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Research Data Management: NIH

NIH Data Management Plan Elements

(Adapted from NIH "Key Elements to Consider in Preparing a Data Sharing Plan")

While the precise content of a data sharing plan may vary depending on the data being generated and collected, addressing the basic questions of What, Who, Where, When, and How can assist researchers and research administrators in formulating a meaningful data sharing plan that communicates essential information about:

  • What data will be shared?
  • Who will have access to the data?
  • Where will the data to be shared be located?
  • When will the data be shared?
  • How will researchers locate and access the data?

What?

Final research data including all metadata and descriptors should be shared to make sharing meaningful and usable by other researchers.

  • What types of data are to be collected in the study and shared (e.g., genetic, physiological, clinical, medical history, etc.)?
  • Will the study include unique data that cannot be readily duplicated?
  • Will individual-level data or raw data also be shared, and if so, will the whole data set be shared? Will aggregate data (e.g., summary statistics or tables) also be shared?
  • What data quality control measures will be implemented?
  • What data documentation will be shared and what commonly accepted data standards or vocabularies will be used to enable others to interpret the data and improve interoperability with other data systems?
  • What format will be used to encode the data?  Will this format be consistent with extant, commonly used standards?

Who?

Data should be shared as broadly as possible to the extent consistent with applicable laws, regulations, rules, and policies.

  • Will the general public have access to some or all of the data?
  • Will access to certain data or certain components of the data be restricted to address specific rules, laws, regulations or policies (e.g., IRBs, human subjects, informed consent, etc.)?
  • What will researchers who seek to obtain data need to do to comply with any data access restrictions?
  • Are there any limitations on release of data that may be considered “sensitive”? 
  • What data sharing agreements will be necessary to appropriately restrict the transfer of protected, sensitive, or confidential data to others and to require that data be used only for research purposes?
  • Who will be operationally responsible for ensuring that no personally identifiable information is made available (e.g., principal investigator, independent curator)? 

Where?

Data repositories with common standards and an established infrastructure dedicated to the appropriate distribution of data would generally be ideal for data sharing.

  • Will an existing database, data repository, data enclave, or archive be used to store and disseminate the data and if so, how the policies and procedures in place for others to access the data are consistent with applicable NIH policies?
  • Will a new repository need to be developed, and if so, who/what will maintain the repository?
  • Will the data be distributed directly by an investigator to those who request it (e.g., through an electronic file)?

When?

Data should be made available as soon as possible and for as long as possible

  • What is the schedule for release of data? What will be shared prior to and upon acceptance for publication?  When will data be submitted to a repository?
  • Will data from ongoing longitudinal studies be released in increments as data become available?
  • How will data maintenance and access be ensured after the award ends? Will there be support for continued sharing of data (e.g., through grant applications, administrative supplements, or other sources) or planned migration of data to another database, data repository, etc.?

How?

Researchers need to be able to easily identify locations of relevant data and to be able to easily access the data.

  • What steps will be taken to help researchers know that the data sets exist? Will registries, repositories, indexes, word-of-mouth, publications, and/or other approaches be used to publicize the availability and accessibility of the data? Will these be linked and cross-referenced so other?
  • How will data be accessed (on the web, via ftp, email, etc.)?

NIH Funding Requirements and Information

As of October 1, 2003, NIH began requiring grant applications seeking $500K or more in direct costs in any single year of the project period to submit a data management plan with the application.

National Institutes of Health (NIH)


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