An Introduction to Research in Radiology Usha N. Menon, Ph.D. Program Manager - Research Diagnostic and Interventional Imaging (DII)
HOOP 64 Handbook of Operating Procedures Applications or Proposals for Sponsored Project Funds Policy Number: 64 POLICY AND GENERAL STATEMENT The University of Texas Health Science Center at Houston ("university") actively promotes research as one of its primary missions . The pursuit of external sources of funds to support research and other activities through sponsored projects is one of the most important efforts of the faculty and staff of the university . The determination of appropriate sponsored project efforts resides with individual faculty members, departmental chairs, and deans. The determination of the technical merit of a solicitation is the responsibility of the sponsoring department and the appropriate dean. Faculty, staff and students are allowed to identify potential sponsors for sponsored project activities . The university provides assistance in the business and administrative aspects of grant and contract proposals through the Office of Sponsored Projects ("OSP"), which facilitates the submission of contract and grant applications and determines the accuracy of the business and administrative aspects of the applications. OSP is responsible for ensuring all proposals are submitted in accordance with the requirements of the sponsor and conform to university policies and The University of Texas System Board of Regents’ Rules and Regulations.
DII Strengths Over 65 faculty members • 10 Sections 2 Basic – 8 Clinical • Body Musculoskeletal Interventional radiology Mammography Neuroradiology Nuclear Pediatric Thoracic
DII Strengths Five Basic Research faculty – engineers, physicists, • mathematicians, etc. Improvements in Imaging methods, AI, image post • processing, etc. Our own 3T MRI core lab – animal and human research • Four Medical Physics Faculty – equipment calibrations, • radionuclide handling, radiation safety, etc. Basic Research and Clinical Research
Research Terminology Clinical Research: Research studies conducted on human subjects Usually done to determine whether a new drug, device, intervention, prevention strategy, screening test, etc. is safe or effective
More Research Terminology • Research Protocol • Principal and co-investigators/key personnel • Consent/assent • Vulnerable populations – children, pregnant women, prisoners. • Sponsored studies – typically funded -industry • Investigator-initiated studies – may or may not be funded
Research Projects Sponsored Investigator-Initiated Drug or Device trial Based on PI’s expertise • • New product/additional use Meticulous planning relating to • • all aspects of the study Almost always prospective • Retrospective or prospective CRO/sponsor coordinates • • QA/QI vs. Research Needs Clinical Trial Agreements • • (CTAs) in place IRB burden on the PI • Meticulous budgeting is crucial Adverse event/protocol deviation • • reporting responsibilities IRB clearance burden is on the • Sponsor • Need to bring in funding to Costs covered by the sponsor do the study •
Clinical research regulations Highly regulated: private data/public funds Patient health data are involved (HIPAA) Federal State Grant-specific Federal grants Private grants UT System/UTHealth Medical School and Departmental
Clinical research regulatory arms at UTHealth Committee for Protection of Human Subjects (CPHS) Focus : Patient safety CPHS at UTHealth = IRB (Institutional Review Board) CCTS - Center for Clinical and Translational Science (QA/QI projects ) Research Protocol • Study coordinator – Karen Swaby RN - for all studies at DII • integrated Research Information Systems (iRIS) software • An application to MHH IRB should also usually be made • Sponsored Projects Administration (SPA) Focus : University/grant regulations and fiscal responsibility Sponsored studies – funded/get products or software - Contracts • Investigator-initiated studies – funded - Grants • Cayuse software •
More Research regulations ALL HUMAN SUBJECT RESEARCH NEEDS TO BE APPROVED BY THE CPHS (IRB) PRIOR TO START OF THE PROJECT Do not review charts for research prior to CPHS approval Research protocol should name all personnel that will have access to charts and research data and they should ALL be research credentialed.
The Basics Mandatory Research credentialing (through the • CITI program) 2 modules – Basic Human Subjects Research and • Good Clinical Practice (GCP) – renew every 3 years Have an updated CV • Prepare a research protocol using a standard • UTHealth template QI/QA projects do not need CPHS approval •
QI/QA submissions • Need to be registered with CPHS • Need to apply to use in a local setting • Cannot be published in research journals – must be published only in QI/QA journals
Examples of Ongoing Projects Retrospective chart review to properly prognosticate • liver disease – majority of the studies Prospective studies to evaluate safety and efficacy of • Inferior Vena Cava Filters Observational study – following up on subjects using a • non-invasive method to distinguish different forms of dementia Compassionate use drugs and devices are being • evaluated QI/QA projects - Reducing patient anxiety before • undergoing joint treatment injections
The Next Steps Seek the services of a statistician - Drs. Cai and Zhang • Begin the protocol submission process on the integrated • Research Information Software (iRIS) website. List Karen Swaby, RN, as Study contact/Secondary study • contact for all studies iRIS form morphs and modifies based on study-related • input Exempt/expedited/full board review by CPHS – risk level • to study subject Seek funding opportunities •
HOOP 64 Handbook of Operating Procedures Applications or Proposals for Sponsored Project Funds Policy Number: 64 POLICY AND GENERAL STATEMENT The University of Texas Health Science Center at Houston ("university") actively promotes research as one of its primary missions . The pursuit of external sources of funds to support research and other activities through sponsored projects is one of the most important efforts of the faculty and staff of the university . The determination of appropriate sponsored project efforts resides with individual faculty members, departmental chairs, and deans. The determination of the technical merit of a solicitation is the responsibility of the sponsoring department and the appropriate dean. Faculty, staff and students are allowed to identify potential sponsors for sponsored project activities . The university provides assistance in the business and administrative aspects of grant and contract proposals through the Office of Sponsored Projects ("OSP"), which facilitates the submission of contract and grant applications and determines the accuracy of the business and administrative aspects of the applications. OSP is responsible for ensuring all proposals are submitted in accordance with the requirements of the sponsor and conform to university policies and The University of Texas System Board of Regents’ Rules and Regulations.
Sources of funding Federal : NIH specifically NIBIB (different funding mechanisms), DoD, NSF, etc. • UTHealth and UT system • Private , philanthropic entities (RWJ Foundation, Josiah Macy Foundation, etc.) • Professional associations (RSNA, SIR, etc.) • Dedicated grants to support: - Collaborative projects (within UT departments, UT system or outside institutions) - Travel - Organizing meetings/workshops - Young investigators, first-time researchers, mid-career investigators - For ensuring equal opportunity/diversity - For obtaining training in areas especially those needing new health policies - Providing training in emerging areas of importance/specialized techniques - Community outreach Departmental resource for funding information: Funding opportunities •
Preparing for a grant submission Fixed and rolling deadlines • Letter of Intent • Planning IS everything • WORK TIMELINES BACKWARDS • Give yourself ample time • The process is rough the first time around • Publish to improve visibility for • self/team/department/university Reach out for questions/guidance/support •
Additional Resources Training is available round the year for all levels of investigators • through Sponsored Projects Administration (SPA) New Investigator Development Program at UTHealth (Office of • Research) Help with grant writing (Office of Research and Center for Clinical • Translational Sciences-CCTS) Summer Research Programs • UTHealth Office of Educational Programs Summer Research for First Yr Medical Students Summer Research - RSNA Summer Research – SIR
Contact Usha Menon: usha.n.menon@uth.tmc.edu Office: 713-704-4656 Karen Swaby: karen.p.swaby@uth.tmc.edu Office: 713-704-2842
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