How To Impact Your Research: An Overview of Research Support Services Quincy J. Byrdsong, Terri Hagan, and Alice Owens-Gatlin Research Services Consultants.

How To Impact Your Research: How To Impact Your Research: An Overview of Research Support An Overview of Research Support

ServicesServices

Quincy J. Byrdsong, Terri Hagan, Quincy J. Byrdsong, Terri Hagan, and Alice Owens-Gatlinand Alice Owens-Gatlin

Research Services ConsultantsResearch Services Consultants

ObjectivesObjectives

To communicate the “vision” of a dynamic To communicate the “vision” of a dynamic research enterprise at Vanderbilt research enterprise at Vanderbilt

To discuss the overall purpose of Research To discuss the overall purpose of Research Support Services and its position in the Support Services and its position in the schematic of the Office of Researchschematic of the Office of Research

To outline the educational and support To outline the educational and support mechanisms of Research Support Servicesmechanisms of Research Support Services

To discuss the goals and functions of Project To discuss the goals and functions of Project IMPACTTIMPACTT

The “Vision”The “Vision”

Create a full-service oriented organization Create a full-service oriented organization designed to improve the research process and designed to improve the research process and ultimately, the quality and safety of human and ultimately, the quality and safety of human and basic research at Vanderbilt.basic research at Vanderbilt.Eliminate research Eliminate research administrativeadministrative processesprocesses as as a barrier to conducting researcha barrier to conducting researchBecome a critical value added service for the Become a critical value added service for the institution by supporting growth of the research institution by supporting growth of the research enterprise through initiatives of importance enterprise through initiatives of importance Feedback Feedback Educate Educate Evaluate Evaluate Feedback Feedback Educate… Educate…

Purpose of Research Support Purpose of Research Support ServicesServices

To provide access to personnel with the To provide access to personnel with the expertise to guide investigators through expertise to guide investigators through the human subjects research process, and the human subjects research process, and provide support in navigating the provide support in navigating the Vanderbilt systemVanderbilt systemTo serve as a liaison between the To serve as a liaison between the investigator or study personnel and the investigator or study personnel and the entities which comprise the VU research entities which comprise the VU research enterpriseenterprise

Office of ResearchOffice of Research

Gordon Bernard, M.D.Assistant Vice Chancellor for Research

Institutional Review BoardResearch Support Services

Jill Pulley, DirectorGrants and Contracts

Quincy J. Byrdsong Alice Owens-GatlinTerri Hagan

EducationEducation

Afternoon DelightsAfternoon Delights

Town Hall MeetingsTown Hall Meetings

GCRC Research GCRC Research Skills WorkshopSkills Workshop

Department RoundsDepartment Rounds

Committee MeetingsCommittee Meetings

Individualized SupportIndividualized Support

IRB Forms IRB Forms

Grant SubmissionGrant Submission

Funding OpportunitiesFunding Opportunities

Communication with Communication with Sponsors Sponsors

IND/IDE guidanceIND/IDE guidance

Study DesignStudy Design

Study Team SupportStudy Team Support

Building the research Building the research teamteam

Creating committeesCreating committees

Guiding study designGuiding study design

Navigating study team Navigating study team through the research through the research process from idea to process from idea to implementationimplementation

Current ProjectsCurrent Projects

Supporting the organization of the Clinical Supporting the organization of the Clinical Research Staff CouncilResearch Staff CouncilCreating the Orientation Manual for clinical Creating the Orientation Manual for clinical research staffresearch staffDeveloping an review program to educate Developing an review program to educate regarding percent effort of faculty and key regarding percent effort of faculty and key study personnelstudy personnelTroubleshooting survey of key study Troubleshooting survey of key study personnel to assess research needspersonnel to assess research needs

History of IMPACTTHistory of IMPACTT

NIH/OHRP offered NIH/OHRP offered grants to Institutions in grants to Institutions in an effort to improve an effort to improve Human Subjects Human Subjects protection protection VUMC awarded funds VUMC awarded funds for Project PROTECT for Project PROTECT (enhanced IRB (enhanced IRB application)application)Follow-up award for Follow-up award for Project IMPACTT which Project IMPACTT which was based on OHRP’s was based on OHRP’s QA/QI programQA/QI program

Specific AimsSpecific Aims

Grounded in the Grounded in the principles of continuous principles of continuous quality improvement, quality improvement, this program will this program will provide:provide:– educational resources, educational resources, – self-assessment tools, self-assessment tools,

and and – technological support to technological support to

investigators and staff. investigators and staff.

IMPACTT ProcessIMPACTT Process

Request by, or randomly Request by, or randomly select an Investigator to visitselect an Investigator to visitInitial pre-assessment Initial pre-assessment interview to communicate interview to communicate the goals of the IMPACTT the goals of the IMPACTT program program ““On-site assessment” on a On-site assessment” on a single protocol utilizing a single protocol utilizing a comprehensive assessment comprehensive assessment tool developed to examine tool developed to examine the necessary elements the necessary elements involved in managing a involved in managing a research studyresearch study

IMPACTT – Goals of the VisitIMPACTT – Goals of the Visit

Assist the research Assist the research team in identifying team in identifying strengths and strengths and weaknessesweaknessesProvide education Provide education Make Make recommendations recommendations for improvement in for improvement in the Investigators the Investigators research programresearch program

IMPACTT - IMPACTT - Measures of the Measures of the Assessment ToolAssessment Tool

Regulatory Regulatory DocumentsDocuments

IRB DocumentationIRB Documentation

Participant Participant Records/Consent/ Records/Consent/ Selection Selection Criteria/Adverse Criteria/Adverse EventsEvents

Record KeepingRecord Keeping

ResponsibilitiesResponsibilities

IMPACTT - OutcomesIMPACTT - Outcomes

An exit interview is conducted at the conclusion of the An exit interview is conducted at the conclusion of the on-site assessmenton-site assessmentA final report which includes the findings and A final report which includes the findings and recommendations is then issued by the IMPACTT teamrecommendations is then issued by the IMPACTT team– The report includes an assessment of each areaThe report includes an assessment of each area

A return visit will be scheduled based the needs A return visit will be scheduled based the needs identified identified – The return visit will be designed to re-assess the focus areas The return visit will be designed to re-assess the focus areas

to measure improvementto measure improvement

An evaluation is obtained from the Investigators and An evaluation is obtained from the Investigators and coordinators to assess the response to the IMPACTT coordinators to assess the response to the IMPACTT initiativeinitiative

BENEFITSBENEFITSIt’s informativeIt’s informativeIt’s free It’s free It provides an open It provides an open forum for questions and forum for questions and answersanswersIt’s comprehensiveIt’s comprehensiveIt’s confidentialIt’s confidentialIt’s quick and relatively It’s quick and relatively painlesspainlessIt gives a fresh set of It gives a fresh set of eyes to assess your eyes to assess your research study/programresearch study/program

How Do I Sign Up?How Do I Sign Up?

Complete a “IMPACTT Program Request” on-lineComplete a “IMPACTT Program Request” on-line Send an email to: Send an email to:

Research.Support.Services@[email protected] Give us a call on the hotline Give us a call on the hotline *322-7343* *322-7343*

Questions?Questions?