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Propose a Study

New streamlined formatting. AS policy remains the same.

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

It is recommended that proposals be submitted to ASC at least 3 months before the funding agency's submission deadline since the ASC may have questions or comments and more than one round of reviews may be required. Consortium studies may need additional time since it requires review/initial screening by the SRWG prior to submission to the ASC.

Proposal timeline

Submission Deadline:

First business day of the month

Review Date:

Third Tuesday of the month

Notification Date:

Approximately one week after review

Definitions

WHI Ancillary Study (AS): An investigation that involves generation of new data not already in the WHI database. Examples include:

  • Specimen assay results

  • Abstraction of records previously collected by WHI but not yet coded (e.g., four-day food records, medical records)

  • Collection of new survey data or clinical data

Initial review of proposed ancillary studies is conducted by the WHI Ancillary Studies Committee (ASC).

Paper Proposals: Projects using or constructing new variables from existing WHI data.

  • A project is a paper proposal if existing WHI data, i.e., data that do not need to be abstracted, are used as is or to construct new variables (e.g., glucose and insulin data or glucose and insulin data being used to construct a HOMA variable.)  Examples include using or analyzing data posted from other ancillary studies, or computing biomarker-calibrated dietary intakes.  These types of projects should be formulated as paper proposals (see Propose a Paper.  This applies whether or not funding is being sought for the project.  If unsure whether AS or paper proposal, please ask the WHI Help Desk (helpdesk@whi.org )


Consortium Proposals: Multi-study or multi-cohort research projects.

  • A consortium project is a formalized agreement whereby a multi-study or multi-cohort research project is carried out by two or more academic institutions or performance sites. WHI is often asked to participate in consortium projects by contributing data and/or biospecimen. If your investigation is a consortium project, before submitting an ancillary study proposal, please follow the guidelines in Propose a Consortium Project

Instructions

Before submitting an ancillary study, please read the following documents:

Submit a WHI AS Application:

  • Application form (right-click and select "Save as" to save form to your PC)

  • DSMB Participant Burden Summary Form (right-click and select "Save as" to save form to your PC) for projects involving participants

  • PLEASE NOTE: If there is any change to your study (including changes to aims, sample size or assays) at any time after submission to the ASC for review, an AS Modification Request form needs to be submitted to ASC for approval. Please email form to helpdesk@whi.org.

Prepare Budget, after ASC approval:

Once ASC-approved, contact the CCC to develop a subaward budget, if needed. Refer to the CCC AS Coordinator contact listed on your ASC approval letter.

Other Useful Information for proposing a WHI AS

  • Current and Completed Studies: lists of approved and funded ancillary studies.  Ancillary study proposals that overlap with previous and ongoing WHI research are not likely to be approved.

  • 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

  • Query Builder: a tool designed to create queries based on study components, demographics, outcomes, specimen availability, test results and more.