An ancillary study is an investigation which is not part of the Jackson Heart Study (JHS) protocol but uses all or a subgroup of the JHS cohort, samples, or data collected by JHS. In most cases, an ancillary study will involve the acquisition of additional interviews or examinations of study participants as well as analysis of blood, urine, tissue or other samples, or images previously collected, which are not compiled as part of the standard JHS data set.
Ancillary studies are subject to the same policies, reviews and approvals as the core JHS protocol. The highest priority will be given to studies which:
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Have the highest scientific merit,
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Do not interfere with the main study objectives
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Produce the least burden on participants
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Have objectives directly related to the study
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Require the unique characteristics of the cohort
A JHS investigator must be involved as either the PI or included as a co-investigator in every ancillary study proposal. A list of JHS investigators and their areas of interest is available at http://jhs.jsums.edu/jhsinfo/
In order to build minority student capacity in research, the Ancillary Studies Subcommittee (ASC) encourages the involvement of African American graduate and undergraduate students. Ancillary study applications must be submitted for review at least 90 days prior to the deadline for the funding application.
Investigators are required to notify the JHS Ancillary Studies Coordinator, Brenda Campbell Jenkins, Brenda.w.campbell@jsums.edu, of their intent to submit an ancillary study prior to submission. Completed ancillary study proposals should be submitted to the Ancillary Studies Coordinator and copied to the ASC Chair and Co-Chair. (Contact information is located at http://jhs.jsums.edu/jhsinfo/ForResearchers/AncillaryStudies/tabid/77/Default.aspx. The ancillary study proposal form is available on the JHS web site (http://jhs.jsums.edu/jhsinfo). Specific questions related to ancillary studies should be directed to the ASC Coordinator.
The JHS Ancillary Studies Subcommittee (ASC), Steering Committee (SC), and the National Heart, Lung and Blood Institute (NHLBI) Project Office must approve ancillary study proposals prior to submission for funding and prior to implementation.
The JHS ASC will use the criteria listed on the “Proposal Review Form” to determine whether an ancillary study should be approved, approved pending revisions, reconsidered after revisions or disapproved. Following review, the investigator will receive electronic notification of ASC actions. The proposal will be sent to the Steering Committee (SC) and NHLBI for review.
Until formal written notification from NHLBI is received, the proposed study cannot be submitted for funding.
The abstract of every approved proposal will be posted on the JHS web site
The post approval procedures include IRB approval, completion and submission of a Data and Materials Distribution Agreement and submission of a Data Request Form.