Information for NYU Women’s Health Study Researchers
The NYU Women’s Health Study in NYU Langone’s Department of Population Health has amassed a rich collection of data and biospecimens that we make available to other investigators. Learn more about the study cohort, data we collect, policies on requesting access to data and biospecimens, and conduct for publishing results that use our data.
Between 1985 and 1991, we enrolled 14,274 women at the Guttman Breast Diagnostic Institute in New York City for a study of endogenous hormones, diet, and breast cancer risk. At enrollment, each woman donated a blood sample and completed a questionnaire about her health, reproductive history, and dietary habits.
Blood samples, stored in −80°C freezers for subsequent laboratory analyses, are used to explore biological differences between women who develop disease and women who remain disease-free.
Every few years, we follow up with participants by mail or telephone, at which time they are asked to complete a questionnaire that updates their health and lifestyle information.
The following table describes the characteristics of our study cohort at enrollment.
|Subject Characteristics||Number (%)|
|Age at enrollment (years)|
|Race or ethnicitya|
|African American||1,489 (12%)|
|Some high school or less||600 (5%)|
|Completed high school||5,666 (49%)|
|Vocational/technical school||332 (3%)|
|Completed college||2,539 (22%)|
|Completed graduate school||2,442 (21%)|
|Body mass index (BMI; kg/m2)b|
|< 20||1,160 (8%)|
|> 30||1,812 (13%)|
|Outdoor walking (hours per week)a|
|< 1||5,554 (45%)|
|≥ 5||1,165 (10%)|
|Use of multivitaminsb|
|aBecause these variables were collected in follow-up questionnaires rather than at baseline, data are missing for some participants (12% for race or ethnicity, smoking, and outdoor walking, and 19% for highest education). Questions on smoking and walking referred to the baseline period.|
|bData are missing for 3% (multivitamin use) and 1% (BMI) of participants.|
Learn more about the characteristics of our study participants.
You may use the following questionnaires going back to 1985 for informational use only:
- Baseline: 1985–1991
- Dietary information: 1985–91
- Follow-up 1: 1991–94
- Follow-up 2: 1995–98
- Follow-up 3: 1998–2003
- Follow-up 4: 2003–06
- Follow-up 5: 2006–09
- Follow-up 6: 2010–15
- Follow-up 7: 2015–18
- Follow-up 8: 2019–present
Please do not copy, distribute, or otherwise use these questionnaires without written permission of the NYU Women’s Health Study. To request permission, email firstname.lastname@example.org.
Data Sharing Policies
Researchers who wish to apply for access to our data must adhere to our data sharing policies.
Investigators who would like access to NYU Women’s Health Study data or biospecimens should contact Anne Zeleniuch-Jacquotte, MD, MS, principal investigator, at email@example.com. Please provide a brief description of your proposal for research using this data, including specific aims, rationale and significance, design and analysis plan, required data variables, type and volume of biological specimen (or specimens) needed, if applicable, and plans for funding. You can use the form for project proposal to the National Cancer Institute Cohort Consortium as a model.
Review of Your Proposal
NYU Women’s Health Study investigators and possibly members of our external advisory board will review your proposal to determine whether the project can be performed in accordance with our privacy and confidentiality policies; is of substantial scientific interest and feasibility; is not being pursued or considered—for instance, in a grant proposal—by another investigator; and has anticipated costs covered (such as case and control selection, database preparation, biospecimen retrieval, and preparation and shipping). Applicants receive a response within two weeks of submitting a request.
If your proposal is approved, one of our investigators will be selected to work with you to facilitate the research. The scope of the project will be described in a written collaborative agreement signed by you and the primary NYU Women’s Health Study investigator.
Use of data from the NYU Women’s Health Study cohort is limited to the specific project for which approval was obtained. If further research or analytic activities develop out of the original project, you must obtain approval from the NYU Women’s Health Study principal investigator.
If, after review, we approve your application to use data from the NYU Women’s Health Study, we provide information on how to apply for grant funding to use our data and biospecimens, proper management of our data and biospecimens, and related study costs.
If you apply for funding—to the National Institutes of Health, for example—you must provide a draft of your grant proposal to the collaborating NYU Women’s Health Study investigator at least three weeks before the application due date. We review your proposal and, if it is approved, write a letter of support cosigned by the collaborating investigator and the principal investigator from the NYU Women’s Health Study.
The NYU Women’s Health Study investigator named to work on the project and the study data manager will provide approximate preliminary data that you may need to prepare a grant application.
All costs for this effort must be borne by the scientist requesting the data or specimens, based on the time required to produce them, because the NYU Women’s Health Study does not have funds to manage the development of outside collaborative arrangements. There will be no charge, however, if the required effort is minimal.
Data and Specimen Management
We approve data and biospecimens for use only by investigators listed in the data request, and as approved by an NYU School of Medicine institutional review board. Investigators must act according to terms in the Data Transfer Agreement (DTA) or Material Transfer Agreement (MTA) and return remaining biospecimens at the completion of the study.
We require active participation of at least one of our investigators to ensure proper use of the study data and biospecimens.
We usually also request support for a database manager from the NYU Women’s Health Study. The cost typically ranges from 10 to 20 percent full-time equivalent (FTE), depending on the complexity of the investigation.
If applicable, we charge for the cost of processing and shipping biospecimens. Costs are based on the volume, type of preparation, and number of samples needed. We work with you to arrange payment, including full overhead, through formal subcontracts with NYU School of Medicine.
It is expected that, as a collaborative investigator, you include at least one NYU Women’s Health Study investigator as a coauthor on any manuscript written using the study’s data. All manuscripts must be reviewed and approved by the NYU Women’s Health Study investigator (or investigators) with coauthor status on the manuscript, and by the principal investigator of the NYU Women’s Health Study, before you submit them for publication.