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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:
…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
                         “Medication” and
                         check status box


                        Pharmacy approval
                            is required
           Proofreading will help
            to avoid confusion

Examples from consent forms
    submitted to the IRB

 -“The patients that undergo ….. AND
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
● 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