NIH Funding and Award Policies
This link describes the NHLBI implementation of the NIH policy requiring all applications that request $500,000 or more in direct costs in any year to first contact the Institute and request approval from the Institute for these type of application.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 the JHS. In most cases, an ancillary study will involve the acquisition of additional interviews; examinations of study participants; 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:
• Have the highest scientific merit
• Do not interfere with the main study objectives
• Produce the least burden on participants
• Have objectives directly related to the study
• 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.
In order to build minority student capacity in research, the Ancillary Studies Subcommittee (ASSC) encourages the involvement of African American graduate and undergraduate students. Ancillary study applications must be submitted for review at least 12 weeks prior to the deadline for the funding application.
Investigators are required to notify the JHS Chief Science Officer (CSO) or the Chairperson of the Ancillary Studies Subcommittee (ASSC) of their intent to submit an ancillary study prior to submission. In addition, the PI must complete the Ancillary Concept Form. The JHS Ancillary Study Resource Unit will review the concept form and provide feedback to the investigators before the proposal may be submitted.
The JHS Ancillary Studies Subcommittee (ASSC), 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 ASSC 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 ASSC 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 website. The post approval procedures include IRB approval, completion and submission of a Data and Materials Distribution Agreement and submission of a Data Request Form.