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Changes
in Scope on NIH Grants and Cooperative Agreements
Posted July 2002
What is a change in scope?
In general, the Principal
Investigator (PI) may make changes in
the methodology, approach, or other aspects of the project
objectives. However, the grantee must obtain prior approval
from the National Institutes of Health (NIH) for changes in scope, direction, type of training,
or other areas that constitute a significant change from the
aims, objectives, or purposes of the approved project. The
grantee must make the initial determination of the significance
of a change and should consult with the Grants Management
Officer (GMO) as necessary.
Please read the Notice of Grant Award to determine if any
restrictions or conditions have been placed on the award.
However, as noted, certain actions in the
following list always require NIH prior approval under the
circumstances specified. Actions that are likely to be considered a
change in scope include, but are not limited to, the following:
- Change in the specific aims approved at the time of award.
- Substitution of one animal model for another.
- Any change from the approved use of animals or human subjects.
- Shifting the research emphasis from one disease area to
another.
- A clinical hold by Food and
Drug Administration (FDA) under a study involving an IND
or an IDE.
- Applying a new technology, e.g., changing assays from
those approved to a different type of assay.
- Transferring the performance of substantive programmatic
work to a third party through a consortium agreement, by
contract, or any other means. NOTE: This type of action
always requires NIH prior approval for grants not subject
to expanded authorities. If the third party is a foreign
component, this prior approval requirement also applies
to grants subject to expanded authorities.
- Change in key personnel.
- Significant rebudgeting, whether or not the particular
expenditure(s) require prior approval. Significant rebudgeting
occurs when expenditures in a single direct cost budget
category deviate (increase or decrease) from the categorical
commitment level established for the budget period by more
than 25 percent of the total costs awarded.
- Incurrence of patient care costs if not previously approved
by NIH or if a grantee desires to rebudget additional funds
into or rebudget funds out of the patient care category.
- The addition of a foreign component requires prior approval
from the NIH Institute/Center's (IC's) Grants Office.
What should a grantee do if there is
a change in scope?
To request approval to make a change in scope, the PI should:
- Prepare a letter, countersigned by his/her institutional
business office, that provides the reason and rationale
for the change and address any budgetary impact to the grant
or cooperative agreement.
- The letter should also include revised budget pages and
curriculum vitae (CVs) as appropriate. Please fax the letter to the appropriate
Grants and Program staff at FIC or the other appropriate
NIH Institute or Center staff.
For more information concerning
changes in scope or other prior approval questions please
refer to the NIH Policy Statement at: http://grants1.nih.gov/grants/policy/nihgps_2001/part_iia_5.htm
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