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

 

Background

A consortium project is a formalized agreement whereby a multi-study or -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. Such projects have the potential to maximize the scientific value of resources generated by WHI. They also have potential challenges, such as ensuring confidentiality of study participants, management of investigator and staff effort, and data harmonization. Consortium projects typically require complex decision-making in the design, analysis, and interpretation of findings.

There are two types of WHI consortia projects: paper proposals and ancillary studies.

  • Ancillary study consortium (ASC) projects generate new data (e.g. a blood assay, an intervention, a questionnaire) and are subject to the WHI Ancillary Study Policy

  • Paper proposal consortium projects combine existing data from WHI with data from another source(s) (e.g., data pooling of existing biospecimen test results with those from another cohort), and are subject to the WHI Publications and Presentations Policy.

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, with the assistance of the Ancillary Study Committee (ASC) Chair when necessary.

For Paper Proposal Consortium 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 one.

5.      P&P Committee review. Consortium projects that are judged to be papers follow the P&P policies and procedures for further review.

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

3.      Scientific Resources Working Group (SRWG) review. 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, 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.      Scientific Interest Group (SIG) discussion. SRWG-recommended consortium proposals are discussed by one or more WHI Scientific Interest Groups (SIG) during a regularly scheduled SIG call to increase collaborations and leverage the scientific expertise within WHI.

5.      Identification of a WHI Consortium Representative. If the project does not yet have a WHI investigator as the consortium representative, the 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. 

6.      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, submit a proposal, and abide by the Ancillary Study Policies

7.      Annual Consortium Progress Report. A special Annual Progress Report is required for Ancillary Study Consortium Projects.