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					    IRB Protocol Applications:
Tips for a Smooth Review Process
  with Examples from the Radiological Section


            Douglas J. Ballon, PhD
      Member, Institutional Review Board
  Associate Professor of Physics in Radiology

             Weill Medical College
              Cornell University
                Your Writeup
- must be in clear English !

- should be concise

- should be written or proofread by the PI

- should avoid highly technical language

 - should utilize the up-to-date application forms
(revised 5/07/07), readily available on the College
webpage under “Basic Science and Clinical Research:
Forms & Policies”

- should not be a copy of the sponsor’s multi-center
clinicial trial protocol
   Know Your IRB Committee !

- Members are from many walks of life,
and not all are scientists or physicians




    19.0 MeV Cyclotron at WMC for making radionuclides
Understand Current IRB Policy

- The Concept of “Continuous Review”

- Stay up to date, because policies change !




               Magnetic resonance spectroscopy of
               the human brain
Research versus Clinical Care




    There are two types of image in the frame.
        One is clinical and one research !
  Understand Government Regulations

● Ionizing Radiation:
X-Ray, PET, SPECT, CT
…are tightly regulated

● Non-ionizing Radiation:
MRI, Ultrasound
…are regulated in a
different way
                            3.0 Tesla MRI at WMC
IRB Application: Radiological Section
IRB Application: Radiological Section
IRB Application: Radiological Section




                            When in
                           doubt, call
                         this number !
IRB Application: Radiological Section



                           Be sure to list
                       radiopharmaceuticals
                               under
                         “Medication” and
                         check status box


                              and…

                        Pharmacy approval
                            is required
           Proofreading will help
            to avoid confusion

Examples from consent forms
    submitted to the IRB

 -“The patients that undergo ….. AND
PRESERVATION OF THEIR NATURAL
HEAD will be followed up to one year.”

 -“Please understand that YOU DO
HAVE TO TAKE PART in this study”
                                         A look under the
                                         covers: The PET
                                         scanner at WMC
             Conclusion
● Be clear, concise, follow all instructions
carefully using up-to-date forms, respond
in a timely and polite manner, and you
will succeed !


                     Left: Original
                     drawing for the
                     cyclotron at WMC

                     Right: a look inside
                     the cyclotron

				
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