text:
Participating Organization(s) |
National Institutes of Health (NIH) |
National Human Genome Research Institute (NHGRI) |
Funding Opportunity Title |
Ethical, Legal, and Social Implications of Returning Research Results to Genomic Research Participants (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
New |
Related Notices |
Funding Opportunity Announcement (FOA) Number |
Companion FOA |
Catalog of Federal Domestics Assistance (CFDA) Number(s) |
93.172, 93.173 |
FOA Purpose |
The purpose of this FOA is to stimulate analytical research on the normative and legal issues involved in deciding whether, when, and how to offer to return individual research results to participants in genomic research studies (especially whole exome or whole genome sequencing studies) or to individuals who have provided samples or data for genomic repositories (such as biobanks or databases such as dbGaP). This FOA is aimed primarily at sole investigators or small teams of investigators who propose modest legal and normative research projects. This FOA is complementary to FOA RFA-HG-11-003 (R01), which invites applications that propose empirical research to develop a preliminary evidence base to inform decision-making about returning research results. It is also complementary to FOA RFA-HG-10-017 (U01), which invites applications for projects designed to generate, process, filter, and interpret data from whole exome or whole genome sequencing in the specific context of an active clinical setting, and to return--and investigate the psychosocial and behavioral implications of returning--genomic results in the clinical setting (as distinct from the traditional research setting). A consortium of investigators will be organized that includes the principal investigators and relevant key personnel funded under all three FOAs; this consortium will address common issues, explore opportunities for synergy among studies, and identify areas of possible consensus that can form the basis for policy recommendations in this area. |
Posted Date |
December 17, 2010 |
Open Date (Earliest Submission Date) |
February 10, 2011 |
Letter of Intent Due Date |
February 10, 2011 |
Application Due Date(s) |
March 10, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Advisory Council Review |
Earliest Start Date(s) |
September 30, 2011 |
Expiration Date |
March 11, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Defining the circumstances, if any, under which individual research results can, should, or should not be offered to participants in genomics research studies (especially whole exome and whole genome sequencing studies) raises complex challenges for genomics researchers, managers of repositories of genomic samples and data, and members of institutional review boards (IRBs). While issues related to the return of results are neither new nor unique to genomics research, several unique characteristics of genomics research make their resolution in this field especially daunting.
First, genomics studies involve the generation of information which will, by definition, be voluminous in quantity and comprehensive in scope. This is particularly the case in whole exome and whole genome sequencing studies, which are becoming increasingly feasible--and thus more common--as sequencing costs continue to decline. In such studies, researchers may or may not uncover the particular variants or variants they were originally looking for (related to the disease or trait of initial interest). However, they will inevitably uncover a large number of incidental findings--findings that are apparently unrelated to the original research questions. Such incidental findings will include variants of both known and unknown significance, information about carrier status, and information about risk for late-onset disorders. Deciding what to do with these findings will present researchers with significant ethical challenges.
Second, the trajectory of genomics research is typically very uncertain and open-ended; samples provided for one study or data generated in the course of one study-- may subsequently be made available (such as through a biobank or a database such as dbGaP) to secondary investigators in far-flung places who have no direct relationship to the participant. These secondary investigators may mine the samples or the data for purposes very different from those contemplated as part of the original study. These studies likewise may uncover new information--not only about risk factors for the disease or trait that was the stated subject of the original study, but about risks for other diseases and traits as well.
Finally, for several reasons, the meaning of much genomic information especially for low penetrance variants and for variants related to common, complex diseases--is likely to be highly indeterminate and hard to interpret. The rapid pace of development of genomic technologies (especially the new sequencing technologies), makes the quality of the data hard to evaluate. Studying many individuals in the context of a research project--and interrogating perhaps tens of thousands of genes in search of variants that are individually relatively rare--will inevitably lead to technical errors and give rise to the potential for analytic false positives. Searching for even well-known disease-associated variants in a research participant without a relevant family history raises the potential for finding clinical false positives." This will particularly be the case with respect to variants that genome-wide-association studies have found are associated with only moderately increased risk for common, complex disease, which may be very hard to interpret on the level of an individual research participant. In addition, sequencing will invariably discover variants in genes known to be associated with disease but which have never before been seen (i.e., private mutations); the significance of these will similarly be hard to discern. Compounding all these problems is the fact that the significance of the information uncovered through genomic analysis may evolve over time as additional knowledge is gained.
All of these factors--coupled with the limited resources typically available to researchers--can make the prospect of offering to return all or even most individual results to the participants in genomics studies unwieldy, and in some cases frankly unrealistic. As a practical matter, some researchers, and some institutions that maintain biobanks, will simply find it beyond their capability to promise to return any individual results and may default to the traditional approach of offering only aggregate study findings and no individual findings at all. On the other hand, certain subsets of findings such as findings of risk alleles for highly penetrant single gene disorders, variants with established pharmacogenomic relevance, and recessive carrier status--may not only have well-established validity, but in some cases, may also be clinically actionable. Deciding the appropriate course of action with respect to findings in these categories raises difficult ethical issues.
There is general consensus among lawyers that if genomic research results are being offered to study participants at all, this should be done only when their analytic validity has been established in a laboratory certified under the Clinical Laboratory Improvements Amendments (CLIA). Most ethicists also agree that results should be offered only in circumstances where they have actual utility. However, considerable controversy exists about the precise threshold of utility that that is required before a result can or should be returned. Some take the position that proven clinical utility is necessary (i.e., that some recognized preventive or therapeutic intervention must exist), while others believe that personal utility (e.g., the possibility that the information could be used for reproductive decision-making or general life planning) or even the mere recognition that the information may be useful in and of itself (e.g., by enhancing one's sense of personal identity) may be sufficient.
Given the lack consensus in this area, a pressing need exists to develop rational and workable criteria to help guide decision-making by researchers, managers of sample and data repositories, and IRBs about what types of information can, should, or should not be offered to participants in genomics studies. Such criteria must be informed both by solid empirical (behavioral and social science) evidence and by normative and legal considerations. This FOA is intended to stimulate research that analyzes the relevant normative and legal considerations. (A complementary FOA, RFA-HG-11-003, is intended to stimulate behavioral and social science research on the relevant issues. A second complementary FOA, RFA-HG-10-017 (U01) is intended to stimulate behavioral and social science research on the relevant issues in the clinical (non-research) context.)
Specific Areas of Research Interest
Topics of interest include, but are not limited to, the following:
An application submitted under this FOA may also incorporate a small, exploratory empirical (e.g., behavioral or social science) research component. However, in most cases, applicants proposing empirically-focused studies should consider applying instead under RFA-HG-11-003 (R01). Applicants proposing large studies with a primarily clinical (non-research) focus should consider applying under RFA-HG-10-017 (U01).
Additional Information for Applicants
A consortium will be organized that includes the principal investigators and relevant key personnel funded under this FOA; this consortium will also include other investigators who are already working on these issues, as well as the investigators to be funded under the two complementary FOAs referenced above. The consortium of investigators will meet at least one time per year, and more frequently by conference call, to identify and address common issues, explore opportunities for synergy among studies, and identify areas of possible consensus that can form the basis for policy recommendations in this area. Travel costs for the principal investigator to attend the annual meetings should be included in the proposed budget.
This FOA will not support the recruitment of human subjects for genomic studies, the collection of genomic samples or data, or the collection of medical or phenotype data. This FOA is also not intended to support the obtaining of reconsent or confirmatory testing of research results in a CLIA-certified laboratory. Applications that request support for these activities will be considered non-responsive and will be returned to the applicant.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIH intends to commit approximately $750,000 per year to this FOA. It is anticipated that 3-5 grants will be awarded. |
Award Budget |
The size of award will vary with the scope of research proposed. Applications must stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. It is anticipated that the budgets of most applications submitted in response to this FOA will be substantially lower than this amount. |
Award Project Period |
The scope of the proposed project should determine the project period. The project period should not exceed 2 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent to:
Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Rockville, MD 20852 should be used for FedEx, UPS and
other courier services
Telephone: 301-402-4997
Email: email@example.com
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) Application Guide must be followed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization's profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NHGRI Review Office by email at firstname.lastname@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not applicable.
Not applicable.
Not applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Not applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH national advisory councill
. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be
subject to the DUNS, CCR Registration, and Transparency Act requirements as
noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: email@example.com
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
Email: email@example.com
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Email: firstname.lastname@example.com
Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S. Postal Service Express or
regular mail)
Rockville, MD 20852 (express/courier service, non-USPS
Telephone: (301) 402-4997
Email: email@example.com
Rudy Pozzatti, Ph.D.
Scientific Review Officer
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9305 (U.S. Postal Service Express or
regular mail)
Rockville, MD 20852 (express-courier service, non-USPS
Telephone: (301) 496-7531
Email: email@example.com
Cheryl Chick
Grants Management Officer
Grants Administration Branch
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane
Suite 3058, MSC 9307
Bethesda, MD 20892 (U.S. Postal Service Express or regular
Rockville, MD 20852 (express courier service, non-USPS
Telephone: (301) 435-7858
E-mail: email@example.com
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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text:
The BFI have announced the guests for this Saturday's screening of the Sixth Doctor story, The Two Doctors. Appearing onstage for the Q&A after the episodes are shown will be: Frazer Hines (Jamie McCrimmon), Tony Selby (Sabalom Glitz), Doctor Who Script Editor and Writer Eric Saward and Visual Effects Designer Mike Kelt.
The Two Doctors screens this Saturday, June 15th at the BFI from 2pm. The event is currently sold out. As previously announced, the July screening will be Remembrance of the Daleks – details HERE.
Thanks to the BFI

subset: commoncrawl


text:
Article by Tiziano Thomas Dossena
On November 14, Alamo Theaters in Yonkers presented, on the 45th anniversary of its release, the Oscar winning film The French Connection, which played to a large audience of enthusiasts, a rather unusual occurrence for a Monday night. The reason for the large crowd was also the presence of Randy Jurgensen, an actor and Police consultant for the movie. The spectators were not disappointed. After the experience of viewing this wonderfully directed film, which offers a realistic and endless car chase among the many thrills, Mr. Jurgensen, a retired police detective, spoke about the little known unusual features of this movie. Some of these will surprise the reader as much they surprised me.
In a scene in which drug dealers are making a purchase, for example, the money in the briefcase is actually real money, or at least the visible bills are… The drug that is being tested by the dealer is real and there are no computer effects in the car chase; what you see is all real. The collisions, obviously, were staged, all but one, but when you see the car driving at 60 mph under the el and missing other cars by an inch or two, well, those were real stunts performed by Randy himself, except when Gene Hackman was visible in the car by the camera; in that case, Mr. Hackman was performing the stunt himself. Once, the famous actor hit a telephone pole and crashed the car; he was brought to the hospital for that incident… A subway train wreck was achieved by placing the two cars next to each other, backing one of them away from the other at high speed, film it and then reverse the film; simple, no?
In another scene, the detectives enter a bar full of apparent low lives; well, in reality most of them were real undercover cops and not actors. Would you have guessed it? The night club in which the duo goes to have a drink is the Copacabana and the performers are really the Three Degrees, and not some unknown act….
The music in the movie was purposely dissonant to raise the tension of the narrative, but there was no music whatsoever during the car chase and all you could hear was the sound of the car engines, the screeching of the tires, the bangs of the smash-ups, all 100% real sounds; no sounds were prepared in the editing booth.
Another interesting fact was that when acting in his scene, staged in a garage where towed cars were brought, Randy was told to just act as a cop who wanted to waste time, allowing the reassembly (or replacement) of a car which had been taken apart; be natural, that's all! He did just that, and what came out was the only humorous scene of the movie! It was another great choice by the Director, William Friedkin.
Mr. Jurgensen also explained that he had strongly objected to the scene in which Eddie Egan (A.K.A. Jimmy 'Popeye' Doyle) shot the unarmed French killer in the back, because that would have been a murder, but the Director told him not to worry and reminded him that he was just a consultant and not the Director. At the opening of the movie, the audience stood up and cheered after that shooting scene, and at that time Mr. Friedkin told him playfully, "I told you so…"
There were many other interesting facts that Mr. Jurgensen and Mr. D'Antoni (son of the producer and a producer himself for other movies with Mr. Jurgensen) offered to the excited public, but I will leave the reader with just one more: the movie was turned down by Movie Studios three times and it was finally when Twentieth Century Fox Film Corporation was practically bankrupt that they offered $2 Millions to start the production of the film, a mere small change left over after their enormous and disastrous financial loss with the historical movie Cleopatra; the movie at the end cost $32 Millions.
Watching the movie, with its hair raising scenes and frenetic rhythm, rediscovering visually in it the old '70s New York, and also listening to the commentary by Mr. Jurgensen and Mr. D'Antoni was a tremendous, unmatchable experience, and I wish more of these anniversary film projections were undertaken with similar results. Certainly, knowing that in the real French Connection sting, $489.000 and plenty of drugs were recovered by Eddie Egan and Sonny Grosso, the two detectives in charge of the case, and meeting some of the heroes of that story made it even more rewarding.


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The challenge was a collaboration between Knight, a civic tech investment organization, and health-care groups that include the Robert Wood Johnson Foundation, the California HealthCare Foundation, the Clinton Foundation and the Health Data Consortium. The seven winners were chosen from nearly 700 submissions.
"Overall, we were really struck by how rich of a class it was, we thought we might only get 200 or 300," said Michael Maness, Knight's vice president of journalism and innovation, who coordinated the initiative. "We're excited about moving into the health area for data because what you see in a lot of these [submissions] is a new way to approaching what 'coverage' is."
The Camden Health Explorer, from the Camden Coalition of Healthcare Providers, was among the lucky awardees and received $450,000 to create an interactive dashboard with real-time health-care enrollment costs and statistics.
Aaron Truchil, the Camden Coalition's associate director for data and evaluation, said he saw the project as part of a data-driven effort to support residents, who previously lacked access to big data for decision-making. He said the open source program was built in partnership with the data firm BlueLabs, and it combines anonymous individual health and medical claims data to display and map results by demographic and geography, to depict potential hot spots and needs.
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"We really wanted to leverage that data to not only benefit our work, but the work of an entire community," Truchil said. "We think it can tell a really powerful story if it gets into the right eyes."
Also chosen as a winner was the Homebrew Sensing Project by Public Laboratories for Open Technology and Science (PLOTS), for the the lab's proposed production of an affordable and mobile chemical analysis tool for residents. The project earned $350,000 from the challenge and was first conceptualized by PLOTS in 2010 during the BP oil spill in the Gulf of Mexico.
"The Knight funding is going to help us to really take this to the next step," said Shannon Dosemagen, PLOTS' president and director of outreach.
"What we're hoping with the spectrometry project is to take an instrument that's traditionally at the price point accessible to governments, corporations and formal researchers, and make it accessible to the independent person who wants to know what's in their water or what's in the soil," she said.
Taking the idea of a social service directory and turning it into a searchable database, Code for America's (CfA's) Ohana API was awarded $210,000 to build an open source app that takes a city's listings of social services and aggregates them into a simple search platform on the Web. The app was unofficially launched in beta in San Mateo County, Calif., by a team of CfA fellows to provide an open source tool that would connect citizens with community resources inside a single database.
"The funding is going to go to primarily packaging up the product," said Anselm Bradford, a CfA fellow and front-end developer for the app. "What we we want to focus on more is the Web API database and make that very easy to employ for different communities."
While The Knight News Challenge has been supporting innovation in a number of industries and fronts, this is the first year it has targeted health care as an area for innovation, Maness said. However, considering both the quality and number of the submissions he conjectured the health-care industry is likely to be reconsidered for next year.
"Really, it's a way of using technology to generate data that we believe has a lot of high utility for people," he said.
The listed winners included the following projects:
The Camden Health Explorer from the Camden Coalition of Healthcare Providers, which was awarded $450,000 to create an interactive dashboard with real-time health-care enrollment costs and statistics.
The Crisis Text Line from DoSomething.org, awarded $350,000 to provide youth with free crisis counseling through text messages and live referral services from counselors.
The Homebrew Sensing Project by Public Laboratories for Open Technology and Science, awarded $350,000 to provide low-cost chemical analysis tools so residents can track hazardous chemicals.
Ohana API from Code for America, which was awarded $210,000 to build an open source app that would connect the public with community resources through a centralized social service database.
The Open Humans Network from PersonalGenomes.org, awarded $500,000 to develop an online portal to connect people willing to share personal health information with researchers to advance medical breakthroughs.
Positive Deviance Journalism from the Solutions Journalism Network, awarded $180,000 to organize a collaboration between newsrooms and the Institute for Health Metrics and Evaluation to supply data for journalistic efforts.
And finally, the SafeUseNow project from Principled Strategies, awarded $208,000 to spearhead an effort to use data as a way to identify and prevent incidents of prescription drug abuse through tracking.


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The Return of the Maggie Valley Moonlight Race – August 27, 2011
|Just announced this morning – December 6, 2010. Imagine how much warmer it will be in August than it is today.
Maggie Valley Moonlight Race to return in 2011
The list of activities enhanced by mountain moonlight grew by one this week with the long anticipated return of a favorite Maggie Valley endurance event.
Announced today (Monday) by race organizer Greg Duff of Glory Hound Events, the Mission Health System Maggie Valley Moonlight Race will return in 2011 and once again entice runners from near and far to lace up their sneakers in the dark.
"After a two-year absence, Glory Hound Events is proud to bring back this fixture of the Western North Carolina running scene," Duff said. "Runners should be pleased to know that we are planning to restore some of the traditions of the past, as well as incorporate some modern aspects for the 30th running."
Hosted by the Maggie Valley Chamber of Commerce, the Moonlight Race will be held Saturday, Aug. 27, 2011. Those participating in the 8K race will gather at the Maggie Valley Fairgrounds and run the same course as was used in 2008, Duff said. The course takes runners 1.2 miles up the valley to Ghost Town, then 2.4 miles in the opposite direction, before returning them 1.2 miles to the finish line back at the fairgrounds.
"The Maggie Valley Area Chamber and Visitors Bureau is extremely pleased to bring back the Moonlight Race in August 2011 for its 30th year," said Teresa Smith, Chamber president. "Runners from all over the world have flocked to the valley throughout the years to participate in the Moonlight Race, and the businesses are happy to have the boost to the local economy that participants provide."
The first Maggie Valley Moonlight Race was held on Aug. 4, 1979, with more than 830 participants. From its start the nighttime race was popular with elite and amateur runners alike, some of whom traveled great distances and from other continents to participate. In its early years, the Moonlight Race's sizable winner's purse attracted internationally-recognized runners from as far away as Australia, New Zealand and Kenya. While prize money is no longer available, Moonlight runners continue to be challenged by the difficulty of this course, Duff said.
"The valley appears to offer a relatively flat course," he said, "but the climb toward the Ghost Town parking lot is a tough one."
"The town of Maggie Valley is excited to be working with Greg Duff of Glory Hound Events to promote the 30th running of the Moonlight Race," Audrey Hager, Maggie Valley's director of special events and festivals, said.
Just as was the case in 1979, town officials hope the return of the Moonlight Race will bring visitors in close contact with Maggie Valley's many businesses and hotels rooms. "We believe this important event will bring economic stimulus to the businesses and put Maggie Valley back on the map," said Hager.
"We are grateful to the Maggie Valley Chamber of Commerce and the town of Maggie Valley for their complete support of this endeavor," said Duff. "We look forward to once again seeing hundreds of people running in the valley this August."
Major sponsors for the returning Moonlight Race to date include Mission Health Systems and the Smoky Mountain News. Registration for the event will open on Feb. 1, 2011. All event information, including a link to online registration, is being updated as it becomes available at www.maggievalleymoonlightrun.com.


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February 22-24, 2013
Hilton Los Angeles International Airport
As the 2013 winter conference season kicks into high gear, Gazzang, the Linux data security company, is going on the road to present at three leading open source conferences: The Southern California Linux Expo (SCALE), ApacheCon North America and Mongo DB Austin.
MongoDB Austin is an annual one-day conference dedicated to the open source, non-relational database MongoDB. Attendees will hear from 10gen engineers who have contributed to the product, learn about t he core concepts of using MongoDB, and hear about exciting new features in MongoDB's most recent releases.
At MongoDB Austin, Gazzang will present the following session:
Automating a Secure MongoDB Deployment with Opscode & Gazzang
Speaker: Eddie Garcia, Vice President of Development
Feb. 14, 2013 at 4:15 pm Central
Hyatt Regency Austin, Austin, TX
This session will explore the real-life use case of a non-profit education collaborative that wanted to secure sensitive student and teacher data on MongoDB using Gazzang zNcrypt™, and demonstrate how Chef can automate the deployment and configuration of Gazzang zNcrypt for MongoDB.
SCALE's mission is to provide educational opportunities on the topic of Open Source software. The Expo's educational focus is composed of (but not limited to) technical seminars and booths where, among other things, both commercial software and hardware vendors, and local non-profit groups (for example, Linux Users Groups), participate in product display, and software demonstrations and tutorials, respectively.
At SCALE, Gazzang will present the following session:
Speaker: Casey Marshall, Developer
Feb. 24, 2013 at 1:30 pm Pacific
Hilton Los Angeles International Airport, Los Angeles, CA
Hockeypuck is an alternative implementation of a public key server, designed for performance, scalability and extensibility. This presentation will share the state of the project and some exciting new applications for the public key server model beyond OpenPGP.
ApacheCon is the official conference, trainings, and expo series of The Apache Software Foundation (ASF), and is the public showcase for Apache innovations. The 2013 conference theme is "Open Source Community Leadership Drives Enterprise-Grade Innovation", focusing on professionally-directed, relevant presentations that demonstrate real-world solutions to specific challenges.
At ApacheCon, Gazzang will present the following session:
Reining in Security Sprawl: Certificate & Key Management for Big Data
Speaker: Dustin Kirkland, CTO
Feb. 27, 2013 at 2:45 pm Pacific
Hilton Portland and Executive Towers, Portland OR
As the amount of security data being generated by cryptographic keys and certificates continues to grow, so does the complexity of managing that info across diverse projects and organizations. This ses sion will explore the challenges of "security sprawl" as it relates to big data, supported by real world case studies across numerous verticals.
About Gazzang
Gazzang provides Linux data security solutions and operational diagnostics that help enterprises protect sensitive information and maintain performance in cloud environments. Gazzang is backed by Austin Ventures and Silver Creek Ventures. For more information, visit www.gazzang.com.
Media Contact
Gazzang, Inc.
Cybele Diamandopoulos
(512) 535-4422


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Go right in and chew him a new head: a case of Mantis religiosa
Complaints: poor energy, frayed nerves, physical depletion, irritability, indecision about having a second child
This 41 year old woman began her consultation by saying: "My energy is not as good as I'd like it to be. I'm taking iron and prenatal vitamins now. Actually, the last time I felt really good was when I was pregnant. I can make it through my day, but I'd like to feel I have more vitality. I don't have enough 'oomph' to exercise. I'm feeling uncreative and I used to feel more creative. I'm feeling uninspired by my job – feeling un-creative, uninspired, really AVERAGE, and I don't like feeling average, I like feeling on top of my game."
This is a woman who was accustomed to finding success for her efforts. She'd been a competitive middle distance runner, a double degree university graduate, and a highly proficient media relations representative for a large government public service organization. Her qualities of "stick-to-it-ive-ness" and attention to detail were useful in her work. She also declared herself as not the 'most patient of people', and I saw in her a sharp intelligence and quickness of mind that was coupled with a low tolerance for slow or sloppy work. Snap judgements, blunt comments and accurate appraisals all comprised a part of her 'smart as a whip' work mentality.
However strong her self-confidence may have once been, it took a near fatal blow with the birth of her son. She said, "I had such a difficult time with him that I felt completely incompetent as a mother." She described her child as an "awful baby". He was "wide awake as soon as he was born and he was super-alert all the time". He couldn't be put down, or he would "Scream his head off, and he'd keep going and going". Breast feeding did not go well, and proper coaching ultimately helped sort out the nursing regime, but unfortunately it came so late that the mother was totally disheartened. The child didn't sleep unless held by his mother, and as her own sleep deprivation accumulated, her health began to decline. As she put it, 2 ½ years into motherhood, "I was a wreck; I swear I've been a wreck. In 2 ½ years I went from feeling about 30 to feeling 60 (years old) – to being completely drained, having no energy to do anything, no joy in life - it was just awful."
Her marriage suffered along with her health. Disagreements and fights came with the territory of caring for an extremely needy youngster. Since returning to work, she felt heartened that at least there she could "actually do something and feel semi-competent". And while from her boss's perspective she's performed well enough, internally her feeling was "I was barely holding together."
Now, she's trying to choose, "do I focus on career…, or do I have a second child…?" The decision is complicated by her depleted state of health, her self-declared post-traumatic stress from her first child (and anxiety about a possible repeat), and her concerns about a lack of parenting solidarity with her husband. For her immediate day to day life, though, the most significant change she was looking for was to feel more patience towards her son, the child who she'd come to feel tormented by. I prescribed Chocolate 30C about six weeks before the appointment, which brought the "insect" remedy into focus as her similimum. After having Chocolate she reported: "I was hoping to feel a lot more patient with my son, and on one hand I noticed that, a bit… but I was feeling much more intolerant of his behavior at times, too. When he was being a total monkey, I just wanted to… to strangle him. Well, not literally, but I just felt I had no tolerance for it, it was just like crrrrrh."
This woman is an expressive speaker, and when describing her frustrations with her demanding son she made numerous and expressive hand gestures – palms up and down like the balancing of weight scales, edge of hand slicing the air in a cutting motion, fiercely gripped fingers as if strangling someone, and so on. She is equally animated by the powerful love that she feels for her son, and sheer frustration.
She spoke of having challenges disciplining her precocious and tireless child whom she described as being "up and down – angelic and awful". Parenting, when it comes to guidance and discipline, is never an easy thing, and for this woman complications arose because her discipline attempts were not supported, and were at times even questioned by her husband, in front of her poorly behaving son. Of this she said "I think it's completely inappropriate, and it just makes me nuts!" As she considers the idea of having a second child, some of her differences with her husband weigh in heavily on the "nay" side. Their "Mr. Intensity" child has "frayed the nerves" of both parents. While on many levels they work well together as a couple, when stressed out, she says of her husband, "when he irritates me, he just completely irritates me, and I think, why the hell am I married to you? You are making me nuts!"
What type of irritation was she experiencing? She feels irritated on all kinds of levels with her husband, but basically she feels a lack of support from him. "But", she said, "he's not an axe murderer… everybody would agree he's a very nice guy. It's just… it's just that his mannerisms just bug the hell out of me. At times it's fine, but when he's irritating me I honestly feel like, UGHHHH!" She couldn't put a word to her feelings; an animal-like cry expressed it best, and at this point she did a type of whole-body gesture – squirming in her seat and moving her arms sharply as if to shake something off. "Sometimes I feel like, sometimes it feels like being married to N (her husband) is like wearing a hair shirt – just so constantly irritating!"
At other times irritation is not nearly a strong enough word to describe her state; this happens when she finds her husband making "provocative comments", typically in the form of sarcasm. She says that he "likes to sort of twist the needle... sort of being deliberately obnoxious". And her reaction to this? She says, "It just makes me angry – my response is to just go right in and chew him a new head!"
A recent mishap, when her son had slipped in the tub and hit his head, brought this feeling into sharp focus once again. Miscommunication and misunderstanding were involved, but in the heat of the moment her anger towards her husband was very intense. Upon reflection, she said of her anger "I don't think I was necessarily appropriate in wanting to rip his head off at that particular moment."
By this point it was clear that this woman was fully in an insect state – the praying mantis insect state! What is she talking about? She's irritated. Her husband irritates her. Certain behaviors "bug" the hell out of her. And her candid response to this irritated and bugged feeling? Anger: she "would have shredded him", "go right in & chew him a new head", "rip his head off". These were descriptions that had my mind leaping to the praying mantis.
The brute violence of her anger can be witnessed in the sexual cannibalism of this insect, and the extreme irritation she felt, not only emotionally but physically – like needing to squirm out of a 'hair shirt'. This is reflected in the development of immature mantises; they molt their skin six or seven times before maturity. Materia medica that existed at the time suggested that this remedy has the potential for being "unfeeling and hard hearted", but the extreme anger and irritability was not well described. Itching skin was noted in the physicals, but a strong quantity of confirmatory rubrics was not to be found in this newish remedy. But the animal state, her animated expression, painted such a vivid picture of the mantis that the prescription was clear. We began with Mantis religiosa 200C, a single dose.
Six weeks later, I saw her again and the change she reported was dramatic. "Whatever it was you gave me was awesome; I feel so much better. The underlying extreme irritation I was feeling… GONE! My son is not getting on my nerves nearly as much as he was. And my irritation with my husband? Before it was high; now it's very, very low. He still bugs me from time to time, but not nearly to the same extent. I'm feeling much more mellow and happy. It's such a relief!"
This was a dramatic change, and I was interested in seeing if she could describe how the "relief" from her previous frayed nerves/extreme irritation state came about. Her answer is hopefully illuminating for identifying the nature of the suffering in Mantis religiosa cases; she said, "It was like something unraveling, like tight wires, loosening and loosening, and then coming down. I can't describe it any other way, but within two weeks for sure, even within a week, I was feeling RELIEF; it's the only way I can describe it, not feeling so bugged, right?" As she said "bugged" she made another gesture with her fantastically expressive hands – a tight gripping gesture as if all the strength of her will was focused in her ruthlessly clenched fingers.
She remained with this remedy for a little under a year. It met her state, and after only two doses she was done with it. Longer term results were lovely. She reported that, "I'm feeling almost mellow, which for me is unheard of!" (She laughs at herself.) Her relationships became healthier, and with her son she said, "I've actually been feeling a lot of joy with him… I think that's what you're supposed to feel when you have a baby and I never felt that. He still runs me off my feet and talks a mile a minute, but I've got a deep sort of contentment which I didn't really have before."
She summed it up with a laugh and said: "I'll take more of that anytime; it was really good – best drug I've ever had! Whatever you pinpointed," and here she made another gesture, first pointing her finger and then ticking her nose with it, "was awesome. Thank you."
Cynthia Shepard lives and practices on Vancouver Island in British Columbia, Canada
Photo: Wikimedia commons; Alvesgaspar
Keywords: irritated, bugged, anger toward husband, insect, depleted, uninspired, praying mantis.
Remedies: Mantis religiosa