Update: The following update relating to this announcement has been issued:
Release
Date: October 8, 2010
Receipt Date: December 3, 2010
Earliest Anticipated
Start Date: March, 2011
National Human Genome Research Institute (NHGRI)
Office of Behavioral and Social Sciences Research (OBSSR)
The National Human Genome Research Institute (NHGRI) along with the Office of Behavioral and Social Sciences Research (OBSSR) announces an Administrative Supplement Program to promote the inclusion of standard phenotypic and environmental exposure measures selected from the PhenX Toolkit (www.phenxtoolkit.org) into existing population-based genomic studies supported by the NIH. The goals of this supplement program are to evaluate the usefulness of PhenX measures and to stimulate their uptake into population studies to enhance genomic research. The inclusion of measures from the PhenX Toolkit will enable researchers to broaden the scope of their studies, examine additional genetic and environmental factors contributing to human health and disease, and combine their studies with other investigators using the same measures to increase power and efficiency of genomic discovery.
Genome-wide association (GWA) studies have identified hundreds of associations between genetic variants and complex human diseases, and for some diseases, such as diabetes and Crohn’s disease, pooling of multiple GWA studies by meta-analysis has led to the discovery of new gene associations. However, most GWA studies have had relatively few phenotypic and exposure measures in common. Harmonizing data across studies that have used disparate measures to collect similar information is difficult and time consuming. Development and adoption of standard phenotypic and exposure measures could facilitate the creation of larger, more comprehensive datasets with a variety of phenotype and exposure data for cross-study analysis, thus increasing statistical power and the ability to detect associations of modest effect sizes and gene-gene and gene-environment interactions.
Recognizing the need for standard phenotypic and exposure measures, particularly as related to GWA studies, NHGRI initiated the PhenX Toolkit in 2006 through RFA-HG-00-006, High-Priority Phenotype and Exposure Measures for Cross-Study Analysis in Genome-Wide Association Studies. The goal of this three-year program was to identify and catalogue 15 high-quality, well-established, and broadly applicable measures for each of 21 research domains for use in GWA studies and other large-scale genomic research. A PhenX domain is a topic area with a unifying theme such as Demographics, Anthropometrics, Neurology, Cancer, or Social Environments. PhenX measures are selected by Working Groups of domain experts using a consensus process and are made available to the scientific community via the PhenX Toolkit (www.phenxtoolkit.org).
Although PhenX is on track to meet its three-year goal of producing 15 measures in each of 21 domains, many of the domains have been released relatively recently and experience has not been sufficient to gauge the impact of the Toolkit nor potential needs for its continuation. NHGRI has been urged to catalyze adoption of PhenX measures in ongoing genomic studies to obtain timely and needed feedback on the value of the resource including gaps in measures, ease of use, and overall usefulness of the PhenX Toolkit for the research community.
This Notice announces the availability of administrative supplements to existing NIH-funded projects to support the incorporation of a minimum of 8-10 PhenX measures into existing population-based genomic research studies that aim to identify the genetic and environmental factors that contribute to health and the development of complex disease. Principal Investigators (PIs) are strongly encouraged to select PhenX measures that are broadly related to a variety of complex traits (e.g., substance use, physical activity, height, weight, etc.) and not just measures related to the primary phenotypes being evaluated in the parent study. Individual-level phenotypic and exposure data collected using PhenX measures, along with previously generated genetic data, will be made available to the broader research community through the National Center for Biotechnology Information's Database of Genotypes and Phenotypes (dbGaP).
PIs should budget for themselves and a data analyst to travel to the Washington, DC area shortly after award for a grantee meeting where they will work together with NHGRI and the PhenX Toolkit grantee, RTI International, to decide upon metrics that will allow a thorough evaluation of the functionality and utility of the PhenX Toolkit, agree upon common approaches for describing and analyzing data collected using the PhenX measures, and identify potential cross-study analyses that can be conducted by the entire set or subsets of PIs. RTI will serve as a facilitator, and if desired, a collaborator in effective incorporation and use of PhenX measures. At a second grantee meeting near the end of the supplement period, PIs will be expected to report findings from analyses of both individual projects and cross-study collaborations and to provide feedback to NHGRI based on the agreed-upon metrics.
A total of $1M is anticipated to be provided in Fiscal Year
2011 to support 6-10 supplements for a project duration of one year.
Administrative supplements are limited to $100,000 in direct costs.
This announcement is for supplements to NIH grants meeting the selection criteria outlined in the section titled "Selection." The grant must have at least one year remaining at the time the award is made.
To be eligible, the PI must be able to demonstrate that the
PhenX measures can be administered to participants within the first three
months of the award to ensure that data collection and analysis will be
completed by the end of the supplement period. Studies should include at least
1,000 participants with previously generated genotype data whom have been
adequately consented for sharing of both genomic and phenotypic data with the
broader research community for a variety of research purposes. Priority will
be given to studies with higher numbers of participants.
To be eligible, the parent grant must be active, and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant.
IMPORTANT: The research proposed by the NIH grantee in the supplement
application must be within the original scope of the NIH-supported grant
project. The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives as long as they are
within the original scope of the project. Any cost increases need to result from
making modifications to the project in order to take advantage of opportunities
that would increase the value of the project consistent with its originally
approved objectives and purposes.
To be considered for an administrative supplement, the
request must be signed by the Authorized Organizational Representative/Signing
Official (AOR/SO), and must describe the need for additional funding and the
categorical costs.
Submit (1) one original, hard copy of the request packet (with original
signatures of the authorized business official) and (2) an electronic copy of
the submitted supplement request as a single email attachment in PDF format to
the contact listed below:
Ms. Monika Christman
Lead Grants Management Specialist
Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
TEL: 301-435-7860
Email: nhgrigab@mail.nih.gov
Requests should be submitted on the PHS398
Application Guide forms (font size and other formatting rules apply as designated
in the instructions), as indicated below. Include only the following elements:
Cover Letter which cites this Notice, and the following information:
PHS 398 Form Page 1 (Face page)
PHS 398 Form Page 2
A brief proposal describing the project, including:
Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:
Inquiries and discussion of plans for responding to this
Notice are strongly encouraged.
1. Scientific/Research
Contacts:
Heather A. Junkins, MS
Scientific Program Analyst, Office of Population Genomics
NHGRI
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
TEL: (301) 402-0343
Email: junkinsh@mail.nih.gov
Erin M. Ramos, PhD MPH
Epidemiologist, Office of Population Genomics
NHGRI
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
TEL: (301) 451-3706
Email: ramoser@mail.nih.gov
2.
Financial or Grants Management Contacts:
Ms. Monika Christman
Lead Grants Management Specialist
Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
TEL: 301-435-7860
Email: nhgrigab@mail.nih.gov