For Researchers

NYU Women’s Health Study Data Sharing and Authorship Policies

  • A. Data sharing policy
    • 1. Request for data and/or specimens

Investigators wishing to have access to NYU Women’s Health Study (NYUWHS) data and/or biological specimens should contact the NYUWHS Principal Investigator (Anne Zeleniuch-Jacquotte, anne.jacquotte@nyumc.org) and provide a brief description of the proposal including the following information (the form for project proposal to the NCI Cohort Consortium at http://epi.grants.cancer.gov/Consortia/cohort.html#proposing can be used as a model): 

  • Specific aims
  • Rationale and significance
  • Design and analysis plan
  • Data variables required
  • Type of biological specimen and volume required (if applicable)
  • Plans for funding
    • 2. Review of proposal

The proposal will be reviewed by the NYUWHS investigators and possibly members of the External Advisory Board. If the project can be performed in accordance with our privacy and confidentiality policies, is deemed of substantial scientific interest and feasible, is not being pursued or considered (for instance in a grant proposal) by another investigator, and anticipated costs (case and control selection, database preparation, biospecimen retrieval, preparation and shipping, etc.) covered, the project may be approved. Applicants will receive a response within two weeks.

  • B. Conduct of studies using NYUWHS data and/or biospecimen
    • 1. Collaborative agreement

If the proposal is approved, a NYUWHS investigator will be named who will work with the external collaborator to facilitate the research. The scope of the project will be described in a written collaborative agreement and signed by the external collaborator and the primary NYUWHS investigator. Use of data from the NYUWHS cohort will be limited to the specific project for which approval was obtained. If further research or analytic activities develop from the original project, the external collaborator must obtain approval from NYUWHS’ Principal Investigator for such activities.

    • 2. Grant applications

If external collaborators apply for funding (e.g. to the NIH), they must provide a draft of the grant proposal to the collaborating NYUWHS investigator at least three weeks prior to the application due date. A letter of support cosigned by the collaborating NYUWHS and the Principal Investigator of the NYUWHS will be provided to the external investigator.

    • 3. Request for preliminary data 

The NYUWHS investigator named to work on the project and the study data manager will provide approximate data that may be needed for preparing a grant application. Since no funds are allocated to manage the development of outside collaborative arrangements, all costs for this effort must be borne by the scientist requesting this information, based on the time required to produce the data. No charge will be made if the required effort is minimal. 

    • 4. Study costs

Active participation of a collaborating NYUWHS investigator is required to ensure proper use of the NYUWHS data and biospecimens. The level of effort will vary according to the size and complexity of the project but will be expected to range from 5% to 10% full time effort (FTE) per year for the NYUWHS investigator(s) named to work on the project. Support for the database manager is usually also requested. The cost is dependent upon the complexity of the investigation but is typically 10% to 20% FTE. Costs for processing and shipping of the biospecimen, if applicable, will be determined based on the volume, type of preparation, and number of samples needed. The arrangement for payments will be through formal subcontracts with NYU School of Medicine, including full overhead.

    • 5. Data and specimen management

Data and/or biospecimens approved for use are approved for use only by investigators listed in the data request and as approved by the NYU School of Medicine Institutional Review Board. Data must be destroyed and remaining biospecimens returned at the completion of the study.

  • C. Authorship policy

It is expected that at least one NYUWHS investigator will be a coauthor on any manuscript using NYUWHS data. This investigator will need to sign-off on any manuscript prior to its submission for publication. All manuscripts must also be submitted for review to the Principal Investigator of the NYUWHS and approval must be obtained before a manuscript can be submitted for publication.