Notice Number: NOT-OH-17-005

Key Dates
Release Date: December 8, 2016

Issued by
The National Institute for Occupational Safety and Health (NIOSH)

Purpose

HHS/CDC policy requires that grant award recipients make research resources including data readily available after publication to qualified individuals within the scientific community for research purposes. CDC requires that all new collections of public health data include a Data Management Plan (DMP). For purposes of this announcement, “public health data” means digitally recorded factual material commonly accepted in the scientific community as necessary to validate research findings including datasets used to support scholarly publications. This new requirement ensures that CDC is in compliance with the following; Office of Management and Budget (OMB) memorandum titled “Open Data Policy Managing Information as an Asset” (OMB M-13-13); Executive Order 13642 titled “Making Open and Machine Readable the New Default for Government Information”; and the Office of Science and Technology Policy (OSTP) memorandum titled “Increasing Access to the Results of Federally Funded Scientific Research” (OSTP Memo).

Investigators seeking NIOSH funding should include a data management plan (DMP) for how they will collect, analyze, store, use and make available the data collected for the proposed project or activity. If data sharing is not possible, applicants need to provide a justification explaining the reasons for not sharing their data. The costs of sharing or archiving data may be included as part of the total budget requested for first-time or continuation awards. awardees for CDC funds should incorporate data release into their study designs and should do the following: (a) set up procedures for protecting personal or proprietary information, (b) ensure data quality, and (c) include appropriate documentation (e.g., data dictionary, codes, etc.) for reuse of data. The CDC AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

Investigators should describe how they will share public health research or non-research data from their project in the form of a brief paragraph in the Resource Sharing Plan section of the application.
Grant reviewers will evaluate the DMP during peer review for completeness and quality at the time of submission and must address the following questions:

What types of data do you plan to generate include the size, file formats, number of files?
Who will find your data useful?
Are there limitations on the secondary research use of data, if the study involved human data?
What transformations will be necessary to prepare data for preservation and sharing?
What metadata documentation will be submitted with the data?
Will a data sharing agreement be required?
What will the agreement state?
Describe whether data will be provided directly to the researchers, or if access will be provided to a restricted online database or at a CDC-controlled site (e.g., the National Center for Health Statistic’s Research Data Center)?
Which archive/repository/central database have you identified as a place to deposit?
What is the expected timeline from data collection to release or anticipated date of release?

Data Management Plan Progress Reporting

Routine reviews and reports specified within the Notice of award (NoA) terms and conditions will be used to monitor awardee progress. Such reports may include an updated DMP that describes the progress made in executing plans indicated in the DMP, necessary changes made to the plans, and/or any additional information related to the data. Awardees should justify changes from the original DMP, and these changes should be concurred by the funding program and approved by both the assigned NIOSH Program Official (PO) and the Grants Management Specialists (GMS) before implementation.

At the end of the project funding period, the awardee will submit a final DMP. The final DMP will include the location of each dataset, any restriction to access, and changes to the plans for long term preservation of the data. The final DMP should also indicate that all laws, regulations, and rights regarding the data have been complied with. The assigned PO should review and determine if the final DMP meets the stated objectives of the initially approved DMP. The GMS and/or the PO will inform the awardee if further actions are needed to meet the stated objectives of the DMP.
Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance consistent with 45 CFR 74.62 or other authorities as appropriate. Such procedures include, but are not limited to, reduction in funding, restriction of funds, or award termination. The DMP is not intended to replace other grant reporting requirements.

Inquiries

Please direct all inquiries to:

Viji Potula, PhD
National Institute for Occupational Safety and Health
Telephone: 404-498-2551
Email: [email protected]