Randomized Controlled Trial Comparing the Franseen Needle With a Fork-tip Needle for EUS-guided Fine Needle Biopsy
Phase: NA
Conditions: EUS Guided Biopsy
Sponsor: Henning Gerke

 
 
 
 
IRB ID #: 
201808820 
 
To: 
 
Henning Gerke 
 
From:  
IRB-01  
DHHS Registration # IRB00000099, 
Univ of Iowa, 
DHHS Federalwide Assurance # FWA00003007 
 
Re: 
Randomized controlled trial comparing SharkCore FNB needles with Acquire FNB needles 
regarding specimen quality and Diagnostic accuracy. 
 
Protocol Number: 
 
 
Protocol Version:  
 
 
Protocol Date:   
 
 
Amendment Number/Date(s): 
 
 
 
Approval Date: 
10/12/18 
 
 
Next IRB Approval 
Due Before: 
10/11/19 
 
Type of Application: 
Type of Application Review:  
Approved for Populations: 
 
 
 New Project  
 Full Board:  
 Children 
 Continuing Review 
Meeting Date: 10/11/18 
 Prisoners 
 Modification  
 Expedited 
 Pregnant Women, Fetuses, Neonates 
 
 
 
 
 
 
 
 
 
 Exempt 
      
 
 
Source of Support: 
 
 
Investigational New Drug/Biologic Name: 
 
Investigational New Drug/Biologic Number: 
 
Name of Sponsor who holds IND: 
 
 
Investigational Device Name: 
 
Investigational Device Number: 
 
Sponsor who holds IDE: 
  
 
 
This approval has been electronically signed by IRB Chair: 
William McGinnis, MD 
10/12/18 1634

IRB ID#: 201808820   10/12/18   Page 2 of 3  
 
 
IRB Approval:  IRB approval indicates that this project meets the regulatory requirements for the protection 
of human subjects.  IRB approval does not absolve the principal investigator from complying with other 
institutional, collegiate, or departmental policies or procedures. 
 
Agency Notification:  If this is a New Project or Continuing Review application and the project is funded by 
an external government or non-profit agency, the original HHS 310 form, “Protection of Human Subjects 
Assurance Identification/IRB Certification/Declaration of Exemption,” has been forwarded to the UI Division of 
Sponsored Programs, 100 Gilmore Hall, for appropriate action.  You will receive a signed copy from 
Sponsored Programs. 
 
Recruitment/Consent:  Your IRB application has been approved for recruitment of subjects not to exceed 
the number indicated on your application form.  If you are using written informed consent, the IRB-approved 
and stamped Informed Consent Document(s) are attached.  Please make copies from the attached "masters" 
for subjects to sign when agreeing to participate.  The original signed Informed Consent Document should be 
placed in your research files.  A copy of the Informed Consent Document should be given to the subject.  (A 
copy of the signed Informed Consent Document should be given to the subject if your Consent contains a 
HIPAA authorization section.)  If hospital/clinic patients are being enrolled, a copy of the IRB approved 
Record of Consent form should be placed in the subject’s electronic medical record. 
 
Continuing Review:  Federal regulations require that the IRB re-approve research projects at intervals 
appropriate to the degree of risk, but no less than once per year.  This process is called “continuing review.”  
Continuing review for non-exempt research is required to occur as long as the research remains active for 
long-term follow-up of research subjects, even when the research is permanently closed to enrollment of new 
subjects and all subjects have completed all research-related interventions and to occur when the remaining 
research activities are limited to collection of private identifiable information. Your project “expires” at 12:01 
AM on the date indicated on the preceding page (“Next IRB Approval Due on or Before”).  You must obtain 
your next IRB approval of this project on or before that expiration date.  You are responsible for submitting a 
Continuing Review application in sufficient time for approval before the expiration date, however the HSO will 
send a reminder notice approximately 60 and 30 days prior to the expiration date. 
 
Modifications:  Any change in this research project or materials must be submitted on a Modification 
application to the IRB for prior review and approval, except when a change is necessary to eliminate apparent 
immediate hazards to subjects.  The investigator is required to promptly notify the IRB of any changes made 
without IRB approval to eliminate apparent immediate hazards to subjects using the Modification/Update 
Form. Modifications requiring the prior review and approval of the IRB include but are not limited to:  changing 
the protocol or study procedures, changing investigators or funding sources, changing the Informed Consent 
Document, increasing the anticipated total number of subjects from what was originally approved, or adding 
any new materials (e.g., letters to subjects, ads, questionnaires). 
 
Unanticipated Problems Involving Risks:  You must promptly report to the IRB any serious and/or 
unexpected adverse experience, as defined in the UI Investigator’s Guide, and any other unanticipated 
problems involving risks to subjects or others.  The Reportable Events Form (REF) should be used for 
reporting to the IRB. 
 
Audits/Record-Keeping:  Your research records may be audited at any time during or after the 
implementation of your project.  Federal and University policies require that all research records be 
maintained for a period of three (3) years following the close of the research project.  For research that 
involves drugs or devices seeking FDA approval, the research records must be kept for a period of three 
years after the FDA has taken final action on the marketing application. 
 
Additional Information:  Complete information regarding research involving human subjects at The 
University of Iowa is available in the “Investigator’s Guide to Human Subjects Research.”  Research 
investigators are expected to comply with these policies and procedures, and to be familiar with the 
University’s Federalwide Assurance, the Belmont Report, 45CFR46, and other applicable regulations prior to 
conducting the research.  These documents and IRB application and related forms are available on the 
Human Subjects Office website or are available by calling 335-6564. 

IRB ID#: 201808820   10/12/18   Page 3 of 3  
 
 
 
 

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