STARS Consortium Data Request

STARS Study Data Request

First Name *

Last Name *

Suffix

Title

Institutional Affiliation

Street *

Street2

City *

State (US Only)

Zip/Postal Code

Country *

Phone

Email *

Select at least one Stars Consortium member who you are working with from this list: *

Data Access User Agreement

The member agrees that they: *

Will not attempt to identify or re-identify any subject from the data sets;

Will not disclose disseminate or otherwise share the data;

Will use appropriate security safe guards to prevent use of the data for other than the purposes for which it is provided

Will destroy their copy of the data set once it has been used for the purposes of the application (the master data set will continue to be held by Star Legacy foundation)

The member understands that: *

Star legacy Foundation does not guarantee that the data are error free;

The data have been cleaned to remove identifiers however, the data base is large and many participants included identifiers throughout the data. If the member sees any identifiers such as dates, , par

They are responsible for their own data analysis. Should the member not be able to perform their own analysis they should contact Star Legacy Foundation who may be able to put them in contact with a s

Request for Data Access

The Stars study was a cohort study with a nested case-control arm. Please select the dataset/s your request pertains to: *

Historical (stillbirths >3 weeks prior to survey)

Case Control (stillbirths/live births <3 weeks prior to survey)

Please review the questionnaires and associated data dictionaries and enter the files you are requesting:

Historical: demo, preg demo etc

Case-control : demo, activity, FM, Sleep etc

Proposed Paper Details

Title of Project: *

Specific purpose: briefly describe your planned use of the data *

Please list the planned authors. *

Planned Timing: Draft to publication committee to review by (provide date) *

Information Security: Please check the information security practices to be used. Study data must be maintained in a secure and controlled environment. *

Institute supported, controlled access server

Institute supported, password protected desktop computer

Encrypted, password protected laptop computer

Encrypted portable media (encrypted external hard drive, encrypted thumb drive)

Unencrypted portable media backup (CD, DVD, thumb drive) stored in locked file cabinet

Other (please describe below)

Ethics Training

I attest that I have completed Ethics training for the protection of human subjects *

Yes

No

Authorship Guidance

Consortium members are encouraged to contact other members to gauge interest in co-authorship The consortium member who requests the data is responsible to report back to Star Legacy Foundation within a year as to the status of the potential paper. This is to avoid members “sitting on a potential paper” Final drafts of manuscripts should be sent to Star Legacy Foundation (attention publication committee) for peer review prior to submitting to chosen journal. This will be a 4 week turn around.

The ICJME authorship guidelines apply viz:

Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3. As all members of the consortium made a contribution to criteria 1 i.e. the conception and design of the project, all consortium members should , at the very least, be acknowledged even if they do not meet authorship criteria 2 and 3

We suggest the following format for acknowledgement of consortium members who are not authors in a manuscript:

The authors acknowledge the contribution to the conception and design of the Study of Trends and Associated Risks for Stillbirth Study (STARS) of the following members of the STARS consortium (listed in alphabetical order) Collins JH, Heazell AEP, Huberty JL, Kliman HJ, McGregor JA, Mitchell EA, O’Brien LM, Parast M, Peesay M, Stacey T, Warland J, Wimmer LJ.

Information about ethical approval for your manuscript is :

This study was approved by the Institutional Review Board (IRB) of the University of Michigan (HUM#00063655). Prior to gaining access to the survey participants were informed about the purpose of the study (to look for trends and risk-factors for stillbirth) as well as contact information for a stillbirth support group (Star Legacy Foundation) if they became distressed whilst completing the survey. Informed consent was gained by the participant clicking an “I agree” button prior to gaining access to the survey.