FINAL NIH STATEMENT ON SHARING RESEARCH DATA

RELEASE DATE:  February 26, 2003

NOTICE:  NOT-OD-03-032

National Institutes of Health ((NIH)

As part of NIH's long-standing policy to share and make available to 
the public the results and accomplishments of the activities that it 
funds, NIH announced and invited comments on a draft statement about 
the sharing of final research data on March 1, 2002.  Since that time, 
NIH has received and reviewed many thoughtful comments from a range of 
scientific organizations and over 150 individuals. Additionally, during 
the comment period, HHS published final modifications for the STANDARDS 
FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION, the 
"Privacy Rule," of the Health Insurance Portability and Accountability 
Act (HIPAA), available at http://www.hhs.gov/ocr/.  The Privacy Rule is 
a federal regulation that governs how certain health care providers, 
health care clearinghouses, and health plans, known as "covered 
entities," use and disclose identifiable health information.  NIH has 
carefully considered the comments and the Privacy Rule, and issues the 
following statement on data sharing:  
 
NIH reaffirms its support for the concept of data sharing.  We believe 
that data sharing is essential for expedited translation of research 
results into knowledge, products, and procedures to improve human 
health.  The NIH endorses the sharing of final research data to serve 
these and other important scientific goals.  The NIH expects and 
supports the timely release and sharing of final research data from 
NIH-supported studies for use by other researchers.  Starting with the 
October 1, 2003 receipt date, investigators submitting an NIH 
application seeking $500,000 or more in direct costs in any single year 
are expected to include a plan for data sharing or state why data 
sharing is not possible.  

As indicated above, all investigator-initiated applications with direct 
costs greater than $500,000 in any single year will be expected to 
address data sharing in their application. Applicants are encouraged to 
discuss their data sharing plan with their program contact at the time 
they negotiate an agreement with the Institute/Center (IC) staff to 
accept assignment of their application as described at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.   
Applicants are reminded that agreement to accept assignment of 
applications over $500,000 must be obtained at least six weeks in 
advance of the anticipated submission date. Instructions related to the 
data sharing policy as it is applied to applications and proposals 
responding to a specific Request for Application (RFA) or Request for 
Proposals (RFP) will be described in the specific solicitation.  In 
some cases, Program Announcements (PA) may request data sharing plans 
for applications that are less than $500,000 direct costs in any single 
year.  Reviewers will not factor the proposed data-sharing plan into 
the determination of scientific merit or priority score. Program staff 
will be responsible for overseeing the data sharing policy and for 
assessing the appropriateness and adequacy of the proposed data-sharing 
plan. 

NIH recognizes that data sharing may be complicated or limited, in some 
cases, by institutional policies, local IRB rules, as well as local, 
state and Federal laws and regulations, including the Privacy Rule.  As 
NIH stated in the March 1, 2002 draft data sharing statement 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html), 
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 the identity of individual subjects. When data 
sharing is limited, applicants should explain such limitations in their 
data sharing plans. 
 
The final NIH statement on data sharing is largely the same as stated 
in the March 1, 2002 draft with the following exceptions:  
 
o  The effective start date has been changed from January 1, 2003 to 
October 1, 2003 receipt date.

o  This policy applies to applicants seeking $500,000 or more in direct 
costs in any year of the project period.  Such applicants are expected 
to contact IC program staff prior to submission and are also expected 
to include a data-sharing plan in their application stating how they 
will share the data or, if they cannot share the data, why not. 
Applicants responding to an RFA or RFP will find instructions related 
to data sharing in the specific announcement.  

o  Several groups and individuals objected to sharing of research data 
prior to publication.  As noted earlier, NIH recognizes that the 
investigators who collect the data have a legitimate interest in 
benefiting from their investment of time and effort.  We have therefore 
revised our definition of "the timely release and sharing" to be no 
later than the acceptance for publication of the main findings from the 
final data set.  NIH continues to expect that the initial investigators 
may benefit from first and continuing use but not from prolonged 
exclusive use.  
 
For more information on data sharing, please see our website at 
http://grants.nih.gov/grants/policy/data_sharing/.

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