STRONG HEART STUDY ANCILLARY STUDY AND SUB-STUDY GUIDELINES AND PROPOSAL

The Strong Heart Study (SHS) welcomes investigators to propose ancillary studies or sub-studies that are related to cardiovascular disease and its risk factors using resources that can be provided by the SHS.

  • Ancillary Studies

An ancillary study requires additional participant contact, for example, administration of a questionnaire, personal interview, physical examination, etc., and separate funding.

Ancillary study proposals must be approved by the SHS Steering Committee, the participating tribes , institutional IRB and the Indian Health Service IRBs.

A proposal is required to be submitted to Dr.Shelley A. Cole (scole@txbiomed.org), Chair of the SHS Steering Committee. An ancillary study proposal form must be completed and therequired narratives attached.

Investigators who are not affiliated with SHS need to work with a SHS investigator (PI or co-investigator).A directory of current SHS investigators is located on the SHS website at  http://strongheartstudy.org/ContactUs.aspx

Submission Deadlines: Investigator-initiated Ancillary Study proposals must be submitted to the SHS no later than three months prior to the due date of the funding agency.Ancillary proposals in response to an RFA must be submitted to the SHS as soon as possible or no later than six (6) weeks prior to the due date of the funding agency.

If summary statistics or other data are needed from the SHS Coordinating Center (CC), at least four (4) weeks will be allowed for the CC to provide the information.Agreement with the SHS CC about the costs needed to perform such tasks is negotiable.

At least two-weeks prior to the grant submission deadline, a near-final draft of the proposal will need to be submitted to the SHS collaborators to allow review for potential errors and omissions regarding participant contact and data availability.
At least two -weeks prior to the grant submission deadline, the final draft of the Resource Sharing Plan (including Data Sharing and Genomic Data Sharing plans if applicable)must be sent to the SHS Steering Committee for review.

  • Sub-studies

A sub-study does not require participant contact.  It uses the SHS repository data and/or specimens to study cardiovascular disease and its related risk factors.  Separate funding may be required, for example, if the sub-study requires additional lab tests.  Sub-study proposals must be approved by the SHS Steering Committee.  

 Investigators who are not affiliated with SHS need to work with a SHS investigator (PI or co-investigator). A directory of current SHS investigators is located on the SHS website at http://strongheart.ouhsc.edu.

A proposal is required to be submitted to Dr. Shelley A. Cole (scole@txbiomed.org), Chair of the SHS Steering Committee.  A sub- study proposal form must be completed and the required narratives attached. 

Submission Deadlines:   Investigator-initiated Sub-Study proposals must be submitted to the SHS no later than two (2) months prior to the due date of the funding agency. Sub-Study proposals in response to an RFA must be submitted to the SHS as soon as possible or no later than six (6) weeks prior to the due date of the funding agency.

If summary statistics or other data are needed from the SHS Coordinating Center (CC), at least four (4) weeks will be allowed for the CC to provide the information.  Agreement with the SHS CC about the costs needed to perform such tasks is negotiable.

  • Data Distribution Requirements for Both Ancillary Studies and Sub-studies

The following data distribution requirements are for both ancillary studies and sub-studies.

A data distribution agreement or a specimens distribution agreement must be signed by the proposing investigators after the proposal has been approved by the SHS Steering Committee.  If using SHS genetic or pedigree data, an additional data access and distribution agreement for genetic data must be signed.


Part 1: Basic Study Information and Projected Impact on SHS

Part 2: Description of the Proposed Ancillary Study or Sub-study

Checklist and Timeline for Ancillary Study and Sub-study Proposal Submission