IRB Manual
      3.7 Approval Process For Amendments To Previously Approved Protocols
   

All protocol amendments must be reviewed and approved by the IRB and the Facility Director prior to their implementation unless the amendment is necessary to alleviate immediate apparent hazards to the subjects or others.  (The IRB must be notified as soon as possible.)  Except for minor amendments, all amendments must be approved by RFMH and the Central Office of OMH or OPWDD prior to their implementation, unless the amendment is necessary to alleviate immediate apparent hazards to the subjects or others. If this emergency provision is used RFMH should be notified as soon as possible. Minor amendments may be implemented after the IRB and Facility Director have approved them, provided that RFMH is notified within 5 days. These requirements for the approval of protocol amendments are in addition to the "annual review" requirements.  Delegation of central office approval authority to NYSPI and NKI as described in Section 3.6 also applies to amendments. (Note: Continuing reviews require approval from RFMH.)

The decision as to whether an amendment is a minor amendment should be made by the IRB and the Facility Director. However, the central office of OMH and OPWDD have the authority to override this decision when an inappropriate designation has been made.  Minor amendments do not increase the level of risk to patients/subjects and do not involve invasive procedures (including x-rays). Minor amendments do not include any procedures for which a full board review is necessary. Dose increases in investigational drug studies and dose increases above PDR recommended dosages for marketed drugs are not minor amendments under any circumstances. 

IRBs may use an expedited review process for amendments to protocols (during the period in which the most current IRB approval is valid - maximum of one year) if:


 
(1)   
The study (including the amendment) falls within the exempt categories;

 
(2)   
The study (including the amendment) involves no more than minimal risk and falls within the expedited categories; or

 
(3)   
The amendment is a minor amendment to a previously approved study during a current approval period.

   

All other protocol amendments must be reviewed at a convened (full board)  meeting of the IRB.

     
   


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