IRB-Investigator/ Research Coordinator Mtg.

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IRB-Investigator/Research Coordinator Mtg.

• Research with Human Tissues at Columbia
• March 9, 2004
• George Gasparis
• Columbia University Medical Center IRB

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IRB Investigator/Research Coordinators Monthly
MeetingMichael Shelanski, M.D., Ph.D.Chair,
Department of Pathology Harshwardhan
Thaker, M.D., Ph.D. Department of Pathology
Director, Cancer Center/Pathology Tissue/Tumor
Bank Jean Paul VonSattel, M.D.Department of
PathologyDirector, New York Brain Bank

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Objectives

• 1) Accessing tissue for research purposes
• 2) Regulatory flexibilities
• 3) Removal of certain regulatory burdens

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When Does Human Subjects Research Need IRB Review?
Not Human Subjects
No IRB Review

Research Needed

HHS Regulations Human Subjects Research that is
not exempt Needs IRB Review

• 
  

Exempt Research Needs Determination of Status by
Someone Other Than The Investigator

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Definition of Research

• -A systematic investigation,
• including research development,
• testing and evaluation, designed
• to contribute to generalizable
• knowledge

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Definition of Human Subject

• - A Living Individual about who an
• investigator (whether professional or
• student) conducting research obtains
• 1. Data through intervention or interaction with
  the individual, or
• 2. Identifiable private information

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Definition of Human Subject

• Private identifiable information
• -must be individually identifiable (i.e., the
• identify of the subject is or may readily be
• ascertained by the investigator or associated
• with the information) in order for obtaining
• the information to constitute research
• involving human subjects. 45 CFR 46.102(f)(2)

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Types of IRB Review for Research with Tissues

• 1) Determination if human subjects research
• 2) Exemption 4
• 3) Expedited Review
• 4) Full Committee Review

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OHRP Guidance

• Issues to Consider in the Research Use of Stored
  Data or Tissues
• http//ohrp.osophs.dhhs.gov/humansubjects/gu
  idance/reposit.htm

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Submission of Protocol in RASCAL

• If your research meets this guidance
• In the Source of Specimen field, state
• that all tissues for the study will be obtained
• form a tissue bank (provide name and
• IRB) in accordance with the OHRP
• Guidance for Repositories.

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Submission of Protocol in RASCAL

• Check the IRB website for a listing of IRB
• approved tissue/tumor banks that meet this
• Guidance, as well as guidance for how to
• proceed.
• http//www.cpmcirb.hs.columbia.edu/root/main.ht
  m