# Change in Scope or Data Sharing

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Learn more about changes in scope and how to request one.

## What constitutes a change in scope? 

In general, a principal investigator may make changes in the methodology, approach, or other aspects of a project. However, a change in scope is a change in the direction, aims, objectives, purposes, or type of research training identified in the approved project. Recipients must obtain prior approval from NINDS for a change in scope. The recipient must make the initial determination of the significance of these changes and should consult with the program officer and grants management specialist identified in their eRA Commons account for guidance. 

### Potential Indicators of a Change in Scope

> Changes in Topic or Techniques - Change in the specific aims approved at the time of award
- Shift of the research emphasis from one disease area to another
- Application of a new technology, such as changing assays from those approved to a different type of assay

> Changes in Research on Human Subjects or Vertebrate Animals - Substitution of one animal model for another
- Change from the approved use of live vertebrate animals
- Change from the approved involvement of human subjects that would result in an increased risk. This includes: 	   - An addition or change that would result in changing the overall human subjects or clinical trial designation of the award 		     - From non-human subjects research to human subjects research (exempt or non-exempt); 
    - From exempt to non-exempt human subjects research; or 
    - From "No Clinical Trial" to "Includes a Clinical Trial." Requests for this change must be submitted to a clinical trial NOFO as a competitive revision. See NIH definition of  clinical trial  and  2.3.5 - Types of Notices of Funding Opportunities . 
  - The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR 46 subparts B, C or D (pregnant women, human fetuses, and neonates; prisoners; or children)
  - Any change to the study protocol that would increase the risk level for subjects including physical, psychological, financial, legal or other risks. This could include the addition of a new study population that would be at higher risk from existing research procedures, the addition of new study procedures that are greater than minimal risk, any modification of existing study procedures that would increase overall risk, or the addition of a new clinical study or a new clinical trial intervention arm not originally proposed that is greater than minimal risk
  - New information indicating a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment
- A clinical hold by FDA under a study involving an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) 

> Changes in Investigator Team - Transfer of the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means. If the third party is a foreign component, NIH prior approval is always required. 
- Change in other senior/key personnel not specifically named in the  NoA  (see  Change in Status, Including Absence, of PD/PI and Other Senior/Key Personnel Named in the NoA  for requirements for NIH approval of alternate arrangements for or replacement of named senior/key personnel). 

> Changes in Budgeting - 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 25 percent or more of the total costs awarded. For example, if the award budget for total costs is $200,000, any rebudgeting that would result in an increase or decrease of more than $50,000 in a budget category is considered significant rebudgeting. The base used for determining significant rebudgeting excludes the effects of prior-year carryover balances but includes competing and non-competing supplements. Significant rebudgeting does not apply to modular grants. 
- Incurrence of research patient care costs if costs in that category were not previously approved by NIH or if a recipient desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category. 
- Purchase of a unit of equipment exceeding $25,000.

## Change in Data Sharing and Management Plan

              - Any change to an approved  Data Sharing and Management Plan  as outlined in the terms & conditions in your  notice of award  requires  **prospective** prior approval (retroactive approval is not allowable)
              - Prior approval requests  must be  submitted either in your RPPR or using the  eRA Prior Approval Module  as described in  NOT-OD-23-185  if the request falls outside of the RPPR submission timeline. Email and other communications are not acceptable. 

## How to Request Prior Approval for a Change in Scope 

A description of the change in scope, as well as a revised Specific Aims page should be submitted to the NINDS program officer and grants management specialist indicated in your eRA Commons account via the institutional signing official. 
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