Einstein IRB Newsletter
Table of Contents (click a link for more details):
Einstein IRB News
- 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:
- Revised Deviation Form
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
- Full Review Submission
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
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.
- 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.
- 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
- Research Coordinator Mentoring
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).
- Newsletter Archive
archive of this IRB Newsletter series is now available.