sickle cell disease (scd) in sub-saharan africa (ssa) collaborative consortium research funding...

25
Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance Webinar Norma B. Lerner MD, MPH W. Keith Hoots MD Christina Rinaldi October 20, 2015

Upload: lindsay-randall

Post on 21-Jan-2016

219 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Sickle Cell Disease (SCD)

in Sub-Saharan Africa (SSA)

Collaborative Consortium

Research Funding Opportunity Announcement

(RFA HL-17- 006)

Technical Assistance Webinar

Norma B. Lerner MD, MPHW. Keith Hoots MD

Christina Rinaldi

October 20, 2015

Page 2: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Program Overview

Program Background

Purpose of the Collaborative Consortium RFA

Goals

Award & Application Information

Registration Process for Foreign Applicants

Submission Process

Review

Resources

Questions

The SCD in SSA Collaborative Consortium Webinar Outline

2

Page 3: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Funding Agency

National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

One of the 27 Institutes and Centers of the National Institutes of Health (NIH)

The SCD in SSA Program: Overview

Page 4: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Funding Mechanisms

RFA–HL-17-006 - Collaborative Consortium (U24 – Cooperative

Agreement)

RFA–HL-17-007- Data Coordinating Center (U24- Cooperative

Agreement)

The SCD in SSA Program: Overview

Page 5: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

The SCD in SSA Program: Overview

Structure

National Heart Lung and Blood Institute (NHLBI)

Consortium Hub (HL-17-006)

Data Coordinating Center (HL-17-007)

Consortium Site

Consortium Site

Governing Body: Steering Committee

Review & Monitoring:Observational Study Monitoring Board (OSMB)

Page 6: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Worldwide burden of SCD is rising >75% SCD births occur in sub- Saharan Africa (SSA)

Clinical Care

- Health resources are limited in many areas - 50-80% of affected children die before age 5

Research- High disease prevalence should facilitate research

- Many nations lack the required infrastructure

SCD in SSA Program: Background

Page 7: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Purpose of this Funding Opportunity (FOA)

Build capacity By supporting a founding Sickle Cell Disease (SCD)

Collaborative Consortium in Sub-Saharan Africa (SSA)

Collaborative Consortium will establish an infrastructure for a future Sickle Cell Disease in Sub-Saharan Africa Research Network

Collaborative Consortium will work closely with a Data Coordinating Center (DCC) supported by a separate FOA (HL-17-007)

Page 8: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

The Collaborative Consortium: Goals

Development of

A sickle hemoglobinopathy database

Shared database elements and

harmonized phenotype definitions,

ontologies

SCD standards of care

Links to existing training programs

Consortium Hub

Consortium Site

Consortium Site

Page 9: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

The Collaborative Consortium: Goals

Planning for Future SCD cohort studies, implementation of

clinical practices, and inclusion of

new African sites

Accomplishing activities over

4 years Development phase: Years 1 and 2 Pilot/planning phase: Year 3 Implementation phase: Year 4

Consortium Hub

Consortium Site

Consortium Site

Page 10: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Cooperative Agreement Requires substantial NHLBI scientific and

programmatic involvement

After award, program staff and appointees assist and participate in project activities

Terms and conditions of this Cooperative Agreement are explained in detail in Section VI of the FOA

The Collaborative Consortium: Award Information

Page 11: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Eligible Applicants

Only institutions located in sub-Saharan Africa

Only one application per institution

The Collaborative Consortium: Application Information

Page 12: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Applicants must

Carefully follow the FOA instructions

http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-17-006.html

Download the SF424 (R&R) application package

http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000 and also follow these instructions except where the FOA instructs you to do otherwise

Adhere to the page limits described in both documents

The Collaborative Consortium: Application

Page 13: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Required registrations information for foreign award applicant organizations

Registration can take 6 weeks or more – start now

All registrations can be requested and completed via the web

The Collaborative Consortium: Registration

Page 14: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

STEP 1: Request an NCAGE (NATO Commercial and Government Entity) Code https://eportal.nspa.nato.int/AC135Public/scage/CageList.aspx

Note: 48 hours after submitting your code request, confirm your correct legal business name and/or physical address is listed in the CAGE system. Go to the Business Identification Number Cross Reference System (BINCS) website; https://www.logisticsinformationservice.dla.mil/BINCS/begin_search.aspx

The Collaborative Consortium: Registration

Page 15: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

STEP 2: Get a DUNS Number

http://fedgov.dnb.com/webform

Register with Dun & Bradstreet (D&B) to get a Data Universal Numbering System (DUNS) Number

The Collaborative Consortium: Registration

Page 16: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

STEP 3: Register with the System for Award Management (SAM) https://www.sam.gov/sam/transcript/Quick_Guide_for_International_Entity_Registration.pdf

You must have NCAGE Code and DUNS Number before registering in SAM

SAM registration must be renewed annually Once CAGE system approves your registration, you will

receive a notification email from SAM.gov. Allow 5 business days

The Collaborative Consortium: Registration

Page 17: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

STEP 4: Complete eRA Commons registration https://public.era.nih.gov/commons/public/registration/registrationInstructions.jsp

eRA Commons requires at least one Signing Official (SO) and at least one Principal Investigator (PD/PI)

Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration.

The Collaborative Consortium: Registration

Page 18: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

STEP 5: Register at Grants.gov http://www.grants.gov/web/grants/register.html

System used for all NIH application submissions Requires a one-time registration in order to submit applications Applicants must have active DUNS number and SAM registration

to complete Grants.gov registration eRA commons and Grants.gov registration can be done

simultaneously Registration is not needed to download an application package

or prepare application Note: Before you can view and complete an application package,

you MUST have Adobe Reader installed on your computer

The Collaborative Consortium: Registration

Page 19: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Letter of Intent (described in the FOA)

A letter of intent is encouraged but not required

Allows the NHLBI to estimate the potential review workload

The Collaborative Consortium: Submission

Page 20: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Key Dates: Earliest application submission date:

- January 26, 2016 Letter of Intent:

- January 26, 2016 Application:

- February 26, 2016- No late applications accepted (no exceptions)- Advise to apply early to make corrections if

needed before due date

The Collaborative Consortium: Submission

Page 21: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Key Dates: Scientific Merit Review:

- July, 2016

Advisory Council Review:- October, 2016

Earliest Start Date: - December, 2016

The Collaborative Consortium: Submission

Page 22: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

All applications to the NIH are evaluated through the NIH peer review system

Criteria are described in the FOA under Application Review Information

NHLBI will ensure that the review panel members have appropriate expertise  

Collaborative Consortium: Review

Page 24: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance

Send questions via this WebEx to Christina Rinaldi and we will respond in real time

If we are unable to respond to your question during this session, we will get back to you via email as soon as possible

Questions??

Page 25: Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance