NIH ANNOUNCES DRAFT STATEMENT ON SHARING RESEARCH DATA

Release Date:  March 1, 2002

NOTICE:  NOT-OD-02-035 (See NOT-OD-03-032 for Update)

National Institutes of Health 

Data sharing promotes many goals of the National Institutes of Health's 
(NIH) research endeavor.  It is particularly important for unique data 
that cannot be readily replicated.  Data sharing allows scientists to 
expedite the translation of research results into knowledge, products, 
and procedures to improve human health.  THE NIH IS DEVELOPING A 
STATEMENT ON DATA SHARING THAT EXPECTS AND SUPPORTS THE TIMELY RELEASE 
AND SHARING OF FINAL RESEARCH DATA FROM NIH-SUPPORTED STUDIES FOR USE 
BY OTHER RESEARCHERS.  INVESTIGATORS SUBMITTING AN NIH APPLICATION WILL 
BE REQUIRED TO INCLUDE A PLAN FOR DATA SHARING OR TO STATE WHY DATA 
SHARING IS NOT POSSIBLE.  This statement will apply to extramural 
scientists seeking grants, cooperative agreements, and contracts as 
well as intramural investigators.   

Institutions and individuals are invited to comment on the draft 
policy.  Additional information is available online on the NIH web site 
at: http://grants.nih.gov/grants/policy/data_sharing/index.htm
Comments must be received no later than June 1, 2002.  They should be 
sent to the Office of Extramural Research, 1 Center Drive, MSC 0152, 
Building 1, Room 150, Bethesda, MD 20817 or by email to dder@nih.gov  
Following consideration of public comments and appropriate revisions, 
it is expected that the new policy will be announced on August 1, 2002 
with a proposed effective date of January 1, 2003.  

Background Information

There are many reasons to share data from NIH-supported studies.  
Sharing data reinforces open scientific inquiry, encourages diversity 
of analysis and opinion, promotes new research, makes possible the 
testing of new or alternative hypotheses and methods of analysis, 
supports studies on data collection methods and measurement, 
facilitates the education of new researchers, enables the exploration 
of topics not envisioned by the initial investigators, and permits the 
creation of new data sets when data from multiple sources are combined.  
By avoiding the duplication of expensive data collection activities, 
the NIH is able to support more investigators than it could if similar 
data had to be collected de novo by each applicant.

NIH-supported basic research, clinical studies, surveys, and other 
types of research produce data that may be shared.  However, NIH 
recognizes that sharing data about human research subjects presents 
special challenges.  The rights and privacy of people who participate 
in NIH-sponsored research must be protected at all times.  Thus, data 
intended for broader use should be free of identifiers that would 
permit linkages to individual research participants and variables that 
could lead to deductive disclosure of individual subjects.  Similarly, 
NIH recognizes the need to protect patentable and other proprietary 
data and the restriction on data sharing that may be imposed by 
agreements with third parties.  It is not the intent of this statement 
to discourage, impede, or prohibit the development of commercial 
products from federally funded research.

There are many ways to share data.  Sometimes data are included in 
publications.  Investigators may distribute data under their own 
auspices.  Some investigators have placed data sets in public archives 
while others have put data on a web site, building in protections for 
privacy through the software while allowing analysis of the data.  
Restricted access data centers or data enclaves facilitate analyses of 
data too sensitive to share through other means.  All of these options 
achieve the goals of data sharing.

However, the NIH also recognizes that in some particular instances 
sharing data may not be feasible.  For example, studies with very small 
samples or those collecting particularly sensitive data should be 
shared only if stringent safeguards exist to ensure confidentiality and 
protect the identity of subjects.

The NIH will expect investigators supported by NIH funding to make 
their research data available to the scientific community for 
subsequent analyses.  Consequently, the NIH will require that data 
sharing be addressed in grant applications (e.g., in sections related 
to significance, budget, and the end of the research plan) and in the 
review of applications.  Funds for sharing or archiving data may be 
requested in the original grant application or as a supplement to an 
existing grant.  Investigators who incorporate data sharing in the 
initial design of the study can more readily and economically establish 
adequate procedures for protecting the identities of participants and 
provide a useful data set with appropriate documentation.  Applicants 
whose research will produce data that are not amenable to sharing 
should include in the application reasons for not making the data 
available.  NIH encourages investigators to consult with an NIH Program 
Administrator prior to submitting an application to determine the 
appropriateness of data sharing and a suitable mechanism to disseminate 
the data.  

This statement on data sharing is an extension of NIH policy regarding 
sharing research resources, which expects that recipients of NIH 
support will provide prompt and effective access to research tools.  
(See NIH Grants Policy, Part II Subpart A, Availability of Research 
Results: Publications, Intellectual Property Rights, and Sharing 
Biomedical Research Resources 
(http://grants.nih.gov/archive/grants/policy/nihgps_2001/nihgps_2001.pdf)
This statement is also an extension of the PHS policy relating to the 
distribution of unique research resources produced with PHS funding 
(see http://grants.nih.gov/grants/guide/notice-files/not96-184.html)  
Principles and guidelines for sharing biomedical research resources can 
be found in online NIH reports at
http://www.nih.gov/science/models/sharing.html
and http://www.nih.gov/news/researchtools/index.htm.  Moreover, this 
statement on data sharing is consistent with the policies of many 
scientific journals publishing the findings of NIH-supported research.  


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