Ancillary Studies Guidelines

NIH Funding and Award Policies

Note:  

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.
Submit Ancillary Proposal

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 before submitting proposal.

Click here to Submit Ancillary Proposal.   

For easy access, the following forms are attached as appendices to these instructions:
 
Appendix A .................................................... Data and Materials Distribution Agreement
 
Appendix B..................................................... Signature Sheet for Ancillary Study Proposal
 
Appendix C.....................................................Statistical Data Request
 
Appendix D..................................................... “Ethical and Practical Guidelines for Reporting Genetic Research Results    To Study Participants: Updated Guidelines from an NHLBI Working Group”     
by Richard Fabsitz et.al. 

Appendix E..................................................... Lab Policies and Procedures
 
Appendix F..................................................... Progress and Report Form
 
 

The following video tutorial provides information on how to register for an account and submit an ancillary study proposal.

 

Registration: http://www.screencast.com/t/kiJYJ0r94 

Concept Form Submission:  http://www.screencast.com/t/QgCTSePWyHe

Ancillary Study Submission:  http://www.screencast.com/t/LSgOVT8qu


FOR ANSWERS TO QUESTIONS: Contact the Administrative Coordinator for the Ancillary Studies Subcommittee:
                            Email: jhsanc@umc.edu 
                            Phone: (601) 815-5778

Download Guidelines (PDF) 01/13/2016

Proposal Form (Template) 01/13/2017
 

Frequently Asked Questions
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, complete the Ancillary Concept form at Ancillary Concept Form.  
After receiving feedback from the Jackson Heart Study, the Principal Investigator should complete the Ancillary Study Proposal Form available on the JHS website.
Yes, it is required that you collaborate with a JHS investigator.
No, you should submit a manuscript proposal to the JHS Publication and Presentation subcommittee. Questions should be submitted to jhspub@umc.edu.

Genetic and Biospecimen proposals

12 weeks prior to grant deadline

Biospecimen Proposals

12 weeks prior to grant deadline

Proposal Involving Participants

12 weeks prior to grant deadline

Service Type

Fee

Simple data request

$3,000

Moderate data request

$5,000

Advanced data request

$5,000

Plasma/Serum Samples:

Fee

Pull, aliquot, and ship

$5 per vial (random order, standard cryovials, labeling, and shipping)

Pull, aliquot, reorganize/pair across visits, and ship

$7.50 per vial

Special tubes, labels, and handling

Negotiated on a case-to-case basis

Shipping outside the US

Additional shipping costs

DNA Samples:

Fee

Standard preparation into plates

$5.00 per sample

Concentrations (for requests above 100ng/uL

$6.50 per sample

Amplications

$30.00 per sample

Shipping in cryovials instead of plates

Additional $1.00 per sample

Shipping outside the US

Additional shipping costs

The Jackson Heart Study Data and Materials Distribution Agreement (DMDA) is a materials transfer agreement. The investigator initiated agreement is required for all approved data and/or material distributions.
Investigator IRB approval is required of all approved data and /or material distributions along with the DMDA.
Proposals involving industry sponsorship, in kind services or collaboration with an investigator with industry ties must complete a Third Party Agreement.
NIH Due Dates for Grant Applications

updated(8/4/2015)

 new R01’s are due the 5th of February, June, and October

  • renew/resubmissions/revised R01’s are due the 5th of March,July, and November
  • new K’s are due the 12th of February, June and October
  • renew/resubmissions/revised K’s are due the 12th of March, July and November.


Activity Codes

Program Description

Application Instructions

Cycle I
Due Date

Cycle II
Due Date

Cycle III
Due Date

R01
new

Research Grants

SF424 (R&R)


February 5

June 5

October 5

U01
new

Research Grants - Cooperative Agreements

SF424 (R&R)


February 5

June 5

October 5

K series
new

Research Career Development

SF424 (R&R)


February 12

June 12

October 12

R03, R21, R33, R21/R33, R34, R36, UH2, UH3, UH2/UH3
new

Other Research Grants and Cooperative Agreements

SF424 (R&R)


February 16

SeeNOT-OD-15-057


June 16

October 16

R15
All - new, renewal, resubmission, revision

Academic Research Enhancement Award (AREA)

SF424 (R&R)


February 25

June 25

October 25

R01
renewal, resubmission, revision

Research Grants

SF424 (R&R)


March 5

July 5

November 5

U01
renewal, resubmission, revision

Research Grants - Cooperative Agreements

SF424 (R&R)


March 5

July 5

November 5

K series
renewal, resubmission, revision

Research Career Development

SF424 (R&R)


March 12

July 16

November 12


CompletedAncillaryStudies

ASN #

Title

Principal Investigator

0002

Relationship of Elevated Iron Stores to Diabetes Mellitus and Nephrology in African Americans

James G. Wilson

0006

Stroke Risk and Progression of Hearing Loss in the Jackson Heart Study

John M. Schweinfurth

0007

The Broad-Novartis Diabetes Initiative: Jackson Heart Study Component

David Altshuler

0008

Genome Wide Admixture Mapping in the Jackson Heart Study

James G. Wilson

0010

Variation in the Cardiac Sodium Channel Gene SCN5A

Dan Roden

0013

Jackson Heart Study Sample Inclusion for Genetic Prediction of Essential Hypertension

Robin Felder

0016

Risk Burden of the SCARBI and ApoF Lipoprotein Metabolic Gene Haplotype in the Jackson Heart Study

Jeffrey Anderson

0018

Analyses of the Allelic Spectrum of Cardiovascular Disease Genes in the Jackson Heart Study

Christine Seidman

0022

The Relationship between Dietary Intake, Gene-Nutrient interactions and Heart Disease in the Jackson Heart Study

Latrice Goosby

0033

The NHLBI’s Candidate Gene Association Resource: the JHS Component


James G. Wilson

0035

Genome wide association scan for diabetic retinopathy in the Jackson Heart Study


Lucia Sobrin

0046

Polymorphisms in hyponatremia and hypernatremia in the Jackson Heart Study


David Cohen

0057

A challenge grant to develop methods for imputations and CNV analysis in genetic studies in African Americans and the Jackson Heart Study

James G. Wilson

0058

A challenge grant to conduct a multi-ethnic study of type 2 diabetes genes in in the Jackson Heart Study

James G. Wilson

0066

Investigation of lipoprotein classes and subclasses as cardiovascular risk factors in African Americans


Krishnaji Kulkarni

0069

Whole exome sequencing in the Jackson Heart Study

Herman Taylor/ James G. Wilson

0087

MH-GRID: Clinical and community based genomic resources defining the genetic, personal, and social-environmental determinants of severe hypertension in African Americans


Gary Gibbons/ Aurelian Bidulescu