Request for Applications (RFA) Number: RFA-10-008

Peer Review Enhancement

Grant Applicant Statement Regarding Plan for Sharing Research Data

Request For Applications (RFA) Number: RFA-HD-10-008  Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network (U10)  
http://grants2.nih.gov/grants/guide/search_results.htm?year=active&scope=rfa
Announcement Type
This is a reissue of RFA-HD-04-023. 

Catalog of Federal Domestic Assistance Number(s)  93.865
Key Dates
Release Date: January 29, 2010
Letters of Intent Receipt Date(s): May 1, 2010
Application Receipt Dates(s): June 1, 2010
Peer Review Date(s): October/November 2010
Council Review Date(s): January, 2011
Earliest Anticipated Start Date: April 1, 2011
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 2, 2010
A workshop on this FOA will be held on February 5, 2010 in conjunction with the Society for Maternal Fetal Medicine meeting in Chicago, IL. The presentation will be available online (http://www.nichd.nih.gov/RFA/HD-010-008/Workshop.htm).

Executive Summary

• Purpose. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement in an ongoing multi-center clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight, prematurity, and medical problems of pregnancy.
• Mechanism of Support. This FOA will utilize the NIH Cooperative Clinical Research (U10) grant award mechanism.
• Funds Available and Anticipated Number of Awards. NICHD intends to commit approximately $5 million total costs in FY2011 to fund up to 16 new and or competing continuation grants in response to this FOA.
• Budget and Project Period. An applicant may request a project period of five years and a base budget for direct costs up to $200,000 per year. 
• Application Research Strategy Length: The U10 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.  See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Applicants may submit only one application in response to this FOA.
• Resubmissions.  Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired.  Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

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PEER REVIEW ENHANCEMENT 

NICHD Division of Scientific Review (DSR)     
Peter Zelazowski, Ph.D.
http://enhancing-peer-review.nih.gov/index.html

WHAT WAS ALREADY IMPLEMENTED in the peer review enhancement process (See Chart 1)

• Early Stage Investigator (ESI)/New Investigator (NI) policies  http://grants.nih.gov/grants/guide/ notice-files/NOT-OD-09-013.html

WHAT WILL BE IMPLEMENTED after January 25, 2010
Next phase of peer review enhancement is to shorten and restructure applications. See the URLs below.

• New application forms PHS 398 http://grants.nih.gov/grants/funding/phs398/phs398.html
• Changes to application page limits and aligning applications with review criteria
  http://grants.nih.gov/grants/guide/notice-files/not-od-09-149.html
  http://grants.nih.gov/grants/guide/notice-files/NOT-HS-10-002.html

• Strict page limit of 12 pages for the Research Plan/Strategy of R01 type RPGs including U10 (cooperative agreement) applications
• Changes in Biographical Sketch and Resources
•  Remember that the FOA (RFA, PA, PAR)instructions supersede the application guide/instruction

What’s New in Peer Review at NIH (Summary)

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Grant Applicant Statement Regarding Plan for Sharing Research Data

In October 1998, Congress passed, and the president signed, Public Law 105-277, known as the Shelby Amendment, which requires, through the provisions of the Freedom of Information Act, federal grantees to make data that result in a published report or that are cited in a federal rule or regulation available to members of the public on request.  While there are increased pressures for access to Federally-funded research data, so are there concurrent pressures for increased data protection.  The NICHD MFMU Network recognizes the NIH goals of data sharing.  A centralized mechanism for creating, managing and distributing research study data that has been collected from multiple clinical centers may be the most efficient and accurate way to ensure that the data set is de-identified.  A centralized mechanism is also the best way to monitor and enforce data use agreements between individual researchers and the MFMU Network.
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. 
All of the informed consent forms used for MFMU Network research studies contain language informing patients that the data are sent to the data coordinating center where they are put into a data base consisting of information from all of the participants in the study, and also that their data may be shared with other Network investigators, the sponsor of the study and other applicable Federal agencies.  The patients are also informed that the data the DCC receives are used only for statistical analysis and will not identify them.  The DCC reviews each of the clinical center’s IRB-approved consent forms to ensure that the correct language is included. 
To ensure patient protection, the following procedures have been established to totally de-identify the data before the DCC releases the research data sets to other investigators:

• the Network code (the unique identifier for each patient consisting of a computer-assigned number and the first initial of the patient’s first name) is removed;
• center number (and, therefore, enrollment location) is removed;
• individual records are scrambled out of sequential order (such as center and number order);
• dates are replaced by the number of days since a random, confidential reference date (which is not released outside the DCC);
• variables with low frequencies for some values that might be used to identify individual participants, are recoded or grouped into large categories (for example, age of mother below 15 and above 45);
• data on some racial/ethnic groups are collapsed when there are few individuals in certain groups or cells.  

In general, the data will be evaluated using accepted statistical and scientific principles and methods to ensure that the risk of re-identification is very small.  The methods and procedures used will be documented per the HIPAA requirements.
Initially, following the completion of a research study, all access to the data (with the exception of a single center ancillary study) is through the Data Coordinating Center which is responsible for conducting continuing secondary statistical analyses of the study data in conjunction with the proposing investigators.  All secondary proposals are reviewed and approved by the Network’s Publications Committee and, when necessary (e.g., after a study has been closed or if a biological fluids analysis not specified in the original protocol is requested), by the investigator’s IRB and the DCC’s IRB.  After a specified time, determined by the Steering Committee, the dataset is released to the Network’s participating centers.  The research data are contained in documented SAS datasets that include formats and important derived variables, such as gestational age at delivery.
The DCC ensures that the policies for use of the released database are followed.  Before releasing the data set to a Network center, an authorized individual from the institution must sign a data use agreement requiring that:

1. the database is for the use of the Network center investigators only and cannot be copied or distributed to other investigators outside their institution;
2. subject confidentiality must be maintained by not seeking or facilitating mechanisms leading to identification of individual subjects; and
3. all publications will acknowledge the assistance of the NICHD, the MFMU Network, and the Protocol Subcommittee in making the database available on behalf of the project.
4. In addition, a disclaimer must be included stating, “the contents of this report represent the views of the authors and do not represent the views of the NICHD MFMU Network”. 

Each investigator given access to the data will also be required to sign an agreement.  If the recipient moves to a new organization, then a new agreement will be required.  Prior to publication of an analysis of Network research, the investigator must provide the DCC with an advance copy of the abstract or manuscript.  The DCC will review the document only to ensure that it does not contain confidential information.
Subsequently (usually six months later or as determined by the Steering Committee), the DCC makes the de-identified data set available for release to external research investigators.  Prior to receiving the data set, the institution and the investigator will be required to sign a data use agreement and follow the procedures as described above.  Only a research investigator employed by an institution with an Institutional Review Board/Human Subjects Review Committee registered with the United States Office for Human Research Protections is qualified to receive the dataset. 
Since the Data Coordinating Center for the NICHD MFMU Network has experience in creating research datasets that protect patient identities and in implementing and monitoring data distribution and data use policies, this institution plans to support the DCC in its responsibilities for data management and data sharing which are in line with the Federal goals.

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