources related to the Institutional Biosafety Committee and Environmental Health and Safety are available to researchers.

Notification of Use: Principal Investigators are required to submit a Notification of Use (NOU) for biological agents, recombinant material, Human and Non-Human Primate Products for Institutional Biosafety Committee (IBC) approval prior to any work being conducted. Materials that require IBC approval prior to work commencing are the following:

All human and non-human primate material (including commercial cell lines)
All risk group 2-3-4 infectious agents
All recombinant material (purchased or manipulated) regulated by NIH-OSP guidelines

Environmental Health and Safety: The Radiation & Occupational Safety (ROccS) Program works to ensure UTMB employees, students, patients, and visitors are free from recognized safety and health hazards, and keeps UTMB in compliance with regulations and recommendations for the use of radioactive materials, X-rays, other radiation devices, and lasers. ROccS also provides resources and consultation related to occupational safety issues to ensure a safe work environment for UTMB employees, visitors and staff. Services include but are not limited to chemical safety, hazard exposure monitoring (chemical, noise, etc.), hazard communication act training, respirator fit testing, and food safety inspections. The program supports the Radiation Safety Committee, Radioactive Drug Research Committee, Chemical Safety Committee and has representation on the General Safety Committee and subcommittees of the Environment of Care.

Regulatory Resources: The Office of Regulated Non-Clinical Studies has a variety of policies, guidance, and resources related to good laboratory practice, FDA requirements, and regulatory standards.

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IACUC Protocol Submission

UTMB offers various resources, tools, and guidance to assist with the protocol submission process.

IACUC Protocol Review

All submissions must be made through the InfoEd protocol management and review system. Links to information on navigating InfoEd for initial review and for amendments are as follows:

Navigating InfoEd for IACUC animal protocols:Guidance and instructions for submitting proposals for IACUC review and approval.

Amending IACUC-Approved Protocols: IACUC review and approval is required prior to making significant changes to animal activities. IACUC Policy #6 outlines how to request changes to an approved animal use protocol.

Clinical Research Information

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Biostatistics

Statistical resources including consultation services, statistical software licenses, and online references.

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. For more information, contact Heidi Spratt, PhD, hespratt@utmb.edu.

Department of Biostatistics & Data Science: The Department of Biostatistics & Data Science offers various statistical services for researchers.

Biostats4You: The Biostats4You website was developed to serve medical and public health researchers and professionals who wish to learn more about biostatistics. The site contains carefully selected and reviewed training materials especially suited for a non-statistician audience.

HyperStat: This online statistics textbook can be used for reference and guidance.

Online Stat Book: Online statistics education, an interactive multimedia course of study.

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Grant Writing Tools

Various templates, trainings, courses, and workshops are available to assist with the grant-writing process.

Grant Writing Template Paragraphs: Template language and paragraphs that can be incorporated into proposals are located here.

Grants for Lunch: Grants-for-Lunch program focuses on developing the grantsmanship skills of UTMB faculty and fellows, and to promote networking within our research community. Informal, interactive discussions cover grant writing and research program management with a primary focus on NIH funding. These sessions are led by experienced research faculty and research administrators, who make a short presentation on the given topic, then open the session for questions and answers. All faculty and fellows are encouraged to attend and participate.

Postdoctoral Scientists Certificate Program (includes proposal preparation): The Graduate School of Biomedical Sciences (GSBS) offers certificate credit for postdoctoral scientists at UTMB. There is no cost to postdocs for this program—all tuition and fees are paid by the GSBS.

GSBS Writing Studio Workshops: The GSBS hosts monthly workshops to help with scientific writing and career development. Advanced registration may be required.

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Budget Development

Guidelines, templates, and other resources are available to assist with developing a study budget.

Federal Budgets: Guidelines and templates for internal budget development are provided by the Office of Sponsored Programs.

Industry Budgets: Industry budgets, Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and Financial guidance are provided by the Office of Clinical Research.

Budgets for Clinical Studies Using the CRC: For studies involving the use of the CRC, please contact Liz Ruiz (ebruiz@utmb.edu)

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Contracts and Agreements

Various templates and guidance related to industry and inter-institutional agreements are available.

Industry Contracts: Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Financial guidance are provided by the Office of Clinical Research here.

Memorandum of Understanding (MOU) and Data Use Agreement (DUA): The Office of Technology Transfer manages The University of Texas Medical Branch's Intellectual property assets while promoting and encouraging scientific research.

Material Transfer Agreement (MTA): Material Transfer Agreements (MTAs) are required when any research materials are exchanged between UTMB and another entity. MTAs control the terms and conditions under which the recipient scientist and institution may use the exchanged materials for research.

IRB Reliance Agreements (IRB): For information regarding use of a IRB-reliance, commercial IRB, or single IRB, please contact the IRB directly.

ClinicalTrials.gov Submission: The Department of Health and Human Services (DHHS) requires clinical trial registration and results submission for ALL NIH-funded clinical trials. This includes phase 1 studies, small feasibility studies, and trials that do not involve any FDA-regulated product, such as trials involving only behavioral interventions.

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Compliance

Various offices and consult services are available for compliance-related concerns.

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.

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.

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Research Cores

Shared resources that provide researchers with tools, technology, and other important study-related resources

Research Cores: Research Cores have shared resources that provide researchers with tools, technology, and other important study-related resources. Various internal and external resource cores are available for UTMB researchers.