Educating IRB Members and the Research Community

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Educating IRB Members and the Research Community

• Charles Hite
• Director, Biomedical and Research Ethics

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Carilion Clinic Background

• Grew from a system made up of 9 hospitals
  totaling 1,600 beds, college of health sciences,
  400 medical group, consolidated laboratory, home
  health and hospice services.
• 10,000 Employees
• 216 Teaching Faculty, 170 Residents

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The Challenge Research

• Transition from a community teaching hospital
  model to a patient-centered, physician-led clinic
  practice model with research as a strategic goal.
• Large Institution, Small Research Presence
• About 250 Active Protocols Under IRB Review

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The Challenge Research

• New Research Department Created
• Competitive Internal Grant Funding Initiated
• No Existing Research Education for Physicians,
  Residents

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The Solution Collaboration

• Five Departments Convene Professional
  Development, Research, Biomedical and Research
  Ethics, Health Sciences Libraries and Clinical
  Data Analysis
• Content Experts Identified As Faculty Materials
  and Methods Developed

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Two Formats

• 1.5 Hour, Interactive Classroom Sessions
• OR
• Internet Accessible Modules with Mastery Testing

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Course Details

• CME Credits Awarded
• Courses Use Student Ideas to engage learners,
  promote information exchange, demonstrate
  literature search, identify complementary outside
  funding sources, illustrate appropriate designs,
  methods and analyses, and teach basics of human
  subjects research protections

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Turning Ideas Into Research Proposals

• Generate research ideas
• Identify researchable problems
• Identify researchable questions related to
  problem
• Identify relevant literature indicating gaps
  (discovery), support for replication research
  (confirmation), support for exploratory research
  (qualitative).
• Summarize, write introduction and literature
  review for research paper

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Knowledge-Based Resources

• Distinguish key evidence-based and
  knowledge-based resources
• Conduct literature searches
• Identify relevant literature
• Retrieve content, recognize options
• Identify appropriate role of library
• Access resources on-campus or remotely

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Identifying Funding Sources

• Conduct viable funding search
• Determine if research idea is fundable
• Identify appropriate funding sources
• Present research idea that fits funders
  interests
• Competent to contact prospective funders

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Research Designs and Methods

• Describe differences between quantitative,
  qualitative, mixed methods designs
• Iterate underlying research perspective driving
  selection of research design
• Identify appropriate research design and
  methodology for research project

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Grant Proposal Writing

• Draft research proposal addressing
• Funding source
• Organizational background
• Project goals and objectives
• Project summary
• Statement of benefits and how benefits can be
  measured
• Timeline

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Statistical Applications Overview

• Distinguish among statistical applications
• Select statistical application suitable for
  research question/hypothesis
• Identify limitations and scope of conclusions
  that can be drawn from statistical results

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IRBs and Research Ethics

• Describe the history of human subjects research
  protections
• Explain differences between human subjects
  research and quality assurance and quality
  improvement projects
• Review criteria for IRB review and approval

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IRB Workshops

• Twice Annually
• 1.5 Hour Programs Over Lunch
• Free to IRB Members and Researchers
• CME, CEU Credit Offered
• Outside Speakers Recruited
• Topics Vulnerable Populations Translating
  Ethics into Regulations Conflict of Interest
  Ethics of Placebo Controlled Trials Recruitment
  of Subjects

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Informed Consent Videos

• Segment from Miss Evers Boys. Cue video to
  2440
• The Informed Consent Zone video by Greg Pak.
  Twenty minutes with poor examples, then positive
  example. See
• www.pakbuzz.com/informed_consent_zone/

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Informed Consent Video

• Locally produced
• Mock Informed Consent Discussion Between
  Researcher and Subject
• Local Research Study Used
• Good and Bad Example Illustrated
• Informed Consent Tips
• Posted on IRB web site

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