Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Sequencing Evidence-generating Research (CSER2) – Clinical Sites with Enhanced Diversity (UM1)

Notice Number: NOT-HG-16-014

Key Dates
Release Date:  March 15, 2016
Estimated Publication Date of Announcement: May, 2016
First Estimated Application Due Date: August, 2016
Earliest Estimated Award Date: June, 2017
Earliest Estimated Start Date: June, 2017

Related Announcements
NOT-HG-16-013

NOT-HG-16-015    

Issued by
National Human Genome Research Institute (NHGRI)

Purpose

The National Human Genome Research Institute intends to issue a Funding Opportunity Announcement (FOA) to solicit applications to support Clinical Sites with Enhanced Diversity for a Clinical Sequencing Evidence-generating Research (CSER2) Program. The intended FOA will be based on concepts recently approved by the National Advisory Council on Human Genome Research and accompanying discussion (http://www.genome.gov/Pages/About/NACHGR/February2016AgendaDocuments/Clinical_Sequencing_Evidence-generating_Research_CSER2.pdf and https://www.youtube.com/watch?v=Af585J2j9V0),  

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Spring 2016 with an expected application due date in Summer 2016.

This FOA will utilize the UM1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The goal of the intended FOA is to establish Clinical Sites with Enhanced Diversity that collectively represent a broad spectrum of clinical conditions and settings.  These sites, with a separate set of Clinical Sites and Coordinating Center (described in separate Notices), will comprise the CSER2 Consortium. Grantees funded under the intended FOA will:1) generate and analyze evidence to further investigate the clinical utility of genome sequencing in multiple clinical contexts; 2) research the critical interactions among patients, family members, health practitioners, and clinical laboratories to better inform implementation of the clinical genome sequencing process; and 3) investigate the feasibility of exchanging genomic, clinical, and health utilization data within an existing healthcare system(s) to build a shared evidence base for clinical decision-making. Applicants will be required to include research on the ethical, legal, and social issues (ELSI) involved in the implementation of clinical sequencing, with a particular emphasis on such issues as they relate to diverse or underserved populations.  Applicants will also be required to include at least 60% of participants from racial or ethnic minorities or other underserved populations that experience poorer health outcomes, to explore genomic medicine implementation in care settings outside of tertiary academic medical centers, and to propose plans for collaborating with stakeholders such as professional societies, payers, regulatory agencies and patient groups.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

 

Inquiries

Please direct all inquiries to:

Lucia Hindorff, Ph.D., M.P.H.
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: hindorffl@mail.nih.gov