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

**SHS ancillary study modifications requiring re-approval by the NHLBI SHS OSMB:

Any previously-approved Strong Heart Study (SHS) ancillary study proposal that is subsequently modified must obtain SHS NHLBI OSMB re-approval if the modification(s):
 

1. Increase the number of ancillary participants by more than 10%
2. Increase ancillary sample volume needed by more than 10%
3. Increase the scope of the project through additional hypotheses/specific aims
4. Increase the amount of participant burden by adding one or more additional participant visits
5. Increase the amount of participant burden by adding additional measures that would result in more than an estimated 30 minutes of additional participant burden

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.

• SHS Ancillary Study Proposal Form
• Special Guidelines for Ancillary Studies submitted for the June, 2019 Steering Committee review (PDF)

Please refer to the following for additional information:

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 (PDF)

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.

• SHS Online Sub-study Proposal Form

Please refer to the following for additional information:

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 (PDF)

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.