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Ancillary Studies
- Getting Started
- Ancillary Study Policy
- Biospecimen Policy
- CHS Guidelines for Genetic Studies - June 2008
- CHS All Stars Ancillary Study
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updated 12/8/23
2023 REVISED POLICY FOR DATA AND SPECIMEN REQUESTS FROM CHS
The CHS-NHLBI contract is currently scheduled to end on October 31, 2024. In preparation for this event, the Lab and Coordinating Center will be closing down activities during the preceding months in preparation for transitioning data and biospecimens to the NIH BioLINCC repository. Therefore, please be aware of the following important information regarding availability of data and specimens for ancillary studies:
Existing Projects
- CHS-approved ancillary studies that include biospecimens and are already submitted for funding: We are committed to honoring previously approved projects but be aware they will require extra coordination with the CHS CC and/or Lab (if funding is awarded).
- CHS-approved ancillary studies pending resubmission for funding (with or without specimens): We will honor the approval but investigators should be aware that they may need to obtain specimens and/or data through NIH BioLINCC, depending on when the project starts.
New Projects
- New ancillary study proposals may be submitted to CHS and will be considered on a case-by-case basis. While CHS cannot at this time provide a commitment to provide specimens or data, the CC and Laboratory can work with investigators to help facilitate obtaining specimens or data from NIH BioLINCC.
Instructions:
Ancillary Study proposals must obtain CHS and NHLBI approval before submission to a funding agency.
- New proposals must be submitted to CHS a minimum of 6 weeks prior to a grant deadline, preferably earlier to allow time for revisions and re-review, if needed.
- New proposals involving subcontracts should be submitted well in advance of this 6-week deadline.
- Revised proposals are not subject to this deadline, although sufficient time for review and for potential further revision should still be provided.
- 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.
To submit your proposal for review: Download the Ancillary Study Proposal form from the Forms & Agreements menu.
- New Data Collection studies: complete the full Ancillary Study Proposal form and send to Ancillary Studies Coordinator along with Lab's biorepository impact report (if relevant).
- Analysis-only studies: complete Part 1 only of the Ancillary Study Proposal form + first planned paper proposal (online submission form via internal site (password protected)). See also: step-by-step instructions.
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:
- 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.
- 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.
Questions? Please contact Erika Enright.
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