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​Propose an Ancillary Study (AS)

AS Quick Links: AS Overview; Propose an Ancillary Study; Prepare AS Budget; Conduct the AS

Requirements
  • All ancillary studies must be submitted to the Ancillary Study Committee (ASC) for approval 
  • Ancillary Studies proposing to contact participants must use the WHI Clincial Coordinating Center (CCC) or Regional Center(s) to make the initial contact.
Steps to propose an Ancillary Study in WHI.
 
  1. Review current and completed ASs for potential overlap.
  2. For information on WHI biospecimen availability, contact the WHI Helpdesk
  3. Find a WHI sponsor.  If you are not a WHI investigator, identify a WHI Investigator as a collaborator. The WHI collaborator will assist in identifying the information on WHI protocol, measurements, and policy, review the specific study plan to assure feasibility of the protocol within the WHI setting, and facilitate access to WHI data once funding is obtained.
  4. Prepare your AS proposal.  See WHI AS proposal format.
  5. When form is complete, please email your application and proposal to the WHI Helpdesk.  Refer to http://www.whi.org for Application Procedures Guide and other useful information. ​​​Submit by the first of the month to be included in that month's Ancillary Study Committee's (ASC) review. Submit the application and proposal at least 2 months before the funding agency’s submission deadline to allow time for you to respond to any questions the ASC may have.  
 
    Approval Process
 
·   ASC review:  You will receive the results of the ASC review about one week following the review.
 
If not approved by the ASC, the ASC will send a letter along with comments from the proposal reviewers.  The ASC may also ask for additional information and/or clarification or to note provisos.  At this point, the investigator may modify or add additional information to the proposal and send it back to the ASC for another review.
 
If approved by the ASC, the ASC will send an approval letter, along with the name of a CCC Administrative Project Coordinator
 
After ASC approval, the investigator may proceed with the next steps (see Prepare AS Budget) while the review process continues.  The investigator may not submit the proposal for funding until receiving final approval from the NHLBI (see below).
 
·   Steering Committee Review:  After ASC approval, the WHI Steering Committee (SC) will review the proposal on its next monthly conference call
 
·   OSMB review: If the AS includes a participant consent form and burden, such as completing forms or phone calls, the CCC will ask the AS PI to complete a WHI Data and Safety Monitoring Board (DSMB) form.  The NHLBI forwards this form to the OSMB for review and approval of the participant burden.
 
·   NHLBI Project Office review:  NHLBI Project Office does the final proposal review.
 
If not approved by the SC, OSMB, or NHLBI:  NHLBI will send the AS PI a letter along with comments from the proposal reviewers.  The investigator may modify or add additional information to the proposal and send it back to the ASC for another review.
 
If approved by the SC, OSMB, and NHLBI:  NHLBI will send the AS PI a final approval letter.  Upon receipt of the approval letter, the investigator may submit the proposal, along with CCC subcontract as needed, for funding.  See Prepare AS Budget.
 
All letters of support from the CCC are contingent on the AS PI completing these steps.   

·   Time Limits on Approval of Specimen Studies

          To ensure that WHI specimens are being used for investigation of the most current and relevant hypotheses, approval for each ancillary study involving specimens will be in effect for 30 months from the date of the NHLBI approval letter.

           There are no limits on the approval of non-specimen studies.

 
Next: Prepare AS Budget​​​.
 
Please contact the WHI Helpdesk with any questions about this process.
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Quick link to documents for:  Propose an Ancillary Study documents 
     ·  WHI AS Policy
     · WHI AS proposal format 
     ·  AS Application form
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