SWAN Repository

 

 

 

 

 

 

 

 

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The Swan Study

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Expedited Review:
NIH Stimulus Applications

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EXPEDITED REVIEW PROCESS FOR NIH STIMULUS APPLICATIONS

SWAN Repository

 

Background:  The 3-tiered review process (itemized below) for the SWAN Repository resources is being expedited to accommodate the NIH stimulus funding applications.

 

EXPEDITED REVIEW PROCEDURE FOR APPLICATIONS TO THE STIMULUS-DERIVED FUNDING (effective March 20, 2009 to November 1, 2009)

 

A.  Submit a Letter of Intent to the Repository Organization (RO):

a.    Indicate that the request is a stimulus-based funding application and the deadline to which you are submitting.

b.    Identify the specific solicitation (including subheading) to which the application is directed

c.    Provide a clear statement of why and how the SWAN Repository resources are optimal for this application.

d.    Include the goals, specific aims and hypotheses, and sample size estimates for the application.

e.    Clearly identify the type of sample, number of samples, volume, processing requirements and storage conditions for samples to be used in the application.

f.     Demonstrate the appropriateness of the laboratory for this application using published data, preliminary data or SOPs.  Make sure that laboratory demonstrates appropriate analyses in human tissue.

g.    If a calibration study with existing SWAN data is needed, fully describe the implementation of that calibration study.

h.    If the request is for already-generated data, double check to assure that there is no known (and knowable) overlap and that proposed use is consistent with the type of data requested.

i.      Provide complete contact information about the principal investigator and complete contact information for the laboratorian (if applicable).

  1. Send the letter of Intent to www.swanrepository.com or merillat@umich.edu
  2. If there is no confirmation of receipt within 3-days, re-contact Repository.
  3. Expect expedited review response within 10 working days of receipt of complete information.
  4. Applications will be responded to in order of receipt. 
  5. A subsequent letter will indicate the findings of the Repository expedited review process and indicate the specimens and data that are approved as well as the amount of time in which the materials will be embargoed.
  6. Send completed NIH applications based on the SWAN Repository resources to the Repository Organization at the time of submission to NIH.  Failure to do so will void the embargo.

 

  •  Applicants for successive rounds of stimulus-related funding need to notify the Repository.

  • Applicants need to notify the Repository of the disposition of their application immediately following NIH review.

  • Use of this expedited review is limited to the stimulus-related funding with tight timelines.  Any other application will require regular Repository review process, as follows:

  1. Repository Organization (RO) reviews for sample availability, appropriate lab procedures, adequate sample size and consistency of request with the Specific Aims.

  2. There is full review by the nine voting members of the SWAN Repository Advisory Group (SRAG) including 4 representatives for the SWAN study, 4 external representatives, and the SWAN New Studies Chair (Dr. Nanette Santoro)]. 

  3.  Concurrence with Advisory Committee recommendation is determined by SWAN Steering Committee following a posting on Repository website.