Human Investigation Committee

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WELCOME
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YCCI Biostatistics, Epidemiology and Study Design
Core

• Jim Dziura

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YCCI Biostatistics, Epidemiology and Study Design
Core

• Develop new methods and tools for study design
  and analysis
• Offer courses and training
• Provide consultative services to clinical and
  translational investigators Biostatistical
  Support Unit

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Biostatistical Support Unit

• Jim Dziura, PhD
• Sunkyung Yu, MS
• Veronika Northrup, MPH
• Haibei Liu, MPH

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Research Protocol

• Studies are useful to the extent that they yield
  valid inferences, first about what happened in
  the study sample and then about generalizing
  these events to people outside the study. The
  goal is to minimize the errors, random and
  systematic, that threaten conclusions based on
  these inferences.
• From Designing Clinical Research 2nd Edition
  (Hulley 2001)

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Components of a Research Protocol

• Research Question The objective of the study
• FINER feasible, interesting, novel, ethical,
  relevant
• Primary aims and hypotheses
• Significance Background information about what
  is known, unknown or uncertain and how study will
  add to existing knowledge

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Components of a Research Protocol

• Design The general framework by which the study
  will be undertaken.
• How are subjects selected for inclusion,
  Direction of Inquiry, How subjects observed
• Two Main Categories
• Observational
• Experimental
• Study Subjects Who is the target population and
  how will subjects be selected to represent this
  population. (balance of feasibility and
  generalizability)
• Inclusion/Exclusion criteria
• Method of recruitment

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Components of a Research Protocol

• Variables Characteristics that change from one
  subject to another
• Outcome variable(s)
• Predictor variable(s)
• Confounders and Effect Modifiers
• How are variables measured
• Statistical Issues There is uncertainty when we
  use a sample to describe whats happening in a
  population.
• Sample size and power calculations
• Plan for analysis of each aim
• Special Issues repeated measures and correlated
  data, missing data, multiple significance testing
  

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Contact Information for Biostatistical Support
Unit
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Protocol Development Support Unit
Melody Sacatos
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Protocol Development

• Develop, edit, and review protocol submittal
  package (HIC application/protocol consent,
  permission, assent forms research authorization
  HIPAA form RAF)
• Re
• Human Subject Protection Regulations, Policies,
  etc.
• HIPAA Privacy Rule
• IRB, University, State Requirements and Policies
• CTSA Grant Requirements
• Best Practices, including GCP E-6

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Protocol Development

• Initial identification of proposed research that
• May be exempt from the Common Rule (45 CFR
  46)
• HIPAA Privacy Rule (45 CFR 160, 162, 164) may
  not be applicable
• May not be considered human subject research
• May qualify for expedited IRB review
• IND or IDE requirements

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Protocol Development

• Protocol Submittal Package
• Location(s), Duration of Study, Number of
  Subjects
• Who will be involved (and what will they do)
• Logical and Data-Based Background (includes
  justification)
• Research Plan (concrete and explicit)
• Consent, permission, assent forms and procedures
• Recruitment material and procedures
• Special Safeguards for Vulnerable Populations
• Provisions for Non-English Speaking Subjects
• Risk/Benefit Ratio
• Provisions for Minimizing Risks
• Confidentiality and Security of Data
• If applicable, Unaffiliated Investigators
  Agreement, Request for Research Affiliate Status
  (institution), or Request for Permission to Serve
  as a PI

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Protocol Development

• Protocols are not just the means to obtain
  approval from an IRB or other review authorities

Its A Tool and A Plan To Be Used Followed
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Protocol Development

• Example
• Minimal Risk Data and Safety Monitoring Plan
• Identify who will monitor the data, assure
  protocol compliance, and conduct safety reviews
  at what frequency (include specific monitoring
  and self audit procedures, and data and document
  control and management)
• Explicit statement of risk with rationale
• Reporting procedures for adverse events,
  including means to inform fellow investigators
  and other study personnel

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Protocol Development

• Must Provide for Review Prior to IRB Submittal

Please Seek Assistance in Planning the
Development of Your Protocol Submittal Package
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Contact Information for Protocol Development
Support Unit

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Human Investigation Committee

• Jean Larson

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HIC Charge

• Ensure that research is designed, approved,
  conducted and supported in adherence to the
  ethical principles of
• Respect for Persons
• Beneficence
• Justice

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HIC Activities

• Establishing Collaborative Relationships
• Research Affiliates
• agencies that will be routinely engaged in
  research
• Collaborating Investigators
• individuals who will be working on a specific
  protocol

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HIC Activities

• Human Subjects Protection Training
• Initial training
• Quarterly large sessions
• First and Second Fridays
• Collaboration with YCCI and Yale Cancer Center
• Annual Research Affiliate meeting
• On request sessions

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HIC Activities

• Protocol Review
• Initial triage for type of review
• Protocol
• Consent forms
• Advertisements
• Review by committee or staff
• Comments to Principal Investigator with requests
  for revisions
• Approval

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HIC Activities

• Ongoing review
• Amendments
• Change of staff
• Change of advertisement
• Change of research plan
• Renewals
• Closure

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Contact Information

• As a resource, call us when you have questions

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Budgeting

• Lynn Mezzanotte and
• Sonja Beamon-Rezendes

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SampleInvoice
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Financial Contact Information
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Education

Gina DAgostino
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Education
Knowledge Skill Capacity
Care Education Group

• Skills Education
• Research Associate Clinical Skills Education
• Knowledge
• Staff In-services
• Human Subject Protection Series
• Workshop Series
• Research Ethics

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Education and Training Contact Information

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Thank you for coming!