NIH Issues Final Data Sharing Statement
The following is an excerpt from a notice sent by the Council
on Governmental Relations (COGR) to member organizations on
2/26/03. As we reported at the COGR membership meeting early this month,
the National Institutes of Health (NIH) announced in the NIH
Guide its final Statement on Sharing Research Data (NOT-OD-03-032).
Reaffirming its support for the concept of the sharing of all
data supporting research results to advance the scientific enterprise,
NIH is requiring any application requesting $500,000 or more
in direct costs in any single year of the project period to
include a plan for data sharing or rationale for why data sharing
is not possible. This requirement will begin with applications
submitted on or after October 1, 2003. You will recall that NIH requires any investigator considering
an application over $500,000 in direct costs in a single year
to receive an agreement to accept the assignment of the application
from the affected Institute or Center six weeks in advance of
the submission date (NOT-OD-02-004). Today's notice encourages
applicants to discuss their data-sharing plan with the program
contact during these assignment discussions. Solicitations will
include instructions for the plans and NIH cautions that some
Program Announcements that anticipate awards totaling less than
$500,000 direct costs in any single year may require a plan.
Further, the notice states that reviewers will not factor the
proposed data plan into the determination of scientific merit
or priority score. The program staff will assess the plans.
To assist applicants in preparing the plans, NIH has posted
a number of resource documents on its web site at: http://grants.nih.gov/grants/policy/data_sharing/index.htm
The final statement is available on this site as well. In response
to concerns over the release of data before publication, NIH
revised its definition of "timely release and sharing" to be
no later than the acceptance for publication of the main findings
from the final data set. Considerations for data sharing plans.
Additional Comments on Feb 28, 2003:
COGR members have contacted us to offer some observations and
advice as applicants prepare their data sharing plans. If the
data produced under an NIH-funded project might be included
in a patent application, a NIH applicant may want to delay distribution
or sharing of the data until the university files the patent
application. NIH recognizes the need for delays in these cases
and offers the following guidance (in FAQ Q. # 9): "While
the NIH understands that the filing of a patent application
to secure intellectual property rights may justify a need to
delay disclosure of research findings, a delay of thirty (30)
to sixty (60) days is generally viewed as a reasonable period
for such activity."
Some editors may object to the distribution or disclosure of research findings before publication (but after acceptance) of an article for a journal. Authors may want to consult with the editor(s) to establish a reasonable timeframe for the implementation of the data-sharing plan. This type of delay should be consistent with NIH's assertion that "NIH recognizes that the investigators who collected the data have a legitimate interest in benefiting from their investment of time and effort. We expect the initial investigators to benefit from first and continuing use but not from prolonged exclusive use."
A data-sharing plan that indicates that there may be delays triggered by the filing of patent applications or the policies of a journal should be sufficient to meet NIH's goals. As the statement released yesterday notes, the program staff will be responsible for oversight and "assessing the appropriateness and adequacy of the proposed data-sharing plan." The preliminary discussion with program staff will be a good opportunity for reviewing these issues.