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EGRP Bulletin - January 29, 2008


from the office of Deborah Winn, Pd.D., Acting Associate Director EGRP

This Bulletin from the Epidemiology and Genetics Research Program (EGRP) brings you news about:

EGRP Seeks Two Branch Chiefs and Additional Program Directors

The Epidemiology and Genetics Research Program (EGRP) seeks two Chiefs to lead its Host Susceptibility Factors and Clinical and Translational Epidemiology Branches, and additional Program Directors to join its staff. EGRP manages the National Cancer Institute’s (NCI) grant-supported research on the etiology of cancer. It is the largest funder of etiologic cancer epidemiology nationally and worldwide.

The Branches

  • The Host Susceptibility Factors Branch (HSFB) focuses on research on personal susceptibility factors such as genetic; epigenetic; immunological and hormonal biological pathways; and social, cultural, and race/ethnic factors.

  • The Clinical and Translational Epidemiology Branch (CTEB) focuses on research on clinical factors that influence development of cancer among persons with underlying diseases and conditions; the progression, recurrence, and mortality from cancer; and new primary cancers.

Qualifications for the Branch Chief positions include U.S. citizenship; doctoral degree and formal training in epidemiology; ability to organize and manage groups and multifaceted scientific projects; ability to plan, direct, and conduct large-scale cancer epidemiology studies; skill in establishing and maintaining collaborations and partnerships with Federal, national, and international organizations' researchers; and the ability to communicate orally and in writing to diverse audiences.

EGRP reorganized last year and changed from a two- to a four-branch structure. Permanent Branch Chiefs recently were named for two of the branches — Britt Reid, D.D.S., Ph.D., for the Modifiable Risk Factors Branch (MRFB), and Mukesh Verma, Ph.D., for the Methods and Technologies Branch (MTB). See related article.

Program Directors

Program Directors are assigned to branches based on the background and interests of individuals and Program needs. Qualifications include U.S. citizenship; doctoral degree and formal training in epidemiology; knowledge of epidemiologic research methodologies necessary to develop epidemiologic research studies; ability to administer, conduct, and evaluate multidisciplinary epidemiologic research; skill in oral communication as it pertains to a research area; and skill in written communication as it pertains to a research program area.

Individuals interested in the Branch Chief or Program Director positions may send letters of interest and resumes to epimeeting@mail.nih.gov.

EGRP Staff News

Ginny HartmullerVirginia (Ginny) Hartmuller, Ph.D., R.D., retired from Federal government service in November 2007. She had been the chief Program Director responsible for managing EGRP’s grant portfolio on diet and nutrition research and for stimulating new initiatives in these areas. In addition, Dr. Hartmuller served as Acting Chief of the Modifiable Risk Factors Branch (MRFB) until her departure.

Dr. Hartmuller was known for working long hours to help prospective grant applicants and grantees, and at the same time, finding time to participate in many activities to advance diet and nutrition cancer epidemiology. Among her most recent contributions, she helped organize the NCI conference Vitamin D and Cancer: Current Dilemmas and Future Needs this past spring, and spearheaded the subsequent funding of a pooled analysis of serum samples from 10 cancer epidemiology cohorts to determine whether low levels of Vitamin D are associated with increased risk of rare cancers.

In addition, she helped write the NCI Program Announcement (PA) Studies of Energy Balance and Cancer in Humans, first issued in 2004, through which EGRP funds four of the grants. Last fall, she was delighted to be able to witness the culmination of that earlier work when the four investigative teams gave presentations on their progress at a meeting of the Transdisciplinary Research on Energetics and Cancer (TREC) Centers, another DCCPS-funded initiative and with which the teams collaborate.

Dr. Hartmuller has used her background in health education, in which she has her Ph.D., and as a Licensed Dietitian and Certified Diabetes Educator to carve out an interesting and varied career. Before joining EGRP in 2001, her Federal government service included working as a Patient Educator in NCI’s Office of Cancer Communications; Coordinator of the Food and Nutrition Information Center at the U.S. Department of Agriculture’s (USDA) National Agricultural Library (1999-2001); and as a Research Policy Officer in NIH’s Office of Research on Women’s Health (1999-2001). For several years while working for the Federal government, she also was an Adjunct Assistant Professor with the University of Maryland’s Department of Nutrition and Food Science.

Before her Federal career, Dr. Hartmuller worked at The Johns Hopkins University (JHU) Medical Institutions for more than 20 years and was affiliated with The JHU Lipid Clinic, as a nutrition researcher and chief nutritionist, and The JHU Diabetes Center, as a nutrition educator and chief nutritionist. She also was an instructor in Pediatrics. Over these years, Dr. Hartmuller designed and conducted nutrition classes for health professionals and individual clients.

Among her other accomplishments, Dr. Hartmuller is a Fellow of the American Dietetic Association and in 2006 was installed into the Hall of Fame at Purdue University, from which she has an M.S. in Institutional Management.

For her next career, Dr. Hartmuller is starting her own business as a nutrition consultant. She enjoys most being a nutrition educator, counselor, and the satisfaction of coming up with creative solutions to helping others — dietitians and other health professional groups and individual clients — achieve their nutritional goals.

Liz GillandersElizabeth (Liz) Gillanders, Ph.D., has joined EGRP as a Program Director in its Host Susceptibility Factors Branch (HSFB) from the National Human Genome Research Institute (NHGRI). At NHGRI, she was a senior research fellow and earlier headed its Genetic Epidemiology Unit within the Cancer Genetics Branch. Her research at NHGRI centered on family-based studies of cancer susceptibility, with an emphasis on melanoma, prostate cancer, and breast cancer. Recently, Dr. Gillanders has been involved in a genome-wide association study of melanoma supported by a Research Training Fellowship in the genetic epidemiology of the cancer.

Dr. Gillanders received her B.A. from The College of William and Mary, Williamsburg, VA; B.S. in Molecular Genetics from The Johns Hopkins University; and Ph.D. in Genetic Epidemiology from The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, where she investigated genetic factors contributing to melanoma susceptibility. She is an Adjunct Assistant Professor at The Johns Hopkins Bloomberg School of Public Health, where she teaches an introductory human genetics course.


Michael DonovanMichael Donovan, Ph.D., a Presidential Management Fellow, has joined EGRP on a 4-month rotation. He is assembling information from across NIH on developments in research on energy balance and cancer risk, including on initiatives, concepts, trends, findings, and future plans to assist EGRP’s Modifiable Risk Factors Branch (MRFB) in program planning.

Dr. Donovan has his Ph.D. in Physiology from the University of California-Davis. His dissertation research investigated the role of nutrition, physical activity, and energy balance in the development of obesity, and adaptation of the gut-brain axis after maintenance on a high-fat diet. Prior to earning his doctoral degree, he was a Howard Hughes Medical Institute summer research intern at Ohio State Medical Center, Columbus, OH, where he conducted clinical research, and he was a research associate in the virology division of the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) Frederick, MD, where he conducted Ebola virus vaccine research.


Damali MartinDamali Martin, Ph.D., M.P.H., has joined EGRP as an NCI Cancer Prevention Fellow. She is learning the responsibilities of a Program Director under the direction of Isis Mikhail, M.D., M.P.H., Dr.P.H., Clinical and Translational Epidemiology Branch (CTEB).

The Cancer Prevention Fellowship Program (CPFP) provides postdoctoral training opportunities in cancer prevention and control, including training toward an M.P.H. degree. Dr. Martin holds a Ph.D. in Cell Biology and Molecular Genetics from the University of Maryland at College Park. She received an M.P.H. in Epidemiology and Biostatistics from The Johns Hopkins Bloomberg School of Public Health, where she investigated human papillomavirus (HPV) viral load and its association with stage of cervical neoplasia.

Through the CPFP, Dr. Martin has worked in the Breast and Prostate Study Group in the Laboratory of Human Carcinogenesis, NCI Center for Cancer Research. Her research focused primarily on studying the association between DNA polymorphisms and risk for breast cancer, and molecular epidemiology related to the study of health disparities. In particular, she focused on elucidating whether differences in tumor biology between African-American and European-American breast cancer patients contribute to lower survival and higher mortality in African-American women. In addition, she examined how biological determinants could affect survival in African-American and European-American breast cancer patients, with the goal of understanding mechanisms of the disease that could be used to identify targets for new prevention and treatment efforts.

EGRP Provides Assistance To Develop Cancer Epidemiology Consortia

Daniela Seminara EGRP is working to facilitate and fund consortia that can conduct the types of large-scale epidemiologic studies needed to address complex questions about the etiology of cancer. Assistance is available through all phases of consortia development. The Program provides assistance in numerous ways, including through grant support, assistance in identifying partners with similar research interests, advice on policies and processes that have proven successful with other cancer epidemiology consortia, participation on steering committees, and in evaluating established consortia. View information about the types of assistance available.

The following operating definition for a Consortium is used:

A consortium in epidemiology is a group of scientists from multiple institutions who have agreed to cooperative research efforts involving, but not limited to, pooling of information from more than one population study for the purpose of combined analyses. The consortium group is able to address scientific questions that cannot otherwise be addressed through the effort of a team of investigators at a single institution due to scope, resources, population size, and need for an interdisciplinary approach. The cooperation usually involves multiple projects over an extended time. Groups participating in a consortium may partner in the writing of research grant applications, but consortia activities are not limited to a specific grant/project.

Creation of a consortium is independent from funding mechanisms and does not indicate definite grant support; however, EGRP and its staff can provide supportive activities and tools.

The Program currently is facilitating and/or funding more than 30 cancer epidemiology consortia. View information about them on our Web site.

Daniela Seminara, Ph.D., M.P.H. (pictured), is EGRP's Scientific Consortia Coordinator; e-mail: seminard@mail.nih.gov.

EGRP Funding Opportunities

EGRP is sponsoring or cosponsoring the following Program Announcements (PA/PAR):

Development, Application, and Evaluation of Prediction Models for Cancer Risk and Prognosis
PA 07-021 for R01
PA 07-022 for R21 		These PAs are to encourage researchers working in the field of cancer control and prevention to: (1) improve existing models for cancer risk and prognosis by developing innovative research projects that use existing data, (2) develop new models for cancer risk and prognosis, and (3) validate new models and evaluate their utility in research and clinical settings. The PAs provide a mechanism of support for investigators to address two major challenges in model development: integrating diverse types of data and ensuring adequate validation. The PAs are not for applications that focus on the identification and characterization of prognostic/diagnostic markers. They are cosponsored with the Applied Research Program (ARP), DCCPS, and the Division of Cancer Treatment and Diagnosis (DCTD).

Contact: Isis Mikhail, M.D., M.P.H., Dr.P.H., Program Director, Clinical and Translational Epidemiology Branch; e-mail: mikhaili@mail.nih.gov
Small Grants Program for Cancer Epidemiology
PAR-06-294 for R03 		This PAR invites applications relating to cancer epidemiology with a primary focus on etiologic cancer research. These are short-term awards intended to provide support for pilot projects, testing of new techniques, or development of innovative projects that could provide a basis for more extended research. Note that this PAR stipulates a 10-page limit to the research plan, including tables and figures.

Contact: Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch, and Acting Chief, Host Susceptibility Factors Branch; e-mail: vermam@mail.nih.gov
Epigenetic Approaches in Cancer Epidemiology
PA-07-298 for R01
PA-07-299 for R21
 These EGRP-sponsored PAs are to stimulate population-based epidemiology research on the roles of DNA methylation markers in cancer. The objectives of the PAs are for researchers to evaluate determinants of methylation patterns, risks of cancer associated with DNA methylation, and markers and modifiers of cancer risk using epidemiologic approaches in existing human population studies.

Contact: Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch, and Acting Chief, Host Susceptibility Factors Branch; e-mail: vermam@mail.nih.gov
Occupational Safety and Health Research
PA-07-318 for R01 		This reissue of PA-04-038 is to encourage research that develops an understanding of the risks and conditions associated with occupational diseases and injuries, explores methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and translates significant scientific findings into prevention practices and products that will effectively reduce work-related illness and injury. Of special interest to NCI is basic, applied, methodological, and statistical research that can advance cancer control activities, including surveillance, dissemination of public health information, and elucidation of susceptibility factors associated with cancer risk in individuals and population subgroups. NCI priority areas include applicable research approaches and methods (e.g., exposure and risk assessment, biomonitoring and surveillance techniques, analysis of cancer risk factors, and characterization of possible carcinogens in mixed exposures). The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced this PA, which is cosponsored with several NIH Institutes.

Contact: Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch, and Acting Chief, Host Susceptibility Factors Branch; e-mail: vermam@mail.nih.gov
Pilot Studies in Pancreatic Cancer
PA-06-314 for R03
PA-06-303 for R21

These trans-NCI PAs are to encourage innovative research across multiple disciplines for better understanding of the biology, etiology, detection, prevention, and treatment of pancreatic cancer. Inquiries about cancer control, epidemiology, and survivorship research proposals are handled by EGRP. Please refer to the PAs for the complete list of contacts.

Contact: Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch, and Acting Chief, Host Susceptibility Factors Branch; e-mail: vermam@mail.nih.gov
red flagResearch on Malignancies in the Context of HIV/AIDS (Reissued under a new title, “Research on Malignancies in AIDS and Acquired Immune Suppression,” and with new PA numbers)
PA-07-455 for R01
PA-07-454 for R21 		These PAs are to encourage research that will improve our understanding of the biological basis of development and progression of cancer in the context of Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) or acquired immune suppression not associated with HIV infection, such as organ transplantation. Novel approaches to discovery and preclinical development of novel therapeutic agents and biomarkers for early diagnosis and monitoring of disease progression are encouraged. Molecular epidemiologic studies of the role of chronic latent viruses and their interaction with one another or with environmental factors in the context of acquired immune suppression or HIV infection leading to the development of tumors or lesions with oncogenic potential also are of interest. These PAs are cosponsored with NCI’s Division of Cancer Biology (DCB), DCTD, and the Office of AIDS Malignancies Program, and with the National Institute of Dental and Craniofacial Research (NIDCR).

Contacts: Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch, and Acting Chief, Host Susceptibility Factors Branch; e-mail: vermam@mail.nih.gov; and
Vaurice Starks, Program Director, Modifiable Risk Factors Branch; e-mail: starksv@mail.nih.gov
Studies of Energy Balance and Cancer in Humans
PA-07-176 for R01
PA-06-405 for R21
 These PAs invite investigator-initiated research to define factors affecting energy balance and mechanisms influencing cancer risk, prognosis, and quality of life. These studies may range from new analyses of existing datasets to additional collection of data and biological specimens in ongoing investigations. To be eligible for these PAs, an applicant previously must have collected measures from human subjects on two or more of the following exposures: diet, physical activity, body composition, and/or related biomarkers (such as blood, urine, exfoliated cells, and/or tissue samples). The knowledge gained is anticipated to provide additional information to better understand the relationships among energy balance, cancer risk, and prognosis. These PAs are cosponsored with NCI’s Office of Cancer Survivorship (OCS), DCCPS, and the Division of Cancer Prevention (DCP).

Contact: Leah Sansbury, Ph.D., Program Director, Modifiable Risk Factors Branch, e-mail: sansburl@mail.nih.gov

red flagExfoliated Cells, Bioactive Food Components, and Cancer (Reissued — note new PA numbers for R0s and R21s)
PA-08-030 for R01
PA-06-360 for R03
PA-08-031 for R21 		These PAs invite researchers to critically evaluate the use of exfoliated cells to monitor the physiological effects of dietary bioactive food components thought to be involved with cancer prevention. The aim is to encourage interdisciplinary collaborations between scientists using exfoliated cells in research and those conducting nutrition research related to cancer prevention. This research will help determine the use of exfoliated cells as a model system to monitor both the absorption and retention of bioactive food components and the concomitant alterations in genomic and epigenetic events that occur in intact cells.

Contact: Britt Reid, D.D.S., Ph.D., Chief, Modifiable Risk Factors Branch; e-mail: reidbr@mail.nih.gov

Small Business Grants
SBIR: R43/44
STTR: R41/42		 Small businesses may obtain support from EGRP through the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer Research (STTR) Programs. These programs support innovative research that has the potential for commercialization. The STTR Program encourages partnerships between small businesses and research institutions. The small business is to conduct at least 40 percent of the research project, and the single, partner institution conducts at least 30 percent of the work.

EGRP is particularly interested in supporting research on tools for assessment of exposures and tools for cancer epidemiology studies. See the full list of suggested topics on EGRP's Web site.

red flagThe Omnibus Solicitations for SBIR and STTR Grant Applications for Fiscal Year 2008 are newly announced in the NIH Guide for Grants and Contracts: SBIR - PA-08-050 and STTR - PA-08-051. See NIH SBIR/STTR Web page for additional information.

Contact: Jay Choudhry, M.S., Program Director, Methods and Technologies Branch; e-mail: choudhrj@mail.nih.gov

Other NIH and NCI Funding Opportunities

EGRP grantees and prospective grantees may be interested in the following Requests for Applications (RFAs):

NIH Director's New Innovator Award Program (DP2) RFA

The NIH Director’s New Innovator Award Program (DP2) supports a small number of new investigators of exceptional creativity who propose bold and highly innovative new research approaches that have the potential to produce a major impact on broad, important problems in biomedical and behavioral research. Thirty awards were made in 2007, and the next deadline for receipt of applications is March 31, 2008. About $55 million in funding will be available for the 5-year period. Up to 24 awards are expected to be made in 2008.

The research proposed need not be in a conventional biomedical or behavioral discipline but must be relevant to the mission of NIH. The New Innovator Awards complement ongoing efforts by NIH and its Institutes and Centers to fund new investigators through R01 grants, which continue to be the major sources of NIH support for new investigators.

Applicants must meet the definition of a new investigator. Please refer to the Request for Applications (RFA) for eligibility criteria. There are no citizenship or residency requirements.

Scientific questions may be directed to Judith H. Greenberg, Ph.D., Director, Division of Genetics and Developmental Biology, National Institute of General Medical Sciences (NIGMS); e-mail: newinnovator@nih.gov.

NIH Roadmap Initiative on Epigenetics RFAs

NIH roadmap bannerAs part of NIH’s Roadmap Initiative, six RFAs on epigenetics have been issued:


Announcement Funding
Announcement		 Grant
Mechanism		 Application
Due Date
Discovery of Novel Epigenetic Marks in Mammalian Cells RFA-RM-07-016 R21 Feb. 14, 2008
Discovery of Novel Epigenetic Marks in Mammalian Cells RFA-RM-07-015 R01 Feb. 14, 2008
Epigenomics Data Analysis and Coordination Center RFA-RM-07-014 U01 March 7, 2008
Reference Epigenome Mapping Centers RFA-RM-07-013 U01 March 7, 2008
Technology Development in Epigenetics RFA-RM-07-012 R21 Feb. 14, 2008
Technology Development in Epigenetics RFA-RM-07-011 R01 Feb. 14, 2008

Please refer to the RFAs for specifics. EGRP’s Mukesh Verma, Ph.D., Chief, Methods and Technologies Branch (MTB), serves on the Implementation Group Committee for this initiative.

NCI Innovative Molecular Analysis Technologies (IMAT) Program RFAs

IMAT logoNCI’s Innovative Molecular Analysis Technologies (IMAT) program supports research projects aimed at developing creative methods and tools by which to understand, prevent, diagnose, and treat cancer. It encompasses closely related Funding Opportunity Announcements (FOAs) in four areas: Innovative Technologies for Molecular Analysis of Cancer, Application of Emerging Technologies for Cancer Research, Innovative Technology Solutions to Cancer Sample Preparation, and Small Business Funding Opportunities. The nine RFAs are listed below. See also NIH Guide Notice, NOT-CA-08-003, for an explanation of these funding opportunities.

red flagCancer epidemiologists may be particularly interested in Application of Emerging Technologies for Cancer Research (RFA-CA-08-008), which solicits grant applications proposing exploratory research projects to evaluate the performance of emerging molecular analysis technologies and develop applications for an appropriate cancer-relevant biological system. Specific areas of focus which may be of particular interest are:

  • technologies suitable for the analysis and characterization of large numbers of samples, including biospecimens, from defined human/patient populations
  • technologies for the measurement of exposures to environmental toxicants, pollutants, mutagenic factors, and/or carcinogens.

Announcement Funding
Announcement		 Grant
Mechanism		 Application
Due Date
Innovative Technologies for Molecular Analysis of Cancer RFA-CA-08-006 R21 March 11, 2008
May 29, 2008
Sept. 24, 2008
Application of Emerging Technologies for Cancer Research RFA-CA-08-007 R21 March 11, 2008
May 29, 2008
Sept. 24, 2008
red flagApplication of Emerging Technologies for Cancer Research RFA-CA-08-008 R33 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovations In Cancer Sample Preparation RFA-CA-08-009 R21 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovations In Cancer Sample Preparation RFA-CA-08-010 R33 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovative Technologies and Applications for the Molecular Analysis of Cancer (SBIR) RFA-CA-08-011 R43/44 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovative Technologies and Applications for the Molecular Analysis of Cancer (STTR) RFA-CA-08-012 R41/42 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovations In Cancer Sample Preparation (SBIR) RFA-CA-08-013 R43/44 March 11, 2008
May 29, 2008
Sept. 24, 2008
Innovations In Cancer Sample Preparation (STTR) RFA-CA-08-014 R41/42 March 11, 2008
May 29, 2008
Sept. 24, 2008

Institutional Clinical and Translational Science Award RFA

NIH has reissued its RFA for the Clinical and Translational Science Award (CTSA) initiative. This award assists institutions to create an integrated academic home for Clinical and Translational Science that has the resources to train and advance multi- and interdisciplinary investigators and research teams with access to innovative research tools and information technologies that apply new knowledge and techniques to patient care. CTSAs attract basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry to develop new professional interactions, programs, and research projects. Through innovative advanced degree programs, the awards foster a new discipline of Clinical and Translational Science that will be much broader and deeper than their separate components.

Letters of intent are due May 17, 2008, for the application due date of June 17, 2008, and letters of intent are due Sept. 21, 2008, for the application due date of Oct. 21, 2008.

Grantsmanship

Step-by-Step Help on Preparing Progress Reports and Final Reports With EGRP

Our Division of Cancer Control and Population Sciences (DCCPS) has developed two new Web pages with brief step-by-step instructions on preparing Progress Report Summaries and Final Reports for EGRP and other components of the Division. We think Principal Investigators supported through EGRP and their staffs will find these instructions helpful:

NIH Data Sharing Policy In Effect for Genome-Wide Association Studies (GWAS)

The new policy for the sharing of data obtained through NIH-supported or -conducted genome-wide association studies (GWAS) goes into effect in January 2008. The policy applies to:

  • Competing grant applications that include GWAS and are submitted to the NIH for the January 25, 2008, and subsequent due dates
  • Proposals for contracts that include GWAS and are submitted to the NIH on or after January 25, 2008
  • NIH intramural research projects that include GWAS and are approved on or after January 25, 2008.

The final policy was announced in the NIH Guide, NOT-OD-7-088, after a period of public consultation with representatives from the scientific and lay communities. A followup Notice, NOT-OD-08-013, provides guidance on implementation and instructions for applicants.

The policy’s goal is to facilitate broad and consistent access to NIH-supported GWAS data to speed the translation of basic genetic research into therapies, products, and procedures that benefit the public health. NIH believes that the full value of GWAS to the public can be realized only if the resulting genotype and phenotype datasets are made available as rapidly as possible to a wide range of scientific investigators. Rapid and broad data access is particularly important for GWAS—these studies generally require significant resources, present challenges in analyzing the large datasets, and provide extraordinary opportunities for making comparisons across multiple studies.

Refer to the NIH GWAS Web site for guidance on implementing the policy, including on developing data-sharing plans for applications and proposals that include GWAS, peer review of GWAS grant applications, submitting data to the NIH GWAS data repository, requesting access to data in the NIH GWAS data repository, oversight of the NIH GWAS initiative, protections for research participants, points to consider for Institutional Review Boards and institutions in their review of data submission plans and institutional certifications, and frequently asked questions and answers.

NIH Issues Revised Policy on Enhancing Public Access to Archived Publications From NIH-Funded Research

NIH policy NOT-OD-05-022 requires that all NIH-funded investigators submit, or have submitted for them, to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided that the NIH shall implement the public access policy in a manner consistent with copyright law.

Revisions to the policy were announced in the NIH Guide, NOT-OD-08-033, this month. Specifically:

  • NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008.
  • Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this policy.
  • PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases.
  • The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article.
  • Beginning May 25, 2008, anyone submitting an application, proposal, or progress report to the NIH must include the PMC or NIH Manuscript Submission reference number when citing applicable articles that arise from their NIH funded research. This policy includes applications submitted to the NIH for the May 25, 2008, due date and subsequent due dates.

Grant Applications Must Tie to Funding Opportunity Announcements

Together with implementation of electronic submission of grant applications, all applications must be submitted in response to specific Funding Opportunity Announcements (FOA). NIH has omnibus parent announcements for use in submitting what were formerly termed “unsolicited” applications. Web page to help identify appropriate FOAs for unsolicited or investigator-initiated applications

Paper Notification of Notice of Awards Stops

NIH no longer provides paper notification of the Notice of Award (NoA) letters as of January 1, 2008. Instead, NoAs are being sent solely via e-mail to grantee organizations and will be accessible in the eRA Commons through the “Status” module. For more information, refer to the NIH Guide Notice, NOT-OD-08-002.

NIH Summarizes Policy on Late Grant Applications

NIH describes its policy on late grant applications in a Notice in the NIH Guide, NOT-OD-08-027, consolidating information from previous Notices.

No NIH staff member, whether in the Center for Scientific Review (CSR) or any of the other Institutes/Centers, has the authority to give permission in advance for a late application. Contacting the Division of Receipt and Referral or any other component of the NIH will not lead to either permission to submit late or an evaluation of the acceptability of the reasons for a delay. Direct inquiries to the Division of Receipt and Referral, CSR, NIH, tel.: (301) 435-0715; fax: (301) 480-1987.

Standing NIH Study Section Members Offered Modified Grant Application Submission, Referral, and Review

NIH is implementing an alternate plan for submission and review of research grant applications from appointed members of chartered NIH Study Sections in order to recognize their outstanding service and to minimize disincentives to study section service. The timing of Study Section meetings and most standard due dates for grant applications overlaps. Thus, reviewers are under pressure to review applications and prepare their own applications simultaneously.

Beginning Feb. 5, 2008, the alternate submission and review procedures, described below, will be available for appointed members of NIH Study Sections. This alternate process is limited to (1) appointed members of chartered standing Study Sections and (2) applications that would normally be received on standard submission dates (but not special receipt dates). Depending on the timing of the submission and the number of other similar applications received during the premeeting time window, NIH staff will decide if the application will be reviewed in a different standing Study Section or in a Special Emphasis Panel (SEP). These applications will be processed and assigned to NIH Institute Review Offices or CSR Integrated Review Groups (IRGs) using the standard referral guidelines.

The continuous submission process will enable appointed members of chartered NIH Study Sections to submit their applications as soon as they are fully developed. Applications will be reviewed no later than 120 days after receipt.

  • Read the NIH Guide Notice, NOT-OD-08-026 for complete information.

NIH Issues New Application Forms: Relinquishing Grant, Noncompeting Continuation Progress Report

EGRP grantees may wish to take note of two recently revised NIH grant forms:

  • Official Statement Relinquishing Interest and Rights in a PHS Research Grant (PHS 3734, rev. 11/07). The form is accepted immediately. There are no changes to the data elements or instructions in this revision of the form. Refer to the NIH Guide Notice, NOT-OD-08-029.
  • Noncompeting Continuation Progress Report for a DHHS Public Health Service Grant (PHS 2590, rev. 11/07). This form is accepted immediately, and all progress reports received on or after March 1, 2008, MUST use the new instructions and form. During the transition period the previous version (interim revision 04/2006) will continue to be available, and progress reports using the previous version will be accepted through Feb. 29, 2008. Please read the instructions carefully. This edition of PHS 2590 implements a number of important policy changes, including the NIH Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies, and registration of clinical trials in ClinicalTrials.gov as required by Public Law 110-85.

    One significant change to PHS 2590 is the business process for submission of the continuation progress report. As of March 1, 2008, only the signed original continuation progress report is required to be submitted to the centralized mailing address. (No additional copies are required.) Refer to the NIH Guide Notice for complete information, NOT-OD-08-030.

NIH Web Site Created To Showcase Small Business Technologies and Products for Potential Partners, Investors, and Licensees

diagramNIH’s Office of Technology Transfer (OTT) and the SBIR/STTR Program Office have identified a way to assist NIH licensees and SBIR/STTR awardees in crossing the so-called “Valley of Death” — the costly divide between early stage technologies and those representing more intermediate stage development eagerly sought by companies. A virtual space, called the Pipeline to Partnership (P2P), has been created where NIH licensees and SBIR/STTR grantees can showcase their technologies and product development for an audience of potential strategic partners, investors, and licensees.

A pipeline of technologies available for partnering is on the OTT Web site as an index searchable by category of technology and stage of development. Once a technology of interest is identified, the interested party is directed to the relevant licensee/awardee developing the technology. All submissions to the site by the licensees and grantees are voluntary, with no endorsement or direct involvement from NIH in the partnering.

Meetings

NIH Regional Seminars on Funding and Grants Administration Set for San Antonio in March, Chicago in June

Registration for this year’s 2-day NIH Regional Seminars on Program Funding and Grants Administration is set for:

These seminars provide a unique opportunity to interact with key NIH experts in extramural program funding and grants administration and cover topics ranging from opportunity identification and application preparation through postaward administration. Presentations are targeted toward research administrators, new and experienced investigators, postdoctoral scientists, and trainees.

Take advantage of this opportunity to meet experts from the NIH SBIR/STTR Programs, Division of Grants Policy, Office of Laboratory Animal Welfare, Office of Human Subject Protections, Program Officers from several different NIH Institutes/Centers, Grants Management Officers, and many others — including a team of experts who will be available to answer your specific Commons and electronic submission questions at the eRA booth.

In addition to the 2-day seminars, attendees also have the opportunity to register for an additional day of eRA Workshops in the areas of:

  • eRA Commons Administration Basics (targeted for Account Administrators)
  • eRA Commons Status for Administrators
  • xTrain (targeted for Administrators and Program Directors of training grants)
  • eRA Commons for Principal Investigators and their Delegates.

Direct inquiries to Ms. Cynthia Dwyer, Communications and Outreach Specialist, Office of Extramural Research, OD, NIH; e-mail: dwyerc@mail.nih.gov.

The seminars were announced in the NIH Guide, NOT-OD-07-076.

NIH Small Business Grants Conference Set for Atlanta, July 22-23, 2008

The annual NIH Small Business Innovation Program/Small Business Technology Transfer (SBIR/STTR) Programs Conference is scheduled for July 22-23, 2008, in Atlanta, GA, and will be hosted by the Georgia Tech Enterprise Innovation Institute. Visit the conference Web site for more information.

EGRP-Supported Research Resources

Long Island Geographic Information System Available for Breast Cancer, Other Diseases

GIS layer graphicThe Geographic Information System for Breast Cancer Studies on Long Island (LI GIS) is an enterprise geographic information system combining an Oracle data warehouse, ESRI ArcGIS Suite, and statistical and spatial software and extensions. It is designed to study potential relationships between environmental exposures and breast cancer on Long Island (Suffolk and Nassau counties) and is available to researchers with approved protocols. The LI GIS also can be used to study other diseases.

This unique research tool offers a full suite of GIS software and extensions related to the study of breast cancer. The LI GIS warehouse has more than 80 datasets covering topographic data; demographic data; health outcome data, including relative breast cancer incidence; and environmental data for Long Island. Additional environmental data are included with less detail and geographic precision for areas 50 kilometers from the two counties, and very limited data for areas within a 100-mile radius from the midpoint of the boundary line between the two counties. The extended area includes counties in Connecticut, New Jersey, New York, Pennsylvania, Rhode Island, and Massachusetts.

Researchers can access the LI GIS remotely or work in its laboratory located in Reston, VA. There is no fee to use the LI GIS or its laboratory; however, funding for research is not provided. The LI GIS was developed as part of the Long Island Breast Cancer Study Project (LIBCSP).

EGRP Contact: Shannon Lynch, M.P.H., Co-Project Officer; e-mail: lynchs@mail.nih.gov.

Breast and Colon Cancer Family Registries (CFRs)

CFR logoThe Breast and Colon Cancer Family Registries (CFRs) are international research infrastructures for investigators interested in conducting population- and clinic-based interdisciplinary studies on the genetic and molecular epidemiology of these cancers and their behavioral implications. A central goal of the CFRs is the translation of this research to the clinical and prevention setting for the benefit of the Registries’ participants and the general public.

The Breast CFR has information and biospecimens contributed by more than 12,500 families across the spectrum of risk for the cancer and from population-based or relative controls. The Colon CFR has information and biospecimens on more than 11,300 families across the spectrum of risk for colon cancer and from population-based or relative controls.

Of particular interest to the CFRs are identification and characterization of cancer susceptibility genes; definition of gene-gene and gene-environment interactions in cancer etiology; and translational, preventive, and behavioral implications of research findings.

Special features of the CFRs include population-based and clinic-based ascertainment; systematic collection of validated family history; epidemiologic risk factor data; clinical and followup data; biospecimens (including tumor blocks and EBV-transformed cell lines); and ongoing molecular characterization of the participating families.

Researchers who are interested in accessing data and/or biospecimens can learn more about the CFRs and the application process at the CFRs Web site. The CFRs do not provide funding for research.

EGRP Contact: Daniela Seminara, Ph.D., M.P.H., Program Director; e-mail: seminard@mail.nih.gov

Cancer Genetics Network (CGN)

The Cancer Genetics Network (CGN) is a national network of centers specializing in the study of inherited predisposition to cancer. The resource is available to the research community at large to support studies on the:

  • genetic basis of human cancer susceptibility
  • integration of this information into medical practice
  • behavioral, ethical, and public health issues associated with human genetics.

The database has information on 24,000 individuals (16,000 families) with cancer and/or a family history of cancer. Data are available on cancer type, a four-generation cancer family history, genetic testing (if performed), genetic mutation if collected in a CGN special study, any known genetic syndromes in the family, biospecimens on many enrollees, annual followup on all enrollees, history of tobacco use, and sociodemographic information. More data are available on subsets of enrollees who have participated in CGN special studies. The population enrolled makes possible research on both common and uncommon tumors.

This unique infrastructure enables studies on genes of moderate and low penetrance, as well as more easily identified high-penetrance genes. The CGN welcomes opportunities to collaborate with research groups on important studies, and/or it can provide data and biospecimens, and a range of services and expertise to support independent studies. Research funding is not provided.

The CGN is operated through a 5-year grant awarded to Massachusetts General Hospital (MGH) in the fall of 2007 by NCI’s Epidemiology and Genetics Research Program (EGRP). MGH is the Data Coordinating Center and subcontracts with 14 centers that provide the infrastructure to support studies. NCI started the CGN in 1998 through a group of EGRP-funded grants. Visit the CGN Web site.

Diane M. Finkelstein, Ph.D., is MGH Program Manager/Principal Investigator, and Nora Horick, M.S., is MGH Project Manager.

EGRP Contact: Carol Kasten, M.D., Program Director; e-mail: kastenca@mail.nih.gov.

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You are welcome to invite others to subscribe to receive occasional Bulletins and News Flashes from the Epidemiology and Genetics Research Program (EGRP).


Last modified:
24 Oct 2008
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