Notice Number: NOT-HD-10-011

Key Dates
Release Date:  May 26, 2010

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Purpose

This Notice provides clarification regarding two requirements set forth in RFA-HD-10-008.

In Section IV.6, Other Submission Requirements, under “Population Available for Clinical Trials,” there was a typographical error in the list of items for which information must be provided in tabular form.  The next to last bullet in that section “Apgar – Perinatal mortality rate (per 1,000 births)” should read “Perinatal mortality rate (per 1,000 births).”  The word “Apgar” is deleted from this bullet.
In Section IV.6, Other Submission Requirements, under “Resource Sharing Plan(s)” the requirement to provide a Data Sharing Plan is clarified as follows:

Under the Terms and Conditions of the cooperative agreement (Section VI.2.A of the FOA), the Maternal Fetal Medicine Units (MFMU) Network has established policies and procedures that govern its operations.  The MFMU Network has adopted the following approach for data sharing and data protection:

“The Network operates under cooperative agreements among multiple research institutions and the research study data that is collected belongs to all of the participating organizations.  The Data Coordinating Center (DCC) for the NICHD MFMU Network is responsible for the management and security of the collaborative research data, and is also responsible for sharing the final research data both with the participating clinical centers, as well as outside investigators, following the guidelines set out by the Steering Committee in the MFMU Network’s policy manual and publications policy.  Data collected at the individual centers are neither shared nor published individually, with the exception of single-center ancillary studies, which are first approved by the Steering Committee.  Before each clinical trial or observational study starts, each participating clinical center gives institutional approval for the release of the research data collected at that center as part of the collaborative dataset.”  (The full text of this guidance may be found at: http://www.nichd.nih.gov/RFA/HD-010-008/Workshop.htm#10).

Therefore, when submitting an application in response to RFA-HD-10-008, applicants should simply indicate whether or not they intend to follow the MFMU Network data sharing plan.  This statement will be sufficient to satisfy the requirement for providing a data sharing plan in applications for this Funding Opportunity Announcement (FOA).

All other elements of this FOA remain unchanged.

Inquiries

For questions regarding this Notice, please contact:

Catherine Y. Spong, M.D.
Branch Chief, Pregnancy and Perinatology Branch (PPB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B03E, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-5575
FAX: 301-496-3790
Email: spongc@mail.nih.gov

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