Notice Number: NOT-HG-16-015

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

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 a Coordinating Center 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 U24 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The goal of the intended FOA is to establish a Coordinating Center that, with the Clinical Sites and Clinical Sites with Enhanced Diversity (described in separate Notices), will comprise the CSER2 Consortium. The CSER2 CC funded under the intended FOA will provide scientific and administrative coordination of cross-consortium work to: 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 for the intended Clinical Sites and Clinical Sites with Enhanced Diversity FOAs will be expected 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; to include at least 25% or 60%, respectively, 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. Applicants to this intended FOA will propose plans to facilitate dissemination of CSER2 resources and best practices, coordinate stakeholder engagement efforts, and support CSER2 Steering Committee, Working Group and stakeholder meetings.

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