An Introduction to Research in Radiology Usha N. Menon, Ph.D. - - PowerPoint PPT Presentation

An Introduction to Research in Radiology

Usha N. Menon, Ph.D. Program Manager - Research Diagnostic and Interventional Imaging (DII)

HOOP 64

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

• f 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.

Handbook of Operating Procedures

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

• Drug or Device trial
• New product/additional use
• Almost always prospective
• CRO/sponsor coordinates
• Needs Clinical Trial Agreements

(CTAs) in place

• Meticulous budgeting is crucial
• IRB clearance burden is on the

Sponsor

• Costs covered by the sponsor

Investigator-Initiated

• Based on PI’s expertise
• Meticulous planning relating to

all aspects of the study

• Retrospective or prospective
• QA/QI vs. Research
• IRB burden on the PI
• Adverse event/protocol deviation

reporting responsibilities

• Need to bring in funding to

do the study

Clinical research regulations

Highly regulated: private data/public funds Patient health data are involved (HIPAA)

Medical School and Departmental UT System/UTHealth

Grant-specific

Federal grants Private grants

State Federal

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

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.

Handbook of Operating Procedures

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