Notice to Applicants for NIH Genome-Wide Association Studies

Notice Number: NOT-OD-06-071

Key Dates
Release Date: May 15, 2006

Update: The following update relating to this announcement has been issued:

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease because the information derived from such studies will be essential for developing new approaches to reduce disease burden and promote health. GWAS are currently defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with phenotypic traits or disease status. The purpose of this Notice is to inform investigators of the NIH plans to (1) update data sharing policies for research applications involving GWAS data; (2) initiate a public consultation process to inform policy development activities over the next few months; and (3) announce the agency's intent to track GWAS applications and awards at a central level.

Need for Broad Data Sharing Policies

Rapid advances in understanding the patterns of human genetic variation and maturing high-throughput, cost-effective methods for genotyping are providing powerful research tools for identifying genetic variants that contribute to health and disease. Consistent with the NIH mission to improve public health through research and the longstanding NIH policy to make available to the public the results of the research activities that it funds, the NIH has concluded that the full value of GWAS can be realized only if the genotype and phenotype datasets derived from GWAS are made available as rapidly as possible to a wide range of scientific investigators. The NIH recognizes that GWAS data release practices must be consistent with the informed consent provided by individual participants and, therefore, encourages investigators to develop informed consent approaches in the future that permit such data sharing.

The NIH considers broad data access to be particularly important for GWAS because of the significant resources involved (which necessarily limits the number of projects that can be supported for any disease), the serious analytical challenges involved in such large datasets, and the powerful opportunities that will be provided by the ability to make comparisons across multiple studies.

Plans for Public Consultation

To ensure maximum benefit to the public health, the NIH is considering policy and programmatic steps to promote broad and consistent sharing of GWAS data for all NIH-supported GWAS genotype-phenotype datasets, such as strong encouragement for early release of phenotype and genotype data, and the development of a central database to serve as a common GWAS repository (consistent with human subject protection issues). Recognizing the range of issues to be considered, the NIH plans to undertake an extensive public consultation effort through interactions with scientific and public stakeholders . The specific plans for these activities will be announced broadly in the near future. Among the potential topics to be considered are: the creation of a central genotype-phenotype database that could serve as a common data repository for all NIH-supported GWAS, requirements for submission of data to such a common repository, appropriate policies for access to GWAS data, standards for participant protection in this rapidly evolving area of science, publication polices that recognize the interests of the researchers who collect samples and associated data, and intellectual property considerations for inventions arising from the use of GWAS data.

Tracking of GWAS Applications and Awards

The NIH encourages applications for large-scale genome-wide genotyping in areas of programmatic relevance to ICs throughout the NIH during this period of rapid development in the associated technology, science, and policy arenas. The NIH will begin tracking GWAS applications at a central level, because these studies are likely to result in findings that will have relevance across a broad spectrum of topics related to health and disease in a way that was not possible previously. Therefore, the NIH requests that all proposed GWAS applications cite this Notice in a cover letter that accompanies the application.

Among the issues that should be addressed in applications by investigators for GWAS are:

A number of these issues are crucial to determining the potential utility of a whole genome analysis strategy and thus the scientific merit and relative program priority of individual studies. The inclusion of detailed phenotypic characterization of the subjects and descriptions of any endophenotypes or secondary phenotypes that have been measured will be essential to determine funding priority. Human subjects and potential privacy issues, if applicable, must be fully addressed prior to the award of funds. Plans for data sharing and how the institution will handle intellectual property will determine whether NIH policy goals can be met by studies described in applications for NIH funds.

Starting immediately, the issues listed above should be addressed carefully in any GWAS applications to NIH, including applications submitted in response to specific GWAS RFAs that some ICs have already released, as well as applications for future RFAs or PAs and unsolicited applications for any of the ICs.

Inquiries

Specific questions about this Notice should be directed to the IC Contacts listed below:

CSR:
Richard Panniers, Ph.D.
Chief, Genes, Genomes and Genetics
Integrated Review Group
Center for Scientific Review, NIH
Rockledge 2, Room 2212
6701 Rockledge Drive
Bethesda , MD 20817
Tel: 301-435-1741
Fax: 301-480-2067
Email: pannier@csr.nih.gov

NCI:
Daniela Seminara, Ph.D., M.P.H.
Scientific Program Officer
Breast and Colon Cancer Family Registries
Program Director
Genetic Epidemiology of Cancer
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute, National Institutes of Health
6130 Executive Blvd.
EPN 5142, MSC 7393
Bethesda, MD 20892
Tel: 301-594-7347
Fax: 301-435-5477
Email: seminard@mail.nih.gov

NCMHD:
Jerome Wilson, MA, Ph.D.
Associate Director for Scientific Program Operations
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd.
Suite 800, MSC 5465
Bethesda, MD 20892
Tel: 301-594-8704
Fax: 301-480-4049
Email: wilsonjer@mail.nih.gov

NCRR:
Anthony Hayward, M.D., Ph.D.
Director, Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Blvd. , Room 906
Bethesda, MD 20892-4874
Tel: 301-435-0791
Email: haywarda@mail.nih.gov

NEI:
Hemin Chin, Ph.D.
Director, Ocular Genetics Program
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Tel: 301-451-2020
Fax: 301-402-0528
Email: hemin@nei.nih.gov

NHGRI:
Teri Manolio, M.D., Ph.D.
Senior Advisor to the Director for Population Genomics
National Human Genome Research Institute
Building 31, Rm. 4B-09
31 Center Drive, MSC 2154
Bethesda, MD 20892-2154
Tel: 301-402-2915
Fax: 301-402-4831
Email: manolio@nih.gov

NHLBI:
Richard R. Fabsitz, Ph.D.
Leader, Genetic Epidemiology Scientific Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8164
Bethesda, MD 20892-7934
Tel: 301-435-0458
Fax: 301-480-1667
Email: rrf@nih.gov

NIA:
Winifred K. Rossi, MA
Deputy Director
Geriatrics and Clinical Gerontology Program
National Institute on Aging, NIH, DHHS
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892-9205
Tel: 301-496-3836
Fax: 301-402-1784
Email: winne_rossi@nih.gov

NIAAA:
Zhaoxia Ren, M.D., Ph.D.
Program Director, Genetics
Division of Neuroscience and Behavior, NIAAA
5635 Fishers Lane, Room 2052, MSC 9304
Bethesda, MD 20892-9304
Tel: 301-443-5733
Fax: 301-443-1650
Email: zren@mail.nih.gov

NIAID:
Maria Y. Giovanni, Ph.D.
Assistant Director for Microbial Genomics & Advanced Tech.
Division of Microbiology and Infectious Diseases
NIAID/NIH/DHHS
6610 Rockledge Dr., MSC 6603, Room 6007
Bethesda, MD 20892-6603
Tel: 301-496-1884
Fax: 301-480-4528
Email: mgiovanni@niaid.nih.gov

NIAMS:
William Sharrock, Ph.D.
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health, DHHS
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda , MD 20892-4872
Tel: 301-594-5055
Fax: 301-480-4543
Email: Ws19h@nih.gov

NIBIB:
Belinda Seto
Building 31, Room 1C14
Bethesda , MD 20892
Tel: 301-451-6768
Fax: 301-480-0679
Email: setob@mail.nih.gov

NICHD:
John Ilekis, Ph.D.
Program Scientist
Genomic and Proteomic Network for Premature Birth Research
Center for Developmental Biology and Perinatal Medicine
National Institute of Child Health and Human Development
Room 4B03
6100 Executive Boulevard, MSC 7510
Bethesda, MD 20892-7510
Tel: 301-435-6895
Fax: 301-496-3790
Email: ilekisj@mail.nih.gov

NIDA:
Jonathan D. Pollock, Ph.D.
Chief
Genetics and Molecular Neurobiology Research Branch
National Institute of Drug Abuse, NIH
6001 Executive Blvd.
Bethesda, MD 20892
Tel: 301-435-1309
Fax: 301-594-6043
Email: jp183r@nih.gov

NIDCD:
Bracie Watson, Jr., Ph.D.
Program Director, Hearing
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
6120 Executive Blvd., 400-C, MSC 7180
Bethesda, MD 20892-7180
Tel: 301-402-3458
Fax: 301-402-6251
Email: watsonb@nidcd.nih.gov

NIDCR:
Thomas Hart, DDS, Ph.D.
Chief
Dental and Craniofacial Genetics
National Institute of Dental and Craniofacial Research
Building 10, Room 5-2531
10 Center Drive
Bethesda , MD 20892
Tel: 301-496-6242
Fax: 301-480-4455
Email: thart@mail.nih.gov
 
NIDDK:
Catherine McKeon, Ph.D.
Division of Diabetes, Endocrine and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy 2, Room 6103
6707 Democracy Blvd.
Bethesda , MD 20892
Tel: 301-594-8810
Fax: 301-480-3503
Email: Catherine.McKeon@nih.gov
 
NIEHS:
Steven R. Kleeberger, Ph.D.
Chief, Laboratory of Respiratory Biology
Director, Environmental Genetics Group
National Institute of Environmental Health Sciences
National Institutes of Health
111 T.W. Alexander Drive
Building 101, D240
Research Triangle Park , NC 27709
Tel: 919-541-3540
Fax: 919-541-4133
Email: kleeber1@niehs.nih.gov
 
NIGMS:
Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25
45 Center Drive , MSC 6200
Bethesda , MD 20892-6200
Tel: 301-594-0943
Email: greenbej@nigms.nih.gov
 
NIMH:
Thomas Lehner, Ph.D., M.P.H.
Acting Director, Office of Human Genetics & Genomic Resources
Chief, Genetic Basis of Mental Disorders Program
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd. , Room 7190, MSC 9643
Bethesda , MD 20892-9643
Tel: 301-443-1706
Fax: 301-402-4740
Email: tlehner@mail.nih.gov
 
NINDS:
Katrina Gwinn-Hardy, M.D.
Neurogenetics
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.
Bethesda , MD 20892
Tel: 301-496-5745
Fax: 301-402-1501
Email: gwinnk@ninds.nih.gov
 
OER:
Office of Extramural Programs, OER, OD, NIH
1 Rockledge Centre, Suite 350
Room 3531
6705 Rockledge Drive , MSC 7963
Bethesda , MD 20892-7963
Email: OERMailbox@mail.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.