 |
 |
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
August 26, 2005 |
EGRP BULLETIN
From the Office of
Edward Trapido, Sc.D., Associate Director
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
This issue of NCI's Epidemiology and Genetics Research Program (EGRP)
Bulletin brings you news about:
EGRP Staff Will Be at American College of Epidemiology Meeting, September 17-20, New Orleans
Debbie Winn |
Marilie Gammon |
EGRP staff will be at this year’s annual meeting of the American College of Epidemiology (ACE) “Epidemiology and Advocacy in the Real World: Focusing Attention on How Advocacy Shapes the Practice of Medicine,” September 17-20, in New Orleans. If you will be there, you are welcome to contact our staff who are attending to arrange a meeting, and to stop by our exhibits.
Debbie Winn, Ph.D., Chief, CGERB, is co-chairing a plenary session with Irene Hall, Ph.D., of the Centers for Disease Control and Prevention (CDC), titled “Research in the Public Eye: The Long Island Breast Cancer Study and Research on Gulf War Illness” on Monday, September 17. Dr. Winn also will give a presentation during the session on challenges of uncovering causes of high breast cancer rates in the Long Island Breast Cancer Study Project (LIBCSP), and Marilie Gammon, Ph.D., of the University of North Carolina at Chapel Hill, will present “Researchers, the Advocacy Community, and the Public: Insights from the Study of Breast Cancer and the Environment on Long Island.”
Dr. Gammon was principal investigator of the centerpiece study of the LIBCSP, a large case-control study of women diagnosed with breast cancer living on Long Island (Nassau and Suffolk counties), New York, that investigated environmental exposures and risk for the cancer. The LIBCSP has been coordinated and funded through EGRP and the National Institute of Environmental Health Sciences (NIEHS). Dr. Gammon now is conducting a follow-up study on the women diagnosed with breast cancer who participated in the initial study with funding from NCI’s Office of Cancer Survivorship, Division of Cancer Control and Population Sciences (DCCPS), of which EGRP is a part.
 Also on Monday, September 17, EGRP Associate Director Ed Trapido, Sc.D., will moderate a luncheon roundtable about consortium epidemiology and the role of the junior investigator.
EGRP staff who are attending the meeting are: Dr. Trapido; Dr. Winn; Mukesh Verma, Ph.D., Acting Chief, Analytic Epidemiology Research Branch (AERB); Shannon Lemrow, Ph.D., Program Director, Office of the Associate Director (OAD); Shannon Lynch, M.P.H., Cancer Research Training Award Fellow, CGERB; Barbara Guest, M.S.W., M.P.H., Program Analyst, OAD; Scott Rogers, M.P.H., Research Associate, CGERB; and Linda Anderson, M.P.A., Director of Communications, OAD.
EGRP Staff News
 Nancy Emenaker, Ph.D., M.Ed., R.D., a Health Scientist Administrator, is on a 6-month rotation with EGRP from the National Institutes of Health’s (NIH) Center for Scientific Review (CSR). She is in a 2-year CSR training program learning the role of Scientific Review Administrators, who are responsible for coordinating the review of grant applications and assuring that NIH policies and guidelines are followed in the process. Dr. Emenaker is working with EGRP’s Virginia (Ginny) Hartmuller, Ph.D., R.D., Analytic Epidemiology Research Branch (AERB), on overseeing the diet and cancer research portfolio and learning the role of the Program Director.
Dr. Emenaker holds an M.Ed. in nutrition education from the University of Cincinnati and a Ph.D. in human nutrition from The Ohio State University. She has extensive experience in nutrition and cancer research with an interest in dietary modulation of colorectal cancer. Prior to coming to the NIH, Dr. Emenaker was an Associate Research Scientist in the Department of Physiology and Cellular Biophysics, Columbia University College of Physicians and Surgeons, and an active member of Herbert Irving Comprehensive Cancer Center's Gastrointestinal Malignancies, Carcinogenesis, and Prevention and Control Programs.
 Shannon Lemrow, Ph.D., who has been a staff scientist in EGRP’s Office of the Associate Director (OAD) working on various initiatives, has become a Program Director. Two years ago, she joined EGRP through the Department of Health and Human Services (HHS) Emerging Leader Program, which brings into the agency young professionals with competencies in science and other professions, and this past summer, she graduated from the program. Dr. Lemrow will begin assuming responsibility for EGRP-funded grants, particularly those with a strong basic biology focus, as well as continuing to work on special projects for the OAD.
She also is a member of the trans-NCI Biorepository Coordinating Committee which is tasked with unifying biorepository management processes to maximize the utility of all repositories maintained and funded by the Institute, and represents the interests of epidemiologists and other population scientists on behalf of our Division of Cancer Control and Population Sciences (DCCPS). Dr. Lemrow received her B.S. in chemistry and biological sciences from Carnegie Mellon University and her Ph.D. in cancer biology from Duke University.
 Shannon Lynch, M.P.H., has joined the Clinical and Genetic Epidemiology Branch (CGERB) as a Cancer Research Training Award Fellow to coordinate its Knowledge Transfer Team (KTT). She will develop and disseminate information materials and products about research resources and tools of use to EGRP grantees, prospective grantees, and the public. Drawing upon her background in environmental epidemiology, Ms. Lynch will help to expand the Web site for the Geographic Information System for Breast Cancer Studies on Long Island (LI GIS) to include maps for the public. She also will be conducting epidemiology research as part of the Agricultural Health Study, under the direction of Michael Alavanja, Dr.P.H., of NCI’s Division of Cancer Epidemiology and Genetics (DCEG).
Ms. Lynch received her M.P.H. in environmental and occupational health from the George Washington University School of Public Health. She completed an internship with the U.S. Environmental Protection Agency (EPA), where she developed and managed reference tools for EPA in response to biological and chemical terrorist events. She also worked as a biologist conducting HIV protease research at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Laboratory of Chemical Physics.
Reports Available from Two EGRP-Supported Workshops
Epidemiology Leadership Workshop Identifies Gaps, Barriers, and Opportunities for Tobacco, Diet/Energy Balance, and Genetic Research
The meeting report from The 1st NCI Epidemiology Leadership Workshop: Tobacco, Diet/Energy Balance, and Genetic Research, which was sponsored by EGRP in the fall of 2004, is available on the Program’s Web site. Seasoned principal investigators funded through EGRP were asked to this by-invitation-only-meeting to identify barriers and gaps in cancer epidemiology and to advance solutions to the study of tobacco diet/energy balance, and genes.
The document includes summaries of state-of-the-science presentations in these areas and on opportunities to explore new collaborations, and individual reports from the four working groups: (1) Challenges to Diet/Energy Balance Epidemiology Research, (2) Haplotypes Versus Genotypes, (3) Design Issues and Strategies in the Study of Rare Cancer, and (4) Susceptibility in Tobacco Carcinogenesis: Genotypes Versus Phenotypes. The Web site also has the speakers’ presentations (PDF format).
Cancer Risk Prediction Models Workshop Identifies Priorities and Resources
Cancer researchers, clinicians, and the public are increasingly interested in statistical models designed to predict the occurrence of cancer. As the number and sophistication of cancer risk prediction models have grown, so too, has interest in ensuring that they are appropriately applied, correctly developed, and rigorously evaluated. In 2004, EGRP cosponsored a workshop on statistical models for predicting a person’s risk of developing cancer, and the meeting report now is published in the Journal of the National Cancer Institute.
Research priorities and resources are identified in the areas of (1) revising existing breast cancer risk assessment models and developing new models, (2) encouraging the development of new risk models, (3) obtaining data to develop more accurate risk models, (4) supporting validation mechanisms and resources, (5) strengthening model development efforts and encouraging coordination, and (6) promoting effective cancer risk communication and decision-making.
Freedman AN, Seminara D, Gail MH, Hartge P, Colditz GA , Ballard-Barbash R, Pfeiffer RM. Cancer risk prediction models: a workshop on development, evaluation, and application. J Natl Cancer Inst 2005 May 18;97(10):715-23.
EGRP Updates Its Topics for Small Business and Small Business-Research Institution Partnership Grants
EGRP has updated its topics of interest for small businesses and small business-research institution partnerships to consider when seeking funding through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs. These programs support innovative research with potential for commercialization. In Fiscal Year (FY) 2003, the National Institutes of Health (NIH) made SBIR grant and contract awards totaling over $525 million and STTR grant awards totaling over $31 million.
In the SBIR Program, funding is usually provided for up to 6 months and $100,000 total cost for Phase I feasibility studies, and for up to 2 years and $750,000 for Phase II projects. The SBIR Program is a set-aside program (2.5% of an agency's extramural budget) for domestic small business concerns to engage in research/research and development that has the potential for commercialization.
The STTR Program requires close collaboration between the small business and a partnered research institution. The small business is to conduct at least 40% of the research project, and the single, partner institution conducts at least 30% of the work. Funding is usually provided for up to 1 year and $100,000 total cost for Phase I feasibility studies, and for up to 2 years and $750,000 for Phase II projects.
EGRP’s topics of interest are:
- Tools for assessment of exposures and biomarkers:
- Development of methods for measuring biomarkers of human exposure or susceptibility, and of nutritional status, and methods for monitoring changes in biomarkers for use in cancer epidemiologic studies.
- Development of new or improved devices for quantitative measurement of human exposure to environmental carcinogens for epidemiologic studies.
- Development of methods to evaluate potential cancer clusters for epidemiologic studies.
- Tools for cancer epidemiology studies:
- Development of tools to model cancer risks from environmental and occupational agents.
- Development of software for electronic capture of risk factor data for cancer epidemiologic studies.
- Build consumer-friendly risk prediction models from epidemiologic data.
- Development of software for tracking biological specimens for cancer epidemiologic studies.
- Development of software for electronic identification, screening, and recruitment of participants, especially minorities, into epidemiologic studies.
- Development of Web-based data collection or applicable bioinformatics tools for cancer epidemiology.
- Development of software or methods for rapid case ascertainment of cancers.
- Development of geographic information systems with special visualization techniques for the simultaneous assessment of environmental exposures and health outcomes.
- Development of tools using publicly available data to identify population-based controls for epidemiologic studies.
- Development of software for analysis of DNA methylation biomarkers for early detection of prostate or breast cancers with use of specimens from biorepositories.
New with the December 1, 2005, receipt date, SBIR/STTR Programs grant applications must be submitted online through Grants.gov using the SF424 Research and Research Related (R&R) form (NOT-OD-05-067). Prospective applicants are strongly encouraged to register with Grants.gov early to ensure that they are ready to take advantage of the electronic submission process.
Learn more about the SBIR and STTR Programs through EGRP’s Web site.
Contact: Jay Choudhry, M.S., Program Director
Grantsmanship
 NIH Requests Input on Plan to Recognize Multiple Investigators
NIH seeks input and advice from the scientific community on various concepts associated with permitting more than one principal investigator to be associated with an NIH-funded grant, contract, or cooperative agreement. The tentative implementation plan is described in a Request for Information (RFI) that appeared in the NIH Guide for Grants and Contracts (NOT-OD-05-055), July 29, 2005. Responses are due by September 15, 2005, and may be submitted online.
The RFI explains that NIH plans to adopt or create grant application forms that include sections for more than one principal investigator. Each of the listed principal investigators will be designated by the grantee institution and will be expected to share responsibility for directing the project or activity supported by the grant. As with current policies, each principal investigator will be responsible and accountable to the grantee institution and to the NIH for the proper conduct of the project or activity.
Information on the identity of each principal investigator will be stored in NIH databases and will appear in reports including: CRISP, Notices of Award, reports accessible through the NIH Commons, and summary statements. The institution will be asked to select a contact principal investigator at the time of application. NIH will ask for a Leadership Plan in applications involving more than one principal investigator. NIH anticipates modification or adoption of grant application forms that permit the involvement of more than one principal investigator before the end of FY 2006. Read more about the tentative implementation plan in the NIH Guide.
Investigators Urged to Submit Manuscripts to NIH PubMed Central
EGRP encourages investigators to participate in NIH’s initiative to enhance public access to publications resulting from NIH-funded research. An NIH policy announced earlier this year and effective May 2, 2005, requests that investigators submit to the Library of Medicine (NLM) PubMed Central (PMC) an electronic version of manuscripts resulting from NIH-supported research after acceptance for publication. The policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, and NIH intramural research studies. Authors stipulate when the manuscripts can be made public.
The policy applies to manuscripts for peer-reviewed research publications and does not apply to book chapters, editorials, reviews, or conference proceedings. PMC is NIH’s free and publicly accessible online, full-text archive of peer-reviewed biomedical, behavioral, and clinical research journal literature.
The policy announcement states: “At the time of submission to PMC, the author specifies the timing of the posting of his or her final manuscript for public accessibility. Posting for public accessibility through PMC is requested and strongly encouraged as soon as possible (and within 12 months of the publisher’s official date of final publication).
“The publisher may choose to furnish PMC with the publisher’s final version, which will supercede the author’s final version. Also, if the publisher agrees, public access to the publisher’s final version in PMC can occur sooner than the timing originally specified by the author.” (A new feature in the NIH Manuscript Submission System (NIHMS) offers authors the option of having third-party designees upload manuscripts on their behalf. Third-party designees may include assistants, libraries, or publishers.)
NIH also plans to use this archive to manage its research portfolio, monitor scientific productivity, and help set research priorities.
Access NIH’s Public Access Web page to link to the NIH Guide Notice “Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research” (NOT-OD-05-022), Authors’ Manual, and other information resources.
Access NIHMS, PubMed Central.
Closeout Feature Available in the eRA Commons
 NIH’s Electronic Resource Administration (eRA) Commons now includes the capability to electronically submit required Closeout Reports—final progress report, final Financial Status Report (FSR), and final inventions statement. The “Commons” is the Web interface where NIH grantees are able to conduct their extramural research administration business electronically. We encourage you and your organization to register and take advantage of the convenience of the Commons through which you can submit grant applications and associated materials, post Progress Reports, and review the status of your applications. Contact your institution to determine if it is already registered or view the listing on the Commons Web site and obtain the information needed to register yourself.
Commons-registered grantee institutions may now query in the Commons Status system for those grants that are in a closeout status. Commons users can then enter the Closeout screens to electronically process and submit the required reports. For the final progress report, users l attach a PDF, Word, or text file. For the Final Financial Status Report, users are directed to the eRA Commons FSR system. For the Final Inventions Statement, users indicate if any inventions are being reported and if so, they are provided with text entry areas to report inventions. Each required report can be submitted independently; however, closeout is not complete until all reports have been submitted.
Flowchart Helps To Determine Applicability of Human Subjects Rules
The NIH Office of Extramural Activities (OER) has developed a new flowchart to help investigators determine whether research involving private information or human biological specimens involves human subjects. Access OER’s Human Subjects Web site to view the flowchart and other information about requirements for protection of human subjects.
Web Page Available on Data Sharing Information Resources
NIH’s OER has a Web page that provides access to various information resources on data sharing. Investigators who submit NIH grant, cooperative agreement, or contract proposals seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible. Access the Web site.
Dates Set for NIH Seminars on Grant Funding
The dates are set for next year’s NIH Regional Seminars on Program Funding and Grants. These annual seminars help demystify the grant application and review process, clarify federal regulations and policies, and highlight current areas of special interest or concern. NIH policy, grants management, review, and program staff provide expertise and encourage personal interaction between themselves and seminar participants. The seminars are appropriate for grants administrators, researchers new to NIH, and graduate students. There will be two seminars in 2006:
- March 30-31, Boston, Mass., co-hosted by Harvard University and Massachusetts General Hospital, and
- May 31-June 1, Riverside, Calif., co-hosted by University of California, Riverside.
Programmatic and logistical information.
Presentations from June 2005 seminar co-hosted by Purdue University.
EGRP-Supported Research Resources
EGRP invites researchers to take advantage of its research resources:
Long Island Geographic Information System for Breast Cancer Studies, Custom Extensions Freely Available
 EGRP-Supported Research Resources The 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. The LI GIS 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. It 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.
Included are four custom ArcGIS software extensions specially developed for LI GIS users but also freely available for researchers to download from the Web site and use for applications beyond Long Island. The extensions are tools for cluster analysis and applying the Empirical Bayes method, a disease rate calculator, and an areal interpolator. They are available for ArcView versions 3.x, 8, and 9.
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. Access to the LI GIS is at no expense, but special requests may involve costs to the researcher. Funding for research is not provided. Apply online.
Contact: Deborah Winn, Ph.D., Chief, CGERB; or Linda Pickle, Ph.D., Surveillance Research Program, DCCPS.
Breast/Ovarian and Colon Cancer Family Registries
 The Breast/Ovarian and Colon Cancer Family Registries (CFRs) are international registries available to researchers who are planning to conduct population- and clinic-based interdisciplinary research with a main focus on the genetic and molecular epidemiology of breast/ovarian and colon cancers. The CFRs have information and biospecimens contributed by more than 23,300 families among whom there is a history of breast and/or ovarian cancer or colon cancer. The spectrum of cancer risk is represented.
Of special interest are collaborations to identify and characterize cancer susceptibility genes; define gene-gene and gene-environment interactions in cancer etiology; and conduct cooperative research on the translational, preventive, and behavioral aspects of such findings.
Researchers who are interested in accessing data and/or biospecimens can learn more about the CFRs and the application process at the Web site. Funding for research is not provided. The CFRs Web site is newly revamped and expanded with much more information for potential collaborators and the public.
Contact: Daniela Seminara, Ph.D., M.P.H., Program Director, CGERB.
Cancer Genetics Network
The Cancer Genetics Network (CGN) supports research on the genetic basis of human cancer susceptibility, the integration of this information into medical practice, and the psychosocial, legal, and public health issues associated with human genetics. Its interests include gene discovery and characterization, gene-environment interaction, and translational and behavioral research. The database has information on 26,000 individuals (16,000 families) with cancer and/or a family history of cancer. Data available include demographic information, relevant medical history, and a four-generation pedigree on each enrollee. The population enrolled makes research possible on both common and uncommon tumors.
For approved studies, the CGN can offer a variety of services. Learn more about the CGN.
Contact: Carol Kasten, M.D., Program Director, CGERB.
On-Going EGRP-Sponsored Funding Opportunities
EGRP is sponsoring or cosponsoring the following the following Program Announcements (PA/PAR):
- Pilot Studies in Pancreatic Cancer ( PA-05-116) – Expires July 2, 2008, unless reissued.
- Small Grants Program for Cancer Epidemiology (PAR-04-159) (Replaces PAR-03-010) – This reissued PAR is effective with November 21, 2006, receipt date. Note new 10-page restriction on research plans including tables and figures.
- Studies of Energy Balance and Cancer in Humans (PA-04-124) - Expires November 2, 2006, unless reissued.
- Exfoliated Cells, Bioactive Food Components, and Cancer (PA-04-114) - Expires November 2, 2007, unless reissued.
- Occupational Health and Safety Research (PA-04-038) - Expires November 23, 2006, unless reissued.
- Research on Malignancies in AIDS and Acquired Immune Suppression (PA-04-157) - Expires November 2, 2007, unless reissued.
- Cohort Studies in Cancer Epidemiology (PAR-04-011) - Expires November 2, 2005. This PA will not be reissued, which means that grant applications for cohort studies in epidemiology may be submitted on the regular grant cycle. Remember that NIH requires that grant applicants with a requested budget over $500,000 in direct costs in any year of the grant contact the appropriate program staff member to obtain approval before submitting applications to the NIH Center for Scientific Review (CSR) for peer review (NIH Guide: NOT-OD-02-004 and NOT-CA-04-004). Approval for NCI epidemiology applications must be sought at least 8 weeks prior to submission to CSR to complete the internal processing by the deadline. Investigators may be interested in knowing of the cohorts currently funded by EGRP.
Links to Other Information Sources About Grants Policies, Funding, and Training
Link to EGRP Staff List
You are welcome to tell others about our ListServ and invite them to subscribe to receive occasional Bulletins and shorter announcements about new developments in grantsmanship and NCI activities relevant to EGRP. To subscribe, contact andersoL2@mail.nih.gov
|
