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Skip Navigation LinksAncillary Studies Overview

​​​Propose a Study 

The WHI scientific community encourages ancillary study proposals from within the WHI community and beyond​​.

Submission Deadline​​​​​

Review date​​​

First business day of the month

Third Tuesday of the month


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

The WHI welcomes proposals from both WHI investigators and ​outside investigators. Collaboration is encouraged to maximize the scientific value of the wealth of epidemiologic data available through WHI. The core research of the WHI has focused on cardiovascular disease, cancer, and bone health. Access to the data and specimens for a wide range of scientific endeavors has enabled research discoveries in other areas such as stroke, osteoporosis, arthritis, obesity, eye and hearing disorders, genetics, and more​.
 
A WHI Ancillary Study (AS) is an investigation that involves generation of new data not already in the WHI database. Examples include:
  • Abstraction of records previously collected by WHI but not yet coded (e.g., four-day food records, medical records)
  • Specimen assay results
  • Collection of new survey data or clinical data
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 Clinical Coordinating Center (CCC) or Regional Center(s) to make the initial contact.
 
Current and Completed Studies includes lists of approved and funded ancillary studies.  Ancillary study proposals that overlap with previous and ongoing WHI research are not likely to be approved.
 
 
Steps to propose an Ancillary Study in WHI.  ​​Basic steps for conducting an AS are outlined below and described in more detail in the following
    1)  Review current and completed ASs for potential overlap as overlap is usually not permitted.
   
2)  For specimen studies, check Description of Biospecimen Available for Use as well as Volume of Biospecimen Available for Use.
    3)  For information on WHI biospecimen availability, contact the WHI Helpdesk
    4)  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.
    5)  Prepare your AS proposal.  See AS Application Procedure Guide​.
   
6)  Complete an AS Application form.  See WHI AS Application Procedure Guide​.
    7)  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 business day of the month to be included in that month'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
 
          ·   DSMB 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 DSMB 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, DSMB, 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, DSMB, 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.

·   Prepare AS Budget (after receiving WHI approval)
  8) Submit Grant Application for funding, working with the WHI Clinical Coordinating Center (CCC) as needed to develop a budget.
       Please contact the WHI Helpdesk with any questions about this process.
·    Conduct the AS (after receiving funding)
     9)  Complete ​the WHI Data and Material Transfer and Use Agreement.
     10)  Send manuscript proposal(s) to the P&P for review and approval to access other WHI data needed for analyses. This may be done any time after AS funding, and is required prior to accessing WHI data.
  11)  Send AS data to the WHI CCC for later posting on the WHI website
12)  WHI AS may be required to, or choose to, submit their data to dbGaP (database of Genotypes and Phenotypes) a central data repository at the National Center for Biotechnology Information (NCBI).  Submission is a condition of the funding agency in many cases.  WHI has specific limitations on the data that can be submitted based upon WHI participant consent.  Therefore, AS investigators submitting genetic data should work with the WHI-CCC and follow the steps outlined in the dbGaP Guidelines or Quick Information Sheet to ensure the data is submitted correctly.  Please contact the WHI-CCC with any questions or help using these guidelines.
 
Other Useful Information about Data and Specimens Available for AS Investigators
 
·   WHI Data: information on data already collected, including specimen results that are available. Access to detailed data may require the assistance of the sponsoring PI or CCC, particularly for studies where additional coding is required (e.g., medications).
·   Biospecimen Available for Use: information about blood and urine collection time points, volume of sample available to AS, descriptions of specimen collection, processing, storage, and quality control, and the timelines for obtaining biospecimens and data
·   Blood and DNA Available to Ancillary Studies (as of 3-6-2013), shows counts of outcomes cases with sample available for use by ASs (data as of Sept. 2012).
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Quick Links to AS documents:
Propose a Study

Prepare AS Budget

Conduct the study