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Consortium/Pooling Project Guidelines and Procedures for the Women's Health Initiative (WHI)

 

Background

A consortium/pooling project is a research project that is developed by an organized group of scientific investigators representing various study cohorts and usually with an independent governance structure. WHI is often asked to participate in consortium/pooling projects by contributing data and/or biospecimens. Such projects have the potential to maximize the scientific value of resources generated by WHI. They also have potential challenges, such as ensuring that independent publication of WHI data is done when possible in advance of pooling, ensuring confidentiality of study participants, and managing investigator and staff effort, data integrity and data harmonization. Consortium/pooling projects typically require complex decision-making in the design, analysis, and interpretation of findings.

There are several types of WHI consortium/pooling projects that result in paper proposals and/or ancillary studies.

  • Ancillary study consortium (ASC) projects generate new data (e.g. a blood assay, an intervention, a questionnaire, follow-up study) and are subject to both the WHI Ancillary Study Policy and the WHI Publications and Presentations Policy
  • Paper proposal consortium projects combine existing data from WHI with data from other sources (e.g., data pooling of existing biospecimen test results, clinical outcomes, and lifestyle assessment data with those from another cohort or cohorts), and are subject to the WHI Publications and Presentations Policy.
  • WHI investigators must submit a consortium application when initiating or leading a consortium. In addition, WHI investigators are expected to also provide manuscript proposals for all manuscript developed for the consortia that they lead with expectation of inviting co-authors.

Procedures for WHI Consortium Projects

1.      WHI Consortium Project Application form completion. This form contains information to support the initial reviews and discussions (Steps 2 – 4). Submit the completed application to the WHI Help Desk (helpdesk@whi.org).

2.      Initial Proposal review. The WHI Clinical Coordinating Center will determine whether consortium involvement by WHI would constitute an ancillary study or a paper proposal.

For Paper Proposal Consortium/Pooling Projects

3.      Publications & Presentations (P&P) Chair review. The P&P Chairs will evaluate the application for contribution to WHI's scientific goals, whether or not WHI could meet the project's goals without participating in the consortium, and the overall feasibility of the project.

4.      Identification of a WHI Consortium Representative. If the project does not yet have a WHI investigator as the consortium representative, the P&P Committee will is assist in identifying someone whose expertise is compatible with the project.

5.      P&P Committee review. Consortium projects that are judged to be papers follow the WHI Publications and Presentations Policy. Essentially, manuscripts developed under consortium agreements are subject to WHI P&P review. Manuscripts that include WHI data must identify WHI in the acknowledgements using standardized language on the WHI website. Consortium papers are not authorized to present WHI-specific data independent of the pooled data analyses unless there is scientifically justified rationale for doing so. The inclusion of WHI-specific data will be evaluated in the context of P&P manuscript review.

For Ancillary Study Consortium/Pooling Projects (NOTE: Please allow at least 3 months for this review process.)

3.      Scientific Resources Working Group (SRWG) review. All consortia that are ancillary studies must be reviewed by SRWG. The ASC Chair presents the consortium application to the SRWG for review of the project's impact on WHI resources, contribution to WHI's scientific goals, whether or not WHI could meet the project's goals without participating in the consortium/pooling project, and the overall feasibility of the project. For projects recommended for further consideration, the SRWG identifies one or more WHI Scientific Interest Groups (SIG) to discuss the proposal.

4.      Identification of a WHI Consortium Representative. If the project does not yet have a WHI investigator as the consortium representative, the applicable SIG assists in identifying one. It is the WHI consortium representative who helps "shepherd" the study through the WHI review process and acts as a liaison between WHI and the consortium leadership.

5.      ASC review. Consortium ancillary studies, and consortium projects judged by the SRWG to be externally-funded WHI core studies, are required to complete an Ancillary Study Application form and a Consortium application, submit the proposal, and abide by both the WHI Ancillary Study Policy (including submission of annual progress reports) and WHI Publications and Presentations Policy.