Western Institutional Review Board Located in Olympia, Washington Privately funded review board WIRB is registered with FDA/OHRP.

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5 Western Institutional Review Board Located in Olympia, Washington Privately funded review board WIRB is registered with FDA/OHRP. WIRB s IRB registration number is IRB , and WIRB s parent organization number is IORG Fully Accredited by AAHRPP since 2003 Reviews in compliance with state and local laws (in addition to federal) 5

6 Serves as a source of IRB review for FH investigators Acts as the review board of record Complies with and assists FH in its compliance with all applicable regulations and law governing human subject research 6

7 Studies that meet the following criteria may be eligible for WIRB review: Phase III or Phase IV clinical trials. Industry sponsored The research is greater than minimal risk The following types of studies most likely would not qualify for WIRB submission: Research that is Investigator Initiated Research that is Florida Hospital Sponsored Planned Emergency Research Research on transplant techniques, procedures or other interventions. Research involving stem cell therapies. Research involving gene therapy or gene transfer. Research involving investigational radiologic procedures. Research which has been submitted to the FH IRB for review. The FH IRB reserves the right to make additional exceptions on eligibility criteria and has final say on whether research must be reviewed by the FH IRB. 7

8 Review FH IRB SOP Assure that funding is available for payment of WIRB fees 8

9 Reviews submission packet for completeness Research is consistent with FH mission Training requirements complete HIPAA Reviews Prep / IC language Procedures to control drugs/devices are in place Management plans for significant COI Keeps WIRB informed of local FH issues Provides training Facilitates communication between WIRB/Investigator/FH 9

10 IRBNet Library now includes WIRB information/forms & WIRB Fee Schedule IRBNet Integration 10

11 It is FH IRB s understanding that all correspondence from WIRB to the PI is copied to the IRB office through IRBNet. For questions specific to IRBNet integration with WIRB and submission specifics Michelle McKinney, IRB office FH WIRB Processing Alicia Joy, IRB Office 11

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14 Amy Logue Center for Interventional Endoscopy 14

15 Florida Hospital Orlando Center for Interventional Endoscopy (CIE) 15

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17 Background EUS-FNA can be performed with 25, 22, or 19 gauge needles. Three randomized trials have attempted to identify the optimal needle for performing FNAs. Of the three studies that compared the 22 and 25G needles, there was no significant difference found in diagnostic accuracy, but there was a trend towards better performance with the 25G needle for FNA of pancreatic head masses. One of the limitations of EUS-guided FNA is the perceived lack of histological samples. A significant advantage of the 19G needle is the ability to procure histological samples. In a recent study of 120 patients who underwent EUS-guided tissue acquisition using the 19G needle, the procedure was technically successful in 119 patients (98.9%) and adequate histological sample was obtained in 116 (97.5%). A major limitation of the study was that patients with pancreatic head or uncinate masses were excluded. Based on the above data, we believe that a randomized trial comparing the 19G and 25G needle is required to identify the better needle for tissue acquisition in patients with pancreatic mass lesions. 17

18 Primary Aim To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. 18

19 Hypothesis The use of a 19G FNA needle reduces the number of passes required to establish a diagnosis. This translates to less sedation, faster patient recovery, better safety and time efficiency. 19

20 Methods Subjects with solid pancreatic masses were randomized to undergo EUS-FNA using a 19G or 25G needle. A pathologist evaluated specimens for onsite diagnostic sufficiency and later for presence of histological core tissue. 20

21 Results Of the 72 randomized subjects, there was no difference in patient demographics or disease characteristics between both groups. There was no difference in the median number of passes required to establish on-site diagnostic sufficiency between the 19 and 25G needles. An advantage of the 19G needle is that it is significantly better for core tissue procurement. With the 19G needle core tissue was obtained in 95% of cases. The 25G needle yielded core tissue in 33% of cases. In hospitals that do not have an on-site Cytopathologist, it is essential that core tissue be collected for histological testing. Histology is best for establishing some specific diagnoses, especially in cases of benign tumors or if immunohistochemical staining is required. 21

22 Conclusion As both the 19and 25G needles perform equally well, the choice of an FNA needle for sampling pancreatic masses should be based on the need for core tissue. 22

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24 Presentations Julie Pepe and Christina Jackson will be speaking at the ARCP Global Conference in San Antonio in April; the presentation is titled: Data Collection: From the Source to Data Analysis and Everything In Between. Certifications NSI s Sarah Napolitano, MS, CHES passed her CHES (Certified Heath Education Specialist) Awards Internal Medicine resident Dr.Preeti Dahiya won first place in the research poster competition at the American College of Physicians meeting last month. Anniversaries Xiang Zhu Celebrating 5 yrs at FH (now with FHCI R&D) 24

25 WIRB (WCG) Consultants visiting next week IRB Fee Schedule Changes to be released in the next couple of weeks. Effective May 1, 2014 Upcoming Event Rebecca Skloot, Author Renewals Please submit at least 30 days in advance. 25

26 Please submit COI documents and other ORA documents to our department mailbox at A schedule of all classes offered by the ORA is available on the ORA website under the calendar tab. 26

27 Rob Deininger 27

28 Thank you for your attendance at Research Matters! 28