Institutional Review Board

IRB Newsletter - July 2012

  Einstein IRB Newsletter
July 2012
 

Table of Contents (click a link for more details):  

Einstein IRB News
  1. Recently Revised Policies
    The following policies were recently revised as part of our ongoing behind the scenes efforts to bring conformity to our policies and procedures.  Please take a few minutes to review the changes:   
  2. Revised Deviation Form
    A revised Deviation Form was posted on 7/19/2012. The information requested is the same but the definition of "sponsor" has been clarified to align with our current policy and a space has been added at the bottom for the IRB Reviewer’s signature. A copy of the signed form will be returned to you to serve as acknowledgement that it was received. When additional action is needed, a letter will accompany the form.
  3. Full Review Submission Checklists
    These new checklists were posted 7/20/2012.  In addition to helping to ensure complete submissions, we have reduced the required number of copies to 6.  The appropriate checklist is required for all new full review submissions as follows:  
  4. Forgery
    The Einstein IRB would like to remind members of the research community that all documents requiring a signature must be signed by the person named on the document.  Rubber stamped signatures and digital copy/paste stamps are generally not accepted. 
  5. Spotlight: IRB Definition of "Enrollment"
    There is often confusion regarding the definition of enrollment. This has practical applications in both the application (where the anticipated number of subjects to be enrolled is entered) and in the progress report (where the number of subjects enrolled is reported).  Unlike various external entities (such as sponsors) that often define enrollment as those subjects who pass the screening phase of a study, the IRB definition is for any subject who consents to participate.
  6. Biostatistics Resource
    The Biostatistical Consultative and Services Support Resource offers a variety of services including a Walk-In Statistics Consulting Center (Tuesdays from 3-5pm in Belfer 1006E) where researchers can drop by to receive advice about their projects from statisticians on a variety of topics, including study design, biostatistics analyses and novel methodologies.
  7. Research Coordinator Mentoring Program
    The OCT offers a mentoring program for research coordinators.  New to research and need help?  Experienced and want to assist others?  Contact Evelyn Koestenblatt (718-920-8022).
  8. Newsletter Archive
    An archive of this IRB Newsletter series is now available.
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