1. IRB-Investigator/ Research Coordinator Mtg. “Research with Human Tissues at Columbia” March 9, 2004 George Gasparis Columbia University Medical Center IRB

2. IRB – Investigator/Research Coordinators Monthly Meeting Michael 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 Pathology Director, New York Brain Bank

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

4. 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

5. Definition of Research -A systematic investigation, -A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge

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

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

8. Types of IRB Review for Research with Tissues Types of IRB Review for Research with Tissues 1)Determination if human subjects research 2)Exemption #4 3)Expedited Review 4) Full Committee Review

9. OHRP Guidance Issues to Consider in the Research Use of Stored Data or Tissues http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htmhttp://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm

10. 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.

11. 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.htm http://www.cpmcirb.hs.columbia.edu/root/main.htmhttp://www.cpmcirb.hs.columbia.edu/root/main.htm