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Family Medicine

Research Readiness Guide

Questions to Consider

Are you:

  • Trying to start your own project?
  • Trying to join and support an existing project

CITI Training

  • The Collaborative Institutional Training Initiative provides required modules for ethics training in human subjects research. This is an institutional requirement before beginning any research study.
  • Directions for completing CITI training
    • Already have a CITI account? See instructions for linking UVA to your existing account.
    • If you have already completed CITI training, you will still have to take a refresher course every three years.
  • You will need to complete the IRB-HSR Researcher Basic Course OR IRB-HSR Researcher Refresher Course if you have previously taken the Basic Course

Developing your Question

  • Most important thing: You should be interested in this! Researchers who are not interested in or passionate about their topic tend to not finish their projects. This results in wasted time and effort from you and others who have been supporting the project.
  • Think about the following:
    • What health conditions/behaviors interest you?
    • What populations interest you?
    • Have you observed anything in clinic that has left you with questions?
    • Is there a need that can be addressed?
  • Once you have a general topic that interests you, refer to the following:

Background Reading

Compliance Information

In addition to the IRB, there are other offices and committees that may need to review and approval a study prior to implementation.

  • Which compliance steps do I need to go through?
    • Use the Study start-up from the Clinical Trials Office: This will take you through a series of questions and provide you with a checklist of the compliance steps you will need to complete and information on how to complete them.
    • You can print the checklist or opt to have it emailed to you.
  • Additional Clinical Trials Office Resources
  • Resource guide for clinical research
    • Note: You will have to login through Knowledge Link
    • This guide allows you to skip around to navigate resources most pertinent to your project

Institutional Review Board (IRB)

  • UVA has two IRBs:
    • Health Sciences Research (IRB-HSR)
    • Social and Behavioral Sciences Research (IRB-SBS)
  • Any research with patients must go through the IRB-HSR
  • Use the determination tree if unsure
  • Resource guide for clinical research
    • Note: You will have to login through Knowledge Link
    • This guide allows you to skip around to navigate resources most pertinent to your project
  • Clinical Trials Office

IRB-HSR

  • There are many types of IRB-HSR submissions. The ones that will be most relevant to you are:
    • Non-Human Subjects Research Determination
      • Quality Improvement projects fall under this category
      • Some journals require that the IRB review a QI project; completing and submitting the form below will demonstrate the study is on record with the IRB and does not need further review
      • Determination of Human Subjects Research
    • Exempt Studies
      • These are studies that pose minimal risk to participants
      • Chart review of EMR data and patients surveys/interviews fall into this category
    • Other types of reviews
      • Example completed table
      • Expedited
        • These are studies that pose minimal risk but are more involved than exempt studies.
        • Behavioral intervention studies normally fall into this category.
      • Full board
        • These are studies that pose beyond minimal risk OR involve randomization (clinical trial)
        • Randomized behavioral interventions fall into this category
      • Clinical Research Connect- All expedited and full board review protocols have to be submitted to CRConnect before the IRB
      • Research with Medical Students or Residents

IRB-SBS

Conducting Your Study

  • Process depends on your research question and data collection needs
  • EMR data pulls
    • Support available in FM and throughout the university
    • Specify what you want to measure and work with an analyst to determine how/if that information can be gathered from EPIC
  • Requesting support
    • Clearly specify your research question
      • Example of helpful request: I am interested in examining the demographic characteristics of our active patients who are high utilizers of the ED. I am defining high utilizers as patients with 5 or more ED visits in the last year. Demographic characteristics I am interested in include: Race, Ethnicity, IFMC status, Language and Insurance Status.
        • This clearly defines the population and variables of interest so the analyst can build a query.
      • Example of not helpful request: I want to look at our patients who are high utilizers.
        • This does not give the analyst any specific information that will help build a query.
      • Be up-front about all the information/support you need. This reduces back and forth, and saves time and effort.
        • Example: You have a research question that involves examining encounter reports. Are you interested in one FM clinic or all? What time frame are you interested in? What pieces of patient information do you need in the report?
        • Example: You are requesting support for data analysis. What variables are you looking at and how do you operationalize them? For instance, do you want to look at age as continuous variable or as different categories (e.g., 18-24, 25-34, etc.)? If you are looking at categories, which is your comparison group?
      • Resources for data requests and support
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