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Ancillary Studies


 

Ancillary Study proposals must obtain CHS and NHLBI approval before submission to a funding agency. 

To submit your proposal for review:  Download the Ancillary Study Proposal form from the Forms & Agreements menu

Instructions:

  • New Data Collection studies:  complete the full Ancillary Study Proposal form
  • Analysis-only studies:  complete Part 1 only + first planned paper proposal (online submission form via internal site (password protected))

Submission Deadlines:  

New proposals must be submitted to CHS a minimum of 6 weeks prior to a grant deadline, preferably earlier if the project involves a subcontract. Proposals received after this deadline will not receive expedited review and may require that investigators postpone their grant submission.

Upcoming Deadlines:

CHS 6-week Deadline NIH Deadline
4/24/19 6/5/19
8/24/19 10/5/19
*12/20/19 2/5/20

*adjusted due to holiday

Agreement with the Coordinating Center and, if applicable, the CHS Central Laboratory about the costs needed to perform an ancillary study is required for Steering Committee approval.

Definition of an Ancillary Study

An ancillary study is an investigation which is not part of the central, NHLBI-funded CHS protocol but uses CHS participants, samples, or data collected by CHS.  An ancillary study can involve acquisition of additional data which are not compiled as part of the standard CHS data set, or analysis of existing CHS data only in a paper or series of papers as part of a new external funding application. 

Support for ancillary studies is derived from sources other than CHS grant or contract funds. Examples include studies funded by investigator-initiated NIH research awards (R01s), grants from academic institutions, private sources (e.g. drug companies), or those performed at no cost (generally because of the special interest of a researcher).

Rationale for Ancillary Studies

Investigators are encouraged to propose and conduct ancillary studies.  Such studies enhance the value of CHS and ensure the continued interest of the diverse group of investigators who are critical to the success of the study as a whole.  They provide an exceptional opportunity for investigators, either within or outside of CHS, to conduct additional projects at minimal cost. 

Types of Ancillary Studies

There are two types of ancillary studies in CHS:

  1. New Data Collection studies generate new CHS data, either through new interaction with participants, or by using existing stored biological specimens, images, medical records, or previously collected data to create new measures.
  1. Analysis-only studies analyze existing CHS data only, in a paper or series of papers as part of a new external funding application, regardless of whether significant Coordinating Center (CC) services (e.g., data set preparation or analysis by a CC Statistician) are requested.

When an Ancillary Study Proposal is Not Required

Proposals to analyze existing CHS data that are supported by external funding already awarded are not considered ancillary studies and may be submitted via the online manuscript proposal form. If the manuscript proposal involves billable CC services such as a dataset then these can be invoiced upon completion via the CC's fee-for-service account.  If your institution requires a subcontract for such services, however, then the project must be routed as an ancillary study. 

 

 

Questions?  Please contact Erika Enright.

 

 

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