NIH Final Statement on Sharing Research Data

1
NIH Final Statement on Sharing Research Data

• Released February, 2003
• Effective October 1, 2003

2
Old Policy

• NIH has always expected the sharing of data
  resulting from NIH funding.
• From the NIH Grants Policy Statement
• Organizations that receive NIH grants or
  cooperative agreements (or contracts) have an
  obligation to preserve research freedom,
  safeguard appropriate authorship, and ensure
  timely disclosure of their scientists' research
  findings

3
New Policy

• Reaffirms NIHs expectation for the timely
  release and sharing of final research data from
  NIH-supported studies for use by other
  researchers.
• Requires that a plan for data sharing be included
  in proposals requesting 500,000 or more in
  direct costs in any one year.

4
New Policy definitions

• Timely is defined as no later than the acceptance
  for publication of the main findings from the
  final data set.

5
New Policy definitions

• Final research data are defined as recorded
  factual material commonly accepted in the
  scientific community as necessary to document,
  support, and validate research findings. This
  does not mean summary statistics or tables
  rather, it means the data on which summary
  statistics and tables are based.

6
New Policy proposal requirement

• Plan should be discussed with Program Manager at
  the time that permission to submit a proposal
  requesting more than 500,000 annual direct cost
  is discussed.
• The data sharing plan is included at the end of
  the research plan and is not included in the
  page limit although reference may be
  appropriate for other sections of the proposal

7
New Policy the plan

• Given the breadth and variety of science that NIH
  supports, neither the precise content for the
  data documentation, nor the formatting,
  presentation, or transport mode for data is
  stipulated. What is sensible in one field or one
  study may not work at all for others.
• Care must be taken to protect the identity and
  privacy of individual subjects in all cases.

8
New Policy the plan

• Data sharing plans may range from simply sending
  data on disks when requested or posting to a
  website to elaborate archives.
• Data sharing plans may include data sharing
  agreements to impose reasonable conditions for
  the use of the data.
• Costs for data sharing may be included in
  proposal budgets or passed on to those requesting
  the data.

9
New Policy review considerations

• 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.

10
New Policy obligations

• If an application describes a data-sharing plan,
  NIH expects that plan to be enacted. If progress
  has been made with the data-sharing plan, then
  this should be described in the progress report.
  In the final progress report, if not sooner,
  steps that have been taken with respect to the
  data-sharing plan should be included.

11
New Policy -- resources

• NIH has a web site devoted to this policy at
  http//grants1.nih.gov/grants/policy/data_sharing/
  index.htm with
• Policy statements
• Implementation guidance
• Data sharing workbook with example plans
• Frequently asked questions
• Links to other resources