Strong Heart Study Ancillary Study and Sub-study Guidelines and Proposals

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.

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.

Policy Guidelines:  Please refer to the following documents for additional information:

Ancillary and Sub-study Policy

Propose an Ancillary Study:  Please complete this Online Ancillary Study Proposal Form   to propose a study.

 

 

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, the participating tribes, institutional IRB and the Indian Health Service IRBs.

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 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.
 

Policy Guidelines:  Please refer to the following documents for additional information:

Ancillary and Sub-study Policy

Propose an Ancillary Study:  Please complete this Online Ancillary Study Proposal Form   to propose a study.

                 

Data Distribution Requirements 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.