Request for Extension of Approval Or Modification of Previously Approved Protocol

Request for Extension of Approval  Or Modification of Previously Approved Protocol 





Principal Investigator Information
Extension Request
In an email addressed to pbossange@framingham.edu, Please describe reason(s) for extension of the research project and provide a revised anticipated end date for the research. Be sure to include:
  1. a copy of the current or new consent form
  2. a copy of the previously approved protocol
  3. a status report of the approved research
See the FSU Policy Regarding Use of Human Subjects in Research for more information.
Modification Request
In an email addressed to pbossange@framingham.edu, please describe each of the planned changes to the original protocol, and provide a justification for each.  [The FSU IRB must review modifications to the previously approved protocol to ensure that the modified protocol continues to meet IRB requirements.]  Be sure to attach:
  1. a copy of the current or new consent form 
  2. a copy of the previously approved protocol 
  3. a description of desired modifications 
See the FSU Policy Regarding Use of Human Subjects in Research for more information.
*State Two Request
In an email addressed to pbossange@framingham.edu, please describe any elements of the original application that were not able to be specified at the time of the original IRB approval request, and provide any documents missing at the time of the Stage One request for approval.  [For example, a data collection instrument may not have been available at the time of the original application.]  Be sure to attach: 
  1. a copy of the current or new consent form 
  2. a copy of the previously approved protocol 
  3. a description of elements of the research design for which Stage Two approval is being requested.

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