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/pooling 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/pooling 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/pooling project application when initiating or leading a consortium/pooling project. 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/Pooling Projects

  1. WHI Consortium/Pooling 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/pooling project involvement by WHI constitutes an ancillary study or a paper proposal.

For Paper Proposal Consortium/Pooling Projects

  1. 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/pooling project, and the overall feasibility of the project.

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

  3. ​P&P Committee review. Consortium/pooling projects that are judged to be papers follow the WHI Publications and Presentations Policy. Essentially, manuscripts developed under consortium/pooling project 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/pooling project 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.)

  1. Scientific Resources Working Group (SRWG) review. All consortia that are ancillary studies must be reviewed by SRWG. The ASC Chair presents the consortium/pooling project 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.

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

  3. ASC review. Consortium/pooling project 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/Pooling Project Application form, submit the proposal, and abide by both the WHI Ancillary Study Policy (including submission of annual progress reports) and WHI Publications and Presentations Policy.

THE WOMEN’S HEALTH INITIATIVE
THE WOMEN’S HEALTH INITIATIVE

The WHI program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services.

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